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  • ISO 9001 Quality Management System
  • ISO 14001 Environmental Management System
  • ISO 22000 HACCP
  • OHSAS 18001 Quality Management System
  • ISO/TS 16949 Automotive Quality System
  • IS0 13485
  • ISO 27001 Information Security
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  • GOST-R Certification
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ISO 9001 Quality Management System

ISO 9001  Quality Management System

ISO is abbreviation of International Organization for standardization, is quality management standard which is occurred by ISO. ISO 9001 certificate betrays that product and services of organization is managed according to management system accepted by international and determines that assurance about quality of product and services always goes on.

 

ISO 9001 is a standard which identifies effective quality management system. When organization meets requirements of this standard, it can take ISO 9001 certificate. This certificate shows that product and services are produced suitable to standard accepted by international. Standard was developed by ISO (International Organization of standardization) which central of it is in Switzerland at Geneva. More than 150 countries are member of ISO. Power of accreditation of certification bodies were given to committees of member countries. In Turkey Accreditation power was given to TURKAK.

 

Quality Management System

         1-ISO 9001:2000  

2-History of ISO 9001:2000

3-Definitions about ISO 9001:2000 and Quality

4-ISO 9001:2000 Quality Management Principles

         5-Parts and Scope of ISO 9001:2000

 

1-ISO 9001:2000   

ISO is abbreviation of International Organization for standardization, is quality management standard which is occurred by ISO. ISO 9001 certificate betrays that product and services of organization is managed according to management system accepted by international and determines that assurance about quality of product and services always goes on.

ISO 9001 is a standard which identifies effective quality management system. When organization meets requirements of this standard, it can take ISO 9001 certificate. This certificate shows that product and services are produced suitable to standard accepted by international. Standard was developed by ISO (International Organization of standardization) which central of it is in Switzerland at Geneva. More than 150 countries are member of ISO. Power of accreditation of certification bodies were given to committees of member countries. In Turkey Accreditation power was given to TURKAK.

ISO 9001 is suitable for any organization looking to improve the way it is operated and managed, regardless of size or sector. However, the best returns on investment come from those companies that are prepared to implement it throughout their organization rather than at particular sites, departments or divisions.

Different standards which are developed for similar Technologies in different countries and different Technologies, are named as ‘’ technical obstacle for trade’’ and these standards are used against producers. Aim of ISO is to prepare recognized ISO 9000 quality management standards by international and to remove like these obstacles in front of trade.

What is the ISO 9000 Series?

The ISO 9000 series of documents was created by the International Organization for Standardization to set international requirements for quality management systems. Now adopted by over 150 countries, use of the series of standards has become commonplace in the business world.

 

The series itself is generic, and is designed to be applicable to any manufacturing or service process. The series is revised and controlled by Technical Committee (TC) 176, made up of international members from many industries and backgrounds. The series is modified periodically. The original standards were published in 1987, first revised in 1994 and the current versions were issued in 2000.
 

The previous ISO 9000 family of standards contained some 20 standards and documents.  The year 2000 ISO 9000 family of standards consists of four primary standards supported by a number of technical reports. The four primary standards are: 

 

  • ISO 9000 – Fundamentals and Vocabulary: this introduces the user to the concepts behind the management systems and specifies the terminology used.
  • ISO 9001 – Requirements: this sets out the criteria you will need to meet if you wish to operate in accordance with the standard and gain certification.
  • ISO 9004 – Guidelines for performance improvement: based upon the eight quality management principles, these are designed to be used by senior management as a framework to guide their organizations towards improved performance by considering the needs of all interested parties, not just customers.
  • ISO 10011: Guidelines for Auditing Quality Systems (watch for ISO 19011, which will merge 10011 and 14011 and, be published in the third quarter of 2001)

Customers are increasingly becoming quality-conscious shoppers. They want to know up front that your business will meet their needs. A certified Quality Management System demonstrates your commitment to quality and customer satisfaction.
 

Implementing a Quality Management System will help you enhance customer satisfaction, achieve consistency, and improve internal processes. It can minimize the risk that customer expectations are not met.

 

Each business has operational processes that are critical to its strategic objectives.  Business improvement relies on your ability to discover strengths, weaknesses, and improvement opportunities.  With our Risk Based Certification approach, ACAR Quality auditors assess how well your Quality Management System supports the areas of greatest importance to you, in addition to measuring compliance against elected standards.

On this page, we will help you understand the  what and why of a Quality Management System—what it is and why your business will benefit from implementing one.

 

Note: ISO 9001 is the most commonly used international standard that provides a framework for Quality Management Systems. It is a generic name given to a family of standards developed to provide a framework around which a quality management system can effectively be based.

 

 

2-History of ISO 9001:2000  

 

  • 1963 MIL/Q/9858 (USA defense technology)
  • 1968 AQAP standards (NATO member countries)
  • 1979 BS 5750(in England)
  • 1987 ISO 9000 serial (by ISO)
  • 1988 EN 29000 standards (by CEN )
  • 1988 TS 6000 issued as quality assurance system standard
  • 1991 TS-EN-ISO 9000
  • 1994 revision by ISO .(9001:1994 / 9002:1994 /9003:1994)
  • 1996 EN 29000 serial EN-ISO 9000 as issued.
  • 2000 revision by ISO and 9001:2000 as issued.

Firstly standard was issued as quality assurance system in 1987 year. In this level, standard was occurred 3 sub-standards: ISO9001, ISO9002, ISO9003. Organizations applied one of these 3 standards according to scopes. Version of this standard was focused to find correct production and to catch false.

Firstly revision was done in 1994 year and standard was issued as quality assurance system. In this level, standard was occurred 3 sub-standards: ISO9001, ISO9002, ISO9003. Organizations applied one of these 3 standards according to scopes. This version of standard, it focused to prevent false as addition.

Last revision of standard was done in 2000 year and standard was issued as quality management system. There is only ISO 9001: 2000. There are no actual standards like ISO 9002 and ISO 9003. But ISO issued ISO 9000, ISO 9004, ISO 19011 supporting ISO 9001:2000. Foundations take only ISO 9001:2000 standard regardless scope. But to certification dependency being to actions, excluded matters of standard are determined on the certificate. This version of standard, as addition to previous version provides to increase continual improvement and productivity in basic of process, it presents management model which holds costumer focusing foreground.

New version of ISO 9001 will come in 2008 year called as ISO 9001:2008.

 

 

3-Definitions about ISO 9001:2000 and Quality  

 

 

Process: Inputs turning to outputs each other related or interacting action team.

Product: Result of process.

System: Related each other or interacting element team.

Management System: Occurring of policy and objectives and succeeding these objectives.

Quality Policy: All aims and management about quality which means formal by organization management.

Quality Management: Actions which are coordinated to control and management of organisation about qualtiy

Continual Improvement: To increase ability of meeting requirements of actions which are repeated.

Productivity: Relations which is between got result with used resources

Definition of Quality: Despite being in use for nearly 50 years, the term TQM still poses problems of definition for writers on quality, and consequently often remain a rather abstract term. There are a number of well-known quality definitions. ISO 8402 [ISO, 1986] defines quality as "the totality of features and characteristics of a product or service that bears on its ability to meet a stated or implied need". [Crosby, 1979] defines quality as "conformance to requirement". [Juran, 1988] defines quality as "fitness for use". Japanese companies found the old definition of quality "the degree of conformance to a standard" too narrow and consequently have started to use a new definition of quality as "user satisfaction" [Wayne, 1983]. Table below defines quality from the view point of different quality professionals and to provide a conceptual scheme for the discussion of TQM. This can be classified in three sections: Customer-base, Service and Manufacturing-base, and Value-based definition.

Customer-based Definitions

  • Edwards [1968] Quality consists of the capacity to satisfy wants...
  • Gilmore [1974] Quality is the degree to which a specific product satisfies the wants of a specific consumer. ·
  • Kuehn & Day [1962] In the final analysis of the marketplace, the quality of a product depends on how well it fits patterns of consumer preferences.
  • Juran [1988] Quality is fitness for use.
  • Oakland [1989] The core of a total quality approach is to identify and meet the requirements of both internal and external customers.
  • Manufacturing & Service-based definitions
  • Crosby [1979] Quality [means] conformance to requirements
  • Price [1985] Do it right first time
  • Value-based definitions
  • Broh [1982] Quality is the degree of excellence at an acceptable price and the control of variability at an acceptable cost.
  • Feigenbaum [1983] Quality is the degree to which a specific product conforms to a design or specification
  • Newell & Dale [1991] Quality must be achieved in five basic areas: people, equipment, methods, materials and the environment to ensure customer’s need are met.
  • Kanji [1990] Quality is to satisfy customers’ requirements continually; TQM is to achieve quality at low cost by involving everyone’s daily commitment

4-ISO 9001:2000 Quality Management Principles 

 

ISO 9001:2000 principles

 

1. Costumer focused: Organizations depend on customers, therefore organization should understand needs of customers now and in the future, adjust to customer requirements and meet customer requirements and endeavor to pass over customer expectations.

2. Leadership: leaders provide union of aim and administrative. Leaders should occur internal ambient to attendances as whole to succeeded objectives of organization.

3. Involvement of people: All level of people is compact of organization, involvement is provided to use their abilities to benefit for the organization.

4. Process Approach: When actions and related resources are managed as a process, successful results are realized as efficiency.

 

P Plan.. Determine objectives & processes 
U Apply. Apply processes 
K Control.. Monitor & measure
I Improve.. Provide continual improvement 



5. System approach to management:  When each other related processes are determined, understood and managed, it provides efficiency and increases productivity of organization for succeeding of objectives.

6. Continual improvement:  permanently objective of organization always should be to improve the whole performance of organization.

Improvement:  It means, increasing the features and characteristic of product and/or increasing of efficiency and productivity of the processes to produce and to distribute them.

7. Realistic approach to make decision:  Efficiency decisions are reliant to data analysis and knowledge's.

8. Each other benefit is reliant on supplier relations:  An organization and its supplier are independent of each other and each other benefit relations contribute plus worth.

 

5-Parts and Scope of ISO 9001:2000 

1. General

        1.1. Index and revision status
        1.2. Purpose and scope
        1.3. Exclusions

2. Company Background

       2.1. Company background and history
       2.2. Activities

3. Definitions And Conventions

       3.1. Definitions and conventions
       3.2. Abbreviations

4. Quality Management System

      4.1. General requirements
      4.2. Documentation and records

5. Management Responsibility

     5.1. Management commitment
     5.2. Customer focus
     5.3. Quality policy
     5.4. Quality system planning
     5.5. Organization and communication
     5.6. Management review

6. Resource Management

     6.1. Provision of resources
     6.2. Human resources and trainings
     6.3. Infrastructure
     6.4. Work environment

7. Product Realisation

      7.1. Planning of product realization
      7.2. Customer related processes
      7.3. Design control
      7.4. Purchasing
      7.5. Operations
      7.6. Measuring and monitoring equipment

8. Measurement, Analysis And Improvement

      8.1. Planning of monitoring and measurement
      8.2. Monitoring and measurement
      8.3. Control of non-conforming product
      8.4. Analysis of data
      8.5. Continual improvement


      8.1 General 
      8.2 Monitoring and measurement 
      8.3 Control of non-conformity product 
      8.4 Data analysis
      8.5 Improvement 


TS EN ISO 9000:2000 Serial 
 

TS EN ISO 9000 standard are occurred from 4 standards. These are;

TS EN ISO 9000:2000 Quality management systems – basic concepts, terms

TS EN ISO 9001:2000 Quality management system – requirements

TS EN ISO 9004:2000 Quality management system – guide to improve

TS EN ISO 19011:2000 guide for inspection of quality and environment

Benefits of ISO 9001

  • - Better management of core business processes.
  • - Increased awareness of quality among staff.
  • - Improved productivity and quality.
  • - Improved internal communications.
  • - Costumer satisfaction
  • - Increasing of costumer,
  • - Better supplier relations
  • - Stiffening of organization image ,
  • - Reduced wastage and cost per unit/service
  • - An important step in the road to Total Quality Management.
  • - Improves Customer Demand: 33.4% of corporations with ISO 9001:2000 report improved customer demand.  This means they are winning more business.  (Source – Dun and Bradstreet Survey)
  • - Protect Your Business: 69.3% of surveyed businesses that do not have ISO 9001:2000 say they have lost a customer bid or proposal to an ISO 9001:2000 certified competitor.  Many of these companies said they didn’t know why they were losing the business until it was too late.
  • - Your Competitors Are Doing It: In many industries, 35 to 40% of your competitors are ISO 9001:2000 Registered or in the process.  The longer you wait to start, the greater is their competitive advantage.
  • - Easy & Cost Effective : Getting ISO 9001:2000 is no longer the costly, time consuming proposition that it once was.
  • - Using our system to become ISO 9001:2000 compliant is very simple and inexpensive.  It will put you way ahead of your competition and will enable you to improve your systems and operations.
  • - Qualify for Government Contracts: The Department of Defense, Food and Drug Administration, Railways, Department of Energy and the General Services Administration have all approved the use of ISO 9001:2000 in contracts and bids.
  • - A template for the creation of a sound quality system and a foundation to develop future quality initiatives.
  • - ISO 9001:2000 Help to identify best practice and ensure everyone in the organization is moving in the right direction
  • - Providing of different from rivals in market actions
  • - Doing as effective of input, production and final control
  • - Providing easily in determining and distribution of powers and responsibilities inside operation
  • - A powerful management tool that complements other key management other key management functions such as financial and strategic planning.
  • - Provide instant dashboard visibility of enterprise-wide quality compliance
  • - Increased Credibility : You can generate a significant increase in business, as many corporations will only deal with
  • - Occurring of documentation (infrastructure) which makes standard of operation actions
  • - Occurring of infrastructure which keeps regularly records in the past
  • - Operation from benefit of certificate which is available in international (demonstrating of quality for export)
  • - Decrease of fault ratio, wastage, repeat operating
  • - Stepping important in institutional way
  • - Certification to internationally recognized standards

ISO 14001 Environmental Management System

ISO 14001 is an international standard developed by the International Organization for Standardization (ISO) through dedicated technical committees representing approximately 150 countries around the world. Its purpose is to enable an organization of any type or size to develop and implement a policy committing it to prevention of pollution, compliance with legal and other requirements, and continual improvement. The realization of this commitment will be a management system that recognizes and manages the primary environmental issues through awareness and assessment of applicable legal requirements, objectives for improvement, assignment of responsibilities, competent personnel, communications, procedures, controls and monitoring, emergency response capability, self correction and assessment, and internal reviews. These processes are to be based on the Plan-Do-Check-Act continual improvement model.

Environmental Management System

        1-History of ISO 14001:2004 

        2-Definitions about 14001:2004 Environmental Management Systems

        3-ISO 14001:2004 Environmental Management Principles

        4-Parts and Scope of 14001:2004 Environmental Management Systems

 

ISO 14001 is an international standard developed by the International Organization for Standardization (ISO) through dedicated technical committees representing approximately 150 countries around the world. Its purpose is to enable an organization of any type or size to develop and implement a policy committing it to prevention of pollution, compliance with legal and other requirements, and continual improvement. The realization of this commitment will be a management system that recognizes and manages the primary environmental issues through awareness and assessment of applicable legal requirements, objectives for improvement, assignment of responsibilities, competent personnel, communications, procedures, controls and monitoring, emergency response capability, self correction and assessment, and internal reviews. These processes are to be based on the Plan-Do-Check-Act continual improvement model. This model has been expanded into seventeen elements:

  1. Environmental policy
  2. Environmental aspects
  3. Legal and other requirements
  4. Objectives and targets
  5. Environmental management program
  6. Structure and responsibility
  7. Training, awareness and competence
  8. Communication
  9. Emergency preparedness and response
  10. Monitoring and measurement
  11. EMS documentation
  12. Document control
  13. Operational control
  14. Nonconformance and corrective and preventive action
  15. Records
  16. EMS audit
  17. Management review

Identify elements of your business that impact on the environment and gain access to the relevant environmental legislation.

Produce objectives for improvement and management program to achieve them, with regular reviews for continual improvement.

Which areas are covered by the ISO 14000 series?

 

The key areas covered by this series are:
 

  • Environmental Management Systems (EMS)
  • Environmental Auditing
  • Environmental Labels and Declarations
  • Environmental Performance Evaluation
  • Life Cycle Assessment (LCA)
  • Environmental Communication
  • Greenhouse Gases (GHG) Monitoring

What it Takes to Put an Effective EMS in Place

In order to put an effective environmental management system in place, the environment needs to become an organizational priority and environmental management be built everywhere. Problems should be looked at as opportunities and the system kept flexible and simple.

Increased awareness of sustainable development gives environmentally credible companies a competitive edge in national and international markets. A certified Environmental Management System proves that your business is taking active steps to fulfill your responsibilities.

Environmental regulations are getting stricter, and so is the law enforcement. Customers and shareholders increasingly demand that businesses diminish the environmental impact from their business, demonstrate what they do, and how they improve. An Environmental Management System helps your organization to be in control of and successfully manage the most significant environmental aspects, e.g. emissions, waste-handling, utilize natural resources, and energy-efficiency.

Getting key processes and challenges under control requires that you are able to identify strengths, weaknesses, and improvement opportunities.  With our Risk Based Certification approach DNV auditors assess how well your Environmental Management System supports the areas of greatest risk to you, in addition to measuring compliance against elected standards.

 

1-History of ISO 14001:2004   

 

Firstly preparing of ISO 14000 environment management systems is reliant to world summit which was done in Rio in June 1992 year and principles of Rio contract. World summit which was done, 1 year after, in 1993 by ISO, for preparing of international environment management system, technique committee was occurred by about representatives of 50 countries.

ISO 14001 environment management system was issued and applied in September 1996 by this committee. ISO 14000 applying are still reliant to basics of voluntary but standard will be mandatory with coactions of social, international organizations and states in near future. Passed levels of environment management system are the following:

1973: Europe Community principles I. Action plan was issued (for applying of protective cautions of environment)

1992: BS 7750 standard

1992: Rio Declaration

1993: ISO /TC 207 environment management technique committee was established to develop by ISO 14000 family standards.

1994: TS 9719 standard (Environment management system – general features)

1996: ISO 14001 standard

April 2005: ISO 14001 current version

2-Definitions about 14001:2004 Environmental Management Systems  

 

Being under responsibility and policy: Organization should determine environment policy and give adhesion commitment to environment management system.

Plan: Organization should determine sizes of action, product and services and select important things. Aims and objectives should be determined to realize commitment and to be realized actions should be programmed to reach aim and objectives.

Applying and operation: Organization should develop support mechanism and abilities to reach the aim and objectives and to be efficiency applied.

Control and corrective action: Organization should measure environmental performance and successful degree of this performance and evaluate monitoring.

Review and developing: Organization should review EMS to develop general environment performance and to develop general successful degree in this performance and develop continuously.

Term and Defınıtıons Related ISO 14001 

Continual developing: continual improvement of organization EMS to provide developing in general environment performance as suitable to the environmental policy of organization.

Environment: Organization whose activity is priged inside weather, water, land, natural resources, plant group (flora), animal group human include ambient these relations.

Environment size: Element which interact with environment and actions, products or services of organization.

Environment effect All type of changes, positive or negative, which are produced by services, product, and action of organization partly or whole in the environment.

Environment policy: Organization declaration which was done to explain intentions and principles, about general environment performance and to provide frame for actions, environmental aim and objectives.

Prevention of pollution: is to prevent, decrease and control pollution. Again work should be done, other operation dependency should be done, operation should have changes, control mechanism and resources should be used efficiently, including material substitution, all type operations and practices should be applied, materials or products should be used.

Able to continue development: Existing needs should not avoid meeting requirements of next generation to develop.

Evaluation of along life: It is a serial regulations in goods and service system, produced from clear materials and energy with goods and services, in along life this system directly to collect know ledges of environment effects and to review

 

3-ISO 14001:2004 Environmental Management Principles 

 

-         An organization should focus on what needs to be done - it should ensure commitment to the EMS and define its policy.

-         An organization should formulate a plan to fulfill its environmental policy.

-         For effective implementation, an organization should develop the capabilities and support mechanisms necessary to achieve its environmental policy, objectives and targets.

-         An organization should measure, monitor and evaluate its environmental performance.

An organization should review and continually improve its environmental management system, with the objective of improving its overall environmental performance

 

4-Parts and Scope of 14001:2004 Environmental Management Systems 

 

ISO 14001 standard clauses

1      Scope

2      Normative standards

3     Definitions

4      EMS requirements and main elements

1      General requirements

1     Environment policy

3      Plan

1      Environment size

2      Legal and other requirements

3      Aim and objectives

4      Environment management program or programs

4      Practices and operation

1      Structure and responsibility

2      Training, consciousness and license

3      Communication

4.      Binding operations to certificate related EMS

5      Certificate control

6      Operation control

7      Getting ready of urgently situation and to be done jobs in this situations

5      Control and corrective action

1      Monitoring and measurement

2      Contempt, corrective –preventive actions

3      Record

4      EMS requirement audit

6      Management review

 

Benefits of ISO 14001:2004

-         Increasing of adjusting to national an/or international regulations

-         Increasing of environment performance

-        Market strategies

-        Providing advantages in international competition

-         Increasing of operation prestige and market allocation

-         Decreasing of expenses increasing of productivity with developing of cost control

-         Getting ready against urgently situations (earth quack, fire, flood etc ) and accident, decreasing of accident etc which result with responsibilities .

-         Controlling and decreasing of pollution starting from resources

-         Providing of input materials and energy saving 
Taking easy of license and power certificates

-         Providing of acceptance in global market because ISO 14001 is known by all world and is used by common language

-         Determining of environment risks and effect of company actions to environment can be controlled and by this means elements which effect badly to environment, are decreased.

-         Decreasing of cost originating from environment effect.

-         Adjusting legal regulations related environment.

-         Decreasing or removing all of environment effect which can be occurred in urgently situations.

-         Documented environment management system and ISO 14001 certificate shows that against legal foundations, regulations and rules are adjusted.

-         Organization gets prestige's providing recognizing in both national and international area.

-         Environment consciousness increase in employees by given training to company staffs.

-         To work in company which is not harmful to environment, then employees are motivated.

-        Consumer expectations related to environment are answered so that we can reach and get conscious consumers.

-         Resources are used efficiency (providing energy, water etc savings).

-         Left wastes to environment are decreased

 

Process of Consultancy

We can help you every step of the way. We have helped many companies implement ISO 14001 Environmental Management System.

We have a proven implementation strategy and processes to help ensure your success.

Documentation plays an important part of an Environmental Management System. We can help you with every level of documentation: 

-         We can write the documents for you.

-         We can provide templates so you can write them on your own.

-         We can review your current documentation for compliance

              -         We can review your current documentation for opportunities for improvement.

Typical Documentation Structure

Documentation requirements are usually divided in four Tiers:

-         Quality Policy and Quality Manual

-         Quality System Procedures

-         Work/Job Instructions

              -         Environmental Management System Records

What is a Quality Manual?

A Environmental Management System Manual is the statement of the organization's quality policy and describing the quality system of an organization. It is usually written by managers from top-level management and the quality department. 

 

What is a Procedure?

Procedures define activities at the departmental level and written by department supervisors. They are usually referred to in a quality system, as a "written" procedure or a "documented" procedure. Procedures should ideally be organized into the ISO 14001 outline structure, indicating the ISO 14001 clause (4.1 - 4.20) under which they fall, though is not an ISO 14001 requirement.

What is a Work Instruction?


Work instructions describe how work is accomplished, it is 100% of how to complete a specific task or operation, and is usually written by the operators and trainers. 

 

What are Records?


ISO 14001 records provide the backbone of the Environmental Management System 

Quality records consist of all forms, or controlled documents and ISO 14001 records (hard copy and electronic) necessary for the quality system to operate. Environmental Management System records usually consist of all completed forms and charts.

 

 

 

ISO 22000 HACCP

ISO 22000:2005 (HACCP), Food safety management systems – Requirements for any organization in the food chain, provides a framework of internationally harmonized requirements for the global approach that is needed. The standard has been developed within ISO by experts from the food industry, along with representatives of specialized international organizations and in close cooperation with the Codex Alimentarius Commission, the body jointly established by the United Nations’ Food and Agriculture Organization (FAO) and World Health Organization (WHO) to develop food standards.

 

ISO 22000:2005 (HACCP) Food Safety Management Systems

1-History of 22000:2005 (HACCP)  

2-Definitions about 22000:2005 (HACCP) Food Safety Management Systems

3-Basic Principles of ISO 22000:2005 (HACCP)

4-Parts and Scope of 22000:2005 (HACCP) Food Safety Management Systems

 

ISO 22000:2005 (HACCP), Food safety management systems – Requirements for any organization in the food chain, provides a framework of internationally harmonized requirements for the global approach that is needed. The standard has been developed within ISO by experts from the food industry, along with representatives of specialized international organizations and in close cooperation with the Codex Alimentarius Commission, the body jointly established by the United Nations’ Food and Agriculture Organization (FAO) and World Health Organization (WHO) to develop food standards.

A major resulting benefit is that ISO 22000(HACCP) will make it easier for organizations worldwide to implement the Codex HACCP (Hazard Analysis and Critical Control Point) system for food hygiene in a harmonized way, which does not vary with the country or food product concerned.

Food reaches consumers via supply chains that may link many different types of organization and that may stretch across multiple borders. One weak link can result in unsafe food that is dangerous to health – and when this happens, the hazards to consumers can be serious and the cost to food chain suppliers considerable. As food safety hazards can enter the food chain at any stage, adequate control throughout is essential. Food safety is a joint responsibility of all the actors in the food chain and requires their combined efforts.

ISO 22000(HACCP) is therefore designed to allow all types of organization within the food chain to implement a food safety management system. These range from feed producers, primary producers, food manufacturers, transport and storage operators and subcontractors to retail and food service outlets – together with related organizations such as producers of equipment, packaging material, cleaning agents, additives and ingredients.

The standard has become necessary because of the significant increase of illnesses caused by infected food in both developed and developing countries. In addition to the health hazards, food-borne illnesses can give rise to considerable economic costs covering medical treatment, absence from work, insurance payments and legal compensation.

As a result, a number of countries have developed national standards for the supply of safe food and individual companies and groupings in the food sector have developed their own standards or programmers for auditing their suppliers. The plethora of more than 20 different such schemes worldwide generates risks of uneven levels of food safety, confusion over requirements, and increased cost and complication for suppliers that find themselves obliged to conform to multiple programmers.

ISO 22000(HACCP), backed by international consensus, harmonizes the requirements for systematically managing safety in food supply chains and offers a unique solution for good practice on a worldwide basis. In addition, food safety management systems that conform to ISO 22000 can be certified – which answers the growing demand in the food sector for the certification of suppliers – although the standard can be implemented without certification of conformity, solely for the benefits it provides.

Developed with the participation of food sector experts, ISO 22000(HACCP), incorporates the principles of HACCP, and covers the requirements of key standards developed by various global food retailer syndicates, in a single document.

“Public sector participation in the development of the ISO 22000 family is also significant,” ISO Secretary-General Alan Bryden commented, “notably that of the FAO/WHO’s Codex Alimentarius Commission, which is responsible for the well-known HACCP (Hazard Analysis and Critical Control Point) system for food hygiene. Thanks to the strong partnership between ISO and Codex, ISO 22000 will facilitate the implementation of HACCP and the food hygiene principles developed by this pre-eminent body in this field.”

Another benefit of ISO 22000 is that it extends the successful management system approach of the ISO 9001:2000 quality management system standard which is widely implemented in all sectors but does not itself specifically address food safety. The development of ISO 22000 was based on the assumption that the most effective food safety systems are designed, operated and continually improved within the framework of a structured management system, and incorporated into the overall management activities of the organization.

While ISO 22000 can be implemented on its own, it is designed to be fully compatible with ISO 9001:2000 and companies already certified to ISO 9001 will find it easy to extend this to certification to ISO 22000. To help users to do so, ISO 22000 includes a table showing the correspondence of its requirements with those of ISO 9001:2000.

ISO 22000:2005 is the first in a family of standards that will include the following documents:

  • ISO/TS 22004, Food safety management systems – Guidance on the application of ISO 22000:2005, which will be published by November 2005, provides important guidance that can assist organizations including small and medium-sized enterprises around the world.
  • ISO/TS 22003, Food safety management systems – Requirements for bodies providing audit and certification of food safety management systems, will give harmonized guidance for the accreditation (approval) of ISO 22000 certification bodies and define the rules for auditing a food safety management system as conforming to the standard. It will be published in the first quarter of 2006.
  • ISO 22005, Traceability in the feed and food chain – General principles and guidance for system design and development, will shortly be circulated as a Draft International Standard.

In partnership with the International Trade Centre (ITC) – the technical cooperation agency of the United Nations Conference on Trade and Development (UNCTAD) and the World Trade Organization (WTO) – ISO is also preparing an easy-to-use check-list for small businesses and developing countries, entitled ISO 22000: Are you ready?

ISO 22000 and ISO/TS 22004 are the output of working group WG 8, Food safety management systems, of ISO technical committee ISO/TC 34, Food products. Experts from 23 countries participated in the working group, together with international organizations with liaison status. In addition to the Codex Alimentarius Commission, these included the Confederation of the Food and Drink Industries of the European Union (CIAA) and the World Food Safety Organization (WFSO). They have been joined for the development of ISO/TS 22003 by experts from the ISO committee on conformity assessment, ISO/CASCO, the International Accreditation Forum (IAF) and the IQNet international certification network.

HACCP Standard Serial

ISO 22000 food safety management system – requirements in food chain organizations

ISO/TS 22003 food safety management system – requirements for bodies which audit food safety management and certification (first quarter of 2006 year)

ISO/TS 22004 Food safety management system – Related ISO 22000: 2005 guide (November 2005)

ISO 22005, Bait and monitoring in food chain – general principles and guide for system design and preparing

Who Can Apply

Directly or indirectly organizations which do certification in the scope of ISO 22000 standard are the following.

A) Organizations,

1. Farmers, 
2. Harvesters , 
3. Bait producers , 
4. Food component producers , 
5. Food producers , 
6. Food sales, 
7. Food Services , 
8. Ready food companies , 
9. organizations which give cleaning and sanitation services, 
10. Carriers, storage and distribution organizations etc.


 

B) Indirect organization

1. Organizations which provide equipment , 
2. Cleaning and sanitation agents, 
3. Packing materials 
4. Organizations which produce other elements contacting with food .

HACCP

HACCP is to present safety product to consumer, reliant occurring and protecting of correctly working system.

Hazard analysis is done in food chain at every level and points starting from getting of raw materials, food preparing, operation, production, packing, storage, transport, critical control points are determined in necessary place and monitors these points, prevents without occurring of problems, every size of organization can apply , produces safety foods as suitable to clearly standards.

WHY IS TS EN ISO 22000:2005 (HACCP)

-         ISO 22000:2005 (HACCP) can be applied in all food chain ,

-         Making decision easy with presenting critical knowledge's to management ,

-         Meeting of all requirements of consumers about food safety .

-         Easy export because this system is known in international level,

-         Decreasing of product gene collecting risk,

-         Increasing of job productivity and satisfaction of employees,

-         Having of consciousness of employees about hygiene and food safety,

-         Process control can be demonstrated by documents,

-         Professional and serious organization which knows responsibility, is occurred ,

-         Decreasing of food poison and death risks ,

-         Adjusting to legal requirements ,

-         Problems which are met in formal audit, are decreased to minimum

-         Costs which are occurred from food wastages (food spoilages, etc) are decreased to minimum,

-         Work environment will be better ,

-         Providing of customer confidence and satisfaction .

-         Being the most successful from rivals in market ,

-         Decreasing of product wastages .

-         Guarding of product safety problems,

-         Experiences can not be got by false, it gives information about potential hazards before,

-       Providing of confidence to meet legal mandatory to produce safety products in food operations

-         ISO 22000:2005 (HACCP) approaches systematically to develop efficiency control ,

-         ISO 22000:2005 (HACCP) can be used every level of food chain,

-        ISO 22000:2005 (HACCP) identifies like ISO 9000 ISO 9000 quality management system ,

-         ISO 22000:2005 (HACCP) is more effect than traditional examination and control system

              -         ISO 22000:2005 (HACCP) is confidence system which was confirmed by FAO / WHO.

 

1-History of ISO 22000:2005   
 

HACCP History

1959-1960: First works, NASA wanted to produce food for astronauts for guaranty food safety with zero false programs to eat,

1963: World health organization (WHO) issued Haccp principles in Codex Alimentations.

1973: NASA (USA national air space Foundation ), Natick American Army laboratory and Pillsbury group company priged common project for astronauts in food production with zero false and HACCP concept entered to literature,

1985: USA national science academy suggested that HACCP should be applied in food operations for food safety,

14 June 1993: HACCP entered to regulations of Europe Community Countries with directives ‘’Hygiene of food matters’’,

1996: It was applied in Europe all food industry as legal,

HACCP became mandatory in Turkey the date of 16 .11. 1997 with Turkish food codex in food industry. Formal newspaper issued the date of 09.06.1998 in ‘’ food production and audit regulations’’ that HACCP system should be applied. HACCP was mandatory with same regulation in meat, milk water products , meat product and milk product producing companies the date of 15.11.2002 after as graduate.

20 February 1998: Denmark issued DS 3027/1998 HACCP standard ,

3 March 2003: TS 13001/Mart 2003 HACCP standard was issued “According to HACCP food safety management- regulations related management system for food producing organization and suppliers’’.

Lastly; ISO 22000 was published in September 2005, to provide a framework of requirements, and confirm a global approach for an international industry. The standard was developed within ISO by experts from the food industry, along with representatives of specialized international organizations. Additional cooperation came from the Codex Alimentarius Commission, which was established by the United Nations’ Food and Agriculture Organization (FAO) and World Health Organization (WHO) to develop food standards chain’’

The Codex HACCP (Hazard Analysis and Critical Control Point) is widely accepted as an essential tool for managing food safety especially when combined with an auditable management system. In fact, ISO 22000 will make it easier for organizations worldwide to implement the Codex HACCP system for food hygiene in way that will be consistent regardless of the specific food product or the country involved. 

Previously, more than 20 different national standards had arisen, creating uneven levels of food safety, adding costs and complications. The new standard was needed to curtail the costs and hardship involved in food-borne illnesses, particularly in developing countries. ISO 22000 is backed by international consensus, generating requirements for good practice on a worldwide basis.

  

2-Definitions about ISO 22000:2005 (HACCP)  

 

What Is Hazard Analysis?

Controlling of process about food hygiene 
Determining of potential problems, 
Providing of needed controls efficiency

Hygiene

There are 3 basics elements about hygiene : 

All ambient which are found starting from purchasing, until services are consumed- Foundation hygiene , 
All food hygiene which are found starting from purchasing, until services are consumed, 
All people hygiene who are found starting from purchasing, until services are consumed 
( These matters are considered in back cycling's , after consuming)

What is hazard?

Briefly: everything which will give to consumer. Classify of it will be in HACCP literature the following:

  • Microbial contagious
  • Physical contagious
  • Chemical contagious
  • Allergens

Microbial contagiousness is basic reason of food resources disease.

Microbial Contagious

  • Viruses
  • Microscopic parasites
  • Food prisoner batteries which come from different resources

Physical Contagious

  • As metal, glass, plastic
  • As stone, leaf
  • As jewelers, hair, nail
  • As dirt, dust, insects, bone

Chemical Contagious

  • Cleaning chemicals
  • Industrial production chemicals
  • Medicine and agriculture chemicals
  • Pesticide poisons

Allergens

  • Foods which substrate danger reactions
  • Immunity reaction against foreign proteins
  • Too many people are in confidence
  • Products are marked generally

Food safety: Assurance which does not give harmful to consumer, when food are prepared as suitable to aim and eaten

Food chain: A food and its components, is phases and operational serials which are found from first production until consuming, production, operating, distribution, storage and transport.

Food safety hazard: biological, chemical or physical elements or food situations which can give inverse effect for health in food.

Food safety policy: Detailed commitment which means top management of organization formal related food safety .

Final product: product which is not operated or changed in further by organization.

Flow diagram: presenting of schema and systematic of interacting and range of steps until final product is occurred.

Control guarding: operation or action which is to guard or to remove or to be acceptable level food safety hazard. 

Prerequisite program: Suitable production should be done in hygienic ambient along food safety and food chain, final product should be safety and it is basic requirements and actions to consume in food safety.

  • (GAP) Good agriculture practices
  • (GVP) Good vet practices
  • (GMP) Good management practices
  • (GHP) Good hygiene practices
  • (GPP) Good production practices
  • (GDP) Good distribution practices
  • (GTP) Good trade practices

Operational prerequisite program (OPRP): Prerequisite program which is identified to control food safety hazards in product and/or process.

CCP (critical control points): control can be applied and food safety steps which are to guard or to remove or to be acceptable level for food safety hazard.

Critical Limit: Criteria which divides acceptable level from unacceptable level.


Monitoring : Planed priging of measurement or observations weather control guard is operating as suitable to aim.

Corrective action: Action which is to remove reason of nonconformity or unwanted case 

Validation : determining of efficiency of data got from control guarding which is governed by OPRP and HACCP plan

Verification: Performing of determined needs by objective evidence.

Validation: Done operations to show that performance of tool, equipment, method or system are suitable for requirements.

Verification: To confirm with written records that tools, equipment methods or systems are suitable for determined aim testing.

Qualification: Occurring clearly part of validation process, control and/or test confirming which is done before using of parts of system.

Calibration: done operations which determines relation between known measurement and worth which was shown on tool in clearly conditions

3-Basic Principles of ISO 22000:2005 (HACCP)  

HACCP is occurred 7 basic principles the following generally: 
1. Doing of hazard analysis 
2. Determining of critical control points 
3. Occurring of critical limits 
4. Establishing of system for monitoring of critical control points 
5. Points which are not under control, are monitored and if there is, corrective action is occurred 
6. Control procedures are applied such that operation of system is audited efficiency.
7. Documentation system which includes procedure and records, is occurred to apply this principles

4-Parts and Scope of ISO 22000:2005 (HACCP)  

 

4 Food safety management system 
4.1 General requirements 
4.2 Documentation requirements

5 Management responsibility 
5.1 Management commitment 
5.2 Food safety policy 
5.3 planning of food safety management system 
5.4 Responsibility and power 
5.5 Food safety team leader 
5.6 Communication 
5.7 Preparing to emergency situation and reaction to them 
5.8 Management review

6 Resources management 
6.1 Providing of resource
6.2 Human Resources 
6.3 Infrastructure 
6.4 Work environment

7 Safety product planning and realizing 
7.1 General
7.2 Prerequisite programs
7.3 First phases of hazard analysis realization 
7.4 Hazard analysis 
7.5 Operational prerequisite programs 
7.6 Occurring of HACCP plan 
7.7 Updating of beginning knowledge and documents determined in PRP and HACCP 
7.8 Verification plan 
7.9 Monitoring system
7.10 Control of non conformity

8 Verification, validation and improvement of food safety management system 

8.1 General
8.2 Validation of control guarding combinasons 
8.3 Control of monitoring and measurement 
8.4 Verification of food management system 
8.5 Improvement 
8.5.1 Continual improvement 
8.5.2 Updating of food safety management system

Benefits of ISO 22000:2005 (HACCP)

A preventative approach to food safety

ISO 22000:2005 (HACCP) can help identify process improvements

ISO 22000:2005 (HACCP) reduces the need for, and the cost of end product testing

ISO 22000:2005 (HACCP) is complementary to quality management systems such as ISO 9000

ISO 22000:2005 (HACCP) provides evidence of due diligence

ISO 22000:2005 (HACCP) reduces the likelihood of product recall & adverse publicity

ISO 22000:2005 (HACCP) enhances customer satisfaction / reduces dissatisfaction

ISO 22000:2005 (HACCP) facilitates better understanding of food packaging safety issues throughout the organization Improves staff performance through the promotion of team spirit

ISO 22000:2005 (HACCP) improves staff morale and motivation through a cleaner working environment

International Acceptances

ISO 22000:2005 (HACCP) provides Market Protection 

Process Of Consultancy

Giving training: Persona is given training regulations and practices about HACCP system. 

 

Pre-preparing of establishing of HACCP system: The following works are realized in this phase: 

 

  • Production process is researched, flow diagram is prepared
  • HACCP team leader is determined
  • Detailed Project works and time plans are prepared

Occurring of HACCP team: Team is occurred that in different disciplines people established HACCP system in the shortest time and the most efficiency.

Pre-Sufficiency Program: Hygiene practices have to correspond to  high standards in the company to apply HACCP system. Therefore required works will be directed.

Product definitions: Using shapes and final product identifications are documented to determine hazards better.

Process flow diagrams: For every product/product group, process flows are determined.

Hazard and risk analysis: In process flow for every level hazards are determined according to possibility of occurring and given harmful.

Determining of critical control points: Critical control points are determined according to hazard analysis.

Identification of limits in critical phases: Limits and objective worth's are determined for every critical control points.

Monitoring system: Control system is established to control critical control points with described test and observation.

Corrective prevention: If there is devotion in critical control points, to be done operations are documented determining.

Verification: To test sufficiency and suitable to standard of HACCP system , methods are determined and documented.

Product identifications: Record system is developed to provide monitoring with evidence in audit.

Taking of corrective and preventive actions: Internal audit is planed to monitor practices after establishing of system and corrective and preventive actions are prepared and practiced according to results of internal audit.

Application of certification: To know more about ISO 22000:2005 (HACCP) and our deliverables through our unique process approach, click here  or contact us  for a discussion.

OHSAS 18001 Quality Management System

The Occupational Health and Safety Assessment Series (OHSAS) specification 18001 and the accompanying guideline OHSAS 18002 have been developed in response to urgent customer demand for a recognizable occupational health and safety management system standard against which their management systems can be assessed and certified. 

OHSAS 18001:2007 is also compatible with the ISO 9001:2000 quality management system and ISO 14001:2004 environmental management system standards, in order to facilitate the integration of quality, environmental and occupational health and safety management systems by organization, if they wish to do so. For more information please click IMS

OHSAS 18001:1999 Quality Management System

1-Definitions about OHSAS 18001:2007    

2-Parts and Scope of OHSAS 18001:2007

3-OHSAS 18001:2007 Online Application Form

 

The Occupational Health and Safety Assessment Series (OHSAS) specification 18001 and the accompanying guideline OHSAS 18002 have been developed in response to urgent customer demand for a recognizable occupational health and safety management system standard against which their management systems can be assessed and certified. 

OHSAS 18001:1999 is also compatible with the ISO 9001:2000 quality management system and ISO 14001:2004 environmental management system standards, in order to facilitate the integration of quality, environmental and occupational health and safety management systems by organization, if they wish to do so. For more information please click IMS

The specification takes a structured approach to OHSAS management. The emphasis is placed on practices being pro-active and preventive by the identification of hazards and the evaluation and control of work related risks. OHSAS 18001 can be used by organization of all sizes regardless of the nature of their activities or location. Organizations can now achieve third party certification for their Occupational Health and Safety management system. 

OHSAS 18001 features include the following elements:

  • OHSAS Policy
  • Planning
  • Implementation and Operation
  • Checking and corrective action
  • Management Review  

Organizations of all kinds are increasingly concerned about achieving and demonstrating sound Occupational Health and Safety performance to their shareholders, employees, clients and other stakeholders by managing the hazards and improving the beneficial effects of their activities, products and services. 

Increasingly, stringent legislation, the development of economic policies, human resources management and other measures are used to foster Occupational Health and Safety protection and welfare. A general growth of concern from stakeholders and other interested parties suggests a clear commitment to Occupational health and Safety is required.

 

What are OHSAS 18001 and OHSAS 18002?

OHSAS 18001 is an assessment specification for Occupational Health and Safety Management Systems. It was developed in response to the need for companies to meet their health and safety obligations in an efficient manner.

To compliment OHSAS 18001, BSI published OHSAS 18002, which explains the requirements of the specification and shows you how to work towards implementation and registration.

Together, this integrated package will provide your business with the practical means of registration:

  • Identify elements of your business that impact on health and safety and gain access to the relevant legislation
  • Produce objectives for improvement and a management program to achieve them, with regular reviews for continual improvement
  • BSI Management Systems will periodically assess the system and, if it meets the requirements, register your company or site to OHSAS 18001

Eliminating risks and hazards: OHSAS 18001 will measure your managements system with regards to several dimensions. The extent of application will depend on such factors as the occupational health and safety policy of the organization, the nature of its activities, andconditions under which it operates.

 

A Successful Management System Should Be Based On:

  • An occupational health and safety policy appropriate for the company.
  • Identification of occupational health and safety risks and legal requirements.
  • Objectives, targets, and programs that ensure continual improvements.
  • Management activities that control the occupational health and safety risks.
  • Monitoring of the occupational health and safety system performance.

§         Continual reviews, evaluation, and improvement of the system.

 

Partner with ACAR for:

  • CONSULTING of your Occupational Health and Safety Management System according to OHSAS 18001, and get critical processes under control. OHSAS 18001 applies to companies of any size, but is especially relevant to companies with a large workforce, manual and heavy work tasks, and/or high risk work environments.

ACAR offers Risk Based Certification worldwide, and holds a wide range of national accreditations. With our global network of local resources, we provide you with the certification most suitable to your needs, type of business, and company location. Wherever you are, our auditors make it a point to know the business you are in

1-Definitions about OHSAS 18001:2007   

 

Accident: Unwanted case which causes death, disease, injury, damage and other loses.

Harm: Potential resource and situation which cause injuring of human, illness, damage of goods and work place.

OHSAS: Factors and requirements which effect comfort of employees, temporary workers, contractor person, visitors and other people in working area.

Ohsas Management System: It is part of all management system making easy, OHSAS risks management about organization action. It includes resources about action plan, responsibilities, experiences, processes, procedures and developing of OHSAS policy of organization, practices, improvement, succeeding, reviewing and continuing.

Risk Evaluation: In all process, thinking of risk size and making decision whether risks are endured.

Performance: Taking basic policy and objectives of organization, related measurable results of OHSAS management system with control of health and safety risks.

Safety: Not to be in situation which is under unacceptable harm risk.

Tolerant Risk: Risk which decreased to enduring level, according to legal mandatory and its OHSAS policy.

2-Parts and Scope of OHSAS 18001:2007   

OHSAS 18001: OHSAS evaluation serial – OHSAS management system specification 
OHSAS 18002: OHSAS management systems – OHSAS 18001 practicing guide SAS STANDARDS ARE OCCURRED FROM THESE PARTS 

1. Scope

2. Normative standards 

3.Terms and definitions 

4. Elements of OHSAS management system 

4.1 General requirements

4.2 OHSAS policy

4.3 Plan 

4.4.Practicing and working 

4.5. Control and corrective actions 

4.6. Management review

 

Benefits of OHSAS 18001:2007

Demonstrating your commitment to Occupational Health & Safety can positively improve the efficiency of internal operations and consequently reduce accidents, danger and downtime. Employee safety and the quality of the working environment are actively improved because objectives and responsibilities are made clearer and all employees are prepared to effectively deal with any future hazards. 


 

Benefits of OHSAS management are the following; 

 

  • Protecting of employees from bad effects of company and accident, providing of works in comfortable and safety ambient.
  • Increasing motivation and attendances of employees
  • Reducing the number of personal injuries through   prevention and control of work place hazards and the risk of major accidents.
  • Ensuring A well-Qualified and enthusiastic workforce by fulfillment of increasing expectations of employees.
  • With taking steps in work environment, operation safety is provided by removing of fire, explosion, out of order of machines etc.
  • Adjusting to national and international standards .
  • Increasing of job performance;
  • Doing of sensitive and responsibility against other operations or customers.
  • Succeeding against rivals .
  • Emergency Planning
  • Document and Record Control
  • Identifying Legal Requirements
  • Reduce insurance premiums
  • Encourage more effective internal and external communication
  • Demonstrate your commitment to the protection of staff, property and plant
  • Improve your safety culture

Demonstrating of sensitivity of organization to occupational safety, in from of formal places

Process of Consultancy

We can help you every step of the way. We have helped many companies to implementOccupational Health and Safety Assessment Series (OHSAS) .We have a proven implementation strategy and processes to help ensure your success.


Documentation plays an important part of a Occupational Health and Safety Assessment Series (OHSAS). We can help you with every level of documentation:

  • We can write the documents for you.
  • We can provide templates so that you can write them on your own.
  • We can review your current documentation for compliance
  • We can review your current documentation for opportunities for improvement.

Typical Documentation Structure

Documentation requirements are usually divided in four Tiers:

  • General requirements.
  • OHSAS Policy.
  • Planning.
  • Practice and operation
  • Control and corrective actions
  • Management review

What is a Occupational Health and Safety Manual?

An Occupational Health and Safety Manual is the statement of the organization's quality policy and the description of  the quality system in organization. It is usually written by managers from top-level and the quality departments. 


 

What is its Procedure?

Procedures define activities at the departmental level and written by department supervisors. They are usually referred to in a quality system, as a "written" procedure or a "documented" procedure. Procedures should be organized ideally into the ISO 9001 outline structure, indicating the ISO 18001 clause (4.1 - 4.20) under which they fall, though is not an ISO 18001 requirement.


 

What is a Work Instruction?

Work instructions describe how work is accomplished, it is 100% of how to complete a specific task or operation, and are usually written by the operators and trainers. 


 

What are Records?

Occupational Health and Safety records provide the backbone of the Occupational Health and Safety Assessment Series.

Occupational Health and Safety records consist of all forms, or controlled documents andHealth and Safety records (hard copy and electronic) necessary for the quality system to operate. Occupational Health and Safety records usually consist of all completed forms and charts.

To know more about OHSAS 18001 and our deliverables through our unique process approach, click here or contact us  for a  discussion.

 

 

 

ISO/TS 16949 Automotive Quality System

Automotive manufacturers require suppliers to certify their quality systems to the industry’s own requirements. It can be a challenge to make the right decision for your organization and develop a system that will satisfy your customers in the years ahead.

To make a decision, it is critical that you understand the various options available, the contractual requirements, and deadlines from the automotive manufacturers. There is one international standard, ISO/TS 16949:2002. In addition there are national standards like QS-9000 and VDA 6.1. Just like ISO/TS 16949:2002, the national standards all incorporate certification to the Quality Management System standard ISO 9001:2000, and are committed to the transition of all their certificates to the ISO/TS 16949:2002 edition.

ISO/TS 16949 Automotive Quality System

Automotive manufacturers require suppliers to certify their quality systems to the industry’s own requirements. It can be a challenge to make the right decision for your organization and develop a system that will satisfy your customers in the years ahead.

To make a decision, it is critical that you understand the various options available, the contractual requirements, and deadlines from the automotive manufacturers. There is one international standard, ISO/TS 16949:2002. In addition there are national standards like QS-9000 and VDA 6.1. Just like ISO/TS 16949:2002, the national standards all incorporate certification to the Quality Management System standard ISO 9001:2000, and are committed to the transition of all their certificates to the ISO/TS 16949:2002 edition.

It is important to note that the general trend is a move away from the national standard schemes to the international ISO/TS 16949:2002, but so far finalized transition dates have not been set for all of them. Big automotive manufacturers like DaimlerChrysler, Ford, and General Motors have already set transition deadlines

Upgrading to ISO/TS 16949The ISO/TS 16969 Quality Management Systems Standards have been formally introduced to the world by the International Automotive Task Force (IATF) and Japan Automobile Manufacturing Association, Inc. (JAMA). Suppliers to the automotive industry who are already QS 9000 certified, have until December of 2006 to transition to the new Standards. ISO/TS 16949 defines the particular requirements for the application of ISO 9001:2000 for automotive production and relevant service part organizations.

Significant Changes: ISO/TS 16949 is a complete rewrite of the QS9000 and includes the Quality System Requirements Standard, ISO9001:2000. The 20 elements of QS 9000 have been replaced with the following 8 sections:

1      Scope

2      Normative Reference

3      Terms and Definitions

4      Quality Management System

5      Management Responsibility

6      Resource Management

7      Product Realization

8      Measurement, Analysis and Improvement

It is reliant standard: 

ISO 9001 (International); 
QS-9000 (Big Three - USA); 
AVSQ (ANFIA - Italy); 
EAQF (FIEV - France); 
VDA 6.1 (VDA/QMC - Germany).

This standard 

FORD GM
CHRYSLER BMW
PEUGEOT CITROEN
AUDI MERCEDES BENZ
GME OPEL FIAT
BOSCH RENAULT
VOLKSWAGEN

were recognized.

Structure Of Iso 16949 System

The date of 26.03.2002 issuing 2nd revision was adjusted with ISO 9001:2000.
With ISO/TS 16949 standard , 
Collecting of knowledge saving in clearly place 
Improving of product quality 
Developing of supplier chain 
Providing of all automotive sector to meet in same quality system 
Increasing of productivity 
Preventing of practicing of different type audit of main industry 
Increasing of qualification and quality levels of sector 
Presenting of more confidence product to consumer

ISO/TS 16949 Process-Based Model

1-Definitions about ISO/TS 16949 Automotive Quality System

Production:

  • Production of materials
  • Parts of services production
  • Montage
  • Realization of processes for heat operation, welding, paint, plating or other operation

Predictive maintenance: Preventive actions which is related results of process data for not occurring problems from maintenance

Preventive Maintenance: Planning maintenance actions which are done to prevent to cut down in the production because of equipment false.

Expensive Portage: Extra costs which is outside contract determined.

Note: It originates from method, amount, not planning or late transport.

Assistant Foundation: directed to production is not realized but they support production foundations.

Foundation: Place which is realized processes occurring advantages.

Special Characteristics: Product or production process which belongs to process parameter. It describes adjusting of legal regulations, suitable, function, performance or next process belonging to security and suitable

 

Benefits of ISO/TS 16949 Automotive Quality System

 

  • Improve automotive supply chain product and process quality.
  • Apply common and consistent international quality system requirements for the automotive industry.
  • Gain confidence in global supplier quality.
  • Implement policies and procedures for a common third party registration scheme to ensure consistency worldwide.
  • Introduce process-based audits focusing on customer satisfaction.
  • Gain global acceptance of the standard in place of national standards.
  • its international recognition is more favorable than in case of other systems
  • the system cares for the continuous development
  • mistake prevention and the decreasing of the faults

the decreasing of the mistakes within the supply chain nonrefundable state encouragement can be applied for the establishment and certification of the ISO/TS 16949 system

Process Of Consultancy

There are key steps that every company implementing an Automotive Quality Management Standard will need to consider:

Step 1: Determine Which Management Standard To Adopt: Different auto manufacturers will have different requirements. ISO/TS 16949 aligns existing US, German, French and Italian automotive quality system requirements but as yet has not been adopted as a mandatory requirement by all auto manufacturers throughout the world. 

Step 2: Purchase the Standard: Before you can begin preparing for your application; you will require a copy of the standard. You should read this and make yourself familiar with it.

Step 3: Review Support Literature And Software: There are a wide range of quality publications and software tools designed to help you understand, implement and become registered to an automotive quality management system.

Step 4: Assemble a Team And Agree Your Strategy: You should begin the entire implementation process by preparing your organizational strategy with top management. 

Step 5: Consider Training: There are many workshops, seminars and training courses available to help you become registered to an automotive management system. 

Step 6: Review Consultancy Options: You can receive advice from independent consultants on how best to implement your quality management system. They will have the experience in implementing a QMS and can ensure you avoid costly mistakes.

Step 7: Choose a Registrar: The registrar is the 3rd party, like BSI Management Systems, who come and assess the effectiveness of your quality management system, and issue a certificate if it meets the requirements of the standard. Choosing a registrar can be a complex issue as there are so many operating in the market. Factors to consider include industry experience, geographic coverage, price and service level offered. The key is to find the registrar who can best meet your requirements. A great place to start is by contacting us. 

Step 8: Develop a Quality Manual: A Quality manual is a high level document that outlines your intention to operate in a quality manner. It outlines why you are in business, what your intentions are, how you are applying the standard and how your business operates.

Step 9: Develop Support Documentation: This is typically a procedure manual that supports the Quality manual. Quite simply, it outlines what you do to complete a task. It describes who does what, in what order and to what standard.

Step 10: Implement your Quality Management System: The key to implementation is communication and training. During the implementation phase everyone operates to the procedures and collects records that demonstrate you are doing what you say you are doing.

Step 11: Consider a Pre-Assessment A pre-assessment normally takes place about 6 weeks into the implementation of the quality system. The purpose of the pre-assessment is to identify areas where you may not be operating to the standard. This allows you to correct any areas of concern you may have before the initial assessment.

Step 12: Gain Registration: You should arrange your initial assessment with your registrar. At this point the registrar will review your management system and determine whether you should be recommended for registration. 

Step 13: Continual Assessment: Once you have received registration and been awarded your certificate, you can begin to advertise your success and promote your business. To maintain your registration, all you need to do is continue to use your quality system. This will be periodically checked by your registrar to ensure that it continues to meet the requirements of the standard.

 

To know more about ISO 16949:2002 and our deliverables through our unique process approach, click here or contact us for a discussion.

 

 

IS0 13485

This Standard is aimed at companies that design, develop, produce, install or service medical devices and specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements.


The newly published EN IS013485: 2003 Medical Devices Quality Management Systems. Requirements for Regulatory Purposes now includes a requirement for senior management "buy-in" as specified in ISO 9001:2000.  However the primary objective is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of BS EN ISO 9001 that are not appropriate as regulatory requirements. Therefore, while BS EN ISO 13485:2003 has the same format as BS EN ISO 9001:2000 and most of the same requirements, compliance with BS EN ISO 13485:2003 does not provide conformity with EN ISO 9001:2000.

Benefits of IS013485: 2003

Benefits of ISO 13485:2003 management are as followings; 
 

-   Is recognized globally as the best quality practices from organizations within the medical device industry 

-   enables you to work within many countries where it is a regulatory requirement and with many organizations where it is a contractual obligation or expectation 

-     helps to create a systematic framework in which organizations monitor, measure and analyze their processes and customer feedback 

-    helps provide a framework for implementation of actions (where necessary) to ensure achievement of planned results and to ensure maintenance of effectiveness of those processes with applicable customer, quality and regulatory requirements 

-      can provide improved performance measurable in key metric areas such as increased sales, increased timeliness in getting products to the global marketplace, reduced costs, fewer errors, less waste, better use of time and resources and lower product failures

IS013485: 2003 Medical Devices Quality Management Systems

1-History of IS0 13485: 2003 Medical Devices Quality Management Systems

2- IS0 13485: 2003 Online Application Form

 
This Standard is aimed at companies that design, develop, produce, install or service medical devices and specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements.


The newly published EN IS013485: 2003 Medical Devices Quality Management Systems. Requirements for Regulatory Purposes now includes a requirement for senior management "buy-in" as specified in ISO 9001:2000. 

However the primary objective is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of BS EN ISO 9001 that are not appropriate as regulatory requirements. Therefore, while BS EN ISO 13485:2003 has the same format as BS EN ISO 9001:2000 and most of the same requirements, compliance with BS EN ISO 13485:2003 does not provide conformity with EN ISO 9001:2000.


BS EN ISO 13485:2003 supersedes EN ISO 13485:2001 and EN 1S0 13488:2001 which will be withdrawn in July 2006. To maintain their certified status all organizations within the medical devices industry must adopt EN 13485:2003


Major differences between EN IS013485: 2003 and ISO 9001:2000 are the requirement to maintain the effectiveness of the system rather than improve it; emphasis on meeting customer and regulatory requirements as against increasing customer satisfaction and a greater requirement for documented procedures which include: 

              -         Those documents required by regulation

-         Responsibility and authority

-         Training procedure, if required

-         Maintenance requirements

-         Health, cleanliness, clothing

-         Environmental conditions

-         Control of contaminated product

-         Risk management

-         Customer requirements

-         Design and development

-         Purchasing process including traceability records and records of verification

-         Reference materials and reference measurement procedures

-         Labeling and packaging

-         Installation and verification

-         Sterilization process validation

-         Identification and validation

-         Preserving product including shelf life

-         Monitoring, measurement and measuring devices

-         Sterilization records, servicing records, batch records, validation

Differences in research and development activities:

-         Determine design transfer activities

-         Document design planning outputs

-         Include risk management in input

-         Approve inputs

-         Document design outputs

-         Include specialist as needed in design review

-         Complete validation before delivery

-         Include clinical trial as required

Added programs to consider:

-         Clinical evaluation

-         Risk management

-         Clinical trials

-         Cleanliness of product and contamination control

-         Requirements for implantable devices

-         Communication of advisory notices

ACAR Consultancy Services specialize in putting in simple uncomplicated quality management systems, that meet the requirements of the EN ISO 13485 medical devices standard, without unnecessary administration

ISO 14971:2007 Risk Management Certification Program 
 

Overview
 

ISO 14971:2007 is a state-of-the-art, international standard that is quickly being recognized as the best process to ensure that all aspects of risk management are considered throughout the product lifecycle for medical devices. 
 

The ISO 14971:2007 for the application of risk management is designed to help manufacturers introduce safe medical devices into the market place. The manufacturer is responsible for identifying and controlling not only the risks associated with their medical device, but evaluating interactions with other devices.  The standard also allows for other healthcare manufacturing organizations to use the process [and obtain certification].  This might include human tissue, animal care products, pharmaceutical manufacturers, etc. who may choose to use this standard.

The standard requires that Top Management demonstrate its commitment to risk management by; 

a) establishing the process,
b) setting the policy for acceptable risk, and

c) reviewing the effectiveness of the process at determined intervals.  

The risk management certification program by ACAR will bring focus to this aspect of the process, and ensure that the manufacturer understands any significant gaps in the organization’s process.

 

1-History of IS0 13485:2003 Medical Devices Quality Management Systems

In November 2000 the Standards EN ISO 13485:1996 and EN ISO 13488:1996 have been accepted as European Standards for replacing the EN 46001 and the EN 46002. (The Standards EN 46001 and EN 46002 were only valid until: 28.2.2004) These Standards are published as EN ISO 13485:2000 and EN ISO 13488:2000 and effective. These Standards are very similar to the EN 46001 and EN 46002 and they are based on the EN ISO 9001(1994) and the EN ISO 9002 (1994), which were valid until 15.12.2003.

In November 2003 the Standard EN ISO 13485 "Medizinprodukte Qualitätsmanagementsysteme Anforderungen für regulatorische Zwecke" has been publicated. The assembling and the structure are based on the EN ISO 9001:2000. The Standard EN ISO 13485:2003 has been harmonized by mid of 2004. The Standards EN ISO 13485:2000 and EN ISO 13488:2000 have been withdrawn and replaced by the Standard EN ISO 13485:2003 on July, 31 2006.

The Standard EN ISO 13485:2003 is an independent Standard, but it refers to EN ISO 9001:2000. The terms of content are mainly taken over from the EN ISO 9001:2000 and they are completed with the specified requirements to medical devices. Therefore the EN ISO 13485:2003 is clearly more extensive than the EN ISO 9001:2000. The intention of the EN ISO 13485:2003 is the fulfillment of the legal requirements. The intention of the EN ISO 9001:2000 is the improvement of the competitiveness.

The requirements of the new EN ISO 13485:2003 are mainly identical to the EN ISO 13485:2000 or rather EN ISO 13488:2000. The law "Medizinprodukte-Gesetz" and the MDD 93/42/ECC are remaining the basis.

EN 46003

This European Standard specifies the quality system requirements for the final inspection and test of medical devices, which are more specific than the general requirements specified in EN ISO 9003:1994. The Standard EN 46003 is not a „stand alone" standard and it can only be used in combination with EN ISO 9003:1994. The specific requirements of the EN 46003 only apply to named groups of medical devices; in-vitro diagnostics and active implantable medical devices are excluded. For sterile medical devices this Standard is not sufficient. 

ISO 27001 Information Security

INFORMATION SECURITY

The ISO 27000-family of information security management standards align with other ISO management system standards, such as ISO 9001 (quality management) and ISO 14001(environmental management), regarding both general structure and the nature of integrating best practices with certification standards.  Certification of an organization to ISO/IEC 27001 is one means of providing assurance that the organization has not only implemented a system for the management of information security in line with the international standard, but also maintains and continuously improves the system.

 

With increased usage of new technology to store, transmit, and retrieve information, we have exposed ourselves to increased numbers and types of threats.  The overall approach to Information Security and integration of different security initiatives needs to be managed in order for each element to be most effective.  An ISMS allows you to coordinate your security efforts effectively.  The implementation of ISO/IEC 27001:2005 will reassure customers and suppliers that information security is taken seriously within your organization and defined processes are in place to deal with information security threats and issues.

 

The new standard can be used by a broad range of organizations – small, medium and large – in most of the commercial and industrial market sectors: finance and insurance, telecommunications, healthcare, utilities, retail and manufacturing sectors, various service industries, transportation sector, government and many others.  ISO/IEC 27001:2005 specifies the processes to enable a business to establish, implement, review and monitor, manage and maintain effective ISMS. 

 

ISO/IEC 27001 is intended to be used with ISO/IEC 17799, the Code of Practice for Information Security Management, which lists objectives, controls, and implementation guidelines. Organizations that implement ISMS in accordance with ISO 17799 are likely to also meet the requirements of ISO/IEC 27001.  This ISO standard is the first in a family of information security related standards which are assigned numbers in the 27000 series.

 

 They include:

 

-         ISO/IEC 27000 - a vocabulary or glossary of terms used in the ISO 27000-series standards

-         ISO/IEC 27002 - the proposed re-naming of existing standard ISO 17799

-         ISO/IEC 27003 - a new ISMS implementation guide

-         ISO/IEC 27004 - a new standard for information security measurement and metrics

-         ISO/IEC 27005 - a proposed standard for risk management, potentially related to the current British Standard BS 7799 part 3

-         ISO/IEC 27006 - a guide to the certification process 

 

 

The ISO 27001:2005 standard effectively covers twelve sections:

 

-         security policy

-         organization of information security

-         asset management

-         human resources security

-         physical and environmental security

-         communications and operations

-         management

-         access control

-         information systems acquisition, development and maintenance

-         information security incident management

-         business continuity management

-         compliance

 

To start with, an assessment is made on how your ISMS have been implemented to identify the gap vs. the standard requirements. After gaps have been filled, the initial audit follows. From the audit, you will receive a report that outlines the key measures needed to receive positive certification. Once no major corrective action is required, you’ll obtain direct certification. Annual compliance audits will follow and the certificate will be renewed every three years as long as systems are maintained.

 

  Steps for Implementing ISO 27001: 2005

1       Define an information security policy

2       Define scope of the information security management system

3       Perform a security risk assessment

4       Manage the identified risk

5       Select controls to be implemented and applied

6       Prepare an SOA (a "statement of applicability").

 

Benefit of ISO 27001:2005

The reputation of ISO and the certification against the internationally recognized ISO 27001:2005 enhances any company’s credibility. It clearly demonstrates the validity of your information and a real commitment to upholding information security. The set up and certification of an ISMS can also transform your corporate culture both internally and externally, opening up new business opportunities with security conscious customers/clients, in addition to improving employee ethics and the notion of confidentiality throughout the workplace. What’s more, it allows you to enforce information security and reduce the possible risk of fraud, information loss and disclosure.

 

-         Minimizing the risk of privacy and security breaches

-         Demonstrating due diligence for compliance with privacy laws

-         Defining the security process

-         Creating security objectives and requirements

-         Cost-effectively managing security risks

-         Ensuring the organization's security objectives are met by providing a roadmap for managing requirements

-         Complying with government, industry and other regulations

-         Providing a uniform platform to show customers and partners how information is secured

Determining the extent of compliance with corporate directives and government policies 

Control Objectives and Controls

In addition to the clauses of the standard, the following are the minimum control objectives and controls in ISO 27001, and they align directly with those in ISO 17799.  Minimally, these objectives and controls shall be a part of the ISMS.  Additional objectives and controls may be necessary, depending on the organization’s requirements.

 

 

A.5 Information Security

-         Information security policy


A.6 Organization of Information Security

-         Internal organization

-         External parties


A.7 Asset Management

-         Responsibility for assets

-         Information classification


A.8 Human Resources Security

-         Prior to employment

-         During employment

-         Termination or change of employment


A.9 Physical and Environmental Security

-         Secure areas

-         Equipment security


A.10 Communications and Operations Management

-         Operational procedures and responsibilities

-         Third party service delivery management

-         System planning and acceptance

-         Protection against malicious and mobile code

-         Back-up

-         Network security management

-         Media handling

-         Exchange of information

-         Electronic commerce services

-         Monitoring


A.11 Access Control

-         Business requirements for access control

-         User access management

-         User responsibilities

-         Network access control

-         Operating system access control

-         Application and information access and control

-         Mobile computing and tele-working


A.12 Information Systems Acquisition, Development, and Maintenance

-         Security requirements of information systems

-         Correct processing in applications

-         Cryptographic controls

-         Security of system files

-         Security in development and support processes

-         Technical vulnerability management


A.13 Information Security Incident Management

-         Reporting information security events and weaknesses

-         Management of information security incidents and improvement


A.14 Business Continuity Management

-         Information security aspects of business continuity mgmt.


A.15 Compliance

-         Compliance with legal requirements

-         Compliance with security policies and standards, and technical compliance

                      -         Information systems audit consideration

 

 

CE Marking

The CE Marking is mandatory European marking for certain products group in conformance with the CE Directives with essential health and safety requirements CE means Conformities European in other words, European Conformity.

The product cannot be placed for service in the market without complying with the provision of the directive in the member countries in European Union. These CE Marking can be regarded as the product trade passage for Europe and many other countries worldwide that also accept and follow to CE Mark requirements.

CE Marking is independent of the quality requirements of the product as it applies with mandatory European safety requirements.

What is CE Marking?

1-Notified Bodies

2-Where is CE-Marking Required?
3-What To Look For In A Notified Body

4-Does Your Product Require CE Marking?

5-Who's Going To Enforce The Requirement For CE Marking?

6-What's New About the New Approach?


The CE Marking is mandatory European marking for certain products group in conformance with the CE Directives with essential health and safety requirements CE means Conformities European in other words, European Conformity.

The product cannot be placed for service in the market without complying with the provision of the directive in the member countries in European Union. These CE Marking can be regarded as the product trade passage for Europe and many other countries worldwide that also accept and follow to CE Mark requirements.

CE Marking is independent of the quality requirements of the product as it applies with mandatory European safety requirements.

 

The European Union (EU) includes the following 25 Member States: Austria, Belgium,Denmark, Eastland, Finland, France, Germany, Greece, Hungary, 

Ireland, Italy, Latvia,Lithuania, Luxembourg, Malta, Poland, Portugal, Slovakia, Slovenia, 

Spain, Sweden, The Netherlands, Czech Republic, UK and Cyprus. These Member States differ in their constitutional and legal systems.

Where harmonization of legal requirements or administrative regulations is necessary, the European Commission -the executive body of the European Union- develops regulations, which after acceptance by the European Council, are called Council Directives or simply directives. Each directive describes the consensus that has been achieved and provides a deadline for the transposition of this consensus into the national laws of each MemberState.

In 1985 a European Council Resolution on a new approach to technical harmonization and standards proposed a radical change in regulating the technical aspects of industrial products. The new approach involves the development of legislation specifying only the essential requirements that are general and mandatory. The detailed technical specifications that may be used to demonstrate conformity with the essential requirements are elaborated in voluntary harmonized standards.

Since 01 January 1993, the completion of the internal market has allowed free movement of goods throughout the territory of the European Union. A condition for such freedom of movement is the application of technical harmonization directives -also referred to as new approach directives- covering a wide range of industrial products such as machinery, personal protective equipment, medical devices, telecommunication terminal equipment, toys, and in vitro diagnostic medical devices and so on.

The conformity assessment of a product or family of products may require the certification by a Notified Body as regulated in the respective directive. Lists of Notified Bodies, the tasks and responsibilities which have been assigned to them and their unique four digit identification number is published and updated in the Official Journal of the European Communities.

If certification is a requirement as part of the conformity assessment procedure, the manufacturer has the option to choose any of the Notified Bodies in any of the Member States of the European Union. 

If a product complies with the requirements of a new approach directive, the manufacturer marks it with the CE-mark. Products which require certification by a Notified Body carry the CE-mark in combination with the number of the Notified Body, for example:

 

1-Notified Bodies  

 

The European new approach directives require the involvement of third parties in the conformity assessment of certain products. Traditionally these third parties had been national authorities of the Member States. However, some Member States had gained good experience in delegating technical work to non-governmental entities. These non-governmental entities were unknown to some Member States and to the European Commission. As there were no uniform criteria for the designation of such entities, the development of European legislation was relatively difficult.

 

The new approach reoriented EU legislative policy on such matters as technical competence, objectivity and transparency as the foundations for the necessary degree of trust in the system, on the basis of documented technical criteria enshrined in the legislation itself and in the appropriate European standards (i. e. EN 45000 series). Member States are invited under all new approach directives to notify the Commission of those bodies which they consider competent to undertake the responsibilities of Notified Bodies. A clear distinction shall be made at the national level between the Notified Bodies who intervene in the pre-market conformity assessment procedures and the national public authorities (national, regional or local) responsible for the market surveillance imposed by the directives for products on the market. 

 

Notified Bodies are free to offer their conformity assessment services for which they are notified to any manufacturer established either inside the EU or in third countries. They may carry out these activities on the territory of other countries either with their own personnel or with subcontractors.

At the time of the first notification with respect to a new approach directive the EU Commission assigns a four digit identification number to the Notified Body. This number will not change when the same Notified Body is notified for other directives at a later stage.

 

Notified Bodies are under surveillance by their national notifying authorities which have the authority to withdraw or modify the notification as soon as the conditions of notification are no longer met.

 

Notified Bodies are and must remain third parties, independent of their clients and other interested parties.

 

With respect to the European Medical Devices Directives Notified Bodies are entitled to perform product as well as quality system management related conformity assessment procedures as outlined in the respective Articles and Annexes of these Directives. Notified Bodies may have a limited scope with respect to the device families and/or the Annexes for which they are notified.

 

2-Where is CE-Marking Required?  

CE-marking compliance is a legal requirement in the European Union member states and the European Economic Area countries. The countries are:


Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia,  

Finland, France, Germany, Greece, Hungary, 

Iceland, Ireland, Italy, Latvia, Lichtenstein, 

Lithuania, Luxemburg, Malta,Norway, Poland, 

Portugal, Slovakia, Slovenia, Spain, 

Sweden, The Netherlands, Turkey, UK 

 

Other countries are likely to adopt the Directives in the future.

3-What To Look For In A Notified Body     

Once it is determined that you manufacture a product that is not subject to the self-certification route, the best way to proceed is to contact a notified body whose qualifications match up with your product, and whose credentials and affiliations match up with your and your target market. After that, there are number of variables to be considered.

  • - Price - Obtain quotes from at least a few notified bodies; pricing can vary dramatically.
  • - Service - Many notified bodies do not provide adequate service; usually due to peak load situations, lengthy European vacations and some simply disregard customer needs.
  • - Consulting - Some notified bodies will (and some will not) offer advice in addition to testing to accelerate the process and simplify the process for you (such as a desk audit of your technical documentation prior to actual submission).
  • - ISO 9000 and Product Certification - Very convenient and economical (when both are required) if a notified body can provide both services.
  • - Documentation - Find a notified body that will accept documents in English. Copyright 2007
  • - Mutual Recognition - Look for a notified body that will accept ISO 9000 registration from a U.S. registrar to avoid duplicate costs; also, find a notified body that will consider using qualified U.S. based subcontractors for audits to reduce travel related expenses.

If you can't find a Notified Body who will comply with the items listed above, keep looking, they do exist.

4-Does Your Product Require CE Marking?   

  • CE Marking is required if your customers are citizens of certain countries and if they purchase certain types of products from you.
    1. Are your current or future customers in the following countries?
    European Union (EU) member states - Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxemburg, the Netherlands, Portugal, Spain, Sweden and United Kingdom.


European Free Trade Association (EFTA) members - Iceland, Liechtenstein and Norway.

Do you now, or will you in the future, ship to these customers the following types of products?

  • - Toys
  • - Construction Products
  • - Pressure Vessels
  • - Telecommunications
  • - Medical Devices
  • - Machinery
  • - Personal Protective Equipment
  • - Satellite Station Equipment
  • - Gas Appliances
  • - Pressure Equipment
  • - Appliances (other than gas)
  • - Non-automatic weighing instruments
  • - Recreational Craft
  • - Lift Machinery
  • - Equipment and Protective systems for explosive atmospheres
  • - Non-Automatic Weighing equipment
  • - Measuring Instruments
  • - In-Vitro Diagnostic Medical Devices
  • - Marine Equipment
  • - Electrical products

5-Who's Going To Enforce The Requirement For CE Marking?    

Each member state of the European Union is bound to adopt into their National Law, regulations and administrative provisions to ensure that products placed on the market are safe. Each country has its own way of handling enforcement.


Many have added staff specifically to conduct spot checks against implemented directives and respond to complaints. Countries have also set in place a combination of return-to-origin procedures, financial penalties, criminal prosecution, etc.

European Union legislation makes European importers liable for the products they import, including the machinery they provide to their employees for work under the PUWER Directive. U.S. exporters are finding that no matter how interested a prospective European customer may be in their product, they will not risk importing non-conforming products when accidents will generate legal action against them. 

6-What's New About the New Approach?   

The implementation of the New Approach policy resulted in the changes outlined below: 

Product Directive Content: directives will be limited to the "essential requirements" or performance levels to which the product must conform.

Previously, the directives included detailed technical specifications which took forever to prepare since it involved the wrong level of bureaucracy and expertise.

Harmonized Standards: the technical specifications required of products to comply with the directive will be established by European standards agencies (CEN, CENELEC, ETSI and EOTA).

Compliance Procedures: the directives are linked to a series of compliance modules based on 4 factors including the nature of risk involved. There is a concerted effort to provide a range of choices to the manufacturer.

CE Marking:  common rules established for the affixing of the CE Marking to products.

Benefits of the CE Marking

 

  • - Accommodate all verifying national regulation for consumer and individual product in European Member states as it single market.
  • - Bring about cost saving for the producer.
  • - Enhance safety of the product 

Supply public bodies with uniform procedure that can be checked

How Do You Acquire CE Marking?

There are a series of steps outlined below. Depending upon your product and the nature of the risks it presents, there are several alternatives also noted that may apply to your situation.

  • -  Determine if any directives apply to your product. If more than one applies you will have to comply with all of them.
  • -  Determine the extent to which your product complies with the essential requirements for design and manufacturing in the applicable directive(s).
  • -  Choose the conformity assessment procedure from the options called out by the directive for your product.

The directives often use a series of questions about the nature of your product to classify the level of risk and refer to a chart called "Conformity Assessment Procedures". The chart includes all of the acceptable options available to a manufacturer to certify their product and affix the CE Marking.

Options for products with minimal risk include self certification where the manufacturer prepares a declaration of conformity and affixes the CE Marking to their own product.

Options for products with greater risks can require tests, audits or additional certificates from a notified body.

  • - Select the applicable product standards and test methods for your product and select an independent lab If the product testing is to be done externally.
  • Establish an authorized representative for regulatory affairs in the European Union for your product. Some directives require that a manufacturer designate in Europe a representative to produce technical documentation in a timely fashion when called upon to do so.
  • - The directives require for many products that a technical file be prepared by the manufacturer. The technical file holds information that verifies that the testing was conducted properly and that the product complies with applicable standards.
  • - Prepare a declaration of conformity that includes a list of the directives and standards that your product conforms to; product identification, the manufacturer's name, address and signature.

The declaration of conformity contains information adequate for tracing the product back to the manufacturer or the authorized representative in the European Union.

Affix the CE Marking to your product. There are specific rules to adhere to in CE Marking. These rules address the size and location of the marking, affixing the CE Marking to products, packaging and material or documents shipped with the product, and specific limitations on when and who is permitted to affix the CE Marking.

 

 

 

 

 

GOST-R Certification

GOST is the Russian word for "norm", and R stands for Russia. For most products, certification is needed if you wish to sell them in Russia. The main products concerned are materials in contact with food and human beings; industrial equipment for food, chemical, oil & gas, construction and other industries; mechanical and electrical goods. Also concerned are consumer products such as foodstuffs, textiles and clothes, cosmetics and perfumery, domestic goods and toys. The certificate can be valid for a one-time-only shipment or for a period of 1 or 3 years.

What is GOST R Certification?

1-Is Russian Certification Necessary For My Products?

2-Whether Obligatory or Voluntary Certification?

3-What Does Hygienic Certificate Mean?

4-What May Require Russian Certification?

5-What Is The Single Shipment Certificates GOST-R?

6-What Does It Mean the Exemption Letter?

7-What is the RTN Permission?

8-TERMS & COST Certification

9-The List Of The Documents Necessary For Certification Of Conformity

10-Sample of Certificates

 

GOST is the Russian word for "norm", and R stands for Russia. For most products, certification is needed if you wish to sell them in Russia. The main products concerned are materials in contact with food and human beings; industrial equipment for food, chemical, oil & gas, construction and other industries; mechanical and electrical goods. Also concerned are consumer products such as foodstuffs, textiles and clothes, cosmetics and perfumery, domestic goods and toys. The certificate can be valid for a one-time-only shipment or for a period of 1 or 3 years.

Since 1993, the Russian Government enacted legislation obliging to certify a number of products and introduced the GOST R system of mandatory certification with the intention of protecting the health and the safety of Russian population.

Original or certified copy of Certificate of Conformity is required for customs clearance at the Russian border as well as for sale and / or marketing within the country.

 

The certified product should be marked by the registered GOST R sign (so called Mark of Conformity), which clearly demonstrates product compliance to the applicable Russian standards

 

1-Is Russian Certification Necessary For My Products? 

 

Russia is a unique country and has unique requirements for safety. If you plan to trade inRussia, you should know and understand the Russian requirements for certification.

 

Your product should conform to the Russian standards which are different and mostly not harmonized with the European or International standards. CE self-declaration is not recognized in Russia and cannot replace the Russian Certificate of Conformity.

 

Basically, almost all consumer products require the mandatory certification; it includes all food products, products for children, perfume and cosmetics, tableware and kitchenware, packaging materials, household and industrial equipment, etc.

 

2-Whether Obligatory or Voluntary Certification?  

 

Obligatory Certificate: This kind of certificate certifies the quality of actually supplied goods and their compliance with contractual terms. A quality certificate contains a profile of goods or confirms their compliance with certain standards or specifications of a delivery order. A certificate of compliance is intended for certification of goods produced by Russian companies or shipped to Russia by an importer-company. A certificate of compliance can be issued for a batch of goods and on a series production. In the former case a certificate is legalized for a company engaged in supplying goods to the Russian market. Its validity varies with terms of a sale contract. In the latter case a foreign manufacturer of supplied goods is both an applicant and a recipient of a certificate. This type of a certificate is valid for a period identified in a certification document. Certification is carried out by our specialists on production premises of a company seeking certification of goods it manufactures. On the basis of results obtained during testing samples of goods in a laboratory an appropriate certificate of series production compliance is issued. 

There are cases where GOST certificate is issued when documents like: a hygienic report, a veterinary certificate, fire safety certificate, etc. are available. These all mean that we must receive all these documents for you before.

 

Voluntary CertificateFor products not subjected mandatory certification according to the Russian law, voluntary certification scheme may be applied. Exporters or importers initiate voluntary certification with the aim to formally prove the conformity of their products to the applicable Russian standards, technical norms or recipes. In other words, GOST Certificate of Conformity is a powerful marketing tool to capture Russian customer.

 

3-What Does Hygienic Certificate Mean?  

 

The hygienic certificate confirms conformity of products and services to the sanitary norms and strict observance of the established rules in the process of manufacture, storage, transportation and the sale of products and services.

 

The term of validity of hygienic certificate may be set up for 5 years. In the certain cases, (manufacturing of experimental sets of new kinds of production, implementation of essentially new technologies, using non-conventional raw material or components), validity of the hygienic certificate may be reduced. In this case concrete conditions (rules) of manufacturing have to be defined in the hygienic certificate.

 

The following types of products are subjected to mandatory hygienic certification:

  • Food products
  • Bottled drinking water; liquor, wine, beer, soft drinks
  • Food raw materials, food supplements and biologically active additives
  • Goods for children
  • Perfumes, cosmetics, items for oral hygiene
  • Chemical and petrochemical products for industrial use, domestic chemicals
  • Materials for items that come into contact with people's skin
  • Disinfectants, disinfectants and deratization products
  • Individual protection means
  • Tobacco products and raw materials
  • Pesticides and agrochemicals
  • Materials that come into contact with food stuff. 

4-What May Require Russian Certification?   

 

According to laws of the Russian Federation, more than 70% of all products to be sold and used in the Russia require mandatory certification. This concerns both locally produced and imported goods.

 

Currently there are over 30 federal laws regulating mandatory certification. The list of products subject to mandatory certification is provided in the Resolution of the Government of the Russian Federation from 13.08.97, and updated in 29.04.02.

 

Based on this list Gosstandard together with the Russian Customs Committee has enacted the List of Products, which needs mandatory certification prior to release onto territory of the RF.

The Russian certification systems regulate laws:

  • Protection of Rights of Consumers
  • Law on Standardization
  • Protection of Rights of Consumers
  • Law on Certification
  • Protection of Rights of Consumers
  • Law on Technical Regulation

5-What is the Single Shipment Certificates GOST-R? 

This kind of certificate is for companies who export their goods only occasionally. The single shipment certificate is valid for one delivery only. But, there is a possibility of few deliveries using this one shipment certificate. The amount of goods which are going to be exported to Russia is written in the certificate. So this amount can be divided in few deliveries.

The one shipment certificate is only for those companies that can prove (by a contract with the Russian receiver or by an invoice) their customer in Russia.

There are the following documents needed to make the Single shipment certificate:

  1. The full name of the company with address info
  2. The exact name of the product with the names of models and types
  3. The technical documentation or operating documentation with descriptions
  4. The invoice in Russian language
  5. The customs tariff code
  6. The contract and the enclosure with all technical descriptions.

Detailed inquiry for certification gost Russia

If you have more questions, fill out this form please. 
Our experts will solve your problems with pleasure.

 

6-What Does The Exemption Letter Mean? 

 

This kind of document confirms that exported or sold product is not subject to mandatory GOST R certification in Russia. 

There are two kinds of Exemption Letters:


 

  • Refusal Explanation Letter - it shows customs bodies that your product do not need the GOST certificate.
  • Information Letter (References) - it shows trade and intermediary companies that your product do not need the GOST certificate.
    The procedure of issuing an Exemption Letter usually takes about 5-7 working days.

The procedure of issuing an Exemption Letter usually takes about 5-7 working days.


First, the documentation (like for the example: technical descriptions of the products, delivery to Russia) is being reviewed. Then, the product is being identified according to the Russian classification system and then according to the technical documentation, the experts are making their conclusions.

There are the following documents needed to make the Exemption Letter:

  1. - The full name of the company with address info
  2. - The exact name of the product with the names of models and types
  3. - The technical documentation or operating documentation with descriptions
  4. - The customs tariff code
  5. - The contract and the enclosure with all technical descriptions. 
     

7-What is the RTN Permission?  

RTN provides permission to operate hazardous equipment or technical devices. This document is needed when the equipment begins operation and throughout the whole service life. The aim is to confirm that the equipment is safe to operate.

 

8-TERMS & COST of Certification   

 

The cost of certification services depends on several key factors:

 

  • - Specificity and type of product
  • - Availability of earlier received certificates
  • - Set of tests
  • - Amount of goods (a batch, certain quantity according to the contract, serial production) and its specific features.
  • - Complexity of laboratory tests norms or recipes.

Our prices are most convenient and reasonable in the market; in each case we will establish them depending on product specifications, type of certificate, term of validity and other factors.

If you wish to receive the exact information on cost and time of reception of the certificate for your products, fill the request form.

 

9-The List Of The Documents Necessary For Certification Of Conformity 

 


For Certification Of A Batch Production:

Manufacturer's information (address, phone, fax)     

Applicant's information

The certificate on registration of firm of the applicant (representation)

Account properties of firm of the applicant (representation)

The exact name of production to be certified, including types and models

The catalogue of production

Earlier received certificates or test reports (are desirable) technical specifications

The letter of guarantee from the manufacturer (applicant)


For Certification Of A Party Of Production:

Manufacturer's info (address, phone, fax)

Applicant's info

The certificate on registration of firm of the applicant (representation)

Account properties of firm of the applicant (representation)

The exact name of production to certify, including types and models

The catalogue of production

Technical specifications

Earlier received certificates or test reports (are desirable)

The quantity of a party of products (is desirable)

Copy of the contract depending on which production is coming

Sample of the product to certify

The application to the contract where the production and its quantity are specified

Copy of the account - invoice (is desirable)

10-Sample of Certificates  

To know more about GOST-R and our deliverables through our unique process approach,click here or contact us for a discussion.

Why is GOST Certification Necessary?

Usually Certificate is necessary for two cases:

  • Customs house
  • Realization of products at Russian market

 

The Law on Certification of Products and Services stipulates two types of certification - mandatory and voluntary certification. The Law on Protection of Rights of Consumers and the Law on Standardization regulate mandatory certification process and identify products that are subject to this type of certification.

 

According to the order of the State Customs Committee of Russia from 01.10.2000, production of foreign manufacturers imported in the country should respond the national quality standards, therefore is the subject to certification.

 

Certification GOST may be carried out concerning the goods or industrial activities of the firm. The goods, passed process of certification and received certificate of conformity GOST by results of expertise, do not meet any difficulties at registration of customs documents.

 

That is why Russian export companies and organizations cannot work with non-certified products

UkrSEPRO Certification

The UkrSEPRO system was introduced by Ukraine Government in 1993, obliging to certify a number of products.


Product conformity assessment is one of the Ukrainian State Technical Policy elements and it aims to provide human and animal with privacy safety as well as environmental protection.

 

The UkrSEPRO system is regulated by the Law of Ukraine “On conformity assessment”and guarantees that product conforms to the safety requirements established by national law.

Original or certified copy of Certificate of Conformity is required for

What is UkrSEPRO Certificate of Conformity?

      1-What is UkrSEPRO Certificate of Conformity? 

      2-The UkrSEPRO Sign 

      3-Application Scope 

      4-How Can You Obtain UkrSEPRO? 

      5-Sorts of UkrSEPRO Certificates 

      6-Sample of Certificates 

1-What is UkrSEPRO Certificate of Conformity? 


The UkrSEPRO system was introduced by Ukraine Government in 1993, obliging to certify a number of products. 

 

Product conformity assessment is one of the Ukrainian State Technical Policy elements and it aims to provide human and animal with privacy safety as well as environmental protection. 

 

The UkrSEPRO system is regulated by the Law of Ukraine “On conformity assessment”and guarantees that product conforms to the safety requirements established by national law.

 

Original or certified copy of Certificate of Conformity is required for customs clearance at the Ukrainian border as well as for sale and / or marketing within the country.

 

For products not subjected to mandatory certification according to the Ukrainian law,voluntary certification scheme or exemption letter ’may be applied. 

 

Exporters or importers initiate voluntary certification with the aim to formally prove the conformity of their products to the applicable Ukrainian standards, technical norms or recipes. In other words, UkrSEPRO Certificate of Conformity is a powerful marketing tool to capture Ukrainian customer.

2-The UkrSEPRO sign 

The certified product should be marked by the registered UkrSEPRO sign or Mark of Conformity, which demonstrates product compliance to the applicable Ukrainian standards. Usage of UkrSEPRO sign was defined in Decree of the Cabinet of Ministers of Ukraine “On approval of description and rules for National conformity mark usage”.


 

The UkrSEPRO mark consists of a sign standing for the UkrSEPRO certification systemcombined with the Certification Body registration number under it.

 

3-Application Scope 

The UkrSEPRO certification system concerns the majority of products sold or/and used in Ukraine:

- consumer products such as foodstuff, textiles, cosmetics and toys

- mechanical and electrical goods

- industrial equipments for food, chemical, oil & gas, construction industries

- telecom equipment

- vehicles

                   - other industries

 

UkrSEPRO covers a wider range of products compared to GOST R system. For example,telecom products are included to UkrSEPRO whereas in Russia, they fall under Telecom Type Approval, which is separate from GOST R.

 

4-How Can You Obtain UkrSEPRO? 

 

Firstly, your products are evaluated and translated by our team and this information is submitted to the official bodies in Kiev in Ukrainian language. For evaluation for the price, an official application is necessary.

 

Secondly, if our proposal is accepted, the process is started and authorized auditors will come and check your production for the conformance. In this case, some samples are taken for testing, and they are sent to the Kiev for evaluation.

 

Lastly, all test are completed, within 15 days and the original Certificates will be sent directly to your address after approval of preliminary drafts of Certificates by you.

Procedure

The UkrSEPRO system is monitored jointly by the State Committee on Technical Regulation and Consumer Policy or Derzhspozhyvstandard and the Federal Customs Service of Ukraine.

 

UkrSEPRO Certificates of Conformity are issued by Certification Bodies accredited by Derzhspozhyvstandard to act on its behalf.

 

The issuance of UkrSEPRO Certificates of Conformity is implemented after technical evaluation of the goods that may include the following:

 

- evaluation of technical documents

- surveillance visits

- sampling, analysis, type testing in accredited laboratories

- factory audits

          - in some cases certification of quality management system

 

The presence of mandatory information and correct translation can be checked by Certification Body who may also give advice concerning technical translation and labeling information for the items to be imported.

 

5-Sorts of UkrSEPRO Certificates: 

 

The variation of UkrSEPRO mostly depend of the duration : 
 

UkrSEPRO Certificates for Single Delivery : In this case, there is an importer Ukrainian Company applies for certification for an individual delivery. This certificate given to the importer according to the Contract and Invoice, for the goods of this delivery. For a different delivery or a different buyer, this certificate is not valid. Sample tests sometimes necessary.

 

UkrSEPRO Certificates for 1 year serial production : These kind of Certificates are given on basis technical documentation and sample tests. Auditing in the factory is not required. For the companies which has ISO 9000 System, are more acceptable, in these evaluations, the products are checked by the Ukrainian norms. Sample tests are necessary.

 

UkrSEPRO Certificates for 2 year serial production : These Certificates are given after auditing on the factory, signing the inspection statement and other documentation, choice and test of samples in Kiev. ISO 9000 helps to collecting documentation, but not essential to obtain UkrSEPRO certificate. This kind of certification is advised, because it has enough duration and it is not very expensive beside long term (5 years) certificates. Sample tests are necessary.

 

UkrSEPRO Certificates for 5 year serial production : In this case, even the company has ISO 9000 from western organizations, it is not enough to obtain 5 year certificate. The Ukrainian Certification Organ checks the firm for all the requirements of ISO 9000 for a long period, after approval parallel to certification work goes on. After testing of the samples this kind of certificates are given to the manufacturer. Every year certainly repeated the inspection control and additional test reports are obligatory. Because of these reasons we don't advise this kind certification to the companies as a difficult and expensive certification. 

6-Sample of Certificates


To know more about UkrSEPRO and our deliverables through our unique process approach, click here or contact us for a discussion.

Why Is It Necessary?

Every country is delayed with the quality of the goods which are imported in. Similarly, theUkraine behaves in the same way and the UkrSEPRO certification carries a great importance in Ukrainian Customs.  

On the other hand, in the domestic market, the local certificate UkrSEPRO is more important than international certificates as ISO 9000 for the reliability and prestige aspects. All of the wholesalers should obtain UkrSEPRO for sales, any foreign or local producers as well.

Integrated Management Systems

ISO 9001, ISO 14001, OHSAS, HACCP ISO22000 management systems are collected in unique roof and systems which is applied whole and requirements are met in same time.

 

Companies give important to customers with ISO 9001 QMS applying, to environment with ISO 14001 with EMS, OHSAS (TS) 18001 occupational health and safety system, for food safety HACCP (ISO 22000) applying shows.

 

Traditionally, organizations have focused on establishing management systems that demonstrate compliance with each specific requirement, sometimes in isolation or even conflict. Whereas in a perfect world, you should have one system that runs your organization and addresses all of its objectives at once, be they quality, environment or any other aspect. It’s a challenge to satisfy the needs of several management systems while running a business. But achieving this can be beneficial to your organization’s efficiency and effectiveness, as well as reducing the cost and disruption of external audits.

 

Proof That You Are Committed to Enhancing Efficiency

Achieving certification of your integrated management system against the relevant standards demonstrates your commitment to efficiency and employee/customer satisfaction, as well as improving your corporate image.

Standards against which your management system may be simultaneously certified through an integrated audit include:


Quality: ISO 9001:2000 
Environment: ISO 14001 
Occupational Health & Safety: OHSAS 18001 
Food Safety: HACCP, ISO 22000 
Aerospace: AS 9000 
Specific sector or customer requirements 
Customer service standards


 

The benefits of Integrated Management Systems

Building an Integrated Management System to address your various requirements enables a more streamlined flow of information throughout the company, plus an improved recognition and understanding of responsibilities and interrelationships.

With a company working as an integrated whole, operational efficiency is increased and overall performance improved, risks are reduced as responsibilities become clearer. In addition, integrating your Management Systems approach can also reduce the cost, time and disruption you may incur while handling separate 3rd party audit and certification programs. 

 

Working with ACAR Quality Consultancy to support integration of your management systems will help your organization develop and improve performance. At ACAR Quality Consultancy, we understand that each audit and certification must contribute to meeting the overall and individual objectives of your organization. Our approach to the development and delivery of an integrated audit program of your management systems ensures a valuable, cost-effective and timely service for every client. You will receive individual certification against each standard (where appropriate). In addition, ACAR Quality Consultancy will issue a Merit Statement summarizing your achievement. 

 

Regular ongoing assessment by ACAR Quality Consultancy helps you to continually apply, improve and monitor your management systems and processes. This improves the reliability of your internal operations to meet customer requirements, as well as overall performance. You may also gain a significant improvement in internal collaboration and in staff motivation and commitment.

 

Possibility Integrated Management Systems (QMS)
 

» Q-E Model


• ISO 9000 + ISO 14001
• ISO/TS 16949 + ISO 14001
• ISO 13485 + ISO 14001
• TL 9000 + ISO 14001
• AS 9100 + ISO 14001
» Q-IS Model 
• ISO 9000 + ISO 27000
» Q-ITS Model 
• ISO 9000 + ISO 20000
» Q-FS Model 
• ISO 9000 + ISO 22000 
» Q-HS Model 
• ISO 9000 + OHSAS 18000
• ISO/TS 16949 + OHSAS 18000
• ISO 13485 + OHSAS 18000
• TL 9000 + OHSAS 18000
• AS 9100 + OHSAS 18000
» Q-S Model 
• ISO 9000 + SA 8000
» Q-CMMi Model 
• ISO 9000 + CMMi 
» Q-SHE Model 
• ISO 9000 + ISO 14001 + OHSAS 18000
• ISO/TS 16949 + ISO 14001 + OHSAS 18000
• ISO 13485 + ISO 14001 + OHSAS 18000
• TL 9000 + ISO 14001 + OHSAS 18000
• AS 9100 + ISO 14001 + OHSAS 18000
» Q-SHEF Model 
• ISO 9000 + ISO 14001 + OHSAS 18000 + ISO 22000
» Q-SHEF Model 
• ISO 9000 + ISO 14001 + OHSAS 18000 + SA 8000
» E-HS Model 
• ISO 14001 + OHSAS 18000
» E-S Model 
• ISO 14001 + SA 8000
» E-FS Model 
• ISO 14001 + ISO 22000
» ITS-S Model 
• ISO 27000 + ISO 22000
» HS-FS Model 
• OHSAS 18000+ ISO 22000
» HS-S Model 
• OHSAS 18000 + SA 8000

Quality and Productivity Training

QUALITY MANAGEMENT  COURSES

DURATION

ISO 9001  Quality Foundation

1 Day

 ISO 9001  Quality  Internal Audit

1 Day

 ISO 9001  Quality  Lead Assessor (Registered)

5 Day

 

ENVIRONMENTAL COURSES

DURATION

ISO 14001 Environmental Foundation

1 Day

ISO 14001 Environmental Internal Audit

1 Day

ISO 14001 Environmental Lead Assessor (Registered)

5 Day

 

HEALTH & SAFETY  SHORT COURSES

DURATION

 OHSAS 18001 Health and Safety Foundation

4 days

 OHSAS 18001 Health and Safety Internal Audit

1 day

OHSAS 18001 Health and Safety  Lead Assessor (Registered)

3 Day

 

FOOD SAFETY  SHORT COURSES

DURATION

ISO 22000 Food Safety Foundation

4 days

 ISO 22000 Food Safety Internal Audit

1 day

 ISO 22000 Food Safety Lead Assessor (Registered)

3 Day

 

MANAGEMENT SHORT COURSES

DURATION

Absenteeism

1 Day

Appraisal Interview

2 Day

Assertiveness

1 Day

Coaching Skills

1 Day

Customer Satisfaction Programme

2 Days

Decision Making

1/2 Day

Feedback in Difficult Situations

1 Day

Handling difficult Customers

1 Day

Influencing Skills

1 Day

Managing Change

1 Day

Managing Effective Meetings

1/2 Day

Managing Stress

1 Day

Presentation Skills

2 Day

Selection Interviewing

1 Day

Supervisor Skills & Team Building

2 Day

Telephone technique

1 Day

Time Management

1 Day

Five Way Management

1/2 Day

 

QA SHORT COURSES

TIME

5 Why's (Gemba Gembutsu)

1 Day

8D Structured Problem Solving

2 Day

APQP

1 Day

AS 9100 Foundation

1 Day

AS 9100 Audit

1 Day

Business Process Analysis (BPA)

1 Day

Customer Satisfaction

1 Day

Failure Mode & Effects Analysis (FMEA)

1 Day

Fault Tree Analysis (FTA)

1 Day

ISO TS 16949 Foundation (1 Day)

1 Day

ISO TS 16949 Foundation (2 Day)

2 Day

ISO TS 16949 Internal Audit

1 Day

ISO TS 16949 Lead Assessor (IRCA Reg.)

5 Day

ISO 13485 Foundation

1 Day

ISO 13485 Audit

1 Day

ISO 9001:2000 Foundation

1 Day

Auditor Training CD Rom (Distance Learning)

 

ISO 9001 Internal Audit (1 Day)

 1 Day

ISO 9001 Internal Audit (2 Days)

2 Day

ISO 9001 Lead Assessor Course (IRCA Reg.)

5 Day

ISO 27001 - See Security Zone

 

ISO 20000 Foundation

1 Day

ISO 20000 Auditing

1 Day

ISO 22000 Lead Auditor (IRCA Reg.)

5 Day

Inspection Techniques

1 Day

Kaizen

2 Day

Measuring Techniques

1 Day

MiniTab

1 Day

MUDA & the Seven Wastes

1 Day

Poka-Yoke

1 Day

Principles & Practices of Quality Management (P&PQM) (3 Days)

3 Day

Process Mapping

1 Day

PPAP

1 Day

Quality Awareness CD Rom

 

Root Cause Analysis (RCA)

1 Day

Statistical Process Control (SPC)

1 Day

Six Sigma

 

Yellow Belt

2 Day

Green Belt

5 Day

Green Belt via Distance Learning

 

Green Belt Registration with British Quality Foundation (BQF)

 

Black Belt (extension)

5 Day

Black Belt (extension) via Distance Learning

 

Black Belt

10 day

Black Belt  via Distance Learning

 

Black Belt Registration with (BQF)

 

Software Quality Assurance (TickIT)

1 Day