1. QUALITY INDUSTRY NATIONAL CONFERENCE “EMPOWERING FUTURE QUALITY PROFESSIONALS” What is Conformity Assessment? D. Iain Muir Senior Manager: Compliance Management SABS Member of the Quality Management and Conformity Assessment Chamber

2. Conformity assessment in context Corporate, Public and Trade Policy Industry association, Government Ministry or Department Require technical infrastructure to: manage risk; be economically efficient; incorporate ‘externalities’ and protect against market failure; ensure the public's confidence in the economy; and participate in the free trade of goods and service WTO Agreements Metrology (measurement and physical standards) Legal metrology (weights and measures) Scientific measurement (microbiological, chemical and non legal physical properties) - Generally a mixture of government owned or private laboratories and research interests International organisations (BIPM and OIML) Regional bodies Documentary standards A range of organisations may develop documentary standards. In the ISO system each country has one national standards representative In some sectors government Ministries or Departments make and define documentary standards Regional bodies

3. Conformity assessment in context Claims of conformity and certification This is the process by which a person or company claims their product or service conforms to a standard or technical specification 1st party 2nd party 3rd party After a claim of conformity or certification, at any level, marks of conformity can be issued to the product or service Testing and inspection activities Peer assessment and accreditation services Further activity to ensure confidence, consistency and competence Often government or quasi- government bodies These bodies have formed regional and international organisations to ensure there is consistency on how peer assessment and accreditation is performed (IAF, ILAC and IEC Schemes) and is the basis for MRAs Conformity assessment

4. Introduction to Conformity Assessment Why Conformity Assessment? Purpose to help companies beginning to explore the possibility of obtaining certification for themselves or their products in order to trade, market or win contracts. to help customers who are seeking clarification of the various certification claims they encounter. For conformity assessment practitioners and bodies.

5. Introduction to Conformity Assessment Governments want to be sure that a countries technical infrastructure is adequate and comparable in order to accept goods Technical infrastructure can be seen in terms of “hardware” and “software” Technical “software” Technical “hardware” SANS, ISO/IEC CASCO standards and guides (provide the “rules” for the hardware) National Measurement Laboratories National Standards Institutes Laboratories Certification Bodies Accreditation Bodies

6. Mechanisms for conformity assessment Testing Inspection Certification Management system Personnel Product Accreditation Mutual recognition & Peer assessment Supplier's declaration of conformity The decision to use one type of conformity assessment, depends on the customer's requirements, the level of risk associated with the product/service and regulatory requirements

7. First party – technical term used when conformity assessment to a standard, specification or regulation is carried out by the supplier organization itself it is a self-assessment known as a supplier's declaration of conformity. Second party – performed by the customer of the organization for example the manufacturer would allow his customer to do an assessment of the product against the requirements Conformity Assessment activities can be characterized as: Mechanisms for conformity assessment

8. Third party – performed by a body that is independent of the organization that provides the product and is not a user of the product for example an independent certification body certifies that another organization conforms with ISO 9001 and issues it with a certificate to this effect Conformity Assessment activities can be characterized as: Mechanisms for conformity assessment

9. Testing - Definition Determination of one or more characteristics of an object of conformity assessment, according to a procedure. NOTE “Testing” typically applies to materials, products or processes. ISO/IEC 17000:2004 (4.2) Testing Inspection Certification Accreditation Mutual recognition & Peer assessment Supplier's declaration of conformity Mechanisms for conformity assessment

10. Common form of conformity assessment Provides the basis for other types of conformity assessment like inspection and product certification Product is tested against a specified set of criteria Used to make decisions on the performance of the product Depending on specific requirements from customers and the risk associated with the product, the testing laboratory may choose to be accredited ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories. ISO 15189:2007 Medical laboratories - Particular requirements for quality and competence Mechanisms for conformity assessment

11. Inspection - Definition Examination of a product design, product, process or installation and determination of its conformity with specific requirements or, on the basis of professional judgement, with general requirements NOTE: Inspection of a process may include inspection of persons, facilities, technology and methodology ISO/IEC 17000:2004 (4.3) Testing Inspection Certification Accreditation Mutual recognition & Peer assessment Supplier's declaration of conformity Mechanisms for conformity assessment

12. Inspection bodies Examine a huge range of products, materials, installations, plants, processes, work procedures and services, in the private as well as the public sector, and report on such parameters as quality, fitness for use and continuing safety in operation Overall aim to reduce risk to the buyer, owner, user or consumer of the item being inspected ISO/IEC 17020 General criteria for the operation of various types of bodies performing inspection Mechanisms for conformity assessment

13. Certification - Definition- Third party attestation related to products, processes, systems or persons” ISO/IEC 17000:2004 (5.5) NOTE 1 Certification of a management system is sometimes also called registration NOTE 2 Certification is applicable to all objects of conformity assessment except for conformity assessment bodies themselves, to which accreditation is applicable Attestation – “Issue of a statement based on a decision following review that fulfillment of specified requirements have been demonstrated” ISO/IEC 17000:2004 (5.2) Testing Inspection Certification Accreditation Mutual recognition & Peer assessment Supplier's declaration of conformity Mechanisms for conformity assessment

14. What is Certification? When a third party gives written assurance that: product (including services), process, personnel, organization or management system conforms to specific requirements “Certification” and “registration” are interchangeable Use of one over the other is largely dependant on the geographical region Mechanisms for conformity assessment

15. Best-known Management System certifications - ISO 9001 & ISO 14001 More than 1 000 000 organizations worldwide certified to ISO 9001 and/or ISO 14001 Management certification is not carried out by ISO ISO does not control the certification bodies ISO does contribute to best practice and consistency of certification bodies through the development of standards and guides Mechanisms for conformity assessment

16. Sector specific standards –  have their basis in ISO/IEC 17021  only differ in those areas which are deemed absolutely necessary and relate specifically to the discipline covered  example, food safety and ISO/TS 22003 General standard – ISO/IEC 17021:2006 General requirements for bodies providing audit and certification of management systems  is applicable for all types of management systems generally Mechanisms for conformity assessment

17. Product certification may consist of: initial product testing with assessment of the quality management system followed up by testing of samples from the factory and/or the open market initial testing and surveillance testing type testing : testing of a sample product The type of product certification scheme chosen Will depend on the level of risk to the consumer as well as other factors For a very low risk product you may have a once-off type test For a high risk product you may have a scheme which has type testing, requires an ISO 9001 management system in place with regular product testing from the factory and also products taken from the outlets for testing Mechanisms for conformity assessment

18. ISO/IEC Guide 65:1996 General requirements for bodies operating product certification systems [Draft = ISO 17065]  can be used in combination with a number of related product standards and guides  to demonstrate that a product complies with specified criteria Mechanisms for conformity assessment

19. Other standards and guides in this family  ISO/IEC Guide 23:1982 (Reconfirmed in 2003) – Methods of indicating conformity with standards for third-party certification systems  ISO/IEC Guide 28:2004 – Conformity assessment - Guidance on a third-party certification system for products  ISO/IEC Guide 53:2005 – Conformity assessment - Guidance on the use of an organization's quality management system in product certification  ISO/IEC Guide 67:2004 – Conformity assessment - Fundamentals of product certification Mechanisms for conformity assessment

20. Objectives of certification of personnel Achieving and promoting a globally accepted benchmark for organizations operating certification of persons Certification of persons is one means of providing assurance that the certified person meets the requirements of the certification scheme Confidence in the respective conformity assessment schemes is achieved by means of a globally accepted process Conformity Assessment Auditor competence: General = ISO 19011 Conformity Assessment Auditor competence: Third party = ISO 17021-Part 2 (Still in draft) Mechanisms for conformity assessment

21. ISO/IEC 17024:2003 (Under Revision) Conformity assessment - General requirements for bodies operating certification of persons  Requirements for a body certifying persons against specific requirements, including the development and maintenance of a certification scheme for personnel Mechanisms for conformity assessment

22. Accreditation - Definition Third-party attestation related to a conformity assessment body conveying formal demonstration of its competence to carry out specific conformity assessment tasks ISO/IEC17000:2004 (5.6) Testing Inspection Certification Accreditation Mutual recognition & Peer assessment Supplier's declaration of conformity Mechanisms for conformity assessment

23. Accreditation is the procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks Management System Accreditation indicates to the client of the certification body that its competence to do the certifications has been independently confirmed Accreditation of testing laboratories, product certification and inspection bodies is independent verification that they are competent to perform the activities for which they are accredited ISO/IEC 17011 Conformity assessment - General requirements for accreditation bodies accrediting conformity assessment bodies Mechanisms for conformity assessment

24. Mutual/Multilateral arrangement/agreement Arrangement or agreement whereby more than two parties recognize or accept one another’s conformity assessment results ISO/IEC 17000:2004 (7.9) Testing Inspection Certification Accreditation Mutual recognition & Peer assessment Supplier's declaration of conformity Mechanisms for conformity assessment

25. How can confidence be achieved? Through cross-border cooperation among conformity assessment bodies and also among accreditation bodies What do MRA’s achieve ?  Reduce the multiple conformity assessment that products, services, systems, processes and materials may need to undergo, especially when they are traded across borders  Contribute to the efficiency of the international trading system by facilitating the acceptance of goods and services everywhere on the basis of a single assessment in one country, Benefit suppliers and customers alike Mutual Recognition Agreements (MRA's) Mechanisms for conformity assessment

26. ISO/IEC Guide 68: 2002 Arrangements for the recognition and acceptance of conformity assessment results Mechanisms for conformity assessment

27. Peer assessment - Definition assessment of a body against specified requirements by representatives of other bodies in, or candidates for, an agreement group ISO/IEC 17000:2004 (4.5) agreement group bodies that are signatories to which an arrangement is based ISO/IEC 17000:2004 (7.10) Testing Inspection Certification Accreditation Mutual recognition & Peer assessment Supplier's declaration of conformity Mechanisms for conformity assessment

28. Peer Assessments are useful To demonstrate competence To ensure quality To create and keep mutual confidence Peer assessment process Carried out by peers or by agreement groups of accreditation bodies or conformity assessment bodies Other certification bodies, other laboratories,etc Parties with similar experiences, training, competence ISO/IEC 17040:2005 Conformity assessment — General requirements for peer assessment of conformity assessment bodies and accreditation bodies Mechanisms for conformity assessment

29. Testing Inspection Certification Accreditation Mutual recognition & Peer assessment Supplier's declaration of conformity ISO/IEC 17050 – 1:2004 Supplier's declaration of conformity - Part 1: General requirements Supplier's declaration of conformity (SDoC) Mechanisms for conformity assessment

30. Purpose of ISO/IEC 17030: enable a uniform approach to the use of third-party marks of conformity to address potential problems arising from different uses of third-party marks of conformity ISO/IEC 17030 concentrates on third party marks of conformity but may also be used as guidance for other applications of marks of conformity ISO/IEC 17030 is based on market feedback and demands from various users and issuers of marks of conformity assessment Marks of Conformity Mechanisms for conformity assessment

31. Confidence in safety, health, environment, fair commerce Regulations based on risk Choice of activities Testing Inspection SDOC Certification Accreditation Independence and Rigor of Conformity Assessment accreditation Verification of competence Perceived Risk supplier’s declaration 1 st party conformity assessment certification 3 rd party conformity assessment 10 0 0 Mechanisms for conformity assessment Selection

32. What is Conformity Assessment? D. Iain Muir iain@sabs.co.za Thank you for your attention