Conformity Assessment and Accreditation Mike Peet Chief Executive Officer

1. Conformity Assessment and Accreditation Mike Peet Chief Executive Officer South African National Accreditation System

2. What is Accreditation? ACCREDITATION Accreditation Body Accreditation Body Need to promote global trade Accreditation Services WTO Request for ensuring competence of CABs Certification Bodies Certification Bodies Inspection Bodies Laboratories Request for CA CA Services Products/Services meeting specifications Suppliers (QMS) Products/ Services Purchasers Consumers ------------------ Regulators Market

3. ISO 9000 CERTIFICATION

4. ISO 9000 CERTIFICATION

5. ISO 14000CERTIFICATION

6. ISO 14001CERTIFICATION

7. WHAT IS THE TREND IN LABORATORY ACCREDITATION

8. ACCREDITATION • Procedure by which: • an authoritative body gives; • a formal recognition; • that a body is competent to carry out specific tasks of Conformity Assessment (CA). • It reduces risks: • for business and its customers • by assuring them that: accredited bodies are competent to carry out the CA work.

9. REQUIREMENTS FOR CONFORMITY ASSESSMENT • Laboratories: ISO/IEC 17025 • QS certification bodies: ISO/IEC Guide 62 • EMS certification bodies: ISO/IEC Guide 66 • Product certification bodies: ISO/IEC Guide 65 • Inspection bodies: ISO/IEC 17020 • Personnel certification bodies: Draft ISO/IEC 17024 (ISO/IEC Guide 62 and ISO/IEC Guide 66 are being revised to be integrated as Draft ISO/IEC 17021)

10. WHAT ISSANAS The South African National Accreditation System. (SANAS) • Formed as a result of Cabinet decision. • Establishment of a single national accreditation body in South Africa. • Umbrella organisation to allow an efficient, co-ordinated approach to accreditation.

11. SCOPEOF ACTIVITY • Accreditation of Certification Bodies QMS, EMS, Personnel, Product(ISO 9000, ISO 14000, etc.) • Accreditation of Laboratories(ISO GUIDE 25, ISO 17025, etc.) • Accreditation of Inspection Bodies (ISO 17020, SABS 0227, etc.) • Accreditation of Proficiency Scheme Providers (ISO GUIDE 43)

12. RESPONSIBILITIES • Encourage accreditation of certification and inspection bodies and laboratories. • International recognition and acceptance of certificates • Harmonise practices and ensure competence within accredited facilities • Harmonise practices and ensure consistency amongst accredited facilities • Establish and maintain critical information and a data base of accredited organisations in South Africa • International mutual recognition agreements (MRA) • Reduce cost of international trade

13. STRUCTURE RAAF DTI Interaction SANAS BOARD &CEO Laboratory/Inspection Division QMS/EMS/Personnel & Product Division Laboratories Certification Bodies Personnel Certifiers

14. STRUCTURE

15. ACCREDITATION PROCESS  ORGANISATION PREPARES DOCUMENTATION AND IMPLEMENTS SYSTEMS IN COMPLIANCE WITH RELEVANT REQUIREMENTS APPLICATION FOR ACCREDITATION TO SANAS OPTIONAL PRE-ASSESSMENT VISIT ASSESSMENT OF THE APPLICANT DOCUMENTATION SITE ASSESSMENT BY SANAS ASSESSORS RESULTS OF DOCUMENTATION AND SITE ASSESSMENTS EVALUATED BY THE APPROVALS COMMITTEE AND ACCREDITATION STATUS DECIDED SPECIALIST TECHNICAL COMMITTEES  AUDIT SAMPLES/ PROF. TEST. Guide 43  SURVEILLANCE VISITS BY SANAS ASSESSORS SANAS BOARD WITHDRAWAL OF ACCREDITATION

16. NML SABS SEMI-STATE PRIVATE ASSESSORS 12% 10% 34% 44%

17. NML SABS SEMI-STATE PRIVATE AAC 14% 3% 25% 58%

18. NML SABS SEMI-STATE PRIVATE STC 10% 10% 29% 51%

19. FACTORS INFLUENCING THE ACCREDITATION DECISION • Results of Proficiency Testing / Audit Sample measurement • The recommendation of the Lead Assessor and the assessment team • Technical guidelines from SANAS Specialist Technical Committees

20. WHAT MAKES SANAS ACCEPTABLE? • We have to comply with international criteria (includes Quality Management system criteria and demonstration of our technical competence with regard to the various sectors we accredit in). • Peer evaluation by international teams with relevant expertise. • Constant updating and benchmarking

21. INTERNATIONAL RECOGNITION LABORATORIES • European co-operation for the Accreditation of laboratories (EA)- calibration since 1993 • Testing since February 1997 mutual acceptance of SANAS certificates in following European countries (Ireland, UK, Holland, France Germany, Switzerland, Sweden, Norway, Denmark, Italy, Spain, Finland, Belgium, Portugal, Austria) • ILAC Arrangement, November 2000, Australia, Belgium, Brazil, Canada, People’s Republic of China, Czech Rep, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Rep of Korea, The Netherlands, New Zealand, Norway, Singapore, South Africa, Spain, Sweden, Switzerland, Chinese Tapei, United Kingdom, USA, Vietnam

22. INTERNATIONAL RECOGNITION CERTIFICATION BODIES • Signed the International Accreditation Forum (IAF) Multilateral Agreement in October 1998 for Quality Management Systems ISO 9000. Gives recognition in EA countries, Australia, New Zealand, Japan, Canada, USA (RAB), China. • Bilateral with EA for Environmental Management Systems ISO 14000

23. BENEFITS OF BECOMING ACCREDITED • Impartial feedback from independent examinations by experts against a defined scope of activity • Comparisons of technical ability against similar facilities • Customer has access to independent complaint mechanism • National in International recognition of competence • International benchmarking

24. CONCLUSION • Accreditation = Impartial and ongoing examination of competence of a facility by an independent and nationally recognised body (SANAS). • Without Accreditation? • Risk to Customer based on assumption • How much risk?