Conformity Assessment and Accreditation Mike Peet Chief Executive

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

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

ISO 9000 CERTIFICATION 450, 000 408, 631 400, 000 343, 643 350, 000 271, 847 300, 000 223, 299 250, 000 200, 000 162, 701 127, 349 150, 000 100, 000 70, 364 46, 571 50, 000 0 Sept ’ 93 J une ’ 94 Dec. ’ 95 Dec. ’ 96 Dec. ’ 97 Dec. ’ 98 Dec. ’ 99 Dec. ’ 00 Num bers of QM S certi fi cati on

ISO 9000 CERTIFICATION / Af West Asia 4.9% Austral New- Zealan 6.7% a m e r Central and South Americas 2.6% Nor th 11.8% Rubber and plastic products 5.7% Basic metal ＆ fabricated metal products 12.8% Wholesale & retail trade 5.8% Electr optical equipment 12.0% Far East 20.0% Construction 10.2% Others 46.1% d （TOTAL 408631） Europe 53.9% QMS certification by region (Y2000) （TOTAL 317126） Machiner equipment 7.3% QMS certification by industrial sector (Y2000) y

ISO 14000 CERTIFICATION 25, 000 22, 897 20, 000 14, 106 15, 000 7, 887 10, 000 4, 433 5, 000 257 0 Dec. ’ 95 1, 491 Dec. ’ 96 Dec. ’ 97 Dec. ’ 98 Dec. ’ 99 Number s of EMS Cer t i fi cat i on Dec. ’ 00

ISO 14001 CERTIFICATION Austral New- Zealan 4.9% / Af West Asia 2.8% r Central and South Americas 2.4% n Construction 5.4% Food product bever tobacco 4.3% Electrical and optical equipment 16.0% North America 7.3% Chemical chemical products 9.0% Far East 34.4% Basic met fabricated metal products 5.7% Europe 48.1% （TOTAL 317126） EMS certification by region (Y2000) Others 54.1% d Machiner equipment 5.5% （TOTAL 17476） EMS certification by industrial sector (Y2000)

WHAT IS THE TREND IN LABORATORY ACCREDITATION 250 200 150 100 50 0 Cal. Labs 1980 1990 1981 1991 1982 1992 Test Labs 1983 1993 1984 1994 Total 1985 1995 1986 1996 1987 1997 1988 1998 1989

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.

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)

WHAT IS SANAS 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.

SCOPE OF 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)

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

STRUCTURE DTI RAAF Interaction SANAS BOARD &CEO Laboratory/Inspection Division Laboratorie s QMS/EMS/Personnel & Product Division Certification Bodies Personnel Certifiers

STRUCTURE B o a rd o f D ir e c t o r s A c c r e d it a t io n A p p ro va l C o m m it t e e L a b o r a to ry / I n s p e c t io n D iv is io n C e r t if ic a t io n B o d y D iv is io n STC Test STC C a lib r a t io n STC I n s p e c t io n STC QMS STC EMS STC P e rs o n n e l A c c r e d it e d L a b o ra to ry A c c r e d it e d L a b o ra to ry A c c r e d it e d I n s p e c t io n B o d y A c c r e d it e d C e r t if ic a t io n b o d y A c c r e d it e d C e r t if ic a t io n b o d y A c c r e d it e d C e r t if ic a t io n b o d y

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

ASSESSORS ASSESSORS NML NML 12% 12% SABS SABS 10% 10% SEMI-STATE SEMI-STATE PRIVATE PRIVATE 34% 44% 34% 44% Assessors used by SANAS NML SABS Semi-State Private

AAC AAC NML NML 14% 14% SABS SABS 3% 3% SEMI-STATE PRIVATE SEMI-STATE PRIVATE 25% 58% 25% 58% Accreditation Approval Committees NML SABS Semi-State Private

STC STC NML NML 10% 10% SABS SABS 10% 10% SEMI-STATE SEMI-STATE PRIVATE PRIVATE 29% 51% 29% 51% Specialist Technical Committees NML SABS Semi-State Private

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

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

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

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

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

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?