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 70,364 100,000 46,571 50,000 0 Sept ’ 93 June ’ 94 Dec. ’ 95 Dec. ’ 96 Dec. ’ 97 Dec. ’ 98 Dec. ’ 99 Dec. ’ 00 Numbers of QMS certification ISO 9000 CERTIFICATION / Af r R u bbe r an d plas t ic We st A sia A u st r al 4 .9 % C e n t r al an d S o u t h N e w - Z e alan A m e r ic as 6 .7 % 2 .6 % pr o du c t s B as ic m e t al & 5 .7 % fabr ic at e d m e t al pr o du c t s 1 2 .8 % Wh o le s ale & r e t ail t r ade … a m e No r th 5 .8 % 1 1 .8 % Ele c tr F ar East o pt ic al e qu ipm e n t 2 0 .0 % 1 2 .0 % C o n s t r u c t io n 1 0 .2 % Ot hers 4 6 .1 % d M ac h in e r e qu ipm e n t (T O T A L 4 0 8 6 3 1 ) Eu r o pe 5 3 .9 % Q M S c e r t if ic a t io n b y r e gio n ( Y 2 0 0 0 ) (T O T A L 3 1 7 1 2 6 ) 7 .3 % Q M S c e r t if ic a t io n b y in d u s t r ia l s e c t o r ( Y 2 0 0 0 ) y ISO 14000 CERTIFICATION 25,000 22,897 20,000 14,106 15,000 7,887 10,000 4,433 5,000 257 0 D e c . ’9 5 1,491 D e c . ’9 6 D e c . ’9 7 D e c . ’9 8 D e c . ’9 9 Numbers of EMS Certification D e c . ’0 0 ISO 14001 CERTIFICATION / A u s t r al N e w - Z e alan 4 .9 % Af r We s t A s ia 2 .8 % C e n t r al an d S o u t h A m e r ic as 2 .4 % n be v e r E le c t r ic al an d C o n s t r u c t io n t o bac c o o pt ic al e qu ipm e n t 5 .4 % 4 .3 % 1 6 .0 % N o r t h A m e r ic a 7 .3 % c h e m ic al pr o du c t s F ar Eas t 9 .0 % 3 4 .4 % B as ic m e t f abr ic at e d m e t al pr o du c t s 5 .7 % (T O T A L 317126) E M S c e r t i f i c a t i o n b y r e gi o n ( Y 2 0 0 0 ) Eu r o pe O thers 4 8 .1 % 5 4 .1 % (T O T A L d M ac h in e r e qu ipm e n t 5 .5 % 17476) E M S c e r t if ic a t io n b y in d u s t r ia l s e c t o r (Y 2 0 0 0 ) 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 Board of Directors Accreditation Approval Committee Laboratory / Inspection Division Certification Body Division STC Test STC Calibration STC Inspection Accredited Laboratory Accredited Laboratory Accredited Inspection Body STC QMS STC EMS STC Personnel Accredited Accredited Accredited Certification body Certification body Certification body 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 NML SABS 12% 10% SEMI-STATE 34% PRIVATE 44% Assessors used by SANAS NML SABS Semi-State Private AAC NML SABS 14% 3% SEMI-STATE 25% PRIVATE 58% Accreditation Approval Committees NML SABS Semi-State Private STC NML SABS 10% 10% SEMI-STATE 29% PRIVATE 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?