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Conformity Assessment and Accreditation
Mike Peet
Chief Executive Officer
South African National Accreditation System
ACCREDITATIONAccreditation Body
Certification Bodies
InspectionBodies Laboratories
Suppliers(QMS)
PurchasersConsumers
------------------Regulators
WTO
Products/Services meeting
specifications
Request for ensuring competence of CABs
Need to promote global trade
CA Services
Accreditation Services
Market
What is Accreditation?
Products/Services
Request for CA
Certification Bodies
Accreditation Body
ISO 9000 CERTIFICATION
408, 631
343, 643
271, 847
223, 299
162, 701127, 349
70, 364
46, 571
0
50, 000
100, 000
150, 000
200, 000
250, 000
300, 000
350, 000
400, 000
450, 000
Sept ’ 93 J une ’ 94 Dec. ’ 95 Dec. ’ 96 Dec. ’ 97 Dec. ’ 98 Dec. ’ 99 Dec. ’ 00
Numbers of QMS certi fi cati on
ISO 9000 CERTIFICATION
Basic metal &fabricated metal
products12.8%
Electr ic a l a n doptical equipment
12.0%
Construction10.2%
Machiner y a n dequipment
7.3%
Others46.1%
Wholesale & retailtrade…5.8%
Rubber and plasticproducts
5.7%
TOTAL 317126( )
QMS certification by industrial sector (Y2000)
Far East20.0%
Australi a /New- Zealan d
6.7%
Central and SouthAmericas
2.6%
Af r ic a /West Asia
4.9%
Nor th A m e ri c a11.8%
Europe53.9%
TOTAL 408631( )
QMS certification by region (Y2000)
2571, 491
4, 433
7, 887
14, 106
22, 897
0
5, 000
10, 000
15, 000
20, 000
25, 000
Dec. ’ 95 Dec. ’ 96 Dec. ’ 97 Dec. ’ 98 Dec. ’ 99 Dec. ’ 00
Numbers of EMS Cert i fi cat i on
ISO 14000CERTIFICATION
ISO 14001CERTIFICATION
North America7.3%
Central and SouthAmericas
2.4%
Australi a /New- Zealan d
4.9%
Af r ic a /West Asia
2.8%
Europe48.1%
Far East34.4%
TOTAL 317126( )
EMS certification by region (Y2000)
Electrical andoptical equipment
16.0%
Chemical s ,chemical products
9.0%
Others54.1%
Machiner y a n dequipment
5.5%
Basic met a l &fabricated metal
products5.7%
Construction5.4%
Food product s ,bever ag e s a n d
tobacco4.3%
TOTAL 17476( )
EMS certification by industrial sector (Y2000)
WHAT IS THE TREND IN LABORATORY ACCREDITATION
0
50
100
150
200
250
Cal. Labs Test Labs Total
1980 1981 1982 1983 1984 1985 1986 1987 1988 19891990 1991 1992 1993 1994 1995 1996 1997 1998
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 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.
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)
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
SANAS BOARD &CEO
Laboratory/InspectionDivision
QMS/EMS/Personnel & Product Division
Laboratories
Certification Bodies Personnel Certifiers
Interaction
STRUCTURE
A ccreditationA pproval
C om m ittee
A ccreditedLaboratory
S TCTest
A ccreditedLaboratory
S TCC alibration
A ccreditedInspection B ody
S TCInspection
Laboratory /Inspection
D ivis ion
A ccreditedC ertif ication body
S TCQ M S
A ccreditedC ertif ication body
S TCE M S
A ccreditedC ertif ication body
S TCP erson nel
C ertif ication B odyD ivis ion
B oard ofD irec tors
ORGANISATION PREPARES DOCUMENTATION AND
IMPLEMENTS SYSTEMS IN COMPLIANCE WITH
RELEVANT REQUIREMENTS
OPTIONAL PRE-ASSESSMENT
VISIT
APPLICATIONFOR ACCREDITATION
TO SANAS 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
SURVEILLANCE VISITS BY
SANAS ASSESSORS
AUDIT SAMPLES/
PROF. TEST.Guide 43
SPECIALISTTECHNICAL
COMMITTEES
SANAS BOARDWITHDRAWAL OF ACCREDITATION
ACCREDITATION
PROCESS
NML SABS SEMI-STATE PRIVATE
ASSESSORS 12% 10% 34% 44%
NML SABS SEMI-STATE PRIVATE
ASSESSORS 12% 10% 34% 44%
Assessors used by SANAS
NML
SABS
Semi-State
Private
Accreditation Approval Committees
NML
SABS
Semi-State
Private
NML SABS SEMI-STATE PRIVATE
AAC 14% 3% 25% 58%
NML SABS SEMI-STATE PRIVATE
AAC 14% 3% 25% 58%
NML SABS SEMI-STATE PRIVATE
STC 10% 10% 29% 51%
NML SABS SEMI-STATE PRIVATE
STC 10% 10% 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
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
WHAT MAKES SANAS ACCEPTABLE?
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