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

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?