Accreditation of Laboratories

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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?
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