Conformity Assessment and Accreditation

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

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What is Accreditation?
ACCREDITATION
Accreditation Body
Accreditation Body
Need to promote global trade
Accreditation Services
WTO
Request for ensuring competence of CABs
Certification Bodies
Inspection Bodies
Laboratories
Certification Bodies
Request for CA
CA Services
Products/Services meeting specifications
Suppliers (QMS)
Purchasers Consumers ------------------ Regulators
Products/ Services
Market
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ISO 9000 CERTIFICATION

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ISO 9000 CERTIFICATION

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ISO 14000CERTIFICATION

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ISO 14001CERTIFICATION
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WHAT IS THE TREND IN LABORATORY
ACCREDITATION
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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.

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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)

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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.

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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)

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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

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STRUCTURE

RAAF
DTI
Interaction
SANAS BOARD CEO
Laboratory/Inspection Division
QMS/EMS/Personnel Product Division


Laboratories
Certification Bodies
Personnel Certifiers
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STRUCTURE

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ACCREDITATION PROCESS
 ORGANISATION PREPARES DOCUMENTATION AND
IMPLEMENTS SYSTEMS IN COMPLIANCE WITH RELEVANT
REQUIREMENTS
APPLICATION FOR ACCREDITATION TO SANAS
OPTIONAL PRE-ASSESSMENT VISIT
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

SPECIALIST TECHNICAL COMMITTEES 
AUDIT SAMPLES/ PROF. TEST. Guide 43
 SURVEILLANCE VISITS BY SANAS ASSESSORS
SANAS BOARD WITHDRAWAL OF ACCREDITATION
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NML
SABS SEMI-STATE PRIVATE ASSESSORS
12 10
34 44
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NML SABS
SEMI-STATE PRIVATE AAC 14
3 25
58

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NML SABS
SEMI-STATE PRIVATE STC 10
10 29
51

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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

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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

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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, Peoples 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

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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

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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

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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?