Conformity Assessment

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Conformity Assessment

• ISO/IEC has defined conformity assessment as
• Conformity assessment is a term used to describe
  the whole process of accreditation and
  certification and is the process of determining
  whether product, processes, systems and people
  meet specified requirements.

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Conformity Assessment

• Certification bodies that grant registration to
  ISO 9001 have to be accredited by recognised
  national accreditation bodies.
• These same accreditation bodies directly accredit
  inspection bodies as well as testing and
  calibration (metrology) laboratories as here the
  requirements go far beyond a formal quality
  management system and require evaluation of the
  technical and infrastructural ability of the
  organisation to perform specific tests or
  measurements or to be proficient in declaring
  that for example pressure vessels are indeed safe.

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Conformity Assessment

• While accreditation is often thought to be mainly
  required for export purposes it has an even
  larger role to pay within a countrys domestic
  economy. Accreditation or conformity assessment
  provides confidence to the buyer or user of
  services.

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Conformity Assessment

• In the internal economy accredited laboratories
  are used to test food and water, concrete and
  other building materials, electrical and
  telecommunication test equipment and the basic
  measuring instruments used in the manufacturing
  industry.
• When you have a blood, urine or other medical
  test you need to have confidence that the outcome
  is correct and that you are nut incorrectly
  diagnosed as having HIV/Aids, malaria or a host
  of other diseases. Veterinary practices must be
  able to diagnose rabies and the many bovine
  diseases that affect both domestic and export
  sales such as foot and mouth, anthrax, mad cow
  disease etc.

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Conformity Assessment
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Conformity Assessment

• The diagram shows clearly that the matter should
  be taken as a whole. Every country needs to
  develop harmonically all the elements that are
  necessary to get international recognition of the
  conformity to certain standards of its exports
  and imports.

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Conformity Assessment

• Inspection
• Inspection has been defined by ISO on its
  Standard 17020 as Examination of product
  design, product, service, process or plant, and
  determination of their conformity with specific
  requirements or, on the basis of professional
  judgement, general requirements. The definition
  adds that inspection of processes includes
  personnel, facilities, technology and
  methodology, as well as that the results of
  inspection may be used to support certification.

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Conformity Assessment

• Inspection is a very important component of
  conformity assessment. It covers mainly
  activities done on industrial sites, like steel
  structures and equipment, pipeline maintenance
  and repair, personnel certification (welders),
  etc. Also, inspection agencies carry sampling of
  lots, submitted later to inspection and/or
  testing and certification. ISO 17020 insist on
  the command that personnel should have on
  statistical sampling an on the design of sampling
  plans.

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Conformity Assessment

• Certification bodiesCertification bodies are in
  charge of the certification of quality systems,
  of products, and of personnel. They are also
  accredited. The standards which requirements they
  should meet to become accredited are the
  following ones
• ISO/IEC STANDARD 17025 - Conformity assessment
  General requirements for the competence of
  testing and calibration laboratories.
• ISO/IEC STANDARD 17024 - Conformity assessment
  General requirements for bodies operating
  certification of persons.
• ISO/IEC 17050 specifies the general criteria for
  a supplier's declaration of conformity in
  relation to International Standards.

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Conformity Assessment

• Certification bodies (2)
• ISO/IEC GUIDE 61 - General requirements for
  assessment and accreditation of
  certification/registration bodies.
• ISO/IEC GUIDE 65 - General requirements for
  bodies operating product certification systems.
• ISO/IEC STANDARD 17020 - Conformity assessment
  General criteria for the operation of various
  types of bodies performing inspection.
• ISO/IEC GUIDE 62 - General requirements for
  bodies operating assessment and
  certification/registration of quality systems.

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Conformity Assessment

• ISO through its Committee CASCO has developed the
  following Guides and Standards, covering the
  following conformity assessment topics
• Vocabulary and general principles of conformity
  assessment
• The development of technical specifications
  suitable for use in conformity assessment
• Code of good practice for conformity assessment
• Operation of testing and calibration laboratories
  and activities
• Proficiency testing by interlaboratory
  comparisons
• Inspection bodies and activities
• Supplier's declaration of conformity (SDoC)
• Product certification bodies and activities
• Management system audit and certification bodies
  and activities
• Personnel certification bodies and activities

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Conformity Assessment

• ISO has developed the following Guides and
  Standards, covering the following conformity
  assessment topics (2)
• Marks of conformity
• Accreditation
• Peer assessment
• Mutual recognition of conformity assessment
  results.

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Conformity Assessment

• International Accreditation Bodies
• ILAC International Laboratory Accreditation
  Cooperation
• IAF International Accreditation Forum
• Regional Accreditation Bodies
• APLAC Asia Pacific Laboratory Accreditation
  Cooperation
• EAL European cooperation for Accreditation of
  Laboratories.
• EAC European cooperation for Accreditation of
  Certification
• AAAC Inter American Accreditation Cooperation
• SAD CMET Southern African Development Community
  Cooperation in Measurement Traceability

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Conformity Assessment
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Conformity Assessment

• EU New Approach Global approach,  Conformity
  Assessment, Legislation   Standardisation
• Since 1987 some 25 Directives, adopted on the
  basis of the New Approach and the Global
  Approach, have progressively come into force.
  These Directives have the dual purpose of
  ensuring the free movement of goods through
  technical harmonisation of entire product
  sectors, and of guaranteeing a high level of
  protection of public interest objectives

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Conformity Assessment

• Innovative features of this legislative technique
  include the definition of mandatory essential
  requirements, the setting up of appropriate
  conformity assessment procedures and the
  introduction of CE marking.
• Business and industry are given a wide choice of
  how to meet their obligations.
• The European standards bodies have the task of
  drawing up technical specifications which offer
  one route to complying with these essential
  requirements.

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Conformity Assessment

• Council Resolution of 07.05.1985, where a 'New
  Approach to technical harmonization and
  standards' is seen as an essential condition for
  improving the competitiveness of European
  industry.
• 2. The Global Approach was completed by Council
  Decision 93/465/EEC.  This Decision lay down
  general guidelines and detailed procedures for
  conformity assessment that are to be used in New
  Approach directives.

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Conformity Assessment

• List of the directives based on the New Approach
  and the Global Approach 
• Directives based on the principles of the New
  Approach which provide for CE marking
• Directives based on the principles of the New
  Approach or the Global Approach, but which do not
  provide for CE marking
• Directives based on the principles of the New
  Approach and the Global Approach
• Proposals for directives based on the
  principles of the New Approach or the Global
  Approach

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Conformity Assessment

• The purpose of this infrastructure arrive to the
• Mutual Recognition Agreements (MRAs). 

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Conformity Assessment

• MODULAR APPROACH TO CONFORMITY ASSESSMENT
• 93/465/EEC Council Decision of 22 July 1993
  concerning the various modules for the various
  phases of the conformity assessment procedures
  and the rules for the affixing and use of the CE
  conformity mark, which are intended to be used in
  the technical harmonization directives.

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Conformity Assessment

• Module A (internal production control)
• Module Aa (Module A plus some additional
• requirements
• Module B (EC type-examination)
• Module C (conformity to type)
• Module D (production quality assurance)
• Module E (product quality assurance)
• Module F (product verification)
• Module G (unit verification)

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