12-14 November 2002, Hyatt Regency Hotel Bishkek, Kyrgyzstan
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Transcript of 12-14 November 2002, Hyatt Regency Hotel Bishkek, Kyrgyzstan
The international technical infrastructure and the
International Organization for Standardization (ISO)
12-14 November 2002, Hyatt Regency Hotel
Bishkek, Kyrgyzstan
Graeme Drake, ISO Central Secretariat, Geneva
5 topics…
Technical infrastructure modelThe model at various levels – an exampleReasons why we need itThe role of ISO in the modelStandards and conformity assessment practices
Technical infrastructure modelPolicy
Government Ministry or Department
Technical infrastructures affect:manage risk;be economically efficient;incorporate ‘externalities’ and protect against market failure;ensure the public's confidence in the economy; andparticipate in the free trade of goods and service
WTO AgreementsRegional groupings
Metrology (measurement and physical standards) Legal metrology(weights and measures) Scientific measurement (microbiological, chemical and non legal physical properties) -
Generally a mixture of government owned or private laboratories and research interests International organisations (BIPM and OIML)
Regional bodies
Documentary standards A range of organisations may develop documentary standards. In the ISO system each country has one national standards representative In some sectors government Ministries or Departments make and define documentary standards
International standardisation bodies (ISO, IEC,ITU,CODEX etc)
Regional bodies
Certification and claims of conformity This is the process by which a person or company claims a good or service is in compliance with a standard or technical specification 1st party2nd party3rd party After certification or a claim of conformity, at any level, marks of conformity can be issued to the product or service
Testing and inspection activities
Peer assessment and accreditation services Backup level of check.
Often government or quasi-government bodies
These bodies have formed regional and international organisations to ensure there is consistency on how peer assessment and accreditation is performed (IAF, ILAC and IEC Schemes)
Basis for MRAs
Regional bodies
Many levels to the technical infrastructure
METROLOGY(PHYSICAL STANDARDS)
SCIENTIFIC LEGAL
DOCUMENTARYSTANDARDS
CERTIFICATIONAND CLAIMS OF
CONFORMITY
PEER ASSESSMENTAND
ACCREDITATIONPOLICY
Trading Standards Service(Legal weights and measures)
MeasurementStandardsLaboratory
Certification bodies
Agreement onTechnical Barriers to Trade
APLMF
Aus
tral
ia
New
Zea
land
Reg
iona
lIn
tern
atio
nal
Regulators
Certification bodies
IQNet, IIOC
IECITU-TCODEX
The basics… why we need a technical infrastructure?
Internal reasons - Efficient and sustainable domestic economies
Economic development and poverty alleviation – technology transfer
Good regulatory practice (GRP) - OECD, APEC and the European ‘New Approach’ – from prescriptive to performance based laws
Level of government intervention and economic efficiency
Risk management
Address market failure – social, health and safety, environment
Allowing for innovation
Interoperability and interconnectivity – the knowledge economy
The basics… why we need a technical infrastructure?
External reasons - Trade – A nation’s competitive advantage
Economic efficiency through competitionInternational commitments – WTO - NotificationGlobalisation and competitive advantage
Private sector requirementsManagerial, owner (shareholder) and consumer confidenceContractual specificationsMarketing and brand differentiation
ISO and its structureISO is a international technical NGO140 countries, a mixture of government, semi-government and private bodiesEach national member body is to represent its government, industry and consumer viewsDevelops international policy and reflects this in international standards and guidesRecognition with related bodies include IEC, ITU and sector specific standardising bodiesLiaison with a number of international bodiesIts special because it produces both sector and horizontal standards and guides
ISO standardization in the model
Published
Final DIS
Draft International Standard (DIS)
Com m ittee Draft (CD)
W orking Draft (W D)
New w ork proposal (NP)Over 200 technical committees in various sectors, over 2000 subcommitees and working groupsOne of the international standardising bodies (IEC, ITU-T, CODEX etc)Technical committees and standards development managed by individual ISO member bodies in accordance with the ISO/IEC Directives through consensusNumber of possible publicationsISO 9001:2000 one of its biggest standardsIncreasing adoption and usage of international standards due to WTO agreements
Policy
Metrology (measurement and physical standards)
Documentary standards
Certification and claims of
conformity
• Accreditation• Peer Assessment
ISO conformity assessment in the model
Developing the technical requirements, including the publishing of a standard, is ½ the storyAfter that, mandatory or voluntary assessment of the product, system or service may be required, and sometimes a mark of conformity as wellThis has the potential to either increase or decrease costs, or enhance or retard international tradeISO/CASCO has developed international guides and standards on how to undertake this assessment function – i.e. assessment of conformity – conformity assessment
Policy
Metrology (measurement and physical standards)
Documentary standards
Certification and claims of
conformity
• Accreditation• Peer Assessment
Conformityassessment
Types of assessment of conformityDeclaration of conformity by 1st party
Suppliers declaration of conformity (SDoC)CASCO future standards 17050 and 17049
Assessment of conformity by 2nd partyProcurement chain contractsGovernment purchasing
Assessment of conformity by 3rd partyProduct certificationManagement systems certification
Mandatory or voluntary conformity assessment
Specific CASCO documents
Current document New document Group Date
1st
Party
ISO/IEC Guide 22:1996
General criteria for supplier’s declaration of conformity
ISO/IEC 17050 and 17049
WG 24
SDoC
Aug
2004
2nd Party
No specific documents
3rd Party
ISO/IEC Guide 23:1982
Methods for indicating conformity with standards for third-party certification systems
Systematic review
2003
ISO/IEC Guide 28:1982
General rules for a model third-party certification system for products
ISO/IEC
Guide 28
WG14 Apr 2005
ISO/IEC Guide 53:1998
An approach to the utilization of a supplier's quality system in third party product certification
ISO/IEC
Guide 53
Adhoc Group on Guide 53
May 2004
Specific CASCO documents (2)3rd
PartyISO/IEC Guide 65:1996
General requirements for bodies operating product certification systems
ISO/IEC Guide 62:1998
General requirements for bodies operating assessment and certification/registration of quality systems
ISO/IEC 17021
General requirements for bodies operating assessment and
certification of management systems
WG 21
Management systems
2005
ISO/IEC Guide 66:1999
General requirements for bodies operating assessment and certification/registration of environmental management systems (EMS)
ISO/IEC Guide 67
Fundamentals of product certification
WG 14
Product certification
April 2005
ISO/IEC 17024
General requirements for bodies operating
certification of persons
WG 17
Personnel certification
July 2003
Supporting processesRegardless of what type of assessment of conformity is being employed there are some fundamental process steps
Current document New document Group Date
Testing Methods of test stipulated by TCs
ISO/IEC 17025:1999
General requirements for the competence of testing and calibration laboratories
ISO/IEC 17025:1999 AMD1
General requirements for the competence of testing and
calibration laboratories
WG 25 Jun 2004
Inspection ISO/IEC 17020:1998
General criteria for the operation of various types of bodies performing inspection
Auditing ISO/IEC 19011:2002
Guidelines for quality and/or environmental management systems auditing
Accreditation and Peer AssessmentCurrent document New document Group Date
Accreditation ISO/IEC Guide 53:1993
Calibration and testing laboratory accreditation systems -- General requirements for operation and recognition
ISO/IEC 17011
General requirements for bodies providing assessment
and accreditation of conformity assessment
bodies
WG 18 Feb
2004
ISO/IEC Guide 21:1996
General requirements for assessment and accreditation of certification/registration bodies
ISO/IEC TR 17010:1998
General requirements for bodies providing accreditation of inspection bodies
Peer Assessment ISO/IEC Guide 43:1997
Parts 1 and 2, Proficiency testing by interlaboratory comparisons
ISO/IEC 17040
General requirements for peer assessment of
conformity assessment bodies
WG 19 Dec 2004
Marks of conformity assessment
CASCO WG 12 is developing ISO/IEC 17030 Third party marks of conformity and their useProducts cannot carry systems related compliance marksSystematic review will take place of ISO/IEC Guide 27:1983 Guidelines for corrective action to be taken by a certification body in the event of misuse of its mark of conformity in 2003Implications for the discussion of labelling at the WTO TBT
Mutual recognition arrangements
Management System / Product/Personnel/
laboratories and tests
CERTIFICATION BODIES
ISO/IECGuides
and Standards
ISO/IEC Guide 68 MRAs –
Dec 2002
Management System / Product/Personnel/
laboratories and tests
CERTIFICATION BODIES
DESIGNATES
ACCREDITS
CERTIFIES CERTIFIES
ACCREDITATION BODY B
ACCREDITATION BODY A
CO
NF
IDE
NC
E
CO
NF
IDE
NC
E
VOLUNTARY MUTUAL
RECOGNITION
REGULATOR G2G MUTUAL RECOGNITION
REGULATOR
ACCREDITS
DESIGNATES
Further information on conformity assessment can be found at the following link:
http://www.iso.org/
or email Graeme Drake, Head of Conformity Assessment
and Secretary of ISO/CASCO at