Challenging times for ISO and international standardization

1
(No Transcript)
2

• International Standards and
• Conformity Assessment
• by Mr. Graeme Drake, Head of Conformity
  Assessment
• ISO Central Secretariat
• UNECE WP6 on
• Regulatory Cooperation and Standardization
  Policies
• Geneva, Switzerland
• 24 November, 2004

3
The technical infrastructure

• Corporate, Public and Trade Policy
• Industry association, Government Ministry or
  Department
• Require technical infrastructure to
• manage risk
• be economically efficient
• incorporate externalities and protect against
  market failure
• ensure the public's confidence in the economy
  and
• participate in the free trade of goods and
  service
• UN and WTO

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 Regional bodies

• Claims of conformity and certification
•  
• This is the process by which a person or company
  claims a good or service conforms with a standard
  or technical specification
•  
• 1st party
• 2nd party
• 3rd party
•  
• After a claim of conformity or certification, at
  any level, marks of conformity can be issued to
  the product or service
• Testing and inspection activities

Accreditation and peer assessment
services   Further activity to ensure confidence,
consistency and competence 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
4
Standardization in the model
Policy
Metrology (measurement and physical standards)
Documentary standards
Claims of conformity and certification

• Accreditation
• Peer Assessment

• Over 200 technical committees in various sectors,
  over 2000 subcommittees and working groups
• One 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
  consensus
• Number of possible publications
• ISO 90012000 one of its biggest standards
• Increasing adoption and usage of international
  standards due to WTO agreements
• General adherence by national bodies to rules for
  standards

5
Conformity assessment
Policy
Metrology (measurement and physical standards)
Documentary standards
Claims of conformity and certification

• Accreditation
• Peer Assessment

• Developing technical requirements in regulations
  or standards is ½ the story
• After that, mandatory or voluntary testing,
  inspection and assessment of the product, system
  or service may be required, and sometimes this
  results in a lable or a mark of conformity
• This has the potential to affect production
  costs, economic efficiency, and international
  trade
• ISO and IEC jointly produce international guides
  and standards that set the agreed requirements on
  how the international conformity assessment
  operates.
• This is done through the ISO Committee on
  conformity assessment (CASCO) which has 99
  countries represented

Conformity assessment
6
ISO and its structure

• ISO is a international technical NGO
• 148 countries, a mixture of government,
  semi-government and private bodies
• Each national member body is to represent its
  government, industry and consumer views
• Develops international policy and reflects this
  in international standards and guides
• Based on consensus through application of the
  ISO/IEC Directives
• Recognition with related bodies include IEC, ITU
  and sector specific standardising bodies
• Liaison with a number of international bodies

7
ISO and the WTO/TBT

• Fully compliant with the six WTO/TBT criteria for
  international standards
• WTO TBT 3rd Triennial Review
• Good Regulatory Practices
• minimizing the use of mandatory technical
  regulations and utilizing voluntary international
  standards, where appropriate, could reduce the
  regulatory burden and open up market access
  opportunities
• avoidance of unnecesary obstacles to trade in
  the preparation, adoption and application of
  technical regulations (including associated
  standards) and conformity assessment procedures,
  including those related to labelling

8
ISO and the WTO/TBT

• Article 5
• Sets out (for government bodies) the use of
  international guides or recommendations and
• the importance of Members using and playing
  a full part in the preparation by appropriate
  international standardizing bodies of guides and
  recommendations for conformity assessment
  procedures
• ... Moreover the Committee (TBT) notes the
  increasing development of international standards
  for conformity assessment procedures.

9
ISO and the WTO/TBT

• Article 6.1.1 Accreditataion
• identifies accreditation as a possible tool for
  Members to verify the technical competence of CA
  bodies.
• When operated according to relevant
  international standards, accreditation offers
  a mechanism which could promote confidence.
• This could reduce trade barriers when
  governmental authorities accept the results of
  accredited bodies.
• Members ensuring that accreditation bodies
  follow provisions on transparence and openess.

10
ISO/CASCO

• 99 members of ISO are members of CASCO
• CASCO undertakes both policy and technical work
• At present it is undertaking a major revision of
  most of its documents, converting some of them
  (those specifying requirements) from guides to
  standards
• There are four areas of focus
• Study and policy
• Technical work (the tool box)
• Promotion and advice
• Market feedback

11
Process and structure
12
Principle 1 the functional approach

• Accepted by CASCO in 2002, the functional or
  process approach sets out the generic framework
  for all conformity assessment activities
• This forms the basis for the new international
  standard on conformity assessment vocabulary
  (17000)

13
Principle 2 International agreements

• WTO Agreements
• ISO/IEC Guide 602004, Code of good practice

14
Principle 3 Common elements

• Internally focused exercise to ensure
  international documents on conformity assessment
  approach the following elements in a common way
  for consistency
• Impartiality
• Confidentiality and public disclosure
• Complaints and appeals
• Management systems

15
General CASCO documents

• ISO/IEC 170002004 Vocabulary and general
  principles and ISO/IEC Guide 22004
• ISO/IEC Guide 602004 Code of good practice
• Common elements
• Impartiality (will be PAS 17001)
• ISO PAS 170022004 Confidentiality
• ISO PAS 170032004 Complaints and appeals
• Disclosure of information (will be PAS 17004)
• Use of management systems in conformity
  assessment (will be PAS 17005)

16
CASCO documentsfor claims of conformity - general

• Testing and calibration laboratories
• ISO/IEC FDAM 17025 to become ISO/IEC 170252005
• Proficiency testing
• ISO/IEC Guide 431997
• Inspection bodies
• ISO/IEC 170201998

17
CASCO documentsfor claims of conformity

• 1st party ISO/IEC 170502004 Suppliers
  declaration of conformity
• 3rd party Product certification
• ISO/IEC Guide 672004 Fundamentals of product
  certification
• ISO/IEC Guide 282004 System 5
• ISO/IEC Guide 532005 Use of the suppliers QMS in
  product certification
• ISO/IEC Guide 651996 for product certification
  bodies
• 3rd party Management systems certification
  (ISO/IEC Guides 62 and 66 to be replaced by
  ISO/IEC 17021)
• 3rd party Marks of conformity (ISO/IEC
  170302003)

18
ISO/IEC Guide 672004

• Outlines 7 product certification systems that
  combine several of the following core elements
  related to product certification
• Sampling
• Testing
• Evaluation
• Decision
• Licensing
• Surveillance

19
ISO/IEC Guide 282004

• General description of one organizational and
  operating approach to product certification based
  on system 5 in ISO/IEC Guide 67
• ISO/IEC Guide 28 covers
• Contracting
• Sampling
• Testing
• Evaluation
• Surveillance
• Certification decision

20
ISO/IEC Guide 282004

• Provides model documents
• Checklist for selecting product requirements
• Application for product certification
• Contract
• Factory inspection
• Conformity certificate

21
CASCO documents for confidence and mutual
recognition

• ISO/IEC 170112004 Accreditation
• ISO/IEC 170402005 Peer assessment
• ISO/IEC Guide 682002 Mutual recognition of
  conformity assessment results (MRAs)

22
ISO/IEC 170112004

• ISO/IEC 170112004, Conformity assessment -
  General requirements for accreditation bodies
  accrediting conformity assessment bodies
• Will replace
• ISO/IEC Guide 581993, Calibration and testing
  laboratory accreditation systems -- General
  requirements for operation and recognition
• ISO/IEC Guide 611996, General requirements for
  assessment and accreditation of
  certification/registration bodies
• ISO/IEC TR 170101998, General requirements for
  bodies providing accreditation of inspection
  bodies

23
ISO/IEC 17011 contd.

• Scope
• Normative references
• Terms and definitions
• Accreditation body
• Management
• Human resources
• Accreditation process
• Responsibilities of the accreditation body and
  the conformity assessment body

24
ISO/IEC 17011 contd.

• inclusion of impartiality
• prohibition on directly undertaking other
  conformity assessment services or consultancy
• bodies related to the accreditation body may do
  this but must have
• different top management
• different people
• no influence
• distinctly different name, logos and symbols
• deliberate identification and management of
  relationships that have the potential for a
  conflict of interest

25
Process and structure
26
Promotion and Support

• Help in writing International Standards so that
  they may be used in conformity assessment
• Promote CASCO tool box to end users
• Provide advice on establishment of conformity
  assessment systems
• Have a specific focus on the use of CASCO
  documents by regulators
• ISO Brochure on Publicising your ISO 9001 and ISO
  14001 certification

27
Market feedback

• Gives interpretations on CASCO documents
• Undertakes market research and surveys to find
  out how widely are the CACSO documents used and
  what people think of them
• Regulators survey 2004
• Triennial comprehensive survey of use and
  national adoption of CACSO documents
• Advises CASCO on new documents and timing of
  revisions based on market feedback

28

• Thank you for your attention
• Please ask questions!
• Mr. Graeme Drake, (drake_at_iso.org)