Transcript Regulation, conformity assessment and standards

The international technical
infrastructure and the
International Organization for
Standardization (ISO)
Graeme Drake, ISO Central Secretariat, Geneva
12-14 November 2002,
Hyatt Regency Hotel
Bishkek, Kyrgyzstan
5 topics…
Technical infrastructure model
The model at various levels – an example
Reasons why we need it
The role of ISO in the model
Standards and conformity assessment
practices
Technical infrastructure model
Policy
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; and
participate in
the free trade of
goods and service
WTO Agreements
Regional
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)
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
Regional bodies
Certification and
claims of
conformity
Peer assessment
and accreditation
services
This is the process
by which a person
or company claims
a good or service
is in compliance
with a standard or
technical
specification
Backup level of
check.
1st party
2nd party
3rd 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
Often government
or quasigovernment
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
IEC
ITU-T
CODEX
International
Agreement on
Technical Barriers to Trade
Regional
IQNet, IIOC
Australia
APLMF
Certification
bodies
New Zealand
POLICY
METROLOGY
(PHYSICAL STANDARDS)
SCIENTIFIC LEGAL
DOCUMENTARY
STANDARDS
CERTIFICATION
AND CLAIMS OF
CONFORMITY
Certification
bodies
Regulators
Measurement
Standards
Laboratory
Trading Standards Service
(Legal weights and measures)
PEER ASSESSMENT
AND
ACCREDITATION
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 competition
International commitments – WTO - Notification
Globalisation and competitive advantage
Private sector requirements
Managerial, owner (shareholder) and consumer confidence
Contractual specifications
Marketing and brand differentiation
ISO and its structure
ISO is a international technical NGO
140 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
Recognition with related bodies
include IEC, ITU and sector specific
standardising bodies
Liaison with a number of
international bodies
Its special because it produces both
sector and horizontal standards and
guides
ISO standardization in the model
Policy
Metrology
(measurement
and physical
standards)
Documentary
standards
Certification
and claims of
conformity
Over 200 technical committees in various
sectors, over 2000 subcommitees 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 9001:2000 one of its biggest standards
Increasing adoption and usage of international
standards due to WTO agreements
• Accreditation
• Peer
Assessment
New work proposal (NP)
Working Draft (WD)
Committee Draft (CD)
Draft International Standard (DIS)
Final DIS
Published
ISO conformity assessment in the model
Policy
Metrology
(measurement
and physical
standards)
Documentary
standards
Certification
and claims of
conformity
Developing the technical requirements, including
the publishing of a standard, is ½ the story
After that, mandatory or voluntary assessment of
the product, system or service may be required,
and sometimes a mark of conformity as well
This has the potential to either increase or
decrease costs, or enhance or retard international
trade
ISO/CASCO has developed international guides and
standards on how to undertake this assessment
function – i.e. assessment of conformity –
conformity assessment
• Accreditation
• Peer
Assessment
Conformity
assessment
Types of assessment of conformity
Declaration of conformity by 1st party
Suppliers declaration of conformity (SDoC)
CASCO future standards 17050 and 17049
Assessment of conformity by 2nd party
Procurement chain contracts
Government purchasing
Assessment of conformity by 3rd party
Product certification
Management systems certification
Mandatory or voluntary conformity assessment
Specific CASCO documents
Current document
1st
Party
ISO/IEC Guide 22:1996
General criteria for supplier’s declaration of conformity
2nd
Party
No specific documents
3rd
Party
ISO/IEC Guide 23:1982
Methods for indicating conformity with standards for third-party
certification systems
New document
Group
Date
ISO/IEC 17050
and 17049
WG 24
SDoC
Aug
2004
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
Party
ISO/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 Guide 66:1999
General requirements for bodies operating
assessment and certification/registration of
environmental management systems (EMS)
ISO/IEC 17021
General requirements for
bodies operating
assessment and
certification of management
systems
WG 21
Management
systems
2005
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 processes
Regardless of what type of assessment of conformity is
being employed there are some fundamental process
steps
Current document
Testing
Auditing
Group
Date
ISO/IEC 17025:1999 AMD1
General requirements for the
competence of testing and
calibration laboratories
WG 25
Jun
2004
Methods of test stipulated by TCs
ISO/IEC 17025:1999
General requirements for the
competence of testing and calibration
laboratories
Inspection
New document
ISO/IEC 17020:1998
General criteria for the operation of
various types of bodies performing
inspection
ISO/IEC 19011:2002
Guidelines for quality and/or
environmental management systems
auditing
Accreditation and Peer Assessment
Accreditation
Current document
New document
Group
Date
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 17040
General requirements for
peer assessment of
conformity assessment
bodies
WG 19
Dec
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
Marks of conformity assessment
CASCO WG 12 is developing ISO/IEC 17030
Third party marks of conformity and their use
Products cannot carry systems related
compliance marks
Systematic 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 2003
Implications for the discussion of labelling at the
WTO TBT
Mutual recognition arrangements
G2G MUTUAL
RECOGNITION
REGULATOR
REGULATOR
DESIGNATES
DESIGNATES
VOLUNTARY
MUTUAL
RECOGNITION
ACCREDITATION
BODY A
ACCREDITATION
BODY B
ACCREDITS
CERTIFIES
Management System /
Product/Personnel/
laboratories and tests
CONFIDENCE
ACCREDITS
CONFIDENCE
CERTIFICATION
BODIES
ISO/IEC
Guides
and
Standards
CERTIFICATION
BODIES
CERTIFIES
Management System /
Product/Personnel/
laboratories and tests
ISO/IEC
Guide 68
MRAs –
Dec 2002
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
[email protected]