Slide 0

Report
Presentation to ITU Consultation on
Conformity Assessment and
Interoperability Testing
Mr. Sean Mac Curtain
Head, Conformity Assessment
CASCO Secretary
20 July 2009, Geneva
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20 July 2009
ISO CS, Geneva
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Contents
What is conformity Assessment
CASCO structure
Conformity assessment standards and the CASCO toolbox
CASCO working groups
Standards development
Conformity Assessment process
Mutual Recognition
CASCO projects
Conclusions
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What is conformity assessment?
Conformity Assessment:
The demonstration that specified requirements
relating to a product, process, system, person or
body are fulfilled.
[Clause 2.1,
ISO/IEC 17000:2004(E): Conformity assessment — Vocabulary and
general principles]
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The 1-1-1 dream of Conformity Assessment
1
1
Standard
Test
Accepted
everywhere
1
Conformity
Assessment
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ISO/CASCO structure
107 ISO members are
represented in CASCO
(71 participating members and
36 observers).
Fifteen international
organizations are liaison
members of CASCO:
BIPM, CEOC, CODEX
Alimentarius, EOQ, Eurolab, IAF,
IFAN, IFIA, IIOC, ILAC, IPC,
IQNet, ITU-T, OIML, UILI.
Both policy and technical work
Continual improvement cycle
CASCO Secretary acts as
Secretary for ISO 9000 Advisory
Group (IAG)
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CASCO Interpretation Panel
Need identified at CPC. Provide a uniform consistent
approach to interpretation and maintenance of existing
standards and guides.
Request to NMB which will where relevant be forwarded
to CASCO.
Interpretation Panel within CPC will address all queries in
a reasonable time.
Possibility of “quick” response or detailed response.
Response will be available on Web page.
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The ISO/CASCO toolbox
The CASCO toolbox consists of 25 documents
covering:
Vocabulary, principles and common elements of
conformity assessment.
Code of good practice.
Product, system, and persons certification.
Testing, calibration, inspection, marks of conformity.
Supplier’s declaration of conformity, accreditation,
peer assessment, and mutual recognition
arrangements.
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Components of the CASCO toolbox (1)
General standards and guides
Subject
Document
Publication date
17000
2004
Code of good practice
Guide 60
2004
Mutual Recognition Arrangements
(MRA’s)
Guide 68
2002
Peer assessment
17040
2005
Accreditation
17011
2004
Marks of conformity
17030
2003
Vocabulary
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Components of the CASCO toolbox (2)
Technical functions
Subject
Document
Publication date
Suppliers declaration of conformity
17050
2004
Testing & calibration laboratories
17025
2005
Guide 43
1997
17020
1998
Guide 23, 28
2003, 2004
Guides 53, 65, 67
2005, 1996, 2004
System certification
17021
2006
Person certification
17024
2003
Proficiency Testing
Inspection
Product certification
For a full list of CASCO documents, visit www.iso.org and follow this path:
Conformity Assessment > Publications and resources > List of CASCO standards and guides
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The “CASCO Toolbox” relationships…
Requirements for accreditation bodies –ISO/IEC 17011 (2004)
Requirements for Certification bodies
Requirements
Requirements
for
for
testing &
Inspection
calibration
bodies
Persons
Part 2 in
preparations
laboratories
ISO/IEC
ISO/IEC
17025
17020
(2005)
(1998)
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20 July 2009
Management
Systems
Products
Conformity
assessments of
suppliers
Revision
Agreed
ISO/IEC 170501
ISO/IEC 170502
(2004)
ISO/IEC
17021
ISO/IEC
17024
ISO/IEC
Guide 65
(2006)
(2003)
(2006)
ISO CS, Geneva
Mutual Recognition ISO/IEC 17040 (2005)
Terms and definitions – ISO/IEC 17000 (2001)
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ISO/IEC 17011
Conformity assessment – General requirements for accreditation
bodies accrediting conformity assessment bodies (2004)
Can also be used as a requirements document for the peer
evaluation process for MRA between accreditation bodies
Competence based document
Important for the purchaser, regulator and the public to know that
CABs are competent to perform their tasks. Increasing the
demand for their competence to be verified. This verification is
done by AB
Also important to know that the AB’s globally operate
competently and that this too is verified though peer
assessment to this standard
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ISO/IEC 17007
Principles and guidance for drafting normative
documents suitable for use for conformity
assessment (FDIS)
Intended for standards developers not applying
the ISO/IEC Directives – industry associations
and consortia, purchasers, regulators,
consumers and non-government groups, AB’s
CAB’s scheme owners etc
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ISO/IEC 17007 continued
Contains 5 principles:
1) Separation of specified requirements for the object
of CA from specified requirements related to CA
activities
2) Neutrality towards parties performing CA activities
3) Functional Approach to CA (selection, determination,
review and attestation and surveillance)
4) Comparability of CA results
5) Good practice in CA
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ISO/IEC 17025
General requirements for the competence of testing and
calibration laboratories (2005)
Competence to carry out tests and/or calibrations
including sampling based
Focused on technical issues and quality management
Applicable to all test and calibration laboratories
(Generic)
Guildelines for establishing applications for specific
fields – should not add additional general
requirements
Revision 2010
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ISO/IEC 17021
Conformity assessment – Requirements for
bodies providing audit and certification of
management systems
Principles and requirements for the
competence, consistency and impartiality of the
audit and certification of management
systems of ALL types and for the bodies
providing these activities
Management system – system to establish policy
and objectives and to achieve those objectives
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ISO/IEC Guide 65 (ISO/IEC 17065)
General requirements for bodies operating product
certification systems (1996)
Undergoing revision to ISO/IEC 17065
Principles and requirements for the competence,
consistency and impartiality of the certification bodies
evaluating and certifying products, processes and
services.
Certification of products, processes and services is a
3rd party CA activity. Therefore bodies performing
this activity are 3rd party conformity assessment bodies
called “certification bodies”
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ISO/IEC 17050 Parts 1 and 2
Conformity assessment – Suppliers declaration of
conformity P1 – general requirements
Part 2 – Supporting documentation (to substantiate a
SDoC)
Purpose is to give assurance of conformity of the
identified object to specified requirements to which
the declaration refers and to identify who is
responsible for that conformity and declaration.
May be used alone or in conjunction with another
conformity assessment procedure for regulatory or
non-regulatory purposes
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Common elements
ISO/IEC International Standards and Guides on
conformity assessment are written on an understanding
of some basic common elements
Impartiality (ISO/PAS 17001)
Confidentiality (ISO/PAS 17002)
Complaints and appeals (ISO/PAS 17003)
Disclosure of information (ISO/PAS 17004)
Use of management systems (ISO/PAS 17005)
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CASCO projects in progress
ISO/IEC 17021 Part 2 (CASCO WG 21), Conformity assessment —
Requirements for 3rd party certification auditing of management systems
(DIS)
ISO/IEC 17007 (CASCO WG 27), Conformity assessment — Guidelines for
drafting normative documents for use for conformity assessment (FDIS)
ISO/IEC 17043 (CASCO WG 28), Conformity assessment — Requirements
for proficiency testing (FDIS)
ISO/IEC 17065 (CASCO WG 29), Conformity assessment — Requirements
for certification bodies certifying products (including services) and processes
(CD)
ISO/IEC 17020 (CASCO WG 31), Conformity assessment — General
criteria for the operation of various types of bodies performing inspection
(WD)
ISO/IEC 17024 (CASCO WG 30), Conformity assessment — General
requirements for bodies operating certification of persons (WD)
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CASCO Working Groups
ISO/CASCO P Members nominate to the WG.
A-Liaison members nominate to WG. D-Liaison can be established
between an organization and a WG.
They are nominated as experts and required to input as experts. WG
group members act as independent experts not as national
delegates.
The WG develops a Working draft document (WD). It evolves into a
Committee Draft (CD) document.
The CD goes to member bodies who distribute to NMC (NMC) for
CASCO.
At this stage no longer the experts but the national consensus
comments.
Responsible for the development of the document (Standard/Guide)
(DIS and FDIS and publication).
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Common Structure
Following a CASCO resolution (12/2002), CASCO Standards
should follow the same structure, wherever possible
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Informative
Preliminary
Title page
Table of contents
Foreword
Introduction (including relationship to other standards)
Normative
General
Title
Scope
Normative references
Normative
Technical
Terms and definitions
Principles
Requirements
Structural requirements
Resource requirements (including Human resources)
Process requirements (including operational functions)
Management system requirements
Normative annexes
Informative
supplementary
Any further explanations that are not part of the normative process
Informative annexes
Bibliography
Indexes
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Conformity Assessment Standards
- Standards generation
ISO Standard
A normative document, developed according to consensus
procedures, which has been approved by the ISO membership
and P-members of the responsible committee in accordance
with Part 1 of the ISO/IEC Directives as a draft International
Standard and/or as a final draft International Standard and
which has been published by the ISO Central Secretariat
ISO/PAS Publicly available specification
A normative document representing the consensus within a
working group.
ISO/TS Technical specification
A normative document representing the technical consensus
within an ISO committee
ISO/TR Technical report
An informative document containing information of a different
kind from that normally published in a normative document.
International Workshop Agreement (IWA)
An IWA is an ISO document produced through workshop
meeting(s) and not through the technical committee process.
ISO Guide
Guides provide guidance to technical committees for the
preparation of standards, often on broad fields or topics
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Conformity Assessment (CASCO)
Objective of CASCO is to ensure that, wherever Conformity
Assessment is used by ISO TC’s, it is used and applied in a
consistent manner and the rules are the same.
We saw the majority of “rules” are contained in ISO/IEC
17007. This rules have been taken from the ISO/IEC
Directives clause 6.7
CASCO has "rules" for when a Technical Committee
needs to use Conformity Assessment.
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ISO/CASCO Rule 1: Neutrality
ISO/CASCO has a neutral policy with regard to the
application of standards by 1st, 2nd or 3rd parties
(includes accreditation).
Standards must be written in a manner that they can
be used through 1st party, 2nd party or 3rd party
conformity assessment activities.
The application of 1st, 2nd or 3rd party should be
decided on by the client ( or regulator) and not by the
TC.
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ISO/CASCO Rule 2
Sector policy is not to encourage the unnecessary
proliferation of sector scheme documents but to assist
where there is a real need.
Food, Motor, Telecommunications, IT
ISO 22000 is Food safety Management System and
cannot contain CA procedures but can develop another
document ISO/TS 22003 which is based on ISO/IEC
17021 and contains the requirements for CB that certify to
ISO 22000.
There are rules for when a sector wishes to develop its
own scheme.
Before a sector develops their own scheme,
communication should be sought between the sector and
CASCO
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Mutual Recognition
International Accreditation Forum (IAF)
International Laboratory Accreditation Cooperation (ILAC)
Peer evaluation
National AB - Country A
Mutual recognition
ISO/IEC 17011
Laboratory
Recognition & acceptance
CB
ISO/IEC 17021
ISO/IEC 17065
Company A
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20 July 2009
ISO/IEC 17011
Laboratory
ISO/IEC 17025
ISO/IEC 17025
Test report
for CB
National AB - Country B
Recognition & acceptance
CB
ISO/IEC 17021
ISO/IEC 17065
Recognition & acceptance
ISO
9001/Product
Recognition & acceptance
Company B
Test report
for CB
ISO
9001/Product
ISO CS, Geneva
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CASCO Priority Projects
IAF-ISO action plan on monitoring the effectiveness of
accredited management system certification
Management system annual survey
A liaisons and interaction with sectors
Changes to clause 6.7 of the Directives
Representation on CASCO WG’s
IAF mandatory documents versus CASCO generated
documents
Interaction with ISO/TC’s
Relationship with intergovernmental organizations
Developing countries and CASCO and
UNIDO/DEVCO/CASCO publications
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Conclusions on conformity assessment
A global framework for conformity assessment will increase consumer and regulator
confidence by:
Providing a common interpretation of test results;
Providing a mechanism for acceptance of certificates and reports
Ensuring consistency and building confidence in products and services
Applying to the International Standards a principle of neutrality;
Defining good practices for market surveillance.
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Useful reading
My ISO Job – Guidance for delegates and experts
Joining in – Participating in International
Standardization
ISO/IEC Directives Part 1 and 2 (mainly used by WG
Convenors and Secretaries)
→ all these documents are available on the TC Server
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Useful links
Very useful information directly available on ISO Website:
ISO Standards development flowchart
ISO Standards development process
and much more at:
http://www.iso.org/iso/standards_development.htm
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ISO
Contact
[email protected]
[email protected]
[email protected]
[email protected]
Thank you
www.iso.org
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20 July 2009
ISO CS, Geneva
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