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1 ISO CS, GenevaSMA20 July 2009
Presentation to ITU Consultation on Presentation to ITU Consultation on Conformity Assessment and Conformity Assessment and
Interoperability TestingInteroperability Testing
Mr. Sean Mac CurtainMr. Sean Mac Curtain
Head, Conformity AssessmentHead, Conformity AssessmentCASCO SecretaryCASCO Secretary
20 July 2009, Geneva20 July 2009, Geneva
2 ISO CS, GenevaSMA20 July 2009
ContentsContents
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
3 ISO CS, GenevaSMA20 July 2009
What is conformity assessment?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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1 Test
1 Conformity
Assessment
1Standard
Accepted everywhere
The 1-1-1 dream of Conformity AssessmentThe 1-1-1 dream of Conformity Assessment
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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)
ISO/CASCO structureISO/CASCO structure
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CASCO Interpretation PanelCASCO 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 The ISO/CASCO toolboxtoolbox
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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Subject Document Publication date
Vocabulary 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
General standards and guides
Components of the CASCO toolbox (1)Components of the CASCO toolbox (1)
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Technical functions
Subject Document Publication date
Suppliers declaration of conformity 17050 2004
Testing & calibration laboratories
Proficiency Testing
17025
Guide 43
2005
1997
Inspection 17020 1998
Product certificationGuide 23, 28
Guides 53, 65, 67
2003, 2004
2005, 1996, 2004
System certification 17021 2006
Person certification 17024 2003
Components of the CASCO toolbox (2)Components of the CASCO toolbox (2)
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…The “CASCO Toolbox” relationships…
Terms and definitions – ISO/IEC 17000 Terms and definitions – ISO/IEC 17000 (2001)(2001)
Requirements for accreditation bodies –ISO/IEC 17011Requirements for accreditation bodies –ISO/IEC 17011 (2004)(2004)
Conformity Conformity assessments assessments of suppliersof suppliers
ISO/IEC ISO/IEC 17050-117050-1
ISO/IEC ISO/IEC 17050-2 17050-2
(2004) (2004)
Mu
tual R
ecog
nit
ion
IS
O/I
EC
17040
Mu
tual R
ecog
nit
ion
IS
O/I
EC
17040
(2005)
(2005)
Requirements forRequirements for Certification Certification bodies bodies
ManagemenManagement t
SystemsSystems
Part 2 in Part 2 in preparationspreparations
ISO/IEC ISO/IEC 17021 17021
(2006)(2006)
Requirements Requirements
for for
testing & testing &
calibration calibration
laboratorieslaboratories
ISO/IEC ISO/IEC
17025 17025
(2005)(2005)
Requirements Requirements
for for
Inspection Inspection
bodiesbodies
ISO/IECISO/IEC
17020 17020
(1998)(1998)
ProductsProducts
Revision Revision AgreedAgreed
ISO/IEC ISO/IEC Guide 65 Guide 65
(2006)(2006)
Persons Persons
ISO/IEC ISO/IEC 17024 17024
(2003)(2003)
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ISO/IEC 17011ISO/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 17007ISO/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 continuedISO/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 17025ISO/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 17021ISO/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)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 2ISO/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 elementsCommon 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 progressCASCO 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 GroupsCASCO 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 StructureCommon Structure
Following a CASCO resolution (12/2002), CASCO Standards should follow the same structure, wherever possible
InformativePreliminary
Title pageTable of contentsForewordIntroduction (including relationship to other standards)
Normative General
TitleScope Normative references
Normative Technical
Terms and definitionsPrinciplesRequirementsStructural requirementsResource requirements (including Human resources)Process requirements (including operational functions)Management system requirementsNormative annexes
Informative supplementary
Any further explanations that are not part of the normative processInformative annexesBibliographyIndexes
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Conformity Assessment StandardsConformity Assessment Standards - Standards generation - 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)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: NeutralityISO/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 ISO/CASCO Rule 2Rule 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 Mutual Recognition
International Accreditation Forum (IAF)International Laboratory Accreditation Cooperation (ILAC)
National AB - Country AISO/IEC 17011
National AB - Country BISO/IEC 17011
Peer evaluation
Mutual recognition
LaboratoryISO/IEC 17025
LaboratoryISO/IEC 17025
CBISO/IEC 17021ISO/IEC 17065
CBISO/IEC 17021ISO/IEC 17065
Test reportfor CB
Company AISO
9001/ProductTest report
for CBRecognition & acceptance
Company BISO
9001/Product
Recognition & acceptance
Recognition & acceptance
Recognition & acceptance
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CASCO Priority ProjectsCASCO Priority ProjectsIAF-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 assessmentConclusions 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 readingUseful 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 linksUseful 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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ISOISO
Contact
maccurtain@iso.org
bleeker@iso.org
marinkovic@iso.org
emorine@iso.org
Thank youwww.iso.org