www.iso.orgwww.iso.org

International Organization International Organization for Standardizationfor Standardization

Update on the ISO 'tool box' of International Standards Update on the ISO 'tool box' of International Standards and Guides for conformity assessmentand Guides for conformity assessment

Mario O. WittnerMario O. WittnerISO/CASCO ChairmanISO/CASCO Chairman

Update on the ISO 'tool box' of International Standards Update on the ISO 'tool box' of International Standards and Guides for conformity assessmentand Guides for conformity assessment

Mario O. WittnerMario O. WittnerISO/CASCO ChairmanISO/CASCO Chairman

ISO CASCO/DEVCO - BIS Regional ISO CASCO/DEVCO - BIS Regional Workshop onWorkshop on

Certification and Conformity Assessment Certification and Conformity Assessment Building Confidence for Building Confidence for Developing CountriesDeveloping Countries

New Delhi–India, 6-7 December 2004New Delhi–India, 6-7 December 2004

ISO STRATEGY 2005-2010ISO STRATEGY 2005-2010in relation to conformity assessmentin relation to conformity assessment

SOME ACTIONS

To encourage the reference and use of standards developed by CASCO by regulators and sector initiatives

To consolidate the relationships with international accreditation bodies and the “operators” of conformity assessment

To monitor the references to ISO name in relation to conformity assessment and the adherence to ISO ethical principles

To provide, maintainTo provide, maintain

and promote and promote

a set of standards a set of standards

extensively used extensively used

for the implementation, for the implementation,

evaluation and recognitionevaluation and recognition

of good practicesof good practices

in Conformity Assessmentin Conformity Assessment

ISO/CASCOISO/CASCO

ISO develops International Standards and Guides on conformity assessment through its Committee on conformity assessment (ISO/CASCO)

99 countries are represented in ISO/CASCO

To study means of assessing the

conformity to standards

To study means of assessing the

conformity to standards

To prepare international normative documents

To prepare international normative documents

To promote mutual recognition and appropriate useof International Standards

To promote mutual recognition and appropriate useof International Standards

Pro

cess

ap

pro

ach

an

d

Pro

cess

ap

pro

ach

an

d

stru

ctu

rest

ruct

ure

Market Feedback

Panel(MFP)

Promotion and Support Group

(CAPS)

CASCO

WG5

WG12

WG14

WG18

WG19

WG21

WG22

WG23

WG24

WG25

WG26

Chairman's Policy and Coordinatio

n Group (CPC)

Regulators

Interface Group

Technical work

Use and feedback

Study and policy

Promotion and support

Study and policyStudy and policyChairman’s Policy and Coordination Group (CASCO CPC)Chairman’s Policy and Coordination Group (CASCO CPC)

MAIN TASKS

• To receive mandates or requests from ISO Council, and CASCO members and other interested parties

• To create recommendations on policies

• To ensure fulfillment of the policies and directives approved (the “Standardization Framework”)

• To plan and assign priorities for the development of standards (the “Standardization Framework”)

ISO/CASCO CPC constitutionISO/CASCO CPC constitution

MOU with ISO:IAF

ILAC

MOU with ISO:IAF

ILAC Others: as needed

Others: as needed

Representatives of internal “liaisons”: COPOLCO;

DEVCO; REMCO; ISO/TC 176; ISO/TC 207; ISO/TC 212

Representatives of internal “liaisons”: COPOLCO;

DEVCO; REMCO; ISO/TC 176; ISO/TC 207; ISO/TC 212

CASCO Working Groups Conveners: 14

CASCO Working Groups Conveners: 14

Secretariat:CASCO Secretary

Secretariat:CASCO Secretary

INTEGRATION OF THE CPC

INTEGRATION OF THE CPC

MEMBERS: IEC/CAB President

6 CASCO “P”members:

ABNT, AENOR, DGN,DSM, SAC, TSE

MEMBERS: IEC/CAB President

6 CASCO “P”members:

ABNT, AENOR, DGN,DSM, SAC, TSE

CASCO ChairmanCASCO Chairman

The CASCO four main policies (internal)The CASCO four main policies (internal)

Terminology

Common elements

Reference to QMS

Sector specific documents

ISO/IEC Standards & Guides ISO/IEC Standards & Guides on Conformity Assessment (examples)on Conformity Assessment (examples)

Subject Previous ISO/IEC document in 2003

Present situation Completion date

Vocabulary Guide 2:1996 17000:2004 (WG 5) 2004-11

Code of good practice Guide 60:1994 Guide 60:2004 (WG 22) 2004-10

Suppliers declaration of conformity Guide 22:1996 17050:2004 (WG 24) 2004-10

Product certification Guide 65:1996Guide 28:1982

Guide 28:2004 (WG 14)Guide 67:2004 (WG 14)

2004-10 

System certification Guide 62:1996Guide 66:1999

17021 (WG 21) 2006-06

Person certification 17024:2003    

Marks of conformity  17030:2003

Testing and calibration laboratories 17025:1999 Amendment to 17025(WG 25)

2005-04

Inspection 17020:1998    

Accreditation Guide 58:1993Guide 61:1996TR 17010:1998

17011:2004 (WG 18) 2004-09

Peer assessment   17040 (WG 19) 2005-03

The basic principles of international The basic principles of international conformity assessmentconformity assessment

ISO/IEC 17000:2004 - VOCABULARY

ISO/IEC Guide 2Revision of

clauses12 to 17

The Functional Approach

Selection, determination,

Review and attestation,surveillance

To put order

Facilitation oftrade:

Terms in aspecialchapter

ISO/IEC Guide 60 ISO/IEC Guide 60 Code of Good Practice for Conformity AssessmentCode of Good Practice for Conformity Assessment

The Guide may be used in conjunction with the WTO-TBT Agreement, to facilitate trade

Ethical and reliable CA services

General principles on good practices for:CA normative documents

CA activities

CA systems and schemes

CA results

Common elements in conformity assessmentCommon elements in conformity assessment

ISO/Council Resolution in 2001 requests CASCO to unify the common contents of its documents

CASCO WG 23 is developing some basic common elements for conformity assessment, including:

Impartiality and avoidance of conflicts of interest

Confidentiality and trust (ISO PAS 17002:2004)

Complaints and appeals (ISO PAS 17003:2004)

Disclosure of information and transparency

Use of management systems

The common elements shall be used in all CASCO documents once the principles and texts are confirmed

1st party conformity assessment1st party conformity assessmentISO/IEC 17050:2004 Parts 1 and 2ISO/IEC 17050:2004 Parts 1 and 2

Supplier’s Declaration of Conformity (SDoC)Supplier’s Declaration of Conformity (SDoC)

1st party attestation of conformity for:

•Products (including services); and

•Management systems

SDoC can be used alone or with another conformity assessment procedure

If a mark is applied to a product, then confusion with a certification (3rd party attestation) mark has to be avoided

SDoC can make reference to standards

Annex A contains a form for presenting a SDoC

Requirements for testing and calibration laboratoriesRequirements for testing and calibration laboratoriesISO/IEC FDAM 17025ISO/IEC FDAM 17025

Alignment withISO 9001:2000

Clause 4: Requirements for “Quality,

administrative and technical, Management Systems”

Conformity with ISO 9001

does not demonstrate, by itself,

competence

Conformity with ISO 17 025 does not

imply conformity with all the requirements of

ISO 9001

3rd party conformity assessment 3rd party conformity assessment Product certificationProduct certification

ISO/IEC Guide 65:1996 establishes the requirements for product certification bodies

ISO/IEC Guide 67:2004 outlines 7 product certification systems (from type testing to full certification)

ISO/IEC Guide 28:2004 describes the most commonly used mix of product certification aspects – the so called ‘System 5 approach’

ISO/IEC Guide 53 builds on a system 5 approach to product certification by including the use of the organizations QMS in determining the product certification decision

3rd party conformity assessment3rd party conformity assessment Management system certification - ISO/IEC DIS 17021 Management system certification - ISO/IEC DIS 17021

Replaces Guides 62 + 66 + … applicable to bodies undertaking certification of any form of management system (e.g. food safety, OH&S, IT security etc)

CASCO WG 21 Co-Conveners:

an accreditation body

a certification body

Contentious issues:

consultancy

related bodies

auditor competence

Includes principles for building confidence

impartiality

technical competence

responsibility

transparency

open system (“openness”)

confidentiality

appeals and complaints

33rdrd party conformity assessment party conformity assessment Management system certification - ISO/IEC DIS 17021 Management system certification - ISO/IEC DIS 17021

THE IMPACT WILL BE SIGNIFICANT

+ than 600,000 organizations certified ISO 9001

+ than 60,000 organizations certified ISO 14 001

1321 system certification bodies (IAF)

Other management systems: for example, Food products safety, Health and Occupational Safety,

Automotive, Aero-spatial, Telecommunications, etc.

Confidence in conformity assessmentConfidence in conformity assessmentAccreditation - ISO/IEC 17011:2004Accreditation - ISO/IEC 17011:2004

Main Objective:

“one standard for the facilitation of the recognition process of the accredited conformity assessment activity”

It replaces Guides 58 (Laboratory accreditation) and 61 (Certification body accreditation) and TR 17 010 (Inspection body accreditation)

It is also useful for the peer assessment of accreditation bodies

Clear statement of incompatibility for the accreditation body between undertaking both accreditation and accredited activities

It affects all 67 members of ILAC (some of whom are members of APLAC), and the 43 members of the IAF (some of whom are members of PAC) and … thousands of laboratories and certification bodies

Peer assessment of CA and accreditation bodiesPeer assessment of CA and accreditation bodiesISO/IEC 17040 (approved)ISO/IEC 17040 (approved)

An agreement group of CA bodies can have as goals: Conformity of bodies with specified requirements Equivalence of results among bodies Acceptance of results from one body by other

bodiesRequirements for: The management committee of the agreement

group Qualifications and selection of the peer assessors Peer assessment process

Annexes Financial aspects Assessment techniques

Outreach to regulatorsOutreach to regulators

CASCO’s documents are designed to apply in both regulatory and voluntary conformity assessment settings

CASCO has a special group – the Regulators Interface Group, convened by JISC (Japan)

A survey of the use of CASCO documents in regulatory contexts is currently underway

CASCO will broaden and expand its efforts to promote the International Standards and Guides on conformity assessment to various regulated sectors

The IAF-ILAC-ISO MoU

In March 2004 the IAF-ILAC-ISO Memorandum of Understanding (MoU) was signed by the ISO Secretary General with approval of the ISO Council. The MoU:

reaffirms ISO/IEC Standards and Guides as the source of requirements for accreditation and conformity assessment bodies and activities;

recognizes that IAF and ILAC may establish guidance documents to ensure consistent application by accreditors, without adding requirements;

establishes the IAF-ILAC-ISO JWG;

confirms the CASCO Chair and Secretary as ISO’s main contact point with IAF and ILAC;

confirms reciprocal involvement in each others work.

The IAF-ILAC-ISO MoU

The last meetings of the JWG:The last meetings of the JWG:

Bern, June 2004

Amsterdam, November 2004

CASCO Five Years PlanCASCO Five Years PlanOngoing workOngoing work

DIS 17 021 DIS 17 021 Management systems Management systems certificationcertification

FD PAS2 17 001 FD PAS2 17 001 ImpartialityImpartiality

FD PAS 17 004 FD PAS 17 004 Disclosure of informationDisclosure of information

FD PAS 17 005 FD PAS 17 005 Reference to QMS in CASCO Reference to QMS in CASCO documentsdocuments

WD 14065WD 14065 Greenhouse gas validation Greenhouse gas validation and and verification bodiesverification bodies

The “Road Map” for CASCOThe “Road Map” for CASCO

2007/2008 Common Elements and Terminology

2009 Product certification (under discussion)

2010 Accreditation and peer assessment

…… Supplier’s declaration of conformity

…… Management system certification

.….. Certification of persons

…… 17 025 - Laboratories

CASCO Five Years PlanCASCO Five Years PlanNew issues ?New issues ?

Guidance on writing technical regulations and Guidance on writing technical regulations and standards that can be used in conformity assessment standards that can be used in conformity assessment (revision of ISO/IEC Guide 7)(revision of ISO/IEC Guide 7)

Market surveillance (support from COPOLCO, Market surveillance (support from COPOLCO,

Resolution 16-2004)Resolution 16-2004)

Credibility of ISO 9001 certificationCredibility of ISO 9001 certification

LabellingLabelling

Industry sector documentsIndustry sector documents

Requirements for auditorsRequirements for auditors

CASCO assistance to developing countriesCASCO assistance to developing countries

CASCO/DEVCO “WORKSHOPS”

GENEVA

SEPTEMBER2003

Latin AmericaCOPANT

Salvador deBahia, Brazil

May2004

South AsiaNew Dehli

December2004

CASCO: A MEMBER OF “JCDCMAS” – JOINT COMMITTEE ON COORDINATION AND ASSISSTANCE TO DEVELOPING COUNTRIES IN METROLOGY,

ACCREDITATION AND STANDARDIZATION

SouthernAfrica

2005

ASEAN region

2005

Further informationFurther information

Thank you for your attention

Further information on conformity assessment can be found at the following link:

http://www.iso.org/iso/en/comms-markets/conformity/iso+conformity.html

or email:

Mr. Mario O. Wittner,

CASCO Chairman (mwittner@iram.org.ar)

or

Mr. Graeme Drake, CASCO Secretary (drake@iso.org)