0ISO CS, Geneva SMA 20 July 2009 Presentation to ITU Consultation on Conformity Assessment and Interoperability Testing Mr. Sean Mac Curtain Head, Conformity

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


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


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]


1 Test

1 Conformity

Assessment

1Standard

Accepted everywhere

The 1-1-1 dream of Conformity AssessmentThe 1-1-1 dream of Conformity Assessment


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


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.


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.


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)


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


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)


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



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


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



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



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


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”


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


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)


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)


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).


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


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


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.


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.


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


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




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


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.


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


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


ISOISO

Contact

[email protected]

[email protected]

[email protected]

[email protected]

Thank youwww.iso.org

Documents

0ISO CS, Geneva SMA 20 July 2009 Presentation to ITU Consultation on Conformity Assessment and Interoperability Testing Mr. Sean Mac Curtain Head, Conformity