Presentation to ITU Consultation on Conformity Assessment and

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

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 SMA 20 July 2009 ISO CS, Geneva

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] SMA 20 July 2009 ISO CS, Geneva

The 1 -1 -1 dream of Conformity Assessment 1 1 Standard Test Accepted everywhere 1 Conformity Assessment SMA 20 July 2009 ISO CS, Geneva

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) SMA 20 July 2009 ISO CS, Geneva

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. SMA 20 July 2009 ISO CS, Geneva

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. SMA 20 July 2009 ISO CS, Geneva

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 SMA 20 July 2009 ISO CS, Geneva 7

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 SMA 20 July 2009 ISO CS, Geneva 8

The “CASCO Toolbox” relationships… Requirements for accreditation bodies –ISO/IEC 17011 (2004) Requirements for Certification bodies Requirements for testing & Inspection calibration bodies Persons Part 2 in preparations laboratories ISO/IEC 17025 17020 (2005) (1998) SMA 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) 9

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 SMA 20 July 2009 ISO CS, Geneva

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 SMA 20 July 2009 ISO CS, Geneva

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 SMA 20 July 2009 ISO CS, Geneva

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 additional general requirements Revision 2010 SMA 20 July 2009 ISO CS, Geneva

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 SMA 20 July 2009 ISO CS, Geneva

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 3 rd party CA activity. Therefore bodies performing this activity are 3 rd party conformity assessment bodies called “certification bodies” SMA 20 July 2009 ISO CS, Geneva

ISO/IEC 17050 Parts 1 and 2 Conformity assessment – Suppliers declaration of conformity P 1 – general requirements Part 2 – Supporting documentation (to substantiate a SDo. C) 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 SMA 20 July 2009 ISO CS, Geneva

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) SMA 20 July 2009 ISO CS, Geneva

CASCO projects in progress ISO/IEC 17021 Part 2 (CASCO WG 21), Conformity assessment — Requirements for 3 rd 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) SMA 20 July 2009 ISO CS, Geneva

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). SMA 20 July 2009 ISO CS, Geneva

Common Structure Following a CASCO resolution (12/2002), CASCO Standards should follow the same structure, wherever possible SMA 20 July 2009 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 ISO CS, Geneva

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 Guides provide guidance to technical committees for the preparation of standards, often on broad fields or topics SMA 20 July 2009 ISO CS, Geneva 21

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. SMA 20 July 2009 ISO CS, Geneva

ISO/CASCO Rule 1: Neutrality ISO/CASCO has a neutral policy with regard to the application of standards by 1 st, 2 nd or 3 rd parties (includes accreditation). Standards must be written in a manner that they can be used through 1 st party, 2 nd party or 3 rd party conformity assessment activities. The application of 1 st, 2 nd or 3 rd party should be decided on by the client ( or regulator) and not by the TC. SMA 20 July 2009 ISO CS, Geneva

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 SMA 20 July 2009 ISO CS, Geneva

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 SMA 20 July 2009 ISO/IEC 17011 Laboratory 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

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 SMA 20 July 2009 ISO CS, Geneva

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. SMA 20 July 2009 ISO CS, Geneva

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 SMA 20 July 2009 ISO CS, Geneva

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 SMA 20 July 2009 ISO CS, Geneva 29

ISO Contact maccurtain@iso. org bleeker@iso. org marinkovic@iso. org emorine@iso. org Thank you www. iso. org SMA 20 July 2009 ISO CS, Geneva