ISO/IEC Toolbox for Conformity Assessment Mr. Adrian O’Connell ISO representative General Manager, Operations Standards Australia Regional ITU Consultation on Conformance Assessment and Interoperability for the Asia-Pacific Region Sydney (Australia), 16-17 September 2010 Agenda 9 September 2010 1 What is the ISO/IEC Toolbox for Conformity Assessment? 2 Where does conformity assessment fit in? 3 The ISO contribution to conformity assessment 4 ISO/CASCO 5 Specific standards and guides 6 Conclusion Copyright © 2010 Standards Australia Limited – CAPABILITY DOCUMENT 2 What is the ISO/IEC Toolbox for Conformity Assessment? A suite of International Standards and Guides that set out general requirements for conformity assessment activities, such as: – – – – – – – Product testing Inspection Self-declaration of conformity Product certification Management system auditing and certification Accreditation and peer assessment Mutual recognition of test and inspection results Produced by ISO’s policy committee on conformity assessment (ISO/CASCO) Recognised as the accepted international standards for conformity assessment by the WTO Technical Barriers to Trade (TBT) Committee Adopted in most countries and used widely in many sectors, including telecommunications 9 September 2010 Copyright © 2010 Standards Australia Limited – CAPABILITY DOCUMENT 3 Where does conformity assessment fit in? Conformity assessment 1st party • After standards publication • Various determination methods – Calibrate – Test – Inspect – Audit – Examine – Evaluate THE TECHNICAL INFRASTRUCTURE Policy Measurement Documentary standards Claims of conformity • Determination of whether a product conforms • Can result in conformity marking of the product Accreditation and peer assessment • 9 September 2010 Supplier’s declaration of conformity 2nd party Purchaser audits the supplier 3rd party Independent certification ISO/IEC Standards and Guides written by ISO Copyright © 2010 Standards Australia Limited – CAPABILITY DOCUMENT 4 Australia’s Technical Infrastructure Bodies Policy and regulation Measurement Documentary standards Various government owned and private testing, inspection and certification facilities Conformity assessment bodies Accreditation bodies 9 September 2010 5 The ISO contribution to conformity assessment 9 September 2010 World Standards Cooperation (WSC) - leading international standards bodies Multi-discipline and cross-sector, including conformity assessment For electrotechnology For telecommunications Collaborate to meet the challenges of converging technologies Use of common conformity assessment standards Copyright © 2010 Standards Australia Limited – CAPABILITY DOCUMENT 6 ISO’s structure Notes Members from 163 countries, covering 98% of world GNI and 97% of world population Over 18,000 international standards based on consensus 195 active technical committees with 3,238 technical groups, 50,000 experts Central Secretariat in Geneva with 153 FTE staff 9 September 2010 Copyright © 2010 Standards Australia Limited – CAPABILITY DOCUMENT 7 ISO/CASCO Notes 111 ISO members are represented in CASCO 18 international organizations are liaison members, including ITU and IEC Undertake policy and technical work, and internal and external engagement and promotion Structured as a continual improvement cycle 9 September 2010 Copyright © 2010 Standards Australia Limited – CAPABILITY DOCUMENT 8 ISO/CASCO Standards and Guides Fundamentals of global conformity assessment − Vocabulary and general principles (ISO/IEC 17000) − Functional approach to conformity assessment • Selection • Determination • Review and decision • Attestation • Surveillance − Common elements to ensure consistent approaches (Impartiality, Confidentiality, Complaints and appeals, Disclosure of information; and Management systems – ISO/PAS 17001-5) − Code of good practice for conformity assessment (ISO/IEC Guide 60) 9 September 2010 Copyright © 2010 Standards Australia Limited – CAPABILITY DOCUMENT 9 ISO/CASCO Standards and Guides Conformity assessment determination methods − Testing and calibration (ISO/IEC 17025) − Inspection (ISO/IEC 17020) − Other methods including in standards below Claims of conformity − Self or suppliers declaration (ISO/IEC 17050) − Product, process and service certification (ISO/IEC Guides 28, 53, 65 and 67) − Management systems audit and certification (ISO/IEC 17021) − Personnel examination and certification (ISO/IEC 17024) − Marks of conformity (ISO/IEC 17030) 9 September 2010 Copyright © 2010 Standards Australia Limited – CAPABILITY DOCUMENT 10 ISO/CASCO Standards and Guides Assurance of claims of conformity − Accreditation (ISO/IEC 17011) − Peer assessment (ISO/IEC 17040) − Proficiency testing (ISO/IEC 17043) Mutual recognition of conformity assessment results and other guidance − Mutual recognition of conformity assessment results (ISO/IEC Guide 62) − How to write technical regulations and standards for use in conformity assessment (ISO/IEC 17007) 9 September 2010 Copyright © 2010 Standards Australia Limited – CAPABILITY DOCUMENT 11 Other ISO/CASCO activities Advice and input into the development of sector applications of conformity assessment standards by ISO and IEC Technical Committees through the CASCO Technical Interface Group (TIG) Outreach to industry and regulatory groups (e.g. automotive, aerospace, railways) through their participation in CASCO Strategic Alliance and Regulatory Group (STAR) Electronic newsletter (www.iso.org/sites/eNewsletters/CASCO/archive.html) Annual survey of management system certificates (currently in excess of 1 million certificates world wide) Annual workshops – 2010 will be on conformity assessment and risk management 9 September 2010 Development of information on market surveillance Training and capability building in developing countries Copyright © 2010 Standards Australia Limited – CAPABILITY DOCUMENT 12 Conclusion ISO/CASCO standards and guides on conformity assessment are the accepted basis for testing, inspection and claims of conformity around the world Adoption and use of these standards and guides will − Enable compliance with WTO obligations and show a commitment to good conformity assessment practice − Provide a common basis on which to compare products and make investment decisions − Provide a traceable path for testing and inspection results and claims of conformity, whether those claims be 1st party (suppliers declarations of conformity), 2nd party, or 3rd party (product certifications) − Increase consumer and regulator confidence and acceptance of products − Be a mechanism to facilitate development and trade 9 September 2010 Copyright © 2010 Standards Australia Limited – CAPABILITY DOCUMENT 13