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National Association of Testing Authorities, Australia NATA accreditation and criteria for validation and verification Mark Worrell – RACI Seminar 27 February 2014 www.nata.com.au National Association of Testing Authorities, Australia Today’s presentation 1. What is NATA? 2. NATA’s recognition 3. NATA’s role 4. International recognition 5. Accreditation process and approach www.nata.com.au National Association of Testing Authorities, Australia What is NATA … • NATA is a not-for-profit company. • Established in 1947 “to meet the needs of government, industry and commerce and thus assist in maintaining the products of industry at a high standard”. • 180 staff • Offices in Sydney (head office), Melbourne, Brisbane, Adelaide and Perth • >3000 accredited facilities - government and private sector • ~3000 active voluntary technical assessors www.nata.com.au National Association of Testing Authorities, Australia NATA’s recognition … • NATA is formally recognised by the Federal Government through a memorandum of understanding: - Government obligations include support for international activities and promotion of NATA’s role in the domestic economy and trade - NATA’s primary obligation is to facilitate a reliable test, measurement and inspection infrastructure www.nata.com.au National Association of Testing Authorities, Australia NATA’s Role … Program Standard Facility Numbers Laboratory ISO/IEC 17025 2269 Inspection ISO/IEC 17020 146 Medical ISO/IEC 15189 702 Medical Imaging RANZCR Standards 59 PTP ISO/IEC 17043 14 R&D Relevant Standards 8 RMP ISO Guide 34 17 Sleep Disorder Services ASA Standards 2 OECD GLP 22 OECD principles Total www.nata.com.au 3239 National Association of Testing Authorities, Australia NATA’s Role … • NATA maintains a co-operative relationship with the organisations that comprise Australia’s Technical Infrastructure Alliance (TIA) - Joint Accreditation System – Australia & New Zealand (JAS-ANZ) - accreditation of certification bodies (management system and product) and inspection bodies - National Measurement Institute - maintenance/production of physical, chemical and biological standards - regulation of trade measurement - Standards Australia - development and publication of documentary standards www.nata.com.au National Association of Testing Authorities, Australia International Mutual Recognition Arrangements … • NATA is a member of both the International Laboratory Accreditation Cooperation (ILAC) and the Asia Pacific Laboratory Accreditation Co-operation (APLAC) • MRAs facilitate the acceptance of calibration, test, measurement and inspection (conformity assessment) reports from an accredited facility in one economy by industry and regulatory authorities in another economy • MRAs are based on a process of peer evaluations – accreditation bodies assessing accreditation bodies - recognise the equivalence of accreditation processes - compliance with ISO/IEC 17011 Conformity assessment – General requirements for accreditation bodies accrediting conformity assessment bodies www.nata.com.au National Association of Testing Authorities, Australia Accreditation Process … • Key elements of the NATA accreditation process include: - Ongoing, on-site assessment of staff and facilities - Assessment teams consisting of specialists (peers) who have a sound understanding of all activities for which accreditation is sought/held - Management systems and technical reviews A focus on demonstrated and practical competence A cooperative, constructive approach A strong foundation for ongoing quality improvement www.nata.com.au National Association of Testing Authorities, Australia Accreditation Process … • Assessment Asking questions of all levels of staff regarding competency and experience Reviewing test methods/validation Observing practical tests/calibrations/inspections Checking quality control and proficiency testing results Ensuring that facility practices are consistent with documented procedures Examining records Report on Assessment www.nata.com.au National Association of Testing Authorities, Australia Further information – www.nata.com.au – Email: [email protected] www.nata.com.au