1. National Association of Testing Authorities, Australia www.nata.com.au NATA accreditation and criteria for validation and verification Mark Worrell – RACI Seminar 27 February 2014

2. National Association of Testing Authorities, Australia www.nata.com.au Today’s presentation 1.What is NATA? 2.NATA’s recognition 3.NATA’s role 4.International recognition 5.Accreditation process and approach

3. National Association of Testing Authorities, Australia www.nata.com.au 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

4. National Association of Testing Authorities, Australia www.nata.com.au 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

5. National Association of Testing Authorities, Australia www.nata.com.au ProgramStandardFacility Numbers LaboratoryISO/IEC 170252269 InspectionISO/IEC 17020146 MedicalISO/IEC 15189702 Medical ImagingRANZCR Standards 59 PTPISO/IEC 1704314 R&DRelevant Standards 8 RMPISO Guide 3417 Sleep Disorder ServicesASA Standards2 OECD GLPOECD principles22 Total3239 NATA’s Role …

6. National Association of Testing Authorities, Australia www.nata.com.au 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

7. National Association of Testing Authorities, Australia www.nata.com.au International Mutual Recognition Arrangements … NATA is a member of both the International Laboratory Accreditation Co- operation (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

8. National Association of Testing Authorities, Australia www.nata.com.au 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

9. National Association of Testing Authorities, Australia www.nata.com.au Accreditation Process … Assessment Asking questions of all levels of staff regarding competency and experience Reviewing test methods/validationvalidation 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

10. National Association of Testing Authorities, Australia www.nata.com.au Further information –www.nata.com.auwww.nata.com.au –Email: mark.worrell@nata.com.au