ISO/IEC 17025, Technical Restructure, National Association of Testing Authorities, Australia ISO/IEC 17025, Technical Restructure, Scopes of Accreditation, Website & Accreditation Publications Updates Member and Technical Assessor Webinars Nov - Dec 2017 Presented by Sue Harry Manager, Stakeholder Relations and John Styzinski General Manager, Operations and technical

Revision of ISO/IEC 17025 Working Group (WG) 44 was established and tasked to review the standard Std Aust representatives on WG44 John Styzinski & TGA Quality Manager Standards review process includes CD = Committee Draft (can include successive versions e.g. CD1, CD2….) DIS = Draft International Standard (29 Dec 2016) FDIS = Final DIS (14 Aug 2017) each stage included a commenting and voting process prior to progressing to the next stage Revision of ISO/IEC 17025 is to be a three year process (from Oct 2014)

NATA sought member and AAC feedback on DIS in early 2017 9 individuals provided comments, 3 of which were AAC committee members WG meetings have been held Feb 2015, May 2015, Aug 2015, Feb 2016, Sept 2016, July 2017 Separate Drafting Group (DG) meetings were also held post CD1, CD2 and DIS to consider comments received in preparation for WG meetings Draft was at FDIS stage for a two month ballot from14 Aug 2017 no changes to the draft were allowed, other than editorial Stds Australia cast Australia’s affirmative vote Publication anticipated by Dec 2017 Stds Australia will fast track the adoption of the ISO version

5. Structural requirements 6. Resource requirements 4. General requirements Impartiality Confidentiality 5. Structural requirements 6. Resource requirements General Personnel Laboratory facilities & environmental conditions Equipment Metrological traceability Externally provided products & services 7. Process requirements Review of requests, tenders and contracts Selection, verification &validation of methods Sampling Handling of test or calibration items Technical records Evaluation of measurement uncertainty Assuring the quality of results Reporting results Complaints Management of nonconforming work Control of data – Information management 8. Management requirements Options A & B Management system documentation (Option A) Control of MS documents (Option A) Control of records (Option A) Actions to address risks & opportunities (Option A) Improvement (Option A) Corrective action (Option A) Internal audits (Option A) Management review (Option A)

Main changes mandatory adoption of ISO/CASCO structure scope of the std covering “laboratory activities” = testing, calibration, sampling greater emphasis on “impartiality”, “risks and opportunities” emphasis on result of a process instead of a detailed description of tasks and steps reduction in the necessary amount of documentation purchasing and subcontracting combined requirements included for information technology and the validation of such systems (as per ISO 15189) metrological traceability clearer with simplified text “decision rules” for pass/fail (how MU is to be taken into account when making statements of conformity) x2 management system options

NATA is preparing Transition Policy including an implementation table gap analysis between 2005 and revised versions of the standard to help facilities familiarise themselves with changes updating NATA’s ISO/IEC 17025 Application Documents face-to-face information forums in each of the states for members and technical assessors release of documents and confirmation of forums will be in early 2018 (subject to the revised std being published) with a three month period before assessment against the standard commencing

ILAC has specified a 3 year transition period from date of publication NATA’s transition process assessments to be scheduled against the new standard from second half of 2018 (date to be confirmed) accredited laboratories to expect assessment (post this date) at time of next scheduled visit (reassessment or surveillance visit) implementation table will identify those specific issues needing to be addressed by laboratories laboratories will need to obtain copy of new standard, transition policy, gap analysis and implementation table complete and submit the implementation table together with a copy of Quality Manual (however named) and/or other relevant quality documentation prior to an assessment

2 options for management systems Option A laboratory to implement a system in accordance with clauses 8.2 to 8.9 will follow same assessment process as currently in place, including document review prior to visit followed by review of records on-site

Option B implement system in accordance with ISO 9001 extent of assessment will depend on the management system being certified by a CB accredited by a signatory to the International Accreditation Forum (IAF) copies of the most recent certification audit report(s) being made available together with close-out of issues identified the management system has established, in support of clauses 4 to 7 of ISO/IEC 17025 management system documentation and control of these control of records actions to address risks and opportunities processes to identify opportunities for improvement corrective action processes internal audits management reviews management system will be assessed in full against the requirements of Option A when the ISO 9001 system has not be independently certified

Review of NATA’s technical structure Realigned technical committee structures reflective of industry groupings Role of the AACs has not changed AACs will provide technical support for all ‘Services’ assigned to them covered by the industry groupings as defined in the scopes of accreditation Some AACs remain unchanged, others have been merged or disbanded Members of the existing AACs have been transferred to the new AACs and additional members appointed where gaps were identified NATA Board approved new AACs in March 2017 Changes to AACs implemented from mid 2017

(Activity types as per scopes) Sector Previous AACs New AACs Industry groupings (Activity types as per scopes) Calibration (Paul McMullen) ICTT PTSP RMP PTSP + RMP (PTSP) (RMP) Infrastructure (Brett Hyland, Marcel Vanderslik) CMT Mechanical NDT PAT Geotechnical / Civil CMT Electro-technology Testing Materials Characterisation Physical Performance Testing Infrastructure and asset integrity Manufactured goods (including ICTT) Materials Inspection (Julian Wilson) (Inspection) Legal & Clinical Services (Andy Griffin, Gill Treloar) Forensic Science Medical Testing MI (incl. DIAS) SDS MI (including DIAS) Legal Human Pathology Workplace and Community Screening Life Sciences (Neil Shepherd, Di Hobday) Biological Chemical Veterinary Animal Health Agribusiness Environment Food & Beverage Healthcare, Pharma & Media Products GLP (no AAC)

Scopes of accreditation Project to review the structure of scopes of accreditation is now coming to completion The primary aims of the project were to introduce a “uniform format across all fields and programs” to improve search function on the NATA website to ultimately allow, if requested, one scope to be issued per facility accredited in more than one field and/or program to improve expression, detail and clarity of information for all parties Will go “live” with the implementation of AIMS (NATA’s new IT system)

In summary all classes and subclasses of tests (or related activities) have now been reviewed and aligned with industry classifications new database has been developed covering 9 data sets 5 mandatory fields of information Standard; Activity; Service; Material/Item/Product; Determination 4 non-mandatory fields of information (Technique, Procedure, Range, MU) to be collected and only displayed based on needs e.g. NATA’s obligations, regulator’s, facility’s, client’s transformed scopes have been sent to facilities from July 2017 for information and checking to ensure that all current items covered by the facilities’ scopes have been captured scopes will again shortly be sent to facilities prior to going live the new database will continue to evolve / be refined as a ‘live’ database

Overview of website changes NATA website is being updated in 2 stages; stage 1 is complete All information on the website has been reviewed publications/ information consolidated into one area accreditation criteria separated from other publications / information Titles of some webpages have changed Accreditation Information and Accreditation Publications pages will become Accreditation Information once accreditation criteria have been revised

About Us (previously About NATA) Our role Mission and strategic plan Our history Our structure About accreditation The benefits Working with industry Working with government Media and Events (previously News) Announcements Newsletters Sector Updates (replaces field updates) Meetings Annual reports NATA young scientists award

Accreditation Information (includes technical assessor information) How to become accredited Charter of service NATA Rules Types of accreditation Fee schedules Accreditation symbols and endorsement materials Technical assessors information and guidance Publications for consultation Contact Us (previously Contact NATA) What do you want to contact NATA about NATA offices Feedback Job opportunities

Accreditation Criteria Publications Repackaged to align with the new scopes of accreditation format based on Standard and Activity Include General NATA Documents and Accreditation Publications General NATA Documents [GND] (applicable to all activities) NATA Rules NATA Privacy Policy About NATA and Accreditation NATA Procedures for Accreditation Charter of Service General Criteria, Guidance and Forms (applicable to more than 1 sector) Specific Criteria, Guidance and Forms (applicable only to 1 sector and/or activity)

Accreditation Publications for each Standard and Activity will include: General Accreditation Criteria [GAC] (policy circulars, technical circulars and standard application documents) Corporate accreditations Proficiency testing Metrological traceability Equipment assurance, in-house calibration and equipment verification Responsibilities of authorised representatives Use of NATA emblem, NATA endorsement and references to accreditation Forensic Operations module SAD ( applicable standard) Maintenance of microbiological reference culture collections Quality control of prepared media and media preparation

General Accreditation Guidance [GAG] (technical notes, information papers, general equipment table) User checks and maintenance of laboratory balances Validation and verification of quantitative and qualitative test methods Liquid-in-glass thermometers General equipment table Electronic measuring equipment as reference standards The in-situ calibration of barometers General [GAF] Laboratory assessment worksheet (applicable standard) e.g. ISO/IEC 17025 laboratory assessment worksheet e.g. ISO/IEC 17020 Review Checklist

Specific [SAF] (if applicable) Specific accreditation criteria, guidance and forms will be specific to an Activity as detailed on the transformed scopes of accreditation Specific Accreditation Criteria [SAC] (appendices/ annexes from application documents) e.g. Calibration ISO/IEC 17025 Appendix e.g. Materials Annex – Cement testing e.g. Life Sciences Annex – Asbestos fibre counting Specific Accreditation Guidance [SAG] (information papers) (if applicable) e.g. Workplace drug-testing – a guide to industry e.g. NDT methods technical issues Specific [SAF] (if applicable) e.g. Notification of establishment of an annex facility e.g. NDT work site advice form