1. 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

2. 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 is to be a three year process (from Oct 2014)

3. 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

4. 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)

5. 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

6. 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 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 (subject to the revised std being published) with a three month period before assessment against the standard commencing

7. 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 (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

8. 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

9. 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

10. 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

11. (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)

12. 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)

13. 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

14. 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

15. 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

16. 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

17. 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)

18. 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

19. 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 laboratory assessment worksheet
e.g. ISO/IEC Review Checklist

20. 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 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