1. IMPLEMENTING THE CHANGES WHAT’S IN IT FOR ACCREDITATION BODIES
National Association of Testing Authorities, Australia
ISO/IEC 17011:2017
IMPLEMENTING THE CHANGES
WHAT’S IN IT FOR ACCREDITATION BODIES
Jennifer EVANS Chief Executive Officer
NATA, Australia

2. FLEXIBILITY is the most significant advantage of ISO/IEC17011:2017
Recognition that ‘one size does not fit all’
Not all industries, regulatory / business / technical environments are alike
Not all conformity assessment bodies are alike
Not all conformity assessment activities are alike
Not all ABs are alike!!
ABs’ rules and procedures need to be ‘fit for purpose’
Expectation that ABs will understand the risks in the environment in which they are operating and adapt their processes accordingly
opportunity to apply risk-based thinking to all sections of standard
e.g. clause 6 Resource requirements, clause 9 Management system requirements

3. Flexibility in the scope of ISO/IEC 17011:2017
This document specifies the requirements for the competence, consistent operation and impartiality of accreditation bodies assessing and accrediting conformity assessment bodies
Standard is applicable to accreditation bodies accrediting CABs performing conformity assessment activities that are outside the MRAs/MLAs (or may never be part of MRAs/MLAs) e.g. domestic schemes, medical imaging
Clause (h) details the required information on scopes of accreditation for ‘other’ CABs

4. Flexibility in the scheme rules and process requirements
ABs shall develop or adopt accreditation schemes*, document rules and processes referring to relevant International Standard or other normative documents
Accreditation scheme = rules and processes relating to accreditation of CABs to which same requirements apply (e.g , 17020, … etc)

5. Flexibility in the scheme rules and process requirements
Accreditation criteria
Schemes can be developed at the level of the international standard
ISO/IEC17025, ISO/IEC17020, ISO15189 etc; or
Schemes can be set up under an international standard + AB interpretation
ISO/IEC17025 – forensic laboratories;
ISO/IEC17025 – construction materials laboratories;
ISO/IEC17025 – food testing laboratories
Schemes covered by ILAC/APLAC MRAs must include ILAC/APLAC mandatory requirements e.g. ILAC P-documents
Schemes may also need to include regulatory requirements

6. Flexibility in the scheme rules and process requirements
Assessment processes
Assessment procedures to be defined and documented incl
assessment techniques and when they can be utilised (i.e. use of on-site assessment ± other assessment techniques),
how scope is covered sufficiently to provide confidence that the CAB complies with accreditation criteria (i.e. how representative samples of CAAs, locations and personnel are selected)
Risk to be considered in relation to selection of techniques to be used, and sampling of CAAs, locations, personnel

7. Flexibility in the scheme rules and process requirements
Scope of accreditation
Flexible scope of accreditation = SoA expressed to allow conformity assessment bodies to make changes in methodology and other parameters which fall within the competence of the CAB as confirmed by the AB
Accreditation cycle
Cycle ≤ 5yrs, accreditation criteria + SoA assessed taking risk into account
Sample of SoA ≤ 2yrs
On-site assessments ≤ 2 yrs, unless use of another assessment technique will achieve same objective and can be justified
Reassessment + accreditation decision at the end of the cycle
Assessment programs for CABs to ensure CAAs representative of the SoA at relevant locations are assessed during the accreditation cycle
Do not need to be the same for each CAB but must comply with scheme process requirements

8. NATA ISO 15189 schemes Medical Testing (ISO15189)
Available to any laboratory performing human pathology testing
Accreditation criteria
ISO NATA interpretative document; ISO 22870
ILAC P documents
Australian regulatory requirements
Assessment program
Initial assessment = on-site assessment, full scope coverage (sampling of individual CAAs), full management system coverage, PT review, witnessing
4 year accreditation cycle
year 1 = document and record review incl PT
year 2 = on-site surveillance assessment, limited scope coverage, full management system review, PT review
year 3 = document and record review incl PT
year 4 = on-site reassessment, full scope coverage (sampling of individual CAAs), limited management system review, PT review, witnessing

9. NATA ISO 15189 schemes Medical Testing – Point of Care Testing (PoCT)
Available only to centrally managed ‘facilities’ performing PoCT
Accreditation criteria
ISO NATA interpretative document; ISO 22870
ILAC P documents
Australian regulatory requirements
Assessment program
Initial assessment = on-site assessment of all sites, full scope coverage (sampling of individual CAAs), full management system coverage, PT review, witnessing
4 year accreditation cycle
year 1 = document and record review incl PT, main site + sample of other sites**
year 2 = on-site surveillance assessment all sites**, limited scope coverage, full management system review, PT review, witnessing
year 3 = document and record review incl PT, main site + sample of other sites**
year 4 = on-site reassessment of all sites, full scope coverage (sampling of individual CAAs), limited management system review, PT review, witnessing
** on-site visit can be replaced by remote assessment

10. Establishing accreditation schemes - factors to consider (clause 4. 6
Regulatory context / expectations
Industry expectations
Public expectations
CABs
Maturity wrt accreditation
Geographic location, availability of technology (e.g. ICT, Skype etc)
Multi-site vs single site
for multi-site – organisational / technical management
Resources e.g. personnel performing CAAs
Ranges of CAAs performed
Type of CAAs
Complexity, level of automation
Availability of proficiency testing, interlaboratory comparisons (ILCs)
Consequences/impact of CAA outcomes

11. Accreditation schemes – what is NATA considering
↑ remote review of documentation and records
traditionally only the review of management system documentation and methods conducted ‘off-site’
potential to utilise e.g. Skype, to review management system
make better use of ‘on-site’ time for technical aspects of assessments
↑ remote assessments
witnessing CAAs esp in remote locations e.g. NDT, inspection, sampling
site/field laboratories with limited SoA
scope extensions
improve the witnessing of CAAs - see more CAAs, personnel
improve responsiveness to clients’ requests
more efficient use of technical assessors/experts ( travel =  time commitment)
 costs for CABs

12. Accreditation schemes – what is NATA considering
↑ sampling of sites for multi-site CABs
traditionally on-site assessments for every site
consider factors such as:
central control of management system
technical control centrally managed
common technology platforms
accreditation history (performance)
stability of CAB’s management, staffing
better use of resources esp technical assessors/experts
 costs for CABs
Accreditation cycles based on CAB’s performance
traditionally used shortened intervals between assessments as a ‘sanction’, no extension of intervals

13. Summary
Greater flexibility and incorporation of risk-based thinking in ISO/IEC17011:2017 provides opportunity for NATA
More efficient assessment processes
potential cost savings (also for accredited CABs)
Better utilisation of resources – AB personnel, technical assessors/experts
Better responsiveness to CABs e.g. requests for scope extensions
Assessment programs can be tailored to risk profile of CABs
↑ focus on high risk CAAs, poorly performing CABs