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

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

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 7.8.3 (h) details the required information on scopes of accreditation for ‘other’ CABs

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. 17025, 17020, 15189 … etc)

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

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

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

NATA ISO 15189 schemes Medical Testing (ISO15189) Available to any laboratory performing human pathology testing Accreditation criteria ISO 15189 + 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

NATA ISO 15189 schemes Medical Testing – Point of Care Testing (PoCT) Available only to centrally managed ‘facilities’ performing PoCT Accreditation criteria ISO 15189 + 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

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

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

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

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