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Accreditation against ISO15189:2022�by UKAS

Albert J Mifsud

Vice-President, CESMA

May 2024

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The Standard

  • Developed by the��International Organization for Standardization

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International Organization for Standardization

  • Founded in 1947
  • About 170 member countries
  • Over 25,000 standards published
  • Member countries adopt ISO standards for in-country use

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National Accreditation Bodies

  • EU Regulation (EC)No 765/2008 requires every member state to establish a National Accreditation Body
  • The designated UK NAB is UKAS

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Accreditation vs Certification

Accreditation means an attestation by a NAB that an organisation meets the requirements set by harmonized standards … to carry out a specific conformity assessment activity.*�i.e. ongoing process

Certification is the third-party confirmation via audit of an organisation’s systems that the organisation has the competence and impartiality to perform specific activities.**�i.e. one off

Sources: edited from * EU Regulation (EC)No 765/2008; **ww.ukas.com/accreditation/about/accreditation-vs-certification/

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UKAS sectors appraised

  • Chemicals
  • Construction & built environment
  • Digital
  • Energy
  • Engineering
  • Environmental
  • Facilities management
  • Food
  • Forensics
  • Health and Safety
  • Health and Social Care
  • Industrial Manufacturing
  • Metrology
  • Oill and Gas
  • Product Safety
  • Security
  • Waste Management

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UKAS appraisal process

  • Application
  • Contract review
  • Pre-assessment
  • Initial assessment
  • Surveillance activities
  • Reassessment activities
  • Extension to scope
  • Unannounced assessments

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Application

  • First application: in-depth application
  • Contract set up
    • Fee set and payment received
    • Assessment Manager allocated
    • Scope of accreditation agreed
    • Pre-assessment
    • Usually desk-top review

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Initial Assessment (1)�Prior to visit

  • Assessment Manager:
    • Reviews application
    • Selects assessment team
    • Agrees assessment dates
      • Aim for 6-9 month lead time
      • Duration ideally 2-3d, often 1-2mo
  • Decision Maker:
    • Reviews and approves plan
    • Assessment plan issued

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Initial Assessment (2)�Assessment visit

  • Assessors review allocated scope
    • Review of documents provided pre-visit
    • Discussion with staff on site
    • Review of additional evidence as requested
    • Witnessing activities
    • Interviews with others (e.g. clinical doctors)
  • Non-conformances with standards raised and remedial action agreed

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Improvement Action Report�(IAR)

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Example IAR

Clause

5.4.5 (a); (b)

Description of Finding

The Laboratory does not have a documented procedure to ensure that specimens are transported and stored prior to commencement of processing within clinically meaningful time frames and in a manner that assures specimen integrity

Agreed/Proposed improvement action

Prepare a project plan for development of standards for specimen delivery that have been agreed with clinical users; update existing audits to include entire pre-analytical stage

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Post Visit

  • Assessment Team:
    • Preparation of report
      • Should be delivered in 1 week
      • In practice delivered in 2-3mo
  • Assessed Body:
    • Provide evidence to clear findings within 1mo
  • Independent Decision Maker (within UKAS):
    • Decides on award/renewal of accreditation

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Overview of accreditation process

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Assessors

  • Volunteer peer assessors & contracted assessors

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  • Applications reviewed by Professional Advisory Committee against set guidelines
  • Assessor ‘Technical’ competencies agreed and recorded
  • Accepted applicants receive whole day training
  • First assessment observed & assessed by experienced assessor
  • Periodic observation by specifically-trained assessor

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Ongoing Assessor training

  • Assessors must show evidence of ongoing CPD
  • Provision of periodic assessor meetings for each specialty
    • To promote consistency among assessors
    • To provide forum to discuss issues
  • Periodic (occasional) UKAS conferences

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Internal oversight to UKAS

Professional (Technical) Advisory Committee

  • Advisory body to UKAS (Medical Labratory Services). ToRs include:
    • Advise on technical and clinical requirements
    • Advise on suitability of new assessors
    • Advise on relationship with other regulatory bodies
    • Receive reports on significant complaints and major non-conformances

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External evaluation of UKAS

  • UKAS is a signatory to European Accreditation (EA) Multi-lateral agreement
  • EA signatories recognise and respect accreditation awarded by other signatories
  • EA signatories are peer evaluated once every 4 years to ISO 17011:2017 Conformity assessment — Requirements for accreditation bodies accrediting conformity assessment bodies

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