Thumbnail

Accreditation Requirements - Medical Testing Laboratories

Useful information

Type of Publication:

Accreditation documents and guidance

Document Date:

2024-04-01

Accreditation requirements

 

  • ISO 15189:2012 Medical laboratories — Requirements for quality and competence (until December 2025)
  • ISO 15189:2022 Medical laboratories — Requirements for quality and competence
  • ISO 15190:2020 - Medical laboratories — Requirements for Safety
  • CAN/CSA-Z902-20 Blood and blood components
  • SCC Requirements & Guidance – Proficiency Testing for Testing and Medical Laboratories
  • SCC Guidance for the Presentation of Laboratory Scopes of Accreditation
  • ILAC P8:11/2023 ILAC Mutual Recognition Arrangement (Arrangement): Supplementary Requirements for the Use of Accreditation Symbols  and for Claims of Accreditation Status
  • ILAC P9:01/2024 ILAC Policy for Proficiency Testing and/or Interlaboratory comparisons other than Proficiency Testing
  • ILAC P10:07/2020 ILAC Policy on Traceability of Measurement Results 

 

Partner

 

  • Bureau de normalisation du Québec (BNQ)

 

Regulator / Scheme owner

 

  • Medical laboratories are required to be accredited in the provinces of Quebec, Ontario, New Brunswick, and Newfoundland and
    Labrador.

 

Buy standards 

Find ILAC documents