Transition to ISO 15189:2022 for accredited laboratories in Canada

Bulletin date:
Bulletin number:
2023-06

Action required

  • Accredited laboratories shall review their existing quality system and prepare for their first assessment against the ISO 15189:2022 according to the timeline described below.

  • Assessors for this program shall be formally qualified to the new standard requirements.

     

Affected customers

SCC and BNQ Medical Laboratories Accreditation Program customers and applicants.

 

Background

ISO 15189:2022 – Medical laboratories – Requirements for quality and competence was published on December 6, 2022. SCC and its partner, Bureau de normalisation du Quebec (BNQ), are implementing their transition plan. You can access BNQ’s communication here.



Key dates


September 2023

  • New applications for accreditation will only be accepted to ISO 15189:2022 starting on September 1, 2023.
  • SCC is ready to transition all documents and to assess laboratories to ISO 15189:2022 by September 1, 2023.

 

September to November 2023

  • Laboratories that have their annual surveillance/reassessment between September 1 and November 30, 2023 can choose to be assessed against the 2022 version or the 2012 version.

 

December 2023 

  • All initial assessments will be conducted against ISO 15189:2022 as of December 1, 2023.
  • All annual surveillance / reassessments will be conducted against ISO 15189:2022 as of December 1, 2023.

 

December 2025

  • Accreditations to ISO 15189:2012 is no longer valid as of December 6, 2025 and laboratories that have not transitioned to ISO 15189:2022 can no longer claim accreditation for their laboratory activities.

 

New requirements

Main changes

  • Management systems requirements are now at the end of the document – starting on page 35 – to align with ISO/IEC 17025:2017- General Requirements for The Competence of Testing and Calibration Laboratories. 
  • Point-of-care testing (POCT) requirements from ISO 22870:2016 are incorporated in the standard’s scope. ISO 22870 has been withdrawn.
  • An increased emphasis on a risk-based management approach throughout the updated standard and the requirements for risk management are aligned with ISO 22367.
  • A focus on laboratory personnel and management, especially in their roles/responsibilities to ensure an effective management system and risk management process implementation.

 

Quality management

  • The quality management section is more specific: internal and external lab personnel are the ones responsible for management system.
  • A significant change in this version is the focus on risk-based management of the laboratory’s quality management system, with an emphasis on the laboratory director’s role to ensure processes are evaluated for effectiveness.

 

Equipment

  • The new standard highlights a risk-based approach to manage measuring equipment. 
  • New equipment requirements (section 6.4.2):
    • ensures access to equipment for correct performance of laboratory activities
    • outlines requirements to be met for equipment outside of a laboratory’s permanent control or manufacturers’ functional specification
    • all equipment items uniquely labelled/identified with maintained register
    • maintain/replace equipment to ensure quality examination results

 

Management System Documentation

  • New sections adding more emphasis on document control including creation (section 8.4.1), amendment (section  8.4.2) and retention of records (section 8.4.3)

 

Deadline

All laboratories have until December 6, 2025 to transition to the new standard. Accreditations certificates for ISO 15189:2012 will no longer be valid after this date.

 

Questions?

For more information, please contact Vivekananthan Kulasingham, Manager Compliance and Assessment Services at vivekananthan.kulasingham@scc-ccn.ca or +1-613-238-3222.