Updated SCC Requirements and Guidance documents impacted by ISO 15189:2022 transition
Action required
Two SCC Requirements and Guidance documents used within the Laboratory Accreditation Programs have been updated as a result of the recent transition to the 4th edition of ISO 15189:2022 Medical laboratories — Requirements for quality and competence.
Note that unless you are performing tests within a medical laboratory, the changes detailed within the aforementioned SCC Requirements and Guidance documents which are listed below do not have a direct impact on your operations.
However, your organization’s Quality Management System (QMS) documentation may require revision to reflect the latest version of these documents. Please review the revised documents and make changes as appropriate.
Conformance to the latest version of the SCC Requirements and Guidance documents is required:
- SCC Requirements & Guidance – Proficiency Testing for Laboratories (Testing and Medical)
SCC Requirements and Guidance for the Presentation of Laboratory Scopes of Accreditation
Affected customers
SCC-accredited laboratories, applicants, assessors, and other stakeholders in the Medical Testing Laboratory Accreditation Program are most affected by this change.
As mentioned above, SCC-accredited laboratories, applicants, assessors and other stakeholders in the Testing and Calibration Laboratory Accreditation Program and the Proficiency Testing Providers Accreditation Program should take note as organizations’ Quality Management System (QMS) documentation may require revisions to reflect the latest version of these documents.
Background
ISO published ISO 15189:2022 - Medical laboratories - Requirements for quality and competence, and SCC revised its applicable requirements and guidance documents to align with the changes.
New requirements
SCC Requirements & Guidance – Proficiency Testing for Laboratories (Testing and Medical) – summary of changes:
- Updated ISO 15189 standard publication date in the introduction.
- Added clause 7.3.7.3 regarding monitoring the performance of examination methods, including point-of-care testing examination methods by comparison with other laboratories’ results. Removed the clause from the previous version of ISO 15189 regarding interlaboratory comparison.
- Removed clause 5.6.3 in Section 4, General and replaced with clause 7.3.7.3 External quality assessment (EQA) from the new version of the standard.
SCC Requirements and Guidance for the Presentation of Laboratory Scopes of Accreditation –summary of changes:
Removed references to ISO 22870 Point-of-care testing (POCT) — Requirements for quality and competence throughout the requirements and guidance document. Point-of-care testing requirements are now incorporated in the new version of ISO15189:2022.
Deadline
The revised SCC-requirements and guidance documents come into effect immediately.
Questions?
Please contact Vivek Kulasingham, Manager Compliance and Assessment Services at vivekananthan.kulasingham@scc-ccn.ca or +1-613-238-3222 for more information.