Accreditation Canada (AC) Diagnostics is pleased to announce the release of version 25.10 (October 2025) of the 15189 ISO Plus™ Diagnostic Imaging Requirements. Diagnostic Imaging facilities currently enrolled in AC Diagnostics accreditation can now access all files related to this version through the client portal, QView™. Navigate to these files in QView™ by clicking General – Accreditation, Diagnostic Imaging Program, Accreditation Requirements. This folder contains the Requirements, a change report comparing version 24.04 to version 25.10, and an updated list of references to support the Requirements. Facilities notified of an upcoming accreditation assessment visit as of October 15, 2025 will be assessed against version 25.10.

A new version of the Requirements was necessary to align with updates to several key reference sources, standards and legislation. This new version also incorporates relevant feedback from interested parties and clients, along with content refinements.

Outlined below are some of the significant changes; however, important changes to modality-specific requirements have also been made. Please refer to the change report in QView™ (B. All Revisions to Requirements V25.10).

Integration of POCT into Sections I–X

• Prior to 2022, there was a separate ISO standard for point-of-care testing (POCT) (ISO 22870:2016). There was a significant amount of repetition between ISO 15189 and ISO 22870. With the release of ISO 15189:2022, the separate 22870 POCT standard was withdrawn, and ISO 15189 was deemed to apply to POCT.
   
• In the AC Diagnostics Requirements, Section XI was a separate section of requirements to assess POCT. Similar to the ISO documents, this section was essentially a repeat of requirements from Sections I–X. To align with ISO, and to avoid duplicated requirements, we have eliminated Section XI in the AC Diagnostics Requirements.
   
• POCT specific language has been integrated into Sections I–X and a new limited checklist for POCT has been created to facilitate the assessment process.
   
• An integrated assessment approach will be used, where some POCT requirements are assessed as part of the overall quality management system, and the others are assessed by a technical assessor using the limited checklist.
   

MRI

After reviewing updated guidelines and references, several changes were made to the MRI requirements to reflect current standards of practice and updated references. For example, several MRI modality specific requirements were updated to incorporate practice guidelines from the ACR Manual on MR Safety (2024) and the ACR Manual on Contrast Media (2024). In addition, the CAR Practice Guidelines on Breast Imaging and Interventions (2025) were referenced for Breast MRI-related requirements.

As you review the new version of the requirements, we welcome your comments/suggestions by email to accreditation@acdiagnostics.ca. Feedback is reviewed by AC Diagnostics and will be considered in future versions of the AC Diagnostics Diagnostic Imaging Requirements.

We thank our clients and interested parties who submitted feedback to help create version 25.10 of the Requirements. Your feedback is instrumental in helping to keep our requirements accurate and reflective of the current practices and references. We would also like to thank the Diagnostic Imaging members of the Accreditation Advisory Panel for their support in the review and approval of the Requirements.