Now accepting CSA Z7396.1-22 scope extensions

Bulletin date:
Bulletin number:
2023-07

Action required

  • Organizations that are already accredited to perform inspections against CSA Z7396.1 should be aware that the 2022 version of the standard has been published.
  • Organizations that want to offer inspections against CSA Z7396.1-22 can apply for a scope extension.

 

Affected customers

Inspection Bodies Accreditation Program customers, applicants and assessors, as well as applicable regulators and Authorities Having Jurisdiction (AHJS). 

 

Background

The CSA Z7396.1 standard undergoes revisions to incorporate improvements, refinements, and new recommendations that reflect evolving industry practices and advancements in healthcare technology. Both the original version and subsequent revisions are considered valid.

 

Customers have the flexibility to decide whether to pursue a scope extension for the Z7396.1-22 version based on their specific needs and jurisdiction. 


Transition to Z7396.1-22 is not mandatory unless it is required by the regulatory authorities in the jurisdictions where the IB operates.

 

New requirements

To apply for a scope extension, organizations shall complete the following actions and submit to SCC for review:

  • Conduct a gap analysis
  • Develop a transition plan
  • Update procedures accordingly
  • Revise inspection forms

 

Deadline

None

 

Questions?

Please contact Abdel Kassou, Manager, Compliance and Assessment Services, at abdel.kassou@scc-ccn.ca or +1 613 238 3222 for more information.