Australia National Pathology Standards (First Edition 2027)
Standard 2: Safety and quality systems – Australia National Pathology Standards (First Edition 2027)

Australia National Pathology Standards (First Edition 2027) 2.04: Adaptable and resilient systems: manage software updates and system changes through a change control process, validate and test changes affecting regulated software before clinical use, communicate outages to staff and users, and keep systems reviewed and updated to industry standards

What does 2.04 require?

Software updates and changes to systems go through change control, a documented path of assessment, approval, implementation, validation and post-change review so that patient safety, result accuracy, data integrity and continuity are not harmed. Any change touching regulated software is validated and tested before clinical use; outages are communicated to staff and to users; and systems are reviewed and brought up to industry standards on a regular basis. Change control reaches laboratory information systems, result-influencing software, interfaces and messaging, device software and firmware, workflows for handling, testing, reporting or storing specimens, and cybersecurity, access and data handling, whether the change is a patch, an upgrade, a configuration edit, an integration or a regulatory alignment.

Maintained by Gerard Blokdyk

What else in your programme already covers this

This control maps to 1 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.

Other controls in Standard 2: Safety and quality systems – Australia National Pathology Standards (First Edition 2027)

Query this from an agent

The graph holds this control, the 1 it maps to, and the evidence behind each claim, over MCP and REST.