ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
Clause 5: Structural and governance requirements – ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence

ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence 5.6: Risk management

What does 5.6 require?

Management shall set up, run and maintain processes that identify, for the laboratory's examinations and activities, both the risks of harm to patients and the opportunities to improve their care, and shall develop actions for each. The laboratory director shall make sure these processes are checked for effectiveness and changed where they are not working (guidance is in ISO 22367 and ISO 35001).

Maintained by Gerard BlokdykControl text last updated

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.

Australia National Pathology Standards (First Edition 2027) · 1 control

  • 4.05 GY and B laboratories: undertake a documented, ongoing risk assessment of the adequacy of onsite supervision covering test volume, complexity and acuity, workforce composition and capability, error and incident data and feedback and complaints, and implement onsite supervision commensurate with the risk where patient safety, quality or service integrity may be compromised

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 Clause 5: Structural and governance requirements – ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence

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

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