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 5.3.2: Conformance with requirements

What does 5.3.2 require?

Laboratory activities shall satisfy the requirements of this document, of users, of regulators and of bodies that grant recognition, and shall do so across the whole documented scope wherever the service is delivered.

Maintained by Gerard BlokdykControl text last updated

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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

  • 1.04 Legislation and standards: comply with applicable Commonwealth, state and territory legislation and regulations, the relevant NPAAC standards and, where no NPAAC standard covers a matter, ISO 15189

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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