ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
Clause 6: Resource requirements – ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence

ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence 6.4.4: Equipment instructions for use

What does 6.4.4 require?

Safeguards shall stop accidental adjustments that could make results invalid. Only staff who are trained, authorized and competent shall operate equipment. Instructions for use, the manufacturer's among them, shall be easy to obtain, and equipment shall be used as its manufacturer specifies unless the laboratory has validated some other use.

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

  • 8.02 Medical device use: use devices for their intended purpose per the manufacturer's instructions for use, classify commercial IVDs used outside their intended purpose (such as unspecified specimen types) as in-house IVDs, and comply with the relevant NPAAC standards and TGA requirements

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 6: Resource requirements – ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence

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