ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
Clause 7: Process requirements – ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence

ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence 7.3.6: Documentation of examination procedures

What does 7.3.6 require?

Examination procedures shall be documented in enough detail that they are applied consistently and give valid results, written in a language staff understand and kept where they are needed. Shortened versions such as bench aids shall match the full procedure and be revised together with it. Manufacturers' instructions for use may be adopted by reference. Where a validated change could alter how results are interpreted, the implications shall be explained to users. All examination documents fall under document control.

Maintained by Gerard BlokdykControl text last updated

What else in your programme already covers this

This control maps to 2 controls across 2 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

  • 10.07 Test procedures: align with best practice guidelines, follow the manufacturer's instructions or the practice's validated and authorised variation, maintain specimen integrity through testing, reporting and disposal, follow a documented standard procedure traceable to the specimen tested, stay readily available to the workforce, and be reviewed regularly

US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) · 1 control

  • 1251 Maintain a written procedure manual for every test, assay and examination, followed by staff, containing the fourteen required elements where applicable, approved, signed and dated by the current director before use and on every change, with retired procedures kept with their dates of use

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 7: Process requirements – ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence

Query this from an agent

The graph holds this control, the 2 it maps to, and the evidence behind each claim, over MCP and REST.

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