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 7.7.1: Complaints: process

What does 7.7.1 require?

The laboratory shall have a complaint handling process including a description of how complaints are received, substantiated, investigated and decided, tracking and recording of complaints and the actions taken, and ensuring appropriate action; a description of the process shall be publicly available.

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.

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

  • 1233 Operate a system that documents every complaint and problem reported to the laboratory and investigates complaints where appropriate

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

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