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 6.8.3: Review and approval of externally provided products and services

What does 6.8.3 require?

Procedures, with records kept, shall cover: setting, reviewing and approving what the laboratory requires of every product and service it obtains from outside; the criteria for qualifying, choosing, evaluating and re-evaluating the performance of external providers; referring samples; making sure bought-in products and services meet the laboratory's requirements, or this document where relevant, before they are used or passed to the user; and acting on the results of provider performance evaluations.

Maintained by Gerard BlokdykControl text last updated

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