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 6.6.7: Reagents and consumables: records

What does 6.6.7 require?

For every reagent and consumable that affects examination performance, records shall be kept of: its identity; the name, lot number, instructions and other information from the manufacturer; the date it arrived and its condition on arrival; its expiry date; when it was first used and when it was withdrawn from service; and records confirming it was accepted initially and remains acceptable. For reagents made up, reconstituted or mixed in the laboratory, the records shall also name who prepared them and give the preparation and expiry dates.

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