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 6.4.7: Equipment records

What does 6.4.7 require?

For each item of equipment that can affect results, records shall be kept covering: the manufacturer and supplier and a unique identification, software and firmware included; the dates it was received, acceptance-tested and put into service; evidence it met the acceptance criteria; where it is currently located; its condition on arrival; the manufacturer's instructions; its preventive maintenance programme; maintenance carried out; any damage, malfunction, modification or repair; performance records such as calibration and verification certificates; and its status. The records shall be easy to obtain throughout the equipment's working life, or longer in line with 8.4.3.

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