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 6.8.1: Externally provided products and services: general
What does 6.8.1 require?
Products and services from outside that affect laboratory activities shall be confirmed as suitable by the laboratory where they are built into its own work, passed to users exactly as received, or used to support how the laboratory runs (for example calibration, maintenance, collection services, consultants, referral laboratories and EQA programmes); the laboratory works with other departments of the organization where needed.
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.
1.05 Contracted services: where the practice subcontracts or coordinates pathology services for other organisations, ensure subcontractors are accredited to the relevant NPAAC standards or a recognised equivalent such as ISO 17025 where NPAAC standards do not apply, and liaise with the subcontractor's scientific, clinical and administrative staff