ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
Clause 8: Management system requirements – ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence 8.8.1: Evaluations: general
What does 8.8.1 require?
The laboratory shall evaluate itself on a planned schedule to show that its management and support processes and the three phases of its core work (before, during and after examination) satisfy what patients and users need and require, and to confirm conformity with this document.
This control maps to 4 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.
1239 Run an ongoing, documented general laboratory systems quality assessment that monitors, assesses and corrects problems in confidentiality, specimen identification, complaints, communications, competency and PT evaluation, reviews the effectiveness of corrective actions, revises procedures to prevent recurrence and discusses the reviews with staff
1249 Run an ongoing, documented preanalytic systems quality assessment covering test requests and specimen submission, handling and referral, with effectiveness review of corrective actions, procedure revision to prevent recurrence and discussion with staff
1289 Run an ongoing, documented analytic systems quality assessment covering the procedure manual, test systems, performance specifications, maintenance, calibration, controls, specialty requirements, comparisons, corrective actions and test records, with effectiveness review, procedure revision and staff discussion
1299 Run an ongoing, documented postanalytic systems quality assessment of test reporting, with effectiveness review of corrective actions, procedure revision to prevent recurrence and discussion with staff