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 8.4.3: Retention of records
What does 8.4.3 require?
Procedures shall be in place covering how records are identified, stored, shielded from unauthorized access or alteration, backed up, archived, retrieved, kept for a defined time and then disposed of. Retention periods shall be stated, and risk may be used to set them. Reported results shall stay retrievable for as long as needed or required. Every record shall remain accessible and readable for its whole retention period and shall be available to management review. Legal liability may call for much longer retention of records such as histology, genetic or paediatric ones.
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.
1105 Retain records for the CLIA minimum periods: requisitions, procedures, analytic and quality control records, PT records, quality assessment records and test reports for two years, pathology reports and histopathology slides for ten years, cytology slides for five years, blocks for two years, tissue until diagnosis, with provisions made for retention if the laboratory closes