supplier selection and performance, and changes to the approved supplier list staff qualification, training and competency records request forms (including the patient chart or medical record only if used as the request form), Records of receipt of samples in the laboratory, e.g. accession records Information on reagents and materials used for examination (lot documentation, certificates of supplies, package inserts) laboratory or work sheets, instrument printouts and retained date and information examination results and reports, instrument maintenance records including internal and external calibration records calibration functions and conversion factors quality control records, incident records and action taken, accident records and action taken risk management records nonconformities identified and immediate or corrective action taken preventive action taken complaints and action taken records of internal and external audits interlaboratory comparisons of examination results records of quality improvement activities minutes of meetings that record decisions made the laboratory’s quality management system records of management reviews (All these records shall be available for laboratory management review) Evaluation and audits General Are evaluation and internal audit processes planned and
supplier selection and performance, and changes to the approved supplier list staff qualification, training and competency records request forms (including the patient chart or medical record only if used as the request form), Records of receipt of samples in the laboratory, e.g. accession records Information on reagents and materials used for examination (lot documentation, certificates of supplies, package inserts) laboratory or work sheets, instrument printouts and retained date and information examination results and reports, instrument maintenance records including internal and external calibration records calibration functions and conversion factors quality control records, incident records and action taken, accident records and action taken risk management records nonconformities identified and immediate or corrective action taken preventive action taken complaints and action taken records of internal and external audits interlaboratory comparisons of examination results records of quality improvement activities minutes of meetings that record decisions made the laboratory’s quality management system records of management reviews (All these records shall be available for laboratory management review) Evaluation and audits General Are evaluation and internal audit processes planned and
Audit-Checklist-Management.docx