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What materials are needed for an on-site laboratory review?

2022-12-25View Original

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On-site evaluations are stressful and busy; preparing thoroughly in advance is the goal for everyone, to stay busy without falling into chaos. Based on my experience with numerous on-site audits, I have summarized the documents that need to be prepared for such audits (applicable to CMA and CNAS) as follows: 1. Documents regarding the establishment of the laboratory, its legal status, and proof of a fixed location ; 2. Management system documents: «Quality Manual», «Procedure Documents», «Work Instructions», «Blank Forms», etc ; 3. Document control list, records of distribution of controlled documents, records of verification of external controlled documents, etc ; 4. Appointment documents for personnel (top management, technical supervisor, quality manager, authorized signatory, internal auditor, supervisor, etc.), employment contracts and social insurance certificates (ideally, 3 months of social insurance coverage), technical records of personnel, work permits, annual training plans and records ; 5. Quality supervision plan and records ; 6. Catalogs and records of qualified services and suppliers, as well as acceptance records for reagents and consumables ; 7. List of subcontractors, records of subcontractor information, subcontract agreements ; (This value should be increased when there is subcontracting.) 8. Contract review materials ; 9. Complaint materials ; 10. Materials on corrective (preventive) measures, improvement measures, and their effectiveness ; 11. Internal audit and management review materials ; 12. Records of the detection method validation report or verification report, and records of measurement uncertainty assessment ; 13. Inventory records of reference materials, distribution records, and periodic verification records ; 14. Instrument and equipment records, usage authorization records, periodic verification plans and calibration plans for instruments and equipment, materials for periodic verification ; 15. Facility and environmental monitoring records ; 16. Records of the issuance of toxic and hazardous substances and waste disposal ; 17. Records of sample transfer and disposal ; 18. Quality control plan (capacity verification, inter-laboratory comparisons, internal laboratory quality control) and materials ; 19. Test report (including original records).

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