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ISO 13485 Audit Checklist

Documentation and Records

  • Documents and changes are approved prior to use? (ISO 13485:2016: 4.2.4)

  • Documents and records are legible and identifiable? (ISO 13485:2016: 4.2.4(e), 4.2.5)

  • Documents of external origin are identified with controlled distribution? (ISO 13485:2016: 4.2.4(f))

  • Firm maintains a quality system record (QSR) which includes or refers to location of procedures? (ISO 13485:2016: 4.2.1(c), (e))

  • Documents and records are retained for required length of time (this includes retention of obsolete controlled documents and records)? (ISO 13485:2016: 4.2.1, 4.2.4, 4.2.5)

  • Change records are reviewed and approved by the same functions that performed original review and approval? (ISO 13485:2016: 4.2.4, 7.3.9)

  • Change records include a description of change, identification of affected documents, approval signatures, approval date, and effective date? (ISO 13485:2016: 7.3.9)

  • Documents are available at point of use and obsolete document are not in use? (ISO 13485:2016: 4.2.4(d), (h))

  • Firm maintains DMRs for each type of device? (ISO 13485:2016: 4.2.1)

  • DMRs contain or make reference to device specifications, production process specifications, quality assurance procedures and specifications (including acceptance criteria), packaging and labeling specifications (including acceptance criteria), and installation, maintenance, and servicing procedures? (ISO 13485:2016: 4.2.1)

  • DHRs are maintained and devices are manufactured according to DMR? Realization processes and product meet requirements? (ISO 13485:2016: 7.1, 8.2.6)

  • DHRs contain or make reference to dates of manufacture, quantity manufactured, quantity released for distribution, acceptance records demonstrating the device was manufactured per DMR, primary identification label and labeling used for each unit, and device identification and/or control numbers used? (ISO 13485:2016: 8.2.6)

  • Firm maintains records for education, training, skills, and experience of resources? (ISO 13485:2016: 6.2 (e))

  • Firm maintains purchasing and supplier records? (ISO 13485:2016: 7.4.1, 7.4.3)

  • Sterilization process parameters and records are maintained for each batch? Ensure sterilization validation records are maintained. (ISO 13485:2016: 7.5.5, 7.5.7)

Customer Requirements

  • Review product requirements. The intended use, customer requirements, and regulatory requirements are addressed? (ISO 13485:2016: 7.2.2)

  • Incoming contracts and orders are reviewed to resolve conflicting information and that customer requirements can be met? (ISO 13485:2016: 7.2.2)

  • Procedures and systems exist for customer communications and feedback? Ensure integration with CAPA system. (ISO 13485:2016: 7.2.3, 8.2.1)

Technical Files

  • Review technical file procedures (ISO 13485:2016: 4.2.1(d))

  • Documents need to ensure planning, operation, and control of technical file processes? (ISO 13485:2016: 4.2.1(d))

  • Documentation addresses a general description of product, intended use(s), and any variants, accessories, or other devices used in combination with product? (ISO 13485:2016: 7.1, 7.2, 7.3.4)

  • Design specifications, standards applied, and results of risk analysis are present? (ISO 13485:2016: 7.1, 7.2, 7.3.4)

  • Principal requirements have been fulfilled? (ISO 13485:2016: 7.1, 7.2, 7.3.4)

  • Techniques used to verify design and validate product(s) clinical data? (ISO 13485:2016: 7.1, 7.2, 7.3.4)

  • Documentation defines sterilization method and validation? (ISO 13485:2016: 7.1, 7.2, 7.3.4)

  • Documentation includes instruction manual(s) and labeling? (ISO 13485:2016: 7.1, 7.2, 7.3.4)

  • Major Suppliers have been documented (ISO 13485:2016: 7.1, 7.2, 7.3.4)


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