ISO 13485 Audit Checklist

• Department

• Auditors

• Auditee

• Conducted on

  Date

Documentation and Records

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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)

  Yes

  No

  N/A

• 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)

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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)

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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)

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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)

  Yes

  No

  N/A

• Yes

  No

  N/A

Customer Requirements

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Ensure that the department document the Policies and procedures for credit and collections management should be clearly documented and communicated

  Yes

  No

  N/A

• Ensure that the documents for the received enquiries from the customer are verified

  Yes

  No

  N/A

• Verify whether the Development plan available with marketing team for status communication to the customer

  Yes

  No

  N/A

• Verify the Quotation communication to the customer taking place considering all the customer requirements.

  Yes

  No

  N/A

• Verify that the customer feedback received annually and whether the satisfaction index is maintained

  Yes

  No

  N/A

• Does the department identify and implement any changes necessary to ensure and maintain the continued suitability, adequacy and effectiveness of the quality management system with the use of the quality policy?

  Yes

  No

  N/A

• Are sales and marketing tasks carried out in accordance with standard operating procedures?

  Yes

  No

  N/A

• Ensure that the records of change control, impact analysis, and closure are verified.

  Yes

  No

  N/A

• Does the department determine requirements specified by the customer, including the requirements for delivery and post-delivery activities?

  Yes

  No

  N/A

• Does the department determine any user training needed to ensure specified performance and safe use of the medical device?

  Yes

  No

  N/A

• Does the department review the requirements related to the product? Is this review conducted prior to the department’s commitment to supply a product to the customer (for example: Submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders)

  Yes

  No

  N/A

• Does the department ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements?

  Yes

  No

  N/A

• Does the department plan and document arrangements for communicating with customers in relation to product information, enquiries, contracts or order handling, including amendments, customer feedback, including complaints, advisory notices?

  Yes

  No

  N/A

Completion

• Comments/Recommendations

• Name and signature

  Sign