Home > ISO 13485 Audit Checklist

Audit Checklists and Guidelines for ISO 13485-2003 Medical Devices Quality Management System

  (Hardcopy or Download)

(ISBN 1-88-1006-85-5)




This audit checklist was designed for organizations that are in need for assessing and for auditing Quality Management Systems based on the international Standard ISO 13485-2003.

The audit checklist addresses all 61 main and sub clauses and the 328 shall requirements of the ISO 13485 -2003 Standard.

A simple rating system is included that enables the user to record compliance measurement based on the audit findings.

The Hard Copy Audit Checklist and Guide contains the following:
  1. Introduction
  2. Description how to apply and use the audit checklist
  3. Short introduction into audit requirements, discerning minor verses major or critical nonconformities, and how to tally respective findings and rate the overall performance
  4. Audit Checklist with 385 questions addressing each shall requirements stated in the Standard
  5. Rating Chart
  6. CD ROM MS Word 7.0, contains all the above documentation, including the Checklists

The Downloadable Audit Checklist and Guide for ISO 13485 Medical Devices Standard contains the following:
  1. Introduction
  2. Description how to apply and use the audit checklist
  3. Short introduction into audit requirements, discerning minor verses major or critical nonconformities, and how to tally respective findings and rate the overall performance
  4. Audit Checklist with 385 questions addressing each shall requirements stated in the Standard
  5. Rating Chart
This audit checklist is a very helpful aid in performing internal audits for QA Managers and personnel assigned to perform internal audits. It will help to save time needed to perform the audit in a systematic and orderly fashion, prevent errors of omission and provide legitimate records. It will enable the organization to submit in documented form audit results for internal and external use, e.g. management review and continual improvement issues, customer satisfaction and certification issues, etc.
The author Gunther B. Gumpp with his team of quality experts has been providing quality services since 1984 to hundreds of companies worldwide and has designed the audit checklists in a format that are easy to read and to use. As far as we know this is the first Audit Checklist and Guide made available worldwide addressing ISO 13485-2003 Standard requirements.


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