ISO 9001:2015 to 13485:2016 Internal Audit Checklist

The checklist is based on information from the 5^th edition of the ISO 9001:2015 and from the 3^rd edition of the ISO 13485:2016 International Standards for Quality Management Systems. The checklist is best used by trained and practicing auditors to evaluate or assess Quality Management Systems requirements based on the standard as you transition from ISO 9001:2015 to include the requirements of ISO 13485:2016. You will see questions on the checklist that refer to the standards and for each clause provisions are made for additional questions.

While the editions of the standards do not line up when comparing the contents and requirements, the ISO 13485:2016 requirements over ISO 9001:2015 are highlighted in yellow and the relevant ISO 13485:2016 clause number appears with the audit question. The auditors are expected to keep in mind that while ISO 13485:2016 requires specific procedures for some QMS processes, the ISO 9001 standard does not require such mandatory procedures; however, the auditors will expect documented information to be available because in the clauses of the standard, the phrase such as ‘documented procedures’ is used to specify that a process, a method, a system, a work instruction, or an arrangement be documented.

The auditors must use a great deal of discretion and therefore must be careful and thoughtful prior to establishing a deficiency against a requirement.  Evidence for visible top management leadership, commitment and quality management action must be looked for.

The bold numbers and tittles used in the first two columns of the checklist indicate the “Requirements” and may be referred to on nonconformity reports prepared by the auditor.

During the assessment of each requirement, auditors record the status of the evaluation by indicating in the right-hand column a Yes – for Acceptable Condition or No – for Deficient Condition

You don’t want to cut corners with audits – buy a complete solution! Need to train your internal auditors? Buy our Internal Audit Checklist together with Internal Auditor Training Materials and save.