The internal audit checklist is based on the information provided in the 2016-09 revision of the AS 9100 Rev D, SAE standard and in the 2016 third edition of ISO 13485:2016 international standard. The checklist is best used by trained and practicing auditors to evaluate or assess Quality Management Systems requirements based on the standards as you include the requirements of ISO 13485:2016. You will see questions on the checklist that refer to the standard and for each clause provisions are made for additional questions.
While both the AS 9100 and ISO 13485 standards deal with Quality Management Systems, the structures of the AS and ISO standards do not exactly line up when comparing the contents, the new requirements and / or new terminology.
- The AS 9100 Rev D standard includes the requirements of ISO 9001:2015 and additional aviation, space, and defense (ASD) industry requirements are highlighted in yellow.
- The additions for ISO 13485 over AS 9100 are highlighted in green and the relevant ISO 13485:2016 clause number appears with the audit question.
The auditors are expected to keep in mind that the AS standard does not require mandatory procedures for the various QMS processes; 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. When using the checklist, 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 assessment of each requirement, auditors record the status of the evaluation by indicating in the right-hand column of the checklist a: Yes – for Acceptable Condition or No – for Deficient Condition
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- ISO 13485:2016/ AS9100 Internal Audit Checklist
- 95 Page Checklist in Microsoft Word
- Technical Support Included