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. Evidence for visible top management leadership, commitment and quality management action must be looked for. The auditors must use a great deal of discretion and therefore must be careful and thoughtful prior to establishing a deficiency against a requirement. The auditors are expected to keep in mind that the standard requires six (6) mandatory procedures, such as with clauses 4.2.4, 4.2.5, 8.2.4, 8.3, 8.5.2, and For other 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.

You will see questions on the checklist that refer to the standard, and for each clause, provisions are made for additional questions. The checklist is best used by trained and practicing auditors to evaluate or assess Quality Management Systems requirements based on the standard. 1 The ISO 13485:2016 Internal Audit Checklist This checklist is based on the information provided in the release of the ISO 13485:2016 international standard.

13485 audit checklist template