This list has been prepared for you by the 13485 Store. You will need to have copies of the ISO 13485:2016 standard and Part 820, quality system regulation / code of federal regulations (21 CFR 820) to use along with this checklist. You will see questions on the checklist that refer to the standard and the regulation where the requirements are expressed as questions.

This checklist is based on the information provided in the 2016-03-01 release of the ISO 13485:2016 international standard and on the code of federal regulations of 2016-05-26. The applicable parts of the regulation that result in additions or revisions for FDA are highlighted in yellow.

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 8.5.3. For other clauses of the standard, and for requirements of the quality system regulation, 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.