13485:2003 to 2016 Transition Gap Checklist (2003 to 2016)

Using ISO 13485:2003 as a baseline, this Gap checklist outlines what areas of your QMS need improvement to meet ISO 13485:2016.
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This list has been prepared for you by the 13485 Store. You will need to have a copy of the ISO 13485:2016 Standard to use along with this checklist. You will see questions on the checklist that refer to the standard where each requirement is expressed as a question. This checklist is based on the information provided in the 2016-03-01 release of the ISO 13485:2016 international standard.

You have the ISO 13485:2003 quality management system in place and to help you with the implementation of ISO 13485:2016, we have highlighted in yellow the requirements that are revisions / additions to the 2003 version. After you have prepared your audit schedule, and assigned responsibility to your auditors for different areas or processes to audit, copy each section of the checklist and the section of the standard for the auditors working with that section.

As you work through the checklist take notes on what is in place, and what needs to be developed. Reference procedures or other documents that you have reviewed and that will provide information for the new QMS. Take notes on the status of the documents, will they need to be revised for the new system or can they be used as is? Also note where processes are in place, but documentation is needed.

Focus on what is in place, and what needs to be developed. While you do want to know if procedures and processes are being complied with, compliance is not your main focus for this audit. Remember that the final outcome of this audit should be a list of things that your organization needs to do to comply with ISO 13485:2016.

Keep in mind that the standard requires six (6) mandatory procedures. In the checklist, we have highlighted in Bold letters where a documented procedure is required, 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, 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. For your purposes, you may apply the most appropriate word.