Does anyone have a checklist to prepare for ISO 13485, Stage I audit?


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I am looking for a checklist to prepare for ISO 13485, Stage I audit - can anyone please share?

Thank you!

Jen Kirley

Quality and Auditing Expert
Hello SGquality,

Your registrar should be willing to describe to you what to expect during the certification process. Some even publish the certification process information. I find that published audit checklists usually just repeat the clauses in the standard. But a Stage 1 audit is meant to confirm you will pass the certification audit by having the processes in place and functioning. You are not yet certified, so there is no such thing as a nonconformance. The auditor will list areas of concern. It is common to expect to see that a round of internal audits have been done, and a management review as well. If there is something missing that would prevent certification (such as no internal audits done) the registrar will likely put the process on pause for you to complete the areas of major concern, if any, then a follow up review would be done to confirm your readiness before scheduling the certification audit.

Please contact your registrar's Customer Service. They should provide you with information of what to expect.

Disclaimer: I contract audit for DQS.
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