ISO 13485 - Is management review required before stage 1?

outdoorsNW

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#1
We are planning to add IS013485 to our AS9100 QMS. I know we are required to have a management review before certification. The way our draft schedule is, a normally scheduled management review (every 3 months) does not fall after implementing the ISO 13485 system and before the stage 1 audit.

While we could do an extra management review, but we would prefer not to. Can we plan the first ISO 13485 management review after stage 1 but before stage 2, with the updated management review agenda ready before stage 1?

I am finding conflicting information if management review needs to be done before the stage 1 audit or can be between stage 1 and stage 2?
 
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Pjservan

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#2
No real written rule on this. Just go into the Stage I audit knowing that the auditor may rise a "concern". I will be ready to show how you plan to bridge the gap between an AS9100 Management Review and ISO13485 Management Review as there are a couple items-if memory serves right- that are different.
 

Sidney Vianna

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#3

Philip B

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#4
Remember that management review is a process not a meeting. If you can demonstrate that you have suitable review processes in place this might suffice. You should be developing processes to cover all of the review inputs by now therefore you just need some outputs (documented of course) and you are doing 'management review'.
 
#5
We are planning to add IS013485 to our AS9100 QMS. I know we are required to have a management review before certification. The way our draft schedule is, a normally scheduled management review (every 3 months) does not fall after implementing the ISO 13485 system and before the stage 1 audit.

While we could do an extra management review, but we would prefer not to. Can we plan the first ISO 13485 management review after stage 1 but before stage 2, with the updated management review agenda ready before stage 1?

I am finding conflicting information if management review needs to be done before the stage 1 audit or can be between stage 1 and stage 2?

hiiiiiiiii...there well let me share my experience with auditing. I have been working as qualtiy Assurance Mananger since 2015. I have encountered with the different auditors. to come to your point, it is better to draft your MR, so that if there are certian lakcs in your MR, then the Auditor will grade minor NC. which means procedure is impleneted, but lacks certain topics to be included. the other choice is little bit difficult as NO MR means no procedure. The company i am working with had made first stage in November 2019 and the second stage we did it on May 10-14, 2020 ( this is online audit). Please draft the procedures, then the auditor will provide you recommendations"" auditor are not fault founders"" .
 

outdoorsNW

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#6
Based on people’s comments, here is more background. We are at the 13485 project plan and schedule development stage. We are just starting out and are trying to start with a detailed, realistic project plan.

We are arranging for outside training sometime in June.

We are dissatisfied with our current CB, and are considering changing. Someone else had the action item to investigate and talk to CBs, but I just inherited that task. I have sent out questions to a few people asking who they have worked with and what they think about the CBs they have worked with. Hopefully later this week we will start talking to CBs.

I don’t think the document Sydney references clear since it says “Activities performed at a preliminary 1st stage include:….evaluating if internal audits and management reviews are being planned and performed,…”
 
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