What to expect during Stage 1 and Stage 2 audits - Certification Audit ISO 9001:2008

  • Thread starter jaykashkap - 2009
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jaykashkap - 2009

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#1
We are a CRO specialising in conducting Phase II Clinical trials. our certification audit is scheduled for 15th Apr, What to expect during Stage 1 and Stage 2 audits?

Thanks in advance.


Jayashree
 

Coury Ferguson

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#2
Re: Certification Audit

Are you looking at ISO9001:2008 or ISO13485 Registration? They are a little different.
 

Stijloor

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#3
Re: Certification Audit

We are a CRO specialising in conducting Phase II Clinical trials. Our certification audit is scheduled for 15th Apr, What to expect during Stage 1 and Stage 2 audits?

Thanks in advance.

Jayashree
CRO = Contract Research Organization?
CRO = Clinical Research Organization?

Your Registrar/Certification Body should have provided you with all relevant information regarding Stage 1 and 2 audits pertaining to your specific industry and applicable standard. Have they submitted this information to you?

Stijloor.
 
J

jaykashkap - 2009

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#4
Re: Certification Audit

We are going in for ISO 9001:2008 certification

Jayashree
 

Coury Ferguson

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#7
Re: What to expect during Stage 1 and Stage 2 audits - Certification Audit ISO 9001:2

We are a CRO specialising in conducting Phase II Clinical trials. our certification audit is scheduled for 15th Apr, What to expect during Stage 1 and Stage 2 audits?

Thanks in advance.


Jayashree
The Stage 1 Assessment is to determine if you are ready for the Stage 2. Stage 1 leans more toward documentation then anything else. There will most likely be a "touch the surface" review of your facility. After that, they will determine if you are ready for the Stage 2. Take notice, that they can/will generate NCs during the Stage 1 assessment. Take the appropriate action on the NCs.

The Stage 2, is an in-depth review of the Quality Management System, for all existing processes and requirements. The time frame is determined by the quantity of personnel, the complexity of the product, and the amount of processes, plus some more. The Stage 2 is the controlling assessment to either recommend or not recommend registration.

This is just some information on the Stage 1 and Stage 2 assessments.
 
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