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iso 13485 - medical device qms, required procedures
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  #9  
Old 26th June 2006, 08:51 AM
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Re: ISO 13485 - List of required / needed procedures and records attached

Hi, all,

In the Forum's experience with ISO 13485 registrars, have they required a separate procedure for Corrective Action and a separate procedure for Preventive Action?

I was thinking that a separate section of the Corrective and Preventive Action procedure could be devoted to Preventive Action so long as that section clearly defined Preventive Action and its activities.

Any opinions on this? Could you mention the registrars you have had experience with? I will be using NQA-USA as my registrar.

Thanks again, Jeff

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Old 26th June 2006, 09:18 AM
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Re: ISO 13485 - List of required / needed procedures and records attached

Quote:
In Reply to Parent Post by HDIGuy

Hi, all,

In the Forum's experience with ISO 13485 registrars, have they required a separate procedure for Corrective Action and a separate procedure for Preventive Action?

I was thinking that a separate section of the Corrective and Preventive Action procedure could be devoted to Preventive Action so long as that section clearly defined Preventive Action and its activities.

Any opinions on this? Could you mention the registrars you have had experience with? I will be using NQA-USA as my registrar.

Thanks again, Jeff
You can combine the two. For discussion on this subject look at the thread, Corrective Action (CA) and Preventive Action (PA) - One or Two Procedures?

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Old 25th July 2006, 12:01 PM
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Please Help! Re: My analysis of the standard produced the following results

Thanks ISO MAN, that's a useful summary.

Quote:
In Reply to Parent Post by kdplaskon

8.5.1 Improvement, General to address the issuance and implementation of advisory notices and notification to regulatory authorities, as required. Such procedures must be capable of implementation at any time.
I'm struggling with a definition of an "Advisory Notice" procedure. I understand that it's mandatory under ISO 13485 section 8.5.1 but it seems such a general process...
  1. Become aware of event requiring notification to customer
  2. Tell customer
  3. Follow-up (if you're diligent!)
Is that it?
  #12  
Old 25th July 2006, 12:27 PM
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Re: ISO 13485 - List of required / needed procedures and records attached

Hi,

My name is Steve (ISO Learner), I work at a small OEM company in California.

My company got the ISO 9001: 2000 certificate several years ago and we would like to get the ISO 13485: 9003 certificate in the future.

My question is: Do I need to update my company's ISO 9001 Quality Policy Manual to meet the 13485 requirement? Or just stay the same?

Do you have any free sample ISO 13485 Quality Policy Manual I can download from you or anyone for reference?

Thanks,

Steve
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Old 25th July 2006, 12:28 PM
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Re: ISO 13485 - List of required / needed procedures and records attached

For the question concerning Advisory Notices -

There are a number of reasons why you might issue an Advisory Notice including:
discuss the use of medical devices
discuss the modification of medical devices
discuss the destruction of medical devices
discuss the return of medical devices

You want to define who makes the decision to issue an AN, how the content is developed, which customers need to receive it, the type of feedback and followup mechanisms to use, what the relationship of an AN is to a CAPA initiative, etc.

There will tie-ins to your Document Control and Configuration Control processes and you might include the review of AN's in Management Review as well.

Hope this gives you a better ideas of what to include in your procedure.


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  #14  
Old 22nd June 2007, 10:33 AM
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Re: ISO 13485 - List of required / needed procedures and records attached

Have you considered what, if any, changes would be needed to meet Title 21 CFR Part 820?
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Old 22nd June 2007, 10:38 AM
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Re: ISO 13485 - List of required / needed procedures and records attached

To which section do you refer. There is no specific 820 requirement for Advisory Notices - do you mean adverse events?

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Old 26th June 2007, 05:39 AM
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Re: ISO 13485 - List of required / needed procedures and records attached

Quote:
In Reply to Parent Post by Al Rosen View Post

You can combine the two. For discussion on this subject look at the thread, Corrective Action (CA) and Preventive Action (PA) - One or Two Procedures?
That is a monster thread, and not for the faint-hearted. There are, however, some real gems amongst all the white noise.


My own take on this issue has always been:

1) Whether PA and CA are covered by one, or more than one, procedure, is less important than engendering a mentality of proactivity, and not just reactivity.

2) Everyone is comfortable with corrective action and correction (yes, they may debate the terminology, I could care less as long it gets done).

3) Everyone is comfortable with the concept of preventing recurrence. However people tend to lock into this as the only required Preventive Action, which I think is wrong.

4) Companies actually do a lot more PA than they realise:

Inspection planning
Maintenance (and planning of)
Process Risk Management
Process contingency planning
Disaster Action plans
Health and Safety schemes
Action and alert level implementation
(Arguably) training, followed by Competency Evaluation


5) I tend to recommend to my clients that they create their own list of the preventive activity that they perform, and how they evaluate the effectiveness of those preventive action processes.
Since probably every CA is probably due to a failure of PA this can be an interesting debate.


6) Part of the answer to the above falls back onto Management Review, which requires both the status of both CAs and PAs to be reviewed. Most of the places I audit only talk about the CAs (and follow-up activity to prevent recurrence).

7) The other reason that Management Review is a good time to cover PA, is because it is at these meetings that the strategic plans for the future are discussed, together with contingency planning for those plans, or decisions that extra resource is required etc etc.
I accept general evidence, minutes etc, that proactive PA is ongoing, I don't need to see complicated forms filled out.
Thank You to Roland Cooke for your informative Post and/or Attachment!
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