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document review(s) and approval(s), iso 13485 - medical device qms, requirements and specifications
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  #1  
Old 9th August 2013, 05:44 PM
IZAKK IZAKK is offline
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Question Does ISO 13485 have a Periodic Document Review Requirement?

Hi, First off, this is a great forum; I canít believe all of the information that is available here. Second, this is my first post so please take it easy on me.

I have recently been given the task of reviewing our QMS documents and performing gap analysis to ISO 13485. In the Document Control procedure that I am reviewing there is a section for periodic document review with a requirement to have review performed on controlled documents every two years at a minimum.

My question is where exactly is the requirement / clause for this in the 13485 standard? And since documents of external origins are controlled do they need to have this review as well? Thanks in advance for any help.

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  #2  
Old 9th August 2013, 06:28 PM
DannyK DannyK is offline
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Re: Does ISO 13485 have a Periodic Document Review Requirement?

The requirement for periodic review originates from: ISO 13485 clause 4.2.3 b
"b) to review and update as necessary and re-approve documents,"

There is no stated requirement to review every 2 years.

Some companies who want a lean system state that they review their documents as part of the internal audit process which they perform every year, therefore they do not need to create a formal review.
Thanks to DannyK for your informative Post and/or Attachment!
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  #3  
Old 9th August 2013, 10:31 PM
Ajit Basrur's Avatar
Ajit Basrur Ajit Basrur is offline
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Re: Does ISO 13485 have a Periodic Document Review Requirement?

Quote:
In Reply to Parent Post by IZAKK View Post

Hi, First off, this is a great forum; I canít believe all of the information that is available here. Second, this is my first post so please take it easy on me.

I have recently been given the task of reviewing our QMS documents and performing gap analysis to ISO 13485. In the Document Control procedure that I am reviewing there is a section for periodic document review with a requirement to have review performed on controlled documents every two years at a minimum.

My question is where exactly is the requirement / clause for this in the 13485 standard? And since documents of external origins are controlled do they need to have this review as well? Thanks in advance for any help.
Welcome to the Cove, IZAKK

In addition to Danny's response, the periodic review frequency could be determined by your organization based on the document type (Manual, Procedures and WI) and typically none exceeding 5 years.

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Thanks to Ajit Basrur for your informative Post and/or Attachment!
  #4  
Old 10th August 2013, 01:31 AM
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somashekar somashekar is offline
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Re: Does ISO 13485 have a Periodic Document Review Requirement?

Quote:
In Reply to Parent Post by IZAKK View Post

Hi, First off, this is a great forum; I can’t believe all of the information that is available here. Second, this is my first post so please take it easy on me.

I have recently been given the task of reviewing our QMS documents and performing gap analysis to ISO 13485. In the Document Control procedure that I am reviewing there is a section for periodic document review with a requirement to have review performed on controlled documents every two years at a minimum.

My question is where exactly is the requirement / clause for this in the 13485 standard? And since documents of external origins are controlled do they need to have this review as well? Thanks in advance for any help.
Hello IZAKK... Welcome to the COVE.
Reviewing QMS documents is just not for the sake of reviewing after any defined time. This is rather an undesireable method which seems to have got into your doc procedure, and is nowhere asked for.
The "as necessary" part in the 4.2.3 b) are the various necessary situations that you will come upon during your business journey.
Like...
1. Medical device engineering change
2. Audit finding
3. Internal non-conformance
4. Customer complaint
5. New or revised regulation
6. Other external changes and information
... and some more
Any of these can trigger a revisit and review of effected documented procedures.
Do not just put into your document control procedure a time based necessity for document review. Some of the necessary points for review are as I have listed up. When you agree, use these as the basis for deciding when document will be reviewed and approved, and be aware and sensitive to these necessities.

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  #5  
Old 11th August 2013, 08:36 AM
v9991 v9991 is offline
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Lurker Re: Does ISO 13485 have a Periodic Document Review Requirement?

apart from triggers viz., audits, complaints/incidents/deviations etc., there is no specific determined review criteira; all regulation asks for is to have change control,,,effective implementation of changes etc.,

it is also an rule of thumb to set a time period (2-years, 3 - years etc)which will trigger standard review mechanism for effectiveness/aligning/optimization of existing system...
Thanks to v9991 for your informative Post and/or Attachment!
  #6  
Old 12th August 2013, 12:16 PM
IZAKK IZAKK is offline
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Re: Does ISO 13485 have a Periodic Document Review Requirement?

Thanks everyone for the help! Are documents of external origin handled differently? Meaning, does 13485 require that I should have a scheduled time period, say annually maybe, to review external documents to ensure the most current or applicable / appropriate revisions are being used?
  #7  
Old 12th August 2013, 09:17 PM
Ajit Basrur's Avatar
Ajit Basrur Ajit Basrur is offline
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Re: Does ISO 13485 have a Periodic Document Review Requirement?

Quote:
In Reply to Parent Post by IZAKK View Post

Thanks everyone for the help! Are documents of external origin handled differently? Meaning, does 13485 require that I should have a scheduled time period, say annually maybe, to review external documents to ensure the most current or applicable / appropriate revisions are being used?
Section 4.2.3 (f) for "documents of external origin" mentions "...to ensure that documents of external origin are identified and their distribution controlled...".

Therefore, there is no periodic review but not a bad idea if you can manage.

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Thanks to Ajit Basrur for your informative Post and/or Attachment!
  #8  
Old 12th August 2013, 11:07 PM
IZAKK IZAKK is offline
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Re: Does ISO 13485 have a Periodic Document Review Requirement?

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In Reply to Parent Post by v9991 View Post

it is also an rule of thumb to set a time period (2-years, 3 - years etc)which will trigger standard review mechanism for effectiveness/aligning/optimization of existing system...
v991, this may be what my procedure is referring to, could you expand on this please? Thanks!
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