Fulfilling ISO 9001 Document Review Requirements

T

Tarrah

#1
Good Morning All!

It has been a while since my last post, but you are all so helpful I would like to solicited some advice from you relating to the review of procedure requirements.

We currently have our review scheduled for every 2 years, however, this requirement is not currently being managed. It is hard to provide evidence that the procedure had or had not been reviewed. Do you have any examples of a system that worked well to provide this objective evidence and helped to maintain compliance to the requirement?

Tarrah
 
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qusys

Trusted Information Resource
#2
Re: Fulfilling Document Reviewing Requirements

Good Morning All!

It has been a while since my last post, but you are all so helpful I would like to solicited some advice from you relating to the review of procedure requirements.

We currently have our review scheduled for every 2 years, however, this requirement is not currently being managed. It is hard to provide evidence that the procedure had or had not been reviewed. Do you have any examples of a system that worked well to provide this objective evidence and helped to maintain compliance to the requirement?

Tarrah
Hi Tarrah,
you could proceed in many ways.
For instance, manage the expiring due date of the document manually, creating a list with all the document and the date of issue, then you can set on Outlook calendar the next review date as per your document procedure ( 2 years), if in the meantime no revision occurred. You can notify the process owner or the owner of the document at least three months before the expiring date.
On the hand , you can buy an electronic document mgmt system that does this job automatically , based upin the features you set.
Hope this helps:bigwave:
 

RoxaneB

Super Moderator
Super Moderator
#3
Re: Fulfilling ISO 9001 Document Reviewing Requirements

Tarrah:

There are several ways to accomplish the activity of document review and they vary from simple to complex and from automatic to manual. It is up to your organization to determine which option will add the most value.

1. Outlook calendar is good - but what if people leave?

2. Excel log of all documents, including next review date. Coordinator contacts document owner for review to be done. Email of review being done is maintained (i.e., record).

3. Electronic software.

Another aspect to consider is the spread of the review dates. If a document owner is responsible for 20 documents and they all come due for review within two weeks, that's a lot of reviewing to do, plus a person's normal job. Considering spreading them out over the course of review period, where possible.
 
K

Ka Pilo

#4
Re: Fulfilling ISO 9001 Document Reviewing Requirements

Good Morning All!

It has been a while since my last post, but you are all so helpful I would like to solicited some advice from you relating to the review of procedure requirements.

We currently have our review scheduled for every 2 years, however, this requirement is not currently being managed. It is hard to provide evidence that the procedure had or had not been reviewed. Do you have any examples of a system that worked well to provide this objective evidence and helped to maintain compliance to the requirement?

Tarrah
It is a good idea to read through every document more frequently and say to yourself "Is this still relevant?" or "Does this match actual practice?" etc

You can include an "Ownership" section of each document stating something like "The Job Title is responsible for ensuring that this document is necessary and that it reflects actual practice."

As for the evidence of review, maintain a record of review even if the contents haven't changed to confirm suitability. Or you may want to add a review date and reviewed by column to this to prove a document has been reviewed.
 
Last edited by a moderator:

RoxaneB

Super Moderator
Super Moderator
#5
Re: Fulfilling ISO 9001 Document Reviewing Requirements

It is a good idea to read through every document more frequently and say to yourself "Is this still relevant?" or "Does this match actual practice?" etc

You can include an "Ownership" section of each document stating something like "The Job Title is responsible for ensuring that this document is necessary and that it reflects actual practice."
While the idea of a more frequent review is practical - depending on the number of documents that Tarrah's organization has established - reading through a document does not provide the objective evidence of the review being done.

Can you provide suggestions on how she should maintain a record of the review. I think this is what is being asked by Tarrah.
 
K

Ka Pilo

#6
Re: Fulfilling ISO 9001 Document Reviewing Requirements

While the idea of a more frequent review is practical - depending on the number of documents that Tarrah's organization has established - reading through a document does not provide the objective evidence of the review being done.

Can you provide suggestions on how she should maintain a record of the review. I think this is what is being asked by Tarrah.
Thanks for the advice. I have edited my post and added my suggestion for "evidence of review" query.

I'm wondering if issue number and issue date will suffice without the "reviewed by" bit on it. What do you think?
 

Colin

Quite Involved in Discussions
#7
Re: Fulfilling ISO 9001 Document Reviewing Requirements

Isn't part of the role of internal audit to review the procedure? In particular 8.2.2 b) where it requires the organisation to determine whether the QMS is effectively implemented and maintained.

The audit records then become the evidence that the review took place and any subsequent actions required following the review.
 

RoxaneB

Super Moderator
Super Moderator
#8
Re: Fulfilling ISO 9001 Document Reviewing Requirements

Isn't part of the role of internal audit to review the procedure? In particular 8.2.2 b) where it requires the organisation to determine whether the QMS is effectively implemented and maintained.

The audit records then become the evidence that the review took place and any subsequent actions required following the review.
An audit (be it internal or external) can not review every possible document within an organization. An audit performs a "review" on a sample number of documents.

Is it not part of the standard that each document be reviewed for its adequacy? This ensures that internal personnel can ensure that the documented process properly aligns with the actual process.
 

Pancho

wikineer
Super Moderator
#9
Re: Fulfilling ISO 9001 Document Reviewing Requirements

Good Morning All!

It has been a while since my last post, but you are all so helpful I would like to solicited some advice from you relating to the review of procedure requirements.

We currently have our review scheduled for every 2 years, however, this requirement is not currently being managed. It is hard to provide evidence that the procedure had or had not been reviewed. Do you have any examples of a system that worked well to provide this objective evidence and helped to maintain compliance to the requirement?

Tarrah
Hi Tarrah,

The requirement in the standard (§4.2.3.b) is for you to "define the controls needed to review and update ... documents". The standard does not mandate a review nor evidence of it. The difference is subtle but important.

You have defined a control to be "review each procedure every two years". Fine. Lucky you to have very stable processes. Why not simply add that "if upon review it is found that no update to the procedure is required, then no further action is necessary. If an update is required, then the procedure is updated in accordance with [SOP: Procedure updates]"?

That would still meet the §4.2.3.b requirement, and save you unnecessary paperwork.

(As a side note, every time someone, anyone, consults a procedure they are also reviewing it. If they find a discrepancy between the procedure and the way they must do the work, they should fix the procedure, if they can, or raise a CAR. If you code this into your QMS, your docs and processes will improve very fast.)

Good luck!
Pancho
 

Colin

Quite Involved in Discussions
#10
Re: Fulfilling ISO 9001 Document Reviewing Requirements

An audit (be it internal or external) can not review every possible document within an organization. An audit performs a "review" on a sample number of documents.

Is it not part of the standard that each document be reviewed for its adequacy? This ensures that internal personnel can ensure that the documented process properly aligns with the actual process.
Roxane, I was think more in terms of reviewing the procedures rather than all documents. I agree that the internal audits will only take a sample of documents but I suspect that most procedures will be reviewed as part of the internal audit programme. As Pancho points out, the clause states 'review and update as necessary'.
 
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