Document Control Procedure Please Review

[Sweetsue28uk]

Hi all

I am currently writing up the necessary procedures for our QMS. I have left the document control until I had a good structure in place and have tried to document it as is as well as ensuring that it meets all the requirements of the clause. Could you please have a read of it and let me know your comments? This is the first procedure I have ever written so any helpful comments would be most appreciated.

Thanks

Sue

[qusys]

Hi Sue,
this is my thoughts about the procedure.
Probably Purpose and Scope should be better defined.
The documented procedure shall respond to 4.2.3 of the ISO standard . If you are going to certificate ISO TS, you shall consider other clauses as well.
The purpose could be to identify actions and responsibilities for ensuring the control of all quality documents related to your QMS.
The scope could be that the procedure applies to all process of your QMS and encompasses all internal and external documents used to manage, perform or verify work . This is only a suggestion : it could be better phrased, I am speaking from general point of view.
I think it is not clear the process of review and update as necessary and re-approve documents. You should also define a time frame when to review documents, even though they are not changed during this time, in order to set a process to re-validate them.
It is not mentioned how you ensure that the changes are identified in the documents.
As to the external documents, it could be useful to better explain how the process is to control their distribution.
These are my first feedback after a first glance review of the documents procedure.
However my suggestion could be to design the process ( Control of Documents) and not seeing it as a functional but in a cross-way all over the organization. To better address this phase of process design, you should be first define who the process owner is.
Hope this helps.

[brahmaiah - 2010]

In Reply to Parent Post by Sweetsue28uk

Hi all

I am currently writing up the necessary procedures for our QMS. I have left the document control until I had a good structure in place and have tried to document it as is as well as ensuring that it meets all the requirements of the clause. Could you please have a read of it and let me know your comments? This is the first procedure I have ever written so any helpful comments would be most appreciated.

Thanks

Sue

Your format is not standard.The standard format is :
Ist row:Company name,Title of Procedure,Doct.No:,Rev.no:
1. Purpose:
2. Scope:
3. Reference: QMS Clause No. Etc.
4.Responsibility: Optional
5.Procedure: Step by step
6.Records: Optional
See attachment for an example
There is also an ISO Stanadard which guides on procrdure format.
V.J.Brahmaiah

[Stijloor]

There is no "standard format" for writing procedures. An organization can decide how to document its procedures. I have seen flow charts, traditional procedures (as you described them), process maps, Wiki-based documents; whatever works for the organization.

(BTW, what ISO Standard are you referring to?)

This document is helpful.

Stijloor.

[ScottK]

In Reply to Parent Post by brahmaiah

Your format is not standard.The standard format is :
Ist row:Company name,Title of Procedure,Doct.No:,Rev.no:
1. Purpose:
2. Scope:
3. Reference:QMS Clause No. Etc.)
4.Responsibility:Optional)
5.Procedure: (Step by step)
6.Records:Optional))
See attachment for an example
There is also an ISO Stanadard which guides on procrdure format.
V.J.Brahmaiah

Thank you for your example and it is certainly suitable but I must agree with Stijloor that for ISO9001 there is no "standard" format.

The organization will use what best suits their operations as long as it meets the minimal requirements of the standard - which are more concerned with the control of the document than the format.

I'm unaware of a standard that defines contents of a procedure for an ISO9001 system. Can you specify what standard? Perhaps you are confusing standards and guidances.

Question for the Original Poster - is this a general home brew QMS or are you going for registration to a standard?

[Stijloor]

In Reply to Parent Post by ScottK

<snip>I'm unaware of a standard that defines contents of a procedure for an ISO9001 system. Can you specify what standard? Perhaps you are confusing standards and guidances.

Yes, a possible reference could be made to these guidelines which are NOT requirements.

From ISO/TR 10013:2001....

4.5 Documented procedures
4.5.1 Structure and format
The structure and format of the documented procedures (hard copy or electronic media) should be defined by the organization in the following ways: text, flow charts, tables, a combination of the above, or any other suitable method in accordance with the needs of the organization. The documented procedures should contain the necessary information (see 4.5.2) and should contain a unique identification. Documented procedures may make reference to work instructions that define how an activity is performed. Documented procedures generally describe activities that cross different functions, while work instructions generally apply to tasks within one function.

Stijloor.

[brahmaiah - 2010]

In Reply to Parent Post by Stijloor

There is no "standard format" for writing procedures. An organization can decide how to document its procedures. I have seen flow charts, traditional procedures (as you described them), process maps, Wiki-based documents; whatever works for the organization.

(BTW, what ISO Standard are you referring to?)

This document is helpful.

Stijloor.

There is an ISO Guideline in the same lines as I have described.I WILL TRY TO GIVE YOU THE NO AFTER REFRRING TO MY LIBRARY.
V.J.Brahmaiah

[Sweetsue28uk]

Hi

Thanks for all your replies. I am attempting to get us registered to ISO9001:2008. In summary up to now I need to clarify the scope and purpose on my document; I need to clarify the process of review, update and reapprove and define a timeframe when to review documents. The changes on each document were going to be identified on the Change Request Form - is this not sufficient - do I actually have to mark them up on the old document as well?

As for external documents, they are accessible by all staff as they are work instructions, therefore there is no control around the distribution they are uncontrolled when printed - is this sufficient?

Thanks

Sue