Templates (Forms) requiring Control - Document Control

vitortavares

Involved In Discussions
#1
Hello,

I had an audit that the auditor as told me that all the forms used by the organization should be controled as being part of the QMS.

Our understanding is that the templates to control are those that the organization established to be part of the QMS and can't be controlled in the sftware system, and others (like purchase forms, bills, contracts, etc.) are controled by nature because they are in the Management software system.

Can any one help me about this? Is our understanding correct? Those it allow to control the QMS?

Thank You
 
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atitheya

Quite Involved in Discussions
#2
Re: Templates to control

Hello! and welcome to the cove,

Forms when used become records and need to be controlled as per Control of Records, clause 4.2.4, ISO9001 and you should already have a documented procedure for that.

A document specifying or describing the form / format and directing the organisation to use the same in their process for records needs to be controlled as per Control of Documents, clause 4.2.3, ISO9001 and you should have a documented procedure for this as well.

Usually my clients include the format within the procedure or as an annexure to the procedure to describe a process and the records to be maintained there-in and as such these are controlled as per Control of Documents. When the same format is printed for use and used to maintain records, it is controlled as per Control of Records.

Soft copy of such documents, and records (and forms) can be controlled by various ways including limiting the access, particularly for changes, among others ways, within your management software system.
 

Le Chiffre

Quite Involved in Discussions
#4
Re: Templates to control

Personally, I control the templates as it ensures a consistent base for the forms. It also reduces review time of the forms as the template provisions can be assumed to be present and correct. If the templates aren't controlled then the reviews of forms and other documents generated from templates have a larger scope and therefore take longer.
In my opinion it's not a necessity but a choice - I would expect an auditor to mention it as an OFI, unless it was found you weren't reviewing the forms adequately. But in that case it's still your decision, either review and control the templates or broaden the scope of the document reviews.
 

SteelMaiden

Super Moderator
Super Moderator
#5
Re: Templates (Forms) requiring Control

Wouldn't a template have to have a certain amount of control just by its very nature of being what it is? A model to create similar documents? Just sayin.....
 
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