Changing Templates Approval Field

[dolly]

Hi all,
Probably this question already came up, but I was not able to find anything that could really answer my question, so I am starting this thread.
sorry if I am making the same question as other person already did.

Currently in our company, we are changing our QMS documentation (we are ISO 9001:2015 certified, and also following some ISO 13485 requirements), and one of the things we have changed was an approval field in every single template/form that was created.

We are a small group (22 people), so templates are then created, reviewed with process owner and if process owner is ok with the template, this is then sent to Quality manager that will release it in the QMS web page where all released documentation is available.

Checking ISO 9001 and ISO 13485, I cannot find anything saying we are making something wrong, but I would like to have also your feedback, as I don't want to have any NC because of this.

Can you please help me with this?

Thank you

 

[qualprod]

Why not to add also the review field?, this way both Review and approval
are included in template/forms, just what the standard require at managing documents

Hope this helps

 

[AndyN]

Hi all,
Probably this question already came up, but I was not able to find anything that could really answer my question, so I am starting this thread.
sorry if I am making the same question as other person already did.

Currently in our company, we are changing our QMS documentation (we are ISO 9001:2015 certified, and also following some ISO 13485 requirements), and one of the things we have changed was an approval field in every single template/form that was created.

We are a small group (22 people), so templates are then created, reviewed with process owner and if process owner is ok with the template, this is then sent to Quality manager that will release it in the QMS web page where all released documentation is available.

Checking ISO 9001 and ISO 13485, I cannot find anything saying we are making something wrong, but I would like to have also your feedback, as I don't want to have any NC because of this.

Can you please help me with this?

Thank you

Welcome! It would help to know what the "templates" are. Forms? I cannot see anything obviously "wrong" with what you describe, if that's what you do - unless it's ineffective for the organization in some way. I personally don't like approvals ON documents. It's unnecessary.

 

[Scanton]

I have much the same view.

In a previous role I inherited a mature document system where every up issue of every document was recorded on the document. This meant that many of the documents had reached the stage where there were more pages of recorded approvals than there was information. This is obviously counterproductive and a waste of paper (if printed).

My documents all have a title, a unique reference and a revision number at the top of the page. The up-issue and approvals information is kept in one easily accessible and write protected place elsewhere.

 

[AndyN]

Why not to add also the review field?, this way both Review and approval
are included in template/forms, just what the standard require at managing documents

Hope this helps

Not really. Documents don't have to bear the actual review/approvals, according to the standard. There are many, many documents in daily use, which we accept as reviewed and approved, but there's no sign off ON the actual document.

The "standards" don't require this, either...

 

[dolly]

Thank you all for your reply.

Due to some issue with my email, I was not able to receive your answers... long time, right?!

Anyway, we didn't implement any review/approval field.
@AndyN, I am referring yes to forms. Here we just call them templates.
Anytime a template/form is required, this need to be discussed with the process owner, to understand if the template already exist or if it makes sense, then if template/form is needed, is developed and is only released if Process owner agreed with it. this approval is done via email or by meeting.

until now is working, and is much better then having signature fields in templates, that need to be removed so people can use it.

thank you all