ISO 9001 - Documentation Control - Letters / Letter Templates

[stephenh]

Hi all,

I have a query regarding the control of letters.

We have a certain procedure flowchart which requires various letters sent at certain points.

I have put the file name of the letters under 'documentation' on the front page of the flowchart. As far as i'm aware they do not need a reference code or logging in the document register. It would sureyl be too much effort to control every single letter we send out in the company?

Any advice would be appreciated, T-minus 11 days to audit!

Stephen

 

[Paul Simpson]

Hi all,

I have a query regarding the control of letters.

We have a certain procedure flowchart which requires various letters sent at certain points.

I have put the file name of the letters under 'documentation' on the front page of the flowchart. As far as i'm aware they do not need a reference code or logging in the document register. It would sureyl be too much effort to control every single letter we send out in the company?

Any advice would be appreciated, T-minus 11 days to audit!

Stephen

Is it important that letters are all sent the same?

If your letters all have standard text in them then you might decide they need control. The level of control is up to you. Some organizations use templates that are all document controlled and protected so bits can't be taken out of them (but with fields where bits can be added).

Don't forget the standard letter or template would be controlled as a document (form) and the completed letter would be controlled as a record.

The level and type of control is up to you.

 

[stephenh]

Thanks Paul,

The letters are generated from a database. Would this cover the requirement for keeping records? can search by dates/status etc.

As for controlling letters, I'm not going to for the time being, I think I will reference them under templates in the Document Register and keep an electronic copy in the ISO > Department file. It's a department I know very little about and as long as they have a method for controlling them then thats fine by me.

 

[Paul Simpson]

The letters are generated from a database. Would this cover the requirement for keeping records? can search by dates/status etc.

OK. The record then is the entry in the database (unless the person putting together the database can "add" to the text in which case the letter is the record (as they may have committed the company to additional requirements.

As for controlling letters, I'm not going to for the time being, I think I will reference them under templates in the Document Register and keep an electronic copy in the ISO > Department file. It's a department I know very little about and as long as they have a method for controlling them then thats fine by me.

Looks fine to me.

 

[pzaltz]

Hi Stephenh,

In my humble opinion, as long as the records are the proof that your procedure was followed, you don´t need to keep a copy of the letter. Otherwise, you'll need to store "copy" every item produced using your quality management system in order to show compliance with the procedures, and you don´t ¿right?
Just make sure that your procedure: a) points to a letter template to follow; and b) The record for demonstrate compliance is your database field "sent letter date".

Good Luck for the audit!!

BRegards,


Pablo