In my organization (registered to TS16949), we currently do not control gauge and tooling drawings. My interpretation of 4.2.3-"Control of documents" and 7.5.1.5 "Management of Production tooling" requires that we should.This is not felt across the board.

What do other organizations do?

Hi AnnieZ, welcome to the Cove!

The short answer is this: other organizations maintain them under document control. I'm a TS 16949 3rd-party auditor, and I would have to write a nonconformity if I saw that they were not controlled.

To me, the standard is very clear on this. 4.2.1d requires documents necessary for effective planning, operation, and control. 4.2.3 states that required documents be controlled. 7.5.1.5 (as you pointed out) also clearly specifies those specific types of documents.

BTW, I'm curious why this is posted in the ISO 13485 medical device forum if your question is about TS 16949...

My question to follow up on this is:
Speaking of TS16949
I know of companies where the mfg. eng. dept. keeps track of this.
Are such companies in control if they have access to the computer server but don't maintain the files because it's the engineers that draw and update?

If they are under control by the mfg. eng. department, then they're still under control. If your system allows for decentralized control that's fine, as long as all of the requirements of 4.2.3 are being met.

AnnieZ:

Howste has got the answer for you. Thank you Howste.

Regards,

Dirk

If they are under control by the mfg. eng. department, then they're still under control. If your system allows for decentralized control that's fine, as long as all of the requirements of 4.2.3 are being met.

I agree. Frequently, this is more a matter of making the procedure reflect the various approaches applied to controlling different types of documents.