Dear All,

We have a simple process in place for the control of calibrated items consisting of a schedule of the due dates for calibration and the associated certificates for all items. The process works effectively without a written procedure.

Our UK registration body have now issued a “significant” non conformity against us requiring a documented procedure for the control of monitoring and measuring devices. They have recognised that all of the records that are in place are fully satisfactory.

The appropriate paragraph fro the standard is :-

……The organisation shall establish documented procedures to ensure that monitoring and measurement can be carried out in a manner that is consistent with the monitoring and measuring requirements……

I interpret this as applying to the use of the device to perform the test, not to the control of the device itself. With hindsight, I now I disagree with their interpretation.

Has anyone else been subjected to this interpretation ? I’m tempted to argue the point at the next visit, but I don’t think that I want to dig my heels in if the whole of the industry is going the other way.

Any comments gratefully received,


Bill Marshall

Although I haven't been audited to 13485:2003, I certainly agree with your interpretation. It doesn't say you need documented procedures for calibration of equipment, it says you need procedures for monitoring and measurement.

I wouldn't wait until their next visit to address this issue, I'd try to contact a technical resource at your registrar to resolve the question while it's still fresh.

I would agree with Howste's interpretation. However, I can see how some would interpret it differently. In order to ensure that monitoring and measurement can be carried out consistent with the requirements, it is implied that the equipment used be calibrated. This is definately something that I would discuss with your registrar to get a clear interpretation, and again agreeing with Howste, I wouldn't wait. One thing that you can suggest and see if your registrar would accept is to have a statement somewhere saying that all equipment used shall be calibrated. Hopefully this helps somewhat. Keep us posted as to what happens, this is an interesting one.

Thanks for the replies, it was good to have confirmation of my interpretation.

I have now discussed it with the registation body and they agreed (provisionally) that the first 2 paragraphs of the clause apply to the use of devices and that the rest of the clause applies to calibration of those items.

The guy I spoke to seemed fairly confident, but will not confirm it until the interpretation is submitted in writing.

So, all that is required to demonstrate an effective calibration system is a schedule and appropriate records, which seems like a victory for common sense. I shall now be looking for other opportunities to demonstrate effective control without resorting to written procedures.

regards

Bill Marshall