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iso 13485 - medical device qms, requirements and specifications, documented procedures (requirements for), documents and documentation (general)
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  #1  
Old 3rd November 2003, 10:18 AM
Bill Marshall Bill Marshall is offline
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Question ISO 13485 Calibration Requirements - Requiring a Documented Procedure for control?

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

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  #2  
Old 3rd November 2003, 12:09 PM
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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.
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Old 3rd November 2003, 12:32 PM
Jimmy Olson Jimmy Olson is offline
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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.
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Old 4th November 2003, 04:10 PM
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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
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Old 31st January 2010, 02:47 PM
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Re: 13485 Calibration Requirements - Requiring a Documented Procedure for control?

Documented procedures for calibration are easy to generate and do not have to be over burdensome. Why not just write one that suits your processes and appease your registrar at the same time?

Bud S.
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Old 12th February 2010, 11:47 AM
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Re: ISO 13485 Calibration Requirements - Requiring a Documented Procedure for control

Although this was written a LONG time ago, the principles are still relevant.

I could appease my registration body, but they are not the primary audience for these documents. We still meet auditors who would like to see more written procedures but who fiind it difficult to demonstrate how the additional documents will improve the process.

I think it's important to write procedures only where they reduce a risk, or otherwise add value to a process. That way, we keep the system simple, and the primary audience (ie the staff) have the instructions that they need without cluttering them up with extras.
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Old 12th February 2010, 01:04 PM
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Re: ISO 13485 Calibration Requirements - Requiring a Documented Procedure for control

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In Reply to Parent Post by Bill Marshall View Post

(...) ……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.
Bill, I have to disagree with your interpretation. IMHO the meaning of this requirement (ISO 13485 Clause 7.6) is for the organization to DOCUMENT a procedure that ensures that the measurement performed is suitable for the requirements. This means a few things actually:
- the inspection methods have to be suitable for the type of measurement; for example you might use a salt spray test to inspect for salt corrosion resistance, instead of an acid spray; another example: you might do a chemical analysis to evaluate the chemical composition of a steel
- the inspection equipment has to be suitable for the inspection performed; for example a caliper would not be suitable to measure a dimension with a tolerance of +/-.002" because it is not accurate enough.
- the inspection equipment has to be 'trustworthy' to ensure valid results; this is your CALIBRATION requirement comes in place

So, your documented procedure needs to specify WHAT you do to ensure that suitable methods and suitable equipment are selected, and reliable equipment is used in order to ensure that the monitoring & measurement is consistent with the requirements. Now, it does not have to be a 'brain surgery' procedure. I like to make procedures in a flowchart format and in a case like this I would use a few decision point (yes/no, true/false, left/right, etc). For example: identify measurement requirements -> is method specified? (i.e. ANSI, ISO, TAPPI, etc) -> NO -> customer approval required?-> YES -> jointly develop method -> ... and so on.

And that's my on this topic for now.
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Old 12th February 2010, 01:06 PM
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Re: ISO 13485 Calibration Requirements - Requiring a Documented Procedure for control

Forgot to add something about inspector's qualifications to my previous posting. Think about INSPECTION as about a process: it has equipment, materials (parts), methods, manpower, etc.
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