What specifically must be calibrated per ISO 9001:2000?

[freelovefest]

I know that this topic has been touched on before but I haven't seen a difinitive answer on exactly what devices ISO 9001 and 13485 require to be controlled to the level of the standards. We are getting inundated with requests to calibrate equipment and I have been commisiond to define the criteria for determing which devices to include in the control system. Please comment on the following statements. Agree, disagree or am I all wet?

Control of "monitoring and measuring devices" is required by ISO standards and FDA regulations. ISO 9001:2000 and 13485:2003 require "devices needed to provide evidence of conformity of product to determined requirements" be identified and controlled to ensure valid measurement results. The CFR Title 21, Part 820, Subpart G, Section 820.72 stipulates "inspection, measuring, and test equipment" be "suitable for its intended purpose" and "capable of producing valid results." Both ISO Standards and FDA Regulations specify equipment calibration as a component of the control system and outline the necessary requirements to ensure the device measurement system achieves the intended purpose.

ISO, in previous releases of 9001, specified IMT&E "used by the supplier to demonstrate the conformance of product to the specified requirements" must be controlled, and periodic calibrations performed. ANSI/ASQC Q9001-1994 element 4.11 CONTROL OF INSPECTION, MEASURING, AND TEST EQUIPMENT, directs the supplier to refer to ISO 100012 QUALITY ASSURANCE REQUIREMENTS OF MEASURING EQUIPMENT for guidance implementing a control system. ISO 100012 is very specific in scope regarding measuring equipment. It is applicable to measuring equipment "used in the demonstration of compliance with a specification"… "it does not apply to other items of measuring equipment".

FDA has provided guidance for implementing a calibration program in Chapter 7 EQUIPMENT AND CALIBRATION, of HHS Publication FDA 97-4179 MEDICAL DEVICE QUALITY SYSTEMS MANUAL: A SMALL ENTITY COMPLIANCE GUIDE. The Guide indicates that "Some instruments need only to be checked to see that their performance is within specified limits, while others may require extensive calibration to a specification." It continues "Sometimes equipment used only for monitoring a parameter need not be calibrated but should be identified (e.g., for monitoring)."

These clarifying statements by FDA along with those by ISO, indicate that:
a. Only devices used to demonstrate product conformance must be controlled to the level outlined in the standard/regulations.
b.Other devices may be checked, verified, or tested based on utilization.

Your comments please,
Jim

The easiest answer is anything you use as either the basis of acceptance or rejection needs to be calibrated, and in QS/TS and other standards, this includes the eyes. The other things that need calibration maybe are things used for control of special processes, or those processes where you can not inspect to see if you met the requirements, like plating or soldering, they would need the temp checked by calibrated means to ensure the control of the process, so anything you use for process validation, or acceptance or rejection at any stage of the process flow.

 

[Graeme]

Jim,

There have been lots of useful suggestions, but I have not seen anyone yet mention the standard that is referred to in the ISO 9001:2000 standard.

The standard to refer to is ISO 10012:2003, Measurement management systems — Requirements for measurement processes and measuring equipment, which replaces the two obsolete standards listed in 9001 clause 7.6. This standard presents the concepts of evaluating the whole measurement system used in the system of production processes. Reading it, you will note that calibration is actually a small (although very important) part of the whole measurement management process.

The measurement management (or "metrological confirmation") process is the system that ensures that measuring instruments are suitable for the indended use. The process actually starts with the product, and determining what measurements must be made for its production, and with what accuracy requirements. Then you move to determining if the selected measuring devices are capable of making the measurement to the required accuracy. From these steps you can also determine any special calibration requirements, and the criticality of the measurement to the process. At this point, if you decide a measurement is not important - it doesn't matter if the result is wrong - you may decide to eliminate the measurement from the process. Any measuring instruments that remain must be calibrated, and the requirements of the measurements made on the product determine the calibration requirements of the instruments.

One of the key requirements in 10012 is that "The metrological characteristics of measuring equipment shall be suitable for its intended use." That is a measurement maangement issue that is outside the scope of the calibration function, yet properly determining suitability for the intended use is vital for deciding what instruments, and which of their functions need to be calibrated, and to what level of accuracy.

As a practical matter, most instruments are calibrated to their manufacturers specifications. A good measurement management system gives you information that can modify that, though. For instance, if all of your voltmeters are +/- 0.01% of reading but the measurements for the product only require +/- 0.25% -- and those voltmeters are used only for those measurements -- you may save money by documenting the requirement and calibrating them to the wider spec.

 

[kevinmurphy]

calibration - what is the frequancy for acceptance

after receiving an iso certified medical client vendor questionnaire there was a calibration question. researching our records I have found we were acquiring an annual calibration certification from calipers to micrometers to opticals to machines. however we stopped receiving certification/inspection over 2 years ago. a foreman actually suggested sending 2 machine certifications that were the only ones up to date (not the machines we use for the client - NOT!!!). we are going to hold off until the pres. oks scheduling the certification tests.

makes me wonder 2 things:
1) what (if anything) did we send for the last 2 years questionnaires.
2) did the client even look at them let alone read them.

quaestionnaires- just another way to meet documentation requirements

 

[FLORICEL - 2008]

monitorind and measuring devices

I need a little help with this control of measuring and monitoring devices. My company is an importer but also assures service to copyprinters. Were should i look for to find measuring and monitoring devices?

 

[Ettore]

Interpretations of ISO 9001 clause 7.6

I attached here some useful links for the interpretation of ISO 9001 clause 7.6
http://www.tc176.org/pdf/rfi028_final.pdf
http://www.tc176.org/pdf/rfi039_7_6afinal.pdf
I hope will be useful

 

[Crusader]

Error on the side of caution.....We got hit for a temperature gage on a piece of equipment that is not controlling the temperature of molten aluminum, it is merely displaying the current temperature used only as a reference. (There are controls/gages elsewhere that are calibrated) But, it didn't matter - all gages connected to that equipment must be calibrated. We got a "finding" and must respond to it. :mg: We debated up and down and lost the battle.

 

[Al Rosen]

Error on the side of caution.....We got hit for a temperature gage on a piece of equipment that is not controlling the temperature of molten aluminum, it is merely displaying the current temperature used only as a reference. (There are controls/gages elsewhere that are calibrated) But, it didn't matter - all gages connected to that equipment must be calibrated. We got a "finding" and must respond to it. :mg: We debated up and down and lost the battle.

Had your system allowed for it, a label on the gauge, Reference Only, you would have not lost the argument. This issue comes up often when power supplies have integral meters for voltage and current. Most of the time, they are not accurate enough for the measurements required, are not calibrated and labled "For Reference Only". External meters with the required accuracy are used to make the measurements.

 

[Helmut Jilling]

Error on the side of caution.....We got hit for a temperature gage on a piece of equipment that is not controlling the temperature of molten aluminum, it is merely displaying the current temperature used only as a reference. (There are controls/gages elsewhere that are calibrated) But, it didn't matter - all gages connected to that equipment must be calibrated. We got a "finding" and must respond to it. :mg: We debated up and down and lost the battle.

If the temp gage truly is used only for reference, then it could be covered or removed, right? If your answer is yes, that it can be blacked out, then the "reference" concept could apply. In that case, it would not have to be calibrated, because it does not meet the test of - "Clause 7.6 requires calibration or verification of measuring equipment “where necessary to ensure valid results.” The fact it is attached to the equipment is not a valid criteria.

You might not have won the argument with the auditor, but you were right.

Now, if covering would not be acceptable, because it is needed, then it could not be considered "reference only." At least this is how I would see the situation.

However,

 

[Louis Reimer]

What to calibrate ?

If a monitoring device is on a process that requires validation (7.5.2) calibrate it. If a monitoring or measuring device is referenced within a procedure that defines a required tolerance i.e. temperature controller of oven is to be set at 350 +/- 10 then it needs to be calibrated.

Paul was correct that if you have an inspection or measureing process upstream then you may be able to use the device for reference only. Provided the device in question is not used on a process line that requires validation. and your Work Instructions and/or procedures do not state a tolerance.

If a client is not calibrating a device and the device is not identified for reference only 7.6(c) "be identified to enable calibration status" that could be a finding or minimum an observation during an audit.

The decision for calibration or not is a decision that starts at 7.1 (c) Monitoring inspection and test activities specific to product, that now leads to 7.5.1 (c) "use of suitable equipment" and (d) the availability and use of monitoring and measuring devices.

If the product specifications require a value of 1% and the monitoring values are controlling +/- .01 %, (100:1 ratio) device could be justified "Reference only"

Exsample: Heating process is controlled at 350 deg +/- 10 Deg, the accuracy of the controllers are +/- 2 degs, (5:1 Ratio) product requires minimum 320 Deg but not greater than 380 otherwise you will create scrap. I would calibrate.

If the product requires a minimum of 320 but not greater than 450, that could be grounds for "reference only" and during preventative maintainance checks are done.

I have always identified the ranges and accuracy of all my monitoring and measuring equipment, and based on this information I could make decisions as to what processes exposed me to the highest risk of faliure or Nonconformance. Where the risk was the highest, calibration and/or additional inspection stages were justified. It also provided me with the required information to purchase replacements that have equal or better specifications so process controls did not degrade.

 

[Crusader]

Thanks for all the assistance. The temp gage will be calibrated not only because of the "ding" but for the reason that it just makes sense to do it and eliminates debates and keeps an audit moving right along like it should. All your points of view have really opened our eyes here though! Our calibration tech is intently watching this thread!