Demystifying ISO 10012:2003 - Measurement Management Systems

  • Thread starter qualitygoddess - 2010
  • Start date
Q

qualitygoddess - 2010

#1
Does anyone have experience using ISO 10012:2003 Measurement Management Systems? I am trying to decide if it is worth purchasing the standard. What topics are covered in the table of contents? What kind of guidance is given for calibrating various types of devices?

If you consider yourself a metrology expert (especially with software), please let me know if I could post some more questions in order to get your professional opinion.

Thank you!
 
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G

Graeme

#2
ISO 10012:2003 highlights

qualitygoddess said:
Does anyone have experience using ISO 10012:2003 Measurement Management Systems? I am trying to decide if it is worth purchasing the standard. What topics are covered in the table of contents? What kind of guidance is given for calibrating various types of devices?

If you consider yourself a metrology expert (especially with software), please let me know if I could post some more questions in order to get your professional opinion.

Thank you!
Thank you for your question, and (since you registered less than a month ago) welcome to The Cove!

I can’t say that I have formally used ISO 10012:2003. However, having been in a calibration environment since the early 1980’s, now working with an ISO 9001:2000 registered calibration lab, and having to recently study it for another purpose, I may be able to offer some information. I also know there is some confusion and a number of mis-conceptions about this standard. So at the risk of this being a long post, here goes.

As you know, the 2000 revision of the ISO 9000 standards focuses on a business process model that includes all parts of the organization. Requirements and other inputs are acted on by a process to produce an output, and improvement is by various feedback processes such as management responsibility and corrective/preventive action. The big process (the business as a whole) is a network of other processes, each of which contribute in some manner to the quality of the product. One of those processes is the measurement management system.

ISO 10012 is referenced in clause 7.6 of ISO 9001:2000 – the versions listed in the text have been replaced by ISO 10012:2003, published in April 2003. It provides guidance for two important quality-related processes – measurement processes as a whole, and “metrological confirmation” of measuring equipment that is used to show compliance with measurement requirements. Here is a quick outline, which should look somewhat familiar:
  • Scope
  • Normative references
  • Terms and definitions
  • General requirements
  • Management responsibility
  • Resource management
  • Metrological confirmation and realization of measurement processes
  • Measurement management system analysis and improvement
Appendix A – Overview of the metrological confirmation process

It is important to know what the standard is not:
  • ISO 10012 is not a stand-alone requirements standard. It is a supplement to ISO 9001:2000. It is there for you and the auditors to use, but an organization cannot be audited to 10012 by itself.
  • The standard is not a calibration process standard. Calibration is mentioned, but as only one of many parts of the metrological confirmation process.
  • The standard is not a requirement for an in-house calibration system. Calibration can be obtained from suppliers and managed just like any other purchase of services.
The measurement management system is the set of business processes that control all of the measurement processes, and ensures that the measuring systems conform to defined requirements. A good measurement management system will be able to identify the required measurements for every important parameter or feature, identify the equipment used to make the measurement, demonstrate that the equipment is capable and the measurement process is validated, and document traceability to appropriate SI units.

Metrological confirmation is the process of ensuring that the measuring instruments (and the whole measurement system) are capable of making valid measurements of the required parameters or features of the product.

Some of the things to do or consider are in this list.
  • Metrological (measurement) requirements are obtained from the product.
  • The measurement management system ensures that
    • the requirements are known and documented
    • the correct measurements are being made
    • the risks and consequences of not managing the measurement process are accounted for
    • measurement processes are controlled
    • measurement equipment is available and adequate for making the measurements
    • people performing measurements are properly trained
    • software used to make measurements is validated
    • measuring equipment and work procedures are identified and controlled
    • the environment of the measurement area is considered, and controlled as necessary
  • Metrological confirmation ensures that
    • the measuring instruments are suitable and capable of making the required measurements
    • the current status is available to the user
    • records are maintained
    • measuring instruments are calibrated
  • Measurement processes must be planned, validated, controlled, documented and implemented.
  • A measurement process specification includes the measurement to be made, the equipment to be used, the skills and training required, and any other relevant factor.
  • Measurement requirements come from the customer, the product, the organization, and statutory or regulatory requirements.
  • Every measurement process must have an estimate of the measurement uncertainty, and the uncertainty should be small enough that it does not have a significant effect on the measurement result.
  • Measurements must be traceable to appropriate SI units of measurement (meter, kilogram, second, ampere, kelvin, candela, mole, radian and the supplemental units based on these.)
  • Nonconforming measuring equipment shall not be used.
Many people believe that 10012 applies only to calibration of measuring equipment. That is wrong. Calibration is important and is a requirement. But, it is only one of many parts of metrological confirmation, which itself is only one part of the measurement management system.



ISO 10012 does not tell you how to calibrate anything (nor do any of the other 12+ standards in the ISO 9000 family). It does not have any calibration procedures. It does require calibration as part of the metrological confirmation process, as calibration is the part that provides traceability to the SI and part of the information about measurement process uncertainty. Calibration (performance verification) procedures may be obtained from the equipment manufacturer, other industry or government sources, defined standards from organizations such as ASTM or ASME, or developed by a metrology engineer.

ISO 10012 does not tell you what specific equipment needs to be calibrated. You have to derive that information from the requirements of the product, customer and other interested parties.

With regard to software, there are a couple of important things. If the software is used only for keeping records, then the organization only has to show that it meets requirements – that’s ordinary rest and evaluation of the software after purchase and installation. If the software is used to make measurement or operate measurement instruments, then it must also be validated. That is, you must be able to demonstrate that the correct operations are done, the mathematical calculations are based on valid algorithms and are performed correctly, the results are interpreted correctly, and the correct data is stored. The classical method of validation is to compare automated results to manual measurement results, but that is not always appropriate or even possible with modern systems.

How's that for a start?
 
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Q

qualitygoddess - 2010

#3
Thanks!

Graeme:

Thanks very much. That was the answer I was basically looking for. Keep an eye out for other posts about software calibration. I have not had to deal with that before, and I'm sure I will have questions.

--Jodi
 
G

Graeme

#4
there is meaning in all things; we just have to figure out what it means

qualitygoddess said:
... software calibration. I have not had to deal with that before, and I'm sure I will have questions. ...
Hmmmm... I have to ask some questions about that, because the term is rather ambiguous.

First, let's make sure that we are using the same (or similar) definition of calibration. Paraphrased from several sources, calibration is the process of verifying the performance of a measuring instrument or system by comparing it to measurement standards of known value and uncertainty, and which have documented traceability to the SI. If the result of the calibration indicates the need for it, then the instrument may be adjusted or repaired. If that is done then the calibration procedure is repeated to verify success of the adjustment or repair, and the customer may get "before" and "after" test results.

(I always like to get that done first, because some older literature and some manufacturers take the position that "calibration" refers only to the adjustment part of the process. That is wrong, because if the instrument is working properly you do not want to tamper with the process by making an unnecessary adjustment!)

There are several possible meanings of "software calibration" ...

I assume from the context and your web site that you do not mean the process of making sure a software module is working correctly - otherwise known as "debugging the code". That leaves a few other possiblities -
  1. Software may be used to control an automated measurement system to perform a calibration. In this context a software process operates one or more measurement standards and possibly the unit under test, sends commands to them and recieves data from them, possibly recieves data from manual inputs by the operator, and stores the results. The software may also make calculations and produce reports. This software typically runs from a computer.
  2. An instrument may have internal operating software (and usually does, these days.) One function of the internal software may be to perform a normalization or standardization routine to determine and store error correction values which are used during measurements. This process is commonly performed after the system is turned on and has properly warmed up, or when significant parameters are changed - for example, an instrument may require that the process be repeated if the ambient temperature changes by more than ± 1.5 °C. The error corrections are in RAM, so they are lost when the system is turned off. This process is often called "accuracy enhancement", "error correction" or "self-calibration".
  3. An instrument may have a special operating mode that is accessed by a calibration laboratory. This "calibration mode" enables internal software that allows the calibration lab to store measurement corrections in permanent memory such as an EEPROM or flash memory. This is effectively using software to adjust the measuring instrument. The calibration mode almost always requires use of a key-lock switch (best because you can put a tamper seal over it) or entry of a password (bad because it is printed in the service manual). Other data is often stored in addition to correction factors; typical examples are model number, options, serial number and the date of the calibration.
That is why I said that "software calibration" is ambiguous. Without additional definition it can refer to software that operates a calibration system, or to an instument's internal function that stores temporary correction values, or to an instument's internal function that permits adjustment by storing corrections in permanent memory. (It may also refer to some new thing that I heven't heard of yet! :D )

Can you please be a little more specific in what sense you are using the phrase?
 
M

missy

#5
I have a few questions:

Must Software for CNC and PLC be validated?

Gage calibration "before" and "after" test results:
1)It is my undertanding that this applies to externally calibrated master blocks, gages etc. And that it also applies to gages calibrated internally. Is this correct?
2)Would this also apply to CMM probes when reset internally?



Thank you!
Missy
 
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