In Reply to Parent Post by Bill Marshall
(...) ……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.