ISO9001 clause 7.6’s first sentence states “The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements.”
The third sentence: states “Where necessary to ensure valid results, measuring equipment shall….”

Do you think the first sentence has limited the third sentence?
In other words, only measuring equipments to provide evidence of product conformity need to be subjected to the regulation of clause 7.6 a) b) c) d) e), and the equipments for measuring process parameters are not covered by this standard?

in my opinion , yes , this is for devices needed for product conformity are the only devices that meant here...but, the devices that are related to product in an indirect way are also included in this sentence , the exclusion here for devices that are not related to product directly or indirectly

Samer

Hi,

Firstly, you will have to detail out the monitoring and measurement devices on which you want to exercise control. This is traditionally detailed in your Calibration Master Plan. These are the ones as spelt out in 7.6 first sentence "needed to provide evidence of conformity of product to determined requirements".

The ones which do not require calibration should be affixed with "Calibration Not Required" and be a part of the General plan detailing all monitoring and measurement devices.

The third sentence details different scenarios for adjustment, safe guarding, calibration or verification etc. and the "where applicable" here means the applicability of these 5 situations.

I don't think there is any limitation of the first sentence by the third.

If the process control instrumentation is used to provide evidence of of conformity of product to determined requirements, it needs to be calibrated. Otherwise not.

An example would be heat treatment of metals.

If the specification is purely for surface hardness and every component is checked, the process control equipment need not be calibrated IMO. However, many HT specifications are written along the lines of temperature and time which would require the equipment used to control these parameters to be calibrated.

ISO9001 clause 7.6’s first sentence states “The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements.”
The third sentence: states “Where necessary to ensure valid results, measuring equipment shall….”

Do you think the first sentence has limited the third sentence?
In other words, only measuring equipments to provide evidence of product conformity need to be subjected to the regulation of clause 7.6 a) b) c) d) e), and the equipments for measuring process parameters are not covered by this standard?

Any gages used to measure anything, are only valid if know to be accurate. Therefore, “Where necessary to ensure valid results, measuring equipment shall….” can apply to anything. If you are measuring a process, and need to ensure valid results, you can't do that without using gages that are known.

Any gages used to measure anything, are only valid if know to be accurate. Therefore, “Where necessary to ensure valid results, measuring equipment shall….” can apply to anything. If you are measuring a process, and need to ensure valid results, you can't do that without using gages that are known.

can apply to anything?... this could be according to the nature of the industry ..as example for pharmacuetical industry ,it could be ....

If you have facility maintenance section as example and suppose they have AVO meter with them . will you -as an Auditor - ask them to verificate this , I dont think so...., this is not applied for anything ..only devices /equipments that are related to product directly or indirectly

can apply to anything?... this could be according to the nature of the industry ..as example for pharmacuetical industry ,it could be ....

If you have facility maintenance section as example and suppose they have AVO meter with them . will you -as an Auditor - ask them to verificate this , I dont think so...., this is not applied for anything ..only devices /equipments that are related to product directly or indirectly


I might ask them IF they are calibrating such a gage if it is important. I may encourage them to calibrate it. I might write an OFI if it is very important. It is unlikely that I would write an NC unless it is clear that it could lead to problems.

Remember, ISO and TS also focuses on process effectiveness, not just product compliance.

We have a very long, thorough thread on gage calibration somewhere here on Elsmar from a few months ago, with many good opinions. I do not wish to start the debate all over again.