ISO 9001 Training

Understanding ISO 9001:2008
Requirements for Quality Management Systems

7.6 Control of Measurement and Monitoring Equipment  

ISO 9001 Training - Key Explanation Points and Tips:

Requirements for what needs to be measured (see clause 4.1c & e; 7.1c) and the acceptance criteria (see clause 7.2.1; 7.1c; 7.3.3c) may come from the customer, regulatory, industry and your own organization.

Product realization planning (see clause 7.1) must determine the following - what specific product and process characteristics needs to be monitored and measured; the criteria for product acceptance; the type of monitoring and measurement equipment (MME) needed; frequency - at what stages of realization to do it; sample size; etc.

You must then determine what MME is appropriate for each measuring or monitoring requirement. Consideration must be given to the measurement capability (precision) of the MME which may have to be several times greater than the tolerance criteria for product measurement.

This would depend on the industry you are in and the criticality of end use for the product (e.g. the precision requirements for ball bearings may be much greater than say for cutting cloth to make a shirt).

Personnel using MME must have competence and training in the use of MME in terms of their function, range and precision of measurement, reliability, use and maintenance.

MME may include measurement and testing tools; equipment; hardware and software. They may be owned by your organization; your employees or the customer. MME may be used to verify product as well as to measure process conformity (e.g. a temperature controller on an oven).

Besides MME used for product conformity, you may need to calibrate and control certain MME used in related and peripheral processes such as production equipment; tooling; maintenance; etc.

To ensure valid measurement and monitoring results, MME must be controlled. A process is required, to control - the identification of monitoring measurement;  selection; purchase; identification; status; calibration; verification; adjustment or re- adjustment; use; handling; maintenance and storage; training; handling of nonconforming MME; etc.

You must keep appropriate records to demonstrate effective operation and control of your MME processes (see clause 4.2.4). These records must include calibration and verification records traceable to national, international or other benchmark used for calibration. 

All MME used for product verification must be capable of being calibrated, verified or both. Calibration is setting or correcting an MME, usually by adjusting it to match or conform to a dependably known and traceable standard (e.g. adjusting a micrometer or caliper to conform to master blocks traceable to national standards).

Verification is confirming that the MME is meeting or performing to acceptable national measurement standards and does not involve any correction or adjustment (e.g. verifying a ruler or tape measure against a calibrated ruler that has been calibrated to a national standard). A ruler or tape measure is generally not capable of being calibrated and when it gets out of calibration its use must be discontinued.