Auditing the Control of Monitoring and Measuring Devices

Auditors often identify nonconformities when calibration practices are compared to the requirements of ISO 9001:2000, clause 7.6. To properly control monitoring and measuring devices, it’s important to understand the difference between “monitoring” and “measuring”, and “devices” and “equipment”.

Monitoring and Measurement
Monitoring can be defined as watching, tracking, or checking, usually for a specific reason. In clause 7.6, monitoring involves observation and supervision activities (using monitoring devices). Monitoring can involve measuring or testing at intervals, especially for the purpose of regulation or control. Measurement is the process of determining physical quantities, magnitudes, or dimensions (using measuring equipment).

Devices and Equipment
The word “device” has several meanings. It can be a non-physical device, such as, a plan, procedure, or technique. Or, it can be a piece of equipment.

Devices deliver qualitative or quantitative results. Qualitative measures are attribute-based, such as, kind, type or direction. Quantitative results are specific measures relating to size, magnitude, or degree. To contrast the terms: a qualitative analysis of a chemical mixture identifies the ingredients; a quantitative analysis identifies the quantity of each ingredient.

A non-physical device could be a survey questionnaire. Physical equipment can be grouped in two categories: indicative ormeasuring. Indicative equipment would something like a low-level fuel alarm, a power on/off indicator, or a go/no-go gauge. Measuring equipment is defined in ISO 9000:2000, 3.10.4, as a measuring instrument, software, measurement standard, reference material, or auxiliary apparatus, or combination thereof, necessary to realize a measurement process (a set of operations to determine the value of a quantity).

Use of Terms in Clause 7.6
With these definitions in mind, lets examine the requirements of clause 7.6. The first paragraph of 7.6 addresses bothmonitoring and measurement, as well as, devices (which includes equipment). However, the third paragraph, including bullets a) through e), is limited to “measuring equipment“. Correctly interpreting the requirements of clause 7.6 requires a close analysis of its precise wording.

ISO 9001:2000 only requires “measuring equipment” to be calibrated. However, there are situations where “measuring equipment” may be used for indicative purposes only, and therefore, may not need to be calibrated. An example would be an ammeter used to indicate current flow, not to measure the current.

Where it is not possible to calibrate monitoring and measuring “devices”, they should be verified or validated. Examples would be a pilot study for a survey questionnaire, or comparisons for sensory testing.

From this description of monitoring and measurement, as well as, devices and equipment, it seems unlikely that an organization would be able to exclude all of clause 7.6 from the scope of its quality management system. If it doesn’t use “measuring equipment”, the organization can exclude the requirements of the third paragraph, bullets a) to e) and the first two sentences of the fourth paragraph. But what about devices other than measuring equipment? Organizations may be excluding all of clause 7.6 without considering their use of non-physical devices.

Note: This article used information from the auditing practices guidance at the ISO Technical Committee 176 web site (see first article in this newsletter) and the book, ISO 9001:2000 for Small Businesses – What to do, Advice from ISO/TC 176, available at the ANSI e-Standards store for $58.00.