ISO 9001 / 9002 INTERNATIONAL STANDARD

Clause 4.11 - TEST, INSPECTION & MEASURING EQUIPMENT

Clause 4.11.1 - General

This clause requires that the equipment that you use in order to prove that the goods you make or supply are correct, is suitable for the purpose. This definition should provide a reasonable guideline as to which types of equipment are covered by this clause, and which are not. For example, it you manufacture vehicle engines, you would need to control equipment used to measure power output, revolutions per minute, compression, various dimensions, etc. You would not need to control equipment used for indication purposes only, such as tape-measures, etc.

Note that each situation is different. You must consider whether equipment is used as a general indicator, or whether it is used to prove that the items is functioning correctly.

In the case of computer equipment, this may extend to include anti-viral software. As most organisations hold records on computer systems, this is a common requirement.

Where other test software or test hardware is used as a means of measuring the performance of goods or of a system, they must be checked at specified intervals, so as to ensure that they are working. In the case of some systems, the self-diagnostic routines may be considered to fulfil this requirement, although some alternative verification should be included if at all possible.

Clause 4.11.2 - Control Procedure

You must :

• determine what is to be measured and what equipment is suitable to make the measurements. this must include consideration of the accuracy required, and if the equipment is capable of achieving it.
• identify all equipment which is to be used, and ensure that is calibrated (i.e. checked for accuracy at appropriate intervals, in a way that proves that it is accurate enough.
• if the calibration is done in-house (i.e. against items which have been calibrated by a suitable external agency), you must specify exactly how this is done and how it is recorded.
• if the equipment is calibrated externally (e.g. by a nationally accredited agency) you must specify how this is controlled and how the calibration results are reviewed, so as to ensure that the equipment is suitable for use. (Calibration only records what measurements were shown by the equipment at various points. You must work out the accuracy from the data that the calibration agency supplies to you)
• identify calibration status (e.g. label the equipment "Calibrated until xx/yy", etc)
• ensure that the equipment is being used by trained persons under suitable conditions
• ensure that the equipment is suitably stored so that it remains in good, accurate condition
• ensure that any adjustment points are secured, so as to prevent users from "tweaking" them,

If the equipment is subsequently found to be unsuitable, you must review all work involving the equipment, and decide upon what action must be taken (e.g. recall of all affected items, issue of warning notices, do nothing because the error was not significant, etc)