7.6 Control of monitoring and measuring equipment

The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirements.

The organization shall document procedures to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements.

As necessary to ensure valid results, measuring equipment shall:

a) be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards: when no such standards exist, the basis used for calibration or verification shall be recorded (see 4.2.5);

b) be adjusted or re-adjusted as necessary: such adjustments or re-adjustments shall be recorded (see 4.2.5);

c) have identification in order to determine its calibration status;

d) be safeguarded from adjustments that would invalidate the measurement result;

e) be protected from damage and deterioration during handling, maintenance and storage.

The organization shall perform calibration or verification in accordance with documented procedures. In addition, the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The organization shall take appropriate action in regard to the equipment and any product affected.

Records of the results of calibration and verification shall be maintained (see 4.2.5).

The organization shall document procedures for the validation of the application of computer software used for the monitoring and measurement of requirements. Such software applications shall be validated prior to initial use and, as appropriate, after changes to such software or its application.

The specific approach and activities associated with software validation and revalidation shall be proportionate to the risk associated with the use of the software, including the effect on the ability of the product to conform to specifications.

Records of the results and conclusion of validation and necessary actions from the validation shall be maintained (see 4.2.4 and 4.2.5).

NOTE Further information can be found in ISO 10012.

7.5.10 Customer property

The organization shall identify, verify, protect, and safeguard customer property provided for use

or incorporation into the product while it is under the organization’s control or being used by the

organization. If any customer property is lost, damaged or otherwise found to be unsuitable for use, the

organization shall report this to the customer and maintain records (see 4.2.5).