Control of monitoring and measuring devices in AS9100 standard
Control of monitoring and measuring devices in AS9100 standard
Clause 7.5.6
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 (see 7.2.1).
The organization shall maintain a register of these monitoring and measuring devices, and define the process employed for their calibration including details of equipment type, unique identification, location, frequency of checks, check method and acceptance criteria.
NOTE: Monitoring and measuring devices include, but are not limited to: test hardware, test software, automated test equipment (ATE) and plotters used to produce inspection data. It also includes personally owned and customer supplied equipment used to provide evidence of product conformity.
The organization shall establish processes 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.
The organization shall ensure that environmental conditions are suitable for the calibrations, inspections, measurements and tests being carried out.
Where necessary ensure valid results, measuring equipment shall
a) be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded;
b) be adjusted or re-adjusted as necessary;
c) be identified to enable the calibration status to be determined;
d) be safeguarded from adjustments that would invalidate the measurement result;
e) be protected from damage and deterioration during handling, maintenance and storage;
f) be recalled to a defined method when requiring calibration.
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 on the equipment and any product affected.
Records of the results of calibration and verification shall be maintained (see 4.2.4).
When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary.
NOTE See ISO 10012-1 and ISO 10012-2 for guidance.
NOTE: Calibration is a verification technique that is not typically applicable to operational software. However it may be applicable to hardware and test or simulator software used to test and validate the deliverable software, related hardware, and systems.
This section also applies to software used for verification purposes. The main requirement for verification software is that it is checked to ensure capability to carry out the proposed verification. The organization shall determine and document how the validation/verification software is developed and controlled.
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on Saturday, January 23rd, 2010 at 3:35 pm and is filed under AS 9100 standard.
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