CALIBRATION IN ISO 9001:2008

K. R. Singhal

The purpose of this paper is to discuss calibration requirements as per ISO 9001:2008 QMS Standard and related issues.

A monitoring, measuring or testing activity is useful and effective only when measurement results are reliable. Measurement results should be sufficiently accurate with a known degree of uncertainty. For this purpose, there is a need to control monitoring and measuring equipment that have the desired level of accuracy and consistency under condition of actual use.

Clause 7.6 of ISO 9001:2008 QMS Standard deals with control of monitoring and measuring equipment. This clause interalia speaks about calibration of monitoring and measuring equipment. The purpose of requirements in clause 7.6 of ISO 9001:2008 QMS Standard is to ensure suitability of monitoring and measuring equipment.

Requirements of Clause 7.6

The organization must determine (i) what to monitor and measure, and (ii) the monitoring and measuring equipment needed. Monitoring and measuring equipment is helpful in providing evidence of conformity of product to determined requirements.

The organization must establish processes to ensure carrying out monitoring and measurement in consistent with the requirements. As such, it is necessary to have a detailed process system established and maintained for keeping the monitoring and measuring equipment accurate and good operating conditions.

Where necessary to ensure valid results – (i) monitoring and measuring equipment must be calibrated or verified, or both, at specified intervals (decided by the organization), or prior to use, against international or national measurement standard, (ii) monitoring and measuring equipment must be adjusted or re-adjusted as necessary, (iii) monitoring and measuring equipment must have identification in order to determine its calibration status – when the calibration or verification was done and what is the due date for calibration or verification, (iv) monitoring and measuring equipment must be safeguarded from such adjustment that invalidates the measurement result, and (v) monitoring and measuring equipment be protected from damage and deterioration.

Where no international or national standards exist for calibration or verification of the equipment, the basis used for calibration or verification must be recorded. It is better to record the process used and the personnel who carried out calibration and verification.

The organization must assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. In such case, the organization must take appropriate action on the equipment and any product affected.

The organization is required to maintain records of the results of calibration and verification.

Whenever computer software is used in the monitoring or measurement bof specified requirements, it is necessary to conform the ability of the computer software to satisfy the intended application. This must be undertaken prior to initial use and re-conformed as necessary.

Note at the end of clause 7.6 of ISO 9001:2008 clarifies that confirmation of computer software’s ability to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use.

Finding international or national standard for calibration or verification

To find out relevant international or national standard for calibration or verification, of monitoring and measuring equipment, it is suggested to refer to the latest ISO Catalogue of Standards for international standards and the latest BIS Catalogue for Indian Standards.

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