In any ISO 9001 registered Quality Management System, the assurance of quality is rooted in the results of inspection and measuring activities by the Quality Department. In order to obtain and maintain certification of this standard, the Quality Management System requires a comprehensive calibration program that is traceable to recognized standards, such as those available at the National Institute of Standards and Technology (NIST).
Document the top-level expectations for the company for the control of monitoring and measuring devices. This is a requirement of the ISO 9001 Standards. Provide an overview of the company's plan to establish procedures for calibration, control, maintenance and protection of your critical inspection equipment. Train your personnel in the appropriate use and storage of those devices.
Document procedures that provide the necessary details for how you meet the your requirements. At a minimum, establish a schedule for calibration that details the calibration intervals for those devices governed by the calibration program. This helps establish consistency regarding the calibration of all measuring and inspection devices used to determine the acceptability of products. Identify to what standards the calibration shall be traceable, such as the NIST or other appropriate standards agency. Detail how the equipment will be protected from damage, deterioration or adjustments that would call into question the measurement certainty of the unit.
Establish a calibration list that identifies all measuring and inspection devices that are part of your program. At a minimum, list the type of tool, its serial number, the calibration interval and its typical location within the facility. Maintain readily identifiable and easily retrievable records for all calibration activities, including the date last calibrated and the date calibration is next due. Ensure each device has a sticker or other means of identification which shows its current calibration status. All of these steps are important to withstand the scrutiny of a third-party audit of your calibration program.
For Reference Only
Many organizations have some measuring devices which are used for set-up activities or measurements that are not quality-critical. Label or otherwise identify these devices as "for reference only," and make absolutely sure that they are not used to make decisions about the quality of a particular product. Failure to do so may result in an auditor raising a nonconformity against your calibration program, calling into question the quality of all products which have passed using that device.
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