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ISO 9001:2008: Monitoring and measuring equipment 7.6
Companies with no monitoring and measuring equipment can claim non-applicability to this section. The clause addresses all measuring equipment that is used for product acceptance, and reconfirmation of computer software as necessary.
The first two paragraphs address monitoring and measuring equipment and can be applicable to service companies as well as manufacturing organizations. Verification, inspection and testing are important ways to ensure the product meets the customer's expectations.
This is done by monitoring and measuring the characteristics of the product during the product realization process. Control monitoring and measuring equipment by ensuring that all devices are:
- Calibrated at intervals or prior to use, based on recognized standards
- Adjusted as necessary in accordance with manufacturer’s instructions
- Identified to enable calibration status to be determined
- Safeguarded from adjustment, which may invalidate results
- Protected from damage during handling, maintenance or storage
- Validity of results from a non-conforming device are re-checked
- Records of calibration and verification are maintained
- Software used for monitoring/measuring is validated prior to initial use
- Computer software used for monitoring and measuring is re-validated
All equipment requiring calibration must be identified and must be calibrated or verified at specific intervals or prior to use:
- Equipment must be calibrated using measurement standards traceable to international or national measurement standards.
- Where there is no standard available for the device the basis for calibration or verification must be recorded.
- The auditors expect to see that traceable standards are used and where applicable have not expired.
- Where calibration is completed by an outsourced process i.e. vendor, the records of traceability must be reviewed.
All equipment requiring calibration must be identified and must be adjusted or readjusted as necessary:
- The auditor will expect to see evidence that equipment found to be out of calibration are adjusted/re-adjusted by qualified personnel and the validity of the previous measuring results are accessed when equipment is found to be out of calibration and appropriate action is taken (may include recall of product).
- The auditor will expect to see that a process is in place to provide traceability of each piece of equipment to the process/product that the equipment was used on.
- The results of calibration and verification are required to be maintained as quality records.
All equipment requiring calibration must be identified and must be identified to show calibration status:
- The auditor will expect to see that each piece of equipment is identified in such a way that the user can determine that the device has current calibration, this may be accomplished by the equipment unique serial number traceable to the calibration record however, the calibration status label is a good practice.
- Other methods may be used however must clearly identify the calibration status. Where the environment is not conducive to the use of stickers, status may be identified by colour-coding, identification number with associated calibration record, and/or calibrated prior to every use.
All equipment requiring calibration must be identified and must be safeguarded from adjustments:
- The auditor would expect to see that a process is in place to ensure that users outside the calibration process do not adjust equipment. Equipment may be verified prior to use however any adjustments made to equipment must meet all requirements of this section.
- Methods to safeguard may include; locking materials for setscrews, tamper-proof seals, limited entrance to calibration areas, and other methods.
All equipment requiring calibration must be identified and must be protected from damage during handling, maintenance and storage:
- The auditor will expect to see that measuring equipment are handled and stored in a manner to protect the equipment from damage.