7.1 Resources

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7.1.5 Monitoring and Measuring Resources

This requirement is comparable to ISO 9001:2008 Clause 7.6 - Control of Monitoring and Measuring Equipment. Observe and record evidence to confirm that where measurement traceability is a requirement; that instruments which are used for measurement, are subject to the following controls:

  1. Devices are calibrated at intervals or prior to use, based on recognized standards;
  2. evices are adjusted as necessary in accordance with manufacturer’s instructions;
  3. Devices are identified to enable calibration status to be determined;
  4. Devices are safeguarded from adjustment, which may invalidate results;
  5. Devices are protected from damage during handling, maintenance or storage;
  6. The validity of results from a non-confirming device are re-checked with a conforming device;
  7. Devices are calibrated by external providers certified to ISO 17025;
  8. Records of calibration and verification are maintained;
  9. Computer software which is used for monitoring/measuring is validated prior to initial use;
  10. Computer software used for monitoring and measuring is re-validated where necessary.

If measurement traceability is not required, verify that those monitoring and measuring resources used by your organization are suitable. You should ensure that documented information is maintained in order to demonstrate suitability of monitoring and measuring equipment. While this is not required, all equipment requiring calibration must be identified and must be:

1. Calibrated or verified at specific intervals, or prior to being used. 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. A Certification Auditor would 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.

2. Adjusted or readjusted as necessary. A Certification Auditor would 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).

A Certification Auditor would also 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.

3. Identified to show calibration status. A Certification Auditor would 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 color-coding, identification number with associated calibration record, and/or calibrated prior to every use.

4. Safeguarded from adjustment. A Certification 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.

5. Protected from damage during handling, maintenance and storage. A Certification Auditor would expect to see that measuring equipment are handled and stored in a manner to protect the equipment from damage.

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