ISO Monitoring-Measuring Resources Control Procedure

The Monitoring-Measuring Resources Control Procedure ISO 9001:2015 establishes methods for using, calibrating, and maintaining monitoring and measuring equipment, as well as associated recordkeeping.

This procedure applies to employees performing monitoring and measurement activities and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements. (12 pages, 1955 words)

ISO Monitoring-Measuring Resources Control Responsibilities:

Quality Management is responsible for the measuring instrument (device) calibration program.

The Purchasing Manager and the Quality Assurance Manager are responsible for ensuring subcontractor monitoring and measuring systems are adequate to assure compliance with safety and quality requirements.

All Employees are responsible for verifying that instruments they use to monitor processes or measure items are within their calibration periods and for ensuring that such instruments are capable of measuring to required accuracy/tolerances.

ISO Monitoring-Measuring Resources Control Definitions:

Calibration – Comparison of a measurement standard or instrument of known accuracy with another standard or instrument to detect, correlate, report, or eliminate by adjustment any variation in the accuracy of the item being compared.

Calibration period – Period during which a certified calibration is valid (e.g., measuring equipment calibrated in March and certification expires in March of next year, calibration period = twelve months).

Monitoring – Routine measurement or observation of monitoring/ measuring equipment, to check its functionality.

Monitoring and measuring equipment – Devices used to collect data and measure, gauge, test, inspect, or otherwise examine items to determine their compliance with specifications.

Reference standard – Standard of the highest order of accuracy in a calibration system, establishing basic accuracy values for that system; typically traceable to a recognized standards body like NIST (USA) or INMS (Canada).

ISO Monitoring-Measuring Resources Control Procedure Activities

• Monitoring and Measuring- General Requirements
• Storage, Handling, and Maintenance
• Calibration System
• Out-of-Tolerance Conditions
• Control of Subcontractor Calibration
• Test of Software

ISO Monitoring-Measuring Resources Control Procedure References

• ISO 9001:2015, “Quality Management Systems-Requirements”, International Organization for Standardization (ISO), Sept., 2015 ” http://www.iso.org.
• ISO 10012:2003, “Measurement Management Systems – Requirements for Measurement Processes and Measuring Equipment”, ISO.
• ANSI/NCSL Z540, American National Standard for Calibration ” see details at http://www.ncslinternational.org.
• Quality Procedures
  • QP1030 CONTROL OF NONCONFORMING OUTPUTS
  • QP1120 EXTERNAL PROVIDER EVALUATION

ISO Monitoring-Measuring Resources Control Forms

• Calibration Record Form
• Calibration Database Form