Monitoring-Measurement Procedure

The ISO Monitoring-Measurement Procedure establishes the methods your company uses to monitor and, where possible, measure the effectiveness of Quality Management System processes with ISO 9001:2015.

This procedure applies to all Quality Management System processes. (4 pages, 790 words)

Department Managers should identify process parameters to be monitored and/or measured to ensure effective, ongoing control of processes they manage. Additional process parameters shall be monitored and/or measured and recorded as specified in relevant written operating instructions.

ISO Monitoring-Measurement Responsibilities

Department Managers are responsible for producing and using process monitoring and measuring data to continuously improve the company’s Quality Management System.

The Quality Assurance Manager is responsible for the accuracy of all process monitoring and measuring devices.

ISO Monitoring-Measurement Definitions

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

Validation – Confirmation, by providing objective evidence, that requirements for a specific intended use or application have been fulfilled; assuring that equipment, processes, software, and/or systems operate as intended so products consistently meet specifications. Among the processes that typically require validation are: mechanical and electrical assembly, chemical/biological processing, and automated inspection, sterilization, packaging, and/or storage.

ISO Monitoring-Measurement Activities

• General Monitoring and Measuring Requirements
• Reporting Monitoring/Measurement Data
• Process Nonconformity
• Review of Process Monitoring/Measurement

ISO Monitoring-Measurement References

• ISO 9001:2015, “Quality Management Systems – Requirements”, International Organization for Standardization (ISO), Nov., 2015.
• Quality Procedures
  • QP1030 CONTROL OF NONCONFORMING OUTPUTS
  • QP1040 NONCONFORMITY AND CORRECTIVE ACTION
  • QP1060 MANAGEMENT REVIEWS
  • QP1100 DESIGN AND DEVELOPMENT
  • QP1170 MONITORING-MEASURING RESOURCES CONTROL
  • QP1200 DATA ANALYSIS AND CONTINUAL IMPROVEMENT