ISO 9001 Calibration

• Free PDCA Guidance
• PLAN your quality system
• DO day-to-day tasks
• CHECK the results
• ACT to improve

• ISO 9000:2005 Principles
• Process approach
• Leadership and people
• Customer focus

• ISO 9001:2008 Base Clauses
• 4.1a - 4.1d Process planning
• 5.1 Management commitment
• 5.3 Quality policy
• 5.2 Customer focus

• ISO 9001:2008 Requirements
• 4.2 Documentation
• 7.1 Process planning
• 6 Resource management
• 5.3.3 Communication
• 6.2 Human resources
• 7.2 Customer processes
• 8.2.1 Customer satisfaction

All monitoring and measurement equipment used for product and process verification must be controlled and calibrated against nationally traceable standards at specified intervals.

You should ensure that such devices are available to guarantee continuity of in-process measurement capabilities. All test equipment must be calibrated either:

• At regular, planned intervals
• Or prior to use

In either case the basis of calibration must be traceable back to an approved laboratory. You must check the laboratory's credentials, this links to Supplier evaluation.

How do I ensure valid results?

Monitoring and measuring equipment must be:

• Calibrated or verified at specified intervals or prior to use, based on recognized standards
• Adjusted or re-adjusted as necessary in accordance with manufacturer’s instructions
• Identified to enable calibration status to be determined
• Safeguarded from adjustment, which would invalidate measurement results
• Protected from damage or deterioration during handling, maintenance or storage

How do I control monitoring and measuring equipment?

• Records of calibration and verification results are maintained in accordance with 4.2.4 Control of records
• The validity of previous measurements when a device is found not to conform to requirements
• Computer software used for monitoring and measuring is validated prior to initial use
• Computer software used for monitoring and measuring equipment is re-validated as necessary

What happens if equipment fails a calibration test?

Decide what action will be taken where test equipment fails calibration, e.g. decide if a product recall is necessary or try to revalidate previous measurements using calibrated equipment. This links to Control of non-conformance.

How do I ensure traceability?

Each instrument should be traceable through its own calibration record which contains:

• Identification number
• Manufacturer and model
• Frequency of calibration
• Reference standards used
• Validation certificates and calibration findings
• Details of actions be taken in case of unsatisfactory results

Should I document our Control of Monitoring and Measuring Equipment Process?

It is not a mandatory requirement to document your control of monitoring and measuring equipment process. However, you should always look to adequately define and control any operational processes that directly impact upon product quality. Therefore, the implementation of a control of monitoring and measuring equipment procedure will be appropriate to most businesses where such activities are undertaken.

How's best to document the process?

Develop and implement a procedure that defines:

• How measuring equipment is calibrated
• The frequency of calibration
• Suitable identification of calibration status  
• How to protect equipment from damage

Looking for help documenting the process?

We provide a Control of Monitoring and Measuring Equipment Procedure template to help you manage this process in many of our ISO Templates.

Measuring the effectiveness of the processes

The effectiveness of the control of monitoring and measuring equipment process is often determined by how an organisation validates its controlled equipment and how it assures validity of subsequent measurements. The competence of staff using monitoring and measuring equipment is sometimes scrutinised.