ISO 9001:2015 Clause 7.1.5

What is ISO 9001:2015 Clause 7.1.5?

Clause 7.1.5 in ISO 9001:2015 is related to “Monitoring and measurement resources.” This clause outlines the requirements for organizations to ensure that the monitoring and measurement activities necessary for providing evidence of conformity of products and services and the effective operation of the quality management system are controlled.

Key points outlined in Clause 7.1.5 include:

Ensuring Measurement Traceability:

Organizations are required to ensure that calibrated or verified measurement equipment is used and maintained to provide confidence in the accuracy of measurements.

Calibration and Verification:

Calibration or verification of monitoring and measurement equipment must be carried out at specified intervals or before use, ensuring the equipment is suitable for its intended purpose.

Handling of Measurement Equipment:

Organizations need to address the handling, preservation, and storage of monitoring and measurement equipment to ensure it remains in a valid state.

Identification of Measurement Status:

When monitoring and measurement results are invalidated due to equipment being out of calibration or verification, organizations are required to take appropriate action.

Record Keeping:

There is a requirement to maintain records of the calibration and verification status of monitoring and measurement equipment.

Clause 7.1.5 of ISO 9001:2015 emphasizes the importance of having reliable and calibrated measurement resources to ensure accurate monitoring and measurement of processes, products, and services within a quality management system.

Other ISO 9001:2015 Clauses:

• The Complete Clause 7
• Clause 7.1.1
• Clause 7.1.2
• Clause 7.1.3
• Clause 7.1.4
• Clause 7.1.6
• Clause 7.2
• Clause 7.3
• Clause 7.4
• Clause 7.5
• Clause 7.5.1
• Clause 7.5.2
• Clause 7.5.3

How does a company comply with Clause 7.1.5?

To comply with Clause 7.1.5 of ISO 9001:2015, which focuses on “Monitoring and measurement resources,” a company should implement a set of processes and practices to ensure the effective control and management of monitoring and measurement equipment. Here are steps and considerations for compliance:

Establish a Calibration Program:

• Identify all monitoring and measurement equipment used in your processes.
• Establish a calibration program that defines the intervals for calibration or verification based on the equipment type and its intended use.

Calibrate and Verify Equipment:

• Regularly calibrate or verify monitoring and measurement equipment according to the established intervals.
• Use accredited calibration services or reference standards to ensure traceability.

Maintain Calibration Records:

• Keep detailed records of all calibration activities, including dates, results, and any adjustments made during calibration.
• Maintain documentation that demonstrates the traceability of measurement standards used.

Equipment Handling and Storage:

• Establish procedures for the proper handling, preservation, and storage of monitoring and measurement equipment to prevent damage or deterioration.
• Train personnel on proper handling procedures.

Identification of Measurement Status:

Identify the status of monitoring and measurement equipment, indicating whether it is calibrated when the last calibration was performed, and if it is suitable for use.

Address Nonconformities:

• Implement a process for addressing nonconformities related to monitoring and measurement equipment.
• Take corrective actions when equipment is found to be out of calibration or does not meet the required standards.

Training and Competence:

• Ensure that personnel using monitoring and measurement equipment are adequately trained and competent in its proper use.
• Provide training on the importance of calibration and proper equipment handling.

Continuous Improvement:

• Periodically review the effectiveness of the monitoring and measurement resource processes.
• Identify opportunities for improvement and make adjustments to enhance the control and reliability of measurement equipment.

Documentation:

• Document the procedures, records, and evidence of compliance with Clause 7.1.5.
• Ensure that the documentation is easily accessible for audits and inspections.

Audit and Monitoring:

• Conduct internal audits to verify compliance with the requirements of Clause 7.1.5.
• Monitor and measure the performance of monitoring and measurement resources to identify areas for improvement.

By implementing these steps, a company can demonstrate its commitment to complying with Clause 7.1.5 of ISO 9001:2015 and ensure the reliability of monitoring and measurement results within its quality management system. It’s essential to integrate these practices into the overall quality management system and foster a culture of continuous improvement.

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