In today’s article, we will address requirement 7.1.5 of ISO 9001, which deals with the need to ensure that resources used for monitoring and measuring product and/or service conformity are in accordance with current specifications and laws. This includes resources such as measuring equipment, calibration instruments, measurement software, among others.
ISO 9001:2015 stipulates that the company needs to define which resources are necessary to ensure relevant monitoring and measurement results. Additionally, the company needs to ensure that the resources are maintained and calibrated according to specific requirements, ensuring traceability as well.
The resources need to be suitable for the intended purpose, ensuring the reliability and accuracy of the measurements. The company also needs to maintain calibration records and ensure accessibility to the verification of resources.
Detailing requirement “7.1.5 Monitoring and Measurement Resources”
To better understand item 7.1.5, we have summarized the information from ISO 9001 below. Let’s see:
- The organization must determine which resources are necessary to ensure valid monitoring and measurement results: This means that the company needs to identify and determine which resources are necessary to perform monitoring and measurement of products and/or services. This includes measuring equipment, calibration instruments, measurement software, inspection systems, among others. The choice of resources needs to consider the ability to provide relevant results, meaning reliable and accurate results.
- Monitoring and measurement resources need to be maintained and calibrated according to specific requirements: The company is responsible for maintaining and calibrating monitoring and measurement resources according to specific requirements. This includes ensuring that the resources are in good working condition, properly maintained, and periodically calibrated (and adjusted if necessary). Just a reminder, calibration is the process of verifying the accuracy of measuring instruments against recognized reference standards (according to norms, laws, internal and external regulations, etc.).
- Resources need to be suitable for the intended purpose: The selected resources need to be appropriate for the intended purpose, meaning they need to be capable of meeting the measurement and monitoring requirements necessary to ensure process, product, and/or service conformity. This means ensuring that the resources are capable of measuring or monitoring relevant characteristics reliably and accurately.
- Ensure traceability of resources: The company needs to establish and maintain traceability of monitoring and measurement resources. This means that the resources must be associated with traceable measurement standards, i.e., the origin and calibration of the resources must be traceable to recognized reference standards. Traceability is important to ensure the reliability of measurement results and compliance with applicable requirements and regulations.
- Maintain adequate records of calibration and verification: The company needs to maintain adequate records of calibration and verification activities for monitoring and measurement resources. The records should include information about calibration dates, obtained results, reference standards used, and any adjustments made. These records also serve as evidence that the resources have been properly calibrated and verified.
In summary, item 7.1.5 of ISO 9001 highlights the importance of determining the necessary resources, maintaining them, and calibrating them appropriately. This ensures suitability for the intended purpose, ensures traceability, and maintains adequate records of calibration and verification.
This guarantees the reliability and accuracy of the measurements performed, as well as compliance with the requirements of the quality management system. In this way, we reduce or even eliminate the possibility of non-conformities related to measurement in the products or services offered by the company.
Importance of item 7.1.5 for your company
Item 7.1.5 of the ISO 9001 standard plays a crucial role for companies as it addresses the importance of monitoring and measurement resources.
To better understand this subject, let’s highlight some points that demonstrate the importance of implementing item 7.1.5 in your company:
- Ensuring product or service conformity: By using appropriate monitoring and measurement resources, the company can ensure that products and/or services meet specified requirements. This is essential for improving customer satisfaction and the quality of provided products and/or services.
- Process control: Having reliable monitoring and measurement resources enables the company to monitor and control processes more accurately. This allows for the identification of deviations or variations in processes, which can lead to the implementation of corrective or preventive actions to improve performance and prevent future issues.
- Data-driven decision-making: The use of suitable monitoring and measurement resources provides reliable data and information about process performance and product/service quality. This ensures that the company makes decisions based on concrete data, making management more efficient.
- Continuous improvement: Consistent and accurate monitoring and measurement enable the company to identify areas for improvement and opportunities to enhance processes, products, and/or services. By regularly evaluating performance through these resources, the company can implement continuous improvement actions and achieve higher levels of efficiency and quality.
- Compliance with regulatory and normative requirements: Many sectors and industries have specific monitoring and measurement requirements established by regulatory bodies. Complying with these requirements is essential for legal compliance and obtaining specific certifications. Adhering to item 7.1.5 ensures that the company is in compliance with these requirements (also known as Legal Metrology).
In summary, item 7.1.5 of the ISO 9001 standard highlights the importance of determining necessary resources, maintaining them, and calibrating them appropriately. This ensures suitability for the intended purpose, traceability, and proper records of calibration and verification.
By doing so, the company ensures the reliability and accuracy of measurements, as well as compliance with quality management system requirements. This reduces or even eliminates the possibility of non-conformities related to measurement in the products or services offered by the company.
The differentiating factor of item 7.1.5 of the ISO 9001 standard in the pursuit of excellence and continuous improvement
The ISO 9001 standard is a reference for quality management systems. Item 7.1.5 addresses the monitoring and measurement of processes, products, and services. It emphasizes the need to establish monitoring and measurement criteria, as well as the collection and analysis of data to assess performance.
By adequately monitoring and measuring, the company can identify deviations, failures, and opportunities for process improvement. This enables the implementation of corrective and preventive actions. Additionally, data collection and analysis can provide valuable insights for decision-making and strategy development.
Compliance with item 7.1.5 is essential for companies to ensure product and/or service conformity, meet customer expectations, and comply with legal and regulatory requirements. It also ensures that compliance can result in tangible benefits such as cost reduction, increased operational efficiency, and the achievement of a competitive advantage in the market.