ISO 9001:2015, Requirement 7.1.5: Monitoring and Measuring Resources

Measuring resources has been a requirement of ISO 9001 since the first edition of the standard was published in Italy in 1987. In fact, the requirement relating to the old point 4.11 clearly mentioned inspection, measurement, and test equipment.

In the 2000 edition, the title was changed, and point 7.6 referred to control of monitoring and measuring devices. In the 2008 revision, there was a further modification, and the requirement referred to the control of monitoring and measurement equipment. The latest change, relating to point 7.1.5 of ISO 9001:2015, refers to the monitoring and measurement of resources, dividing the requirement into two points:

• The first (7.1.5.1) concerns monitoring and measuring resources
• The second (7.1.5.2) concerns traceability but refers to measuring equipment

The shift from "equipment or devices" to "resources" is not significant but emphasizes the fact that not only adequate devices are necessary to carry out the measurement, but also competent people, ad hoc methods, and a suitable environment; in a word: resources. In this article, we will talk about measuring devices, examining the requirements of point 7.1.5, namely:

• Determining and providing suitable resources to ensure that the results are valid and reliable (7.1.1 and 7.1.5.1)
• Ensuring the suitability of the selected monitoring and measuring resources (7.1.5.1 a)
• Maintaining the integrity of monitoring and measuring resources (7.1.5.1b)
• Determining suitable resources to ensure that the results are valid and reliable (7.1.1 and 7.1.5.1)
• Preserving evidence that monitoring and measuring resources are suitable for the purpose (7.1.5.1)
• Calibrating and verifying measuring equipment (7.1.5.2a)
• Indicating the calibration status (7.1.5.2b)
• Safeguarding monitoring and measuring instruments (7.1.5.2c)
• Determining the impact due to any defective instruments and solving the problem (7.1.5.2)

Determining and providing suitable resources to ensure that the results are valid and reliable (7.1.1 and 7.1.5.1)

What does this first point mean? First of all, there is an important distinction to be made in interpreting this requirement, which is implicit when referring to the fact that monitoring and measurement are used to verify the conformity of products and services. In the standard, there are requirements relating to monitoring that are used to make decisions that do not concern the conformity of products and services, and then there are the requirements of point 7.1.5.1 that do not apply to monitoring and measurement activities (e.g., monitoring information relating to internal and external issues, as required in point 4.1).

The integrity of products and services depends on the quality of the resources used to create and evaluate their characteristics. This clause implies that there are ways to verify the conformity of products and services that are different from simple monitoring or measurement because not only physical quantities are measurable, but also intangible ones.

The quality of a product or service is judged by the extent to which it meets our needs and expectations. Some of these needs and expectations can be expressed objectively and objectively and can, therefore, be quantified, while other qualities, for example of services, are absolutely subjective. ISO 9000: 2015 defines measurement as a process to determine a value and explains that the value determined is, generally, a quantity. The term measurement is therefore not limited only to physical and exact quantities.

Many characteristics of quality are not measured in units of the International System but as a percentage, and these percentages are often averages based on samples with a confidence interval. Monitoring and measurement resources include monitoring and measuring tools (software, measurement standards, materials used as references, etc.) but also the people who monitor and measure the characteristics of the product and service, the methods used in the process, and the environment in which the measurements are performed.

Determining the resources of the measurement and monitoring process is necessary to ensure their validity and reliable results because:

1. If the device used to measure the characteristics of quality is inaccurate, unstable, damaged, or in some way defective, it will not be known whether the product or service possesses the required characteristics;
2. If the people carrying out the measurements are not competent, it will never be known whether all those factors that can influence the accuracy and precision of the measurement have been taken into consideration;
3. If the method that people use is not based on a solid foundation, it will never be known whether the results can be trusted or not;
4. If the environment where the measurement was taken was not suitable, it will not be known whether the results can be relied upon or not

Nothing is known about an object until it can be measured, but it must be measured accurately and precisely. The devices used, therefore, must be fit for their purpose and be checked to ensure continued fitness for purpose. How do you demonstrate that you have fulfilled all the requirements of this requirement? It will be sufficient to demonstrate that the resources necessary to guarantee valid and reliable results have been determined and provided:

• Presenting evidence of an analysis carried out to determine monitoring and measurement requirements;
• Presenting plans for the development or adoption of additional monitoring and measuring controls and devices;
• Presenting evidence that these any controls or devices have been adopted as planned

Ensuring the suitability of the selected monitoring and measuring resources (7.1.5.1 a)

Monitoring and measurement activities vary depending on the nature of what needs to be verified and the accuracy and precision that is required. Measuring hygiene levels in a food processing plant requires different devices, skills, methods, and environment than monitoring the flow of traffic that passes through road sections where there are road works. In addition to this distinction, any uncertainty in the measurement system must be taken into account.

When a guarantee of suitability is required for the devices in use, the people who use them, the methods used, and the environment must be able to reflect and guarantee the required accuracy and precision; otherwise, the results of the measurement and monitoring will not be valid or reliable, and the decisions taken using the results of these devices will be imperfect.

To demonstrate that the resources provided are suitable for the specific type of monitoring and that the measurement activities undertaken can be carried out safely, you must:

• Presenting evidence of the policies governing the determination of resources for monitoring and measurement;
• Demonstrate that the choice of resources is at the discretion of the person carrying out the measurement, presenting evidence of his competence;
• Where the choice of resources is limited by prescribed requirements, select a representative sample of monitoring and measurement activities

Maintaining the integrity of monitoring and measuring resources (7.1.5.1b)

Maintaining the integrity of monitoring and measurement over time serves to ensure their continued fitness for purpose. This means that not only must the devices be maintained, but also that a certain level of competence must be maintained for the people who carry out the measurements, that the methods used must remain suitable, and that the environment in which the measurements and monitoring are carried out must always be the one expected.

If the product and service measures are to have meaning, they must be performed in a way that provides reliable results that other people, both inside and outside the organization, can rely on. If the integrity of the measurement is questioned and the organization cannot demonstrate the validity of the measurements, the quality of the product could inevitably be questioned.

To demonstrate that the resources provided are kept intact to ensure their continued suitability over time, you can:

• Presenting evidence of preventive maintenance plans;
• Select a representative sample of physical monitoring and measuring devices to confirm that:
  • 1. The selected devices are subject to a maintenance program;
  • 2. There is evidence that preventive maintenance is being carried out on these devices
• Show the database that collects non-conformities and explain that none of these non-conformities is linked to monitoring and measurement equipment that has proved defective;
• Present the indicators of the process, the system, and the service and the plans for their monitoring and measurement;
• Select a representative sample of the devices used to measure non-physical quantities and confirm that they have been maintained in line with any changes that have occurred regarding what they measure