Where is calibration mentioned in ISO 9001-2015

The ISO 9001 is a quality management system defined by a set of specific standards that helps businesses run as smoothly as possible. One of the clauses under this system, Monitoring and Measuring Resources, refers to the requirements of conformity that are set for all products and services.

What is monitoring and measuring resources for ISO 9001? The process of monitoring and measuring resources for ISO 9001 includes making sure that all equipment is valid, up to date, and working properly. All measurements that are taken must be accurate and recorded for monitoring purposes.

Monitoring and measuring resources, as outlined in ISO 9001 requirements, is not exactly what it sounds like. With very specific guidelines for how things should be measured within the business, there are lots to learn about this ISO clause.

Keep reading to find out everything you need to know about Monitoring and Measuring Resources for ISO 9001.

ISO 9001:2015		ISO 9001:2008		Summary of Changes
7.1.5	Monitoring And Measuring Resources	7.6	Control Of Monitoring And Measuring Equipment	This requirement is comparable to ISO 9001:2008 Clause 7.6 – Control of Monitoring and Measuring Equipment. It is likely that organizations complying with ISO 9001:2008 will already be undertaking the activities required by this clause.

Monitoring and Measuring Resources

Monitoring and measuring resources along ISO 9001 guidelines is a process that involves a few steps to ensure that everything is accurate and thorough. In this section, we will be going over the basics of Monitoring and Measuring Resources.

Take a look at the list below to find out what the general steps of monitoring and measuring resources are.

Monitoring and Measuring Resources Process:

Determine resources needed for accurate results
Provide resources
Measure to verify products/services against requirements
Document results for monitoring

Before being able to take accurate and recorded measurements, the resources that are needed to obtain these results must be determined. Once the needed resources have been identified and determined, they must also be acquired.

When any product or service is measured, it must be measured according to the specific requirements that are outlined by ISO 9001. To ensure that these results are accurate, these guidelines must be carefully followed.

ISO 9001 measurements are completed by machines and equipment that are verified for use, or have already been approved by their requirements in other words. This equipment can even include digital computer software.

All of this equipment must be properly adjusted and calibrated before performing any measurements. The adjustments and calibrations must be performed to the exact standards of ISO 9001, as well as the recommendations of the manufacturer.

Some of the ways that equipment and measurement devices might be verified against ISO 9001 requirements aside from following the checklist would be to directly compare one non-verified machine to one that is verified.

For instance, if there is a new machine that has not been verified by ISO 9001 previously, the company personnel will need to make sure that it can follow the necessary guidelines correctly by comparing it directly to a verified piece of equipment.

There is a set of rules when it comes to adjusting and calibrating the measurement equipment before use. This can include the settings that it will be adjusted to, when and how it can be adjusted, the procedure for moving the machine, who should make these adjustments, and more.

Just like almost any other clause within ISO 9001 standards, Monitoring and Measuring Resources is very detailed and specific in order to help organizations come out with the best and most accurate results.

With the use of these strict measurement standards, there is virtually no room for mistakes when all guidelines are properly adhered to. This is increasingly important when it comes to running a business because resources are everything.

If a business does not have control over the resources that are coming in and out, they will not be able to establish a clear vision of where the company is going.

All adjustments and calibrations that take place during this process, as well as the actual measurements that are required, must be neatly recorded and documented for monitoring purposes.

This will help the company personnel to keep track of the resources that they have measured, while being able to compare and contrast the numbers with previous and future statistics.

In the next section, we will be going over in detail the specific requirements for adjusting and calibrating the measurement machines to prepare them for accurate results.

Measurement Traceability Requirements

When it comes to monitoring and measuring resources under ISO 9001 guidelines, there are certain guidelines that must be strictly adhered to for the most accurate results possible.

Measurement traceability is the process of validating the equipment that will be used to measure products and resources. This is an ISO requirement and will give the organization confidence that all measurements are completely correct.

The specific standards for measurement traceability are outlined briefly in the list below and explained more in detail throughout the rest of this section.

Instruments Used for Measurement:

Calibrated in intervals before being used (following standards)
Adjusted according to the manufacturer’s instructions
Able to identify calibration status
Protected from an adjustment that could affect results of measurement
Protected from damages during moving, repairs, or storage
Non-conforming devices are checked against a conforming device
Calibrated by ISO certified providers
Calibration and verification records kept and maintained
Computer software confirmed and validated before use
Computer software re-validated if needed

To begin, the instruments that are used for measuring resources must always be calibrated in intervals before being used, while following the specified standards in doing so.

They must also be adjusted according to the instructions provided by the manufacturer prior to being used to make accurate measurements. In a visible area on the outside of the machine, the operators must be able to clearly identify the status of calibration during these adjustments.

In addition, the machines and measurement equipment in question must be constantly protected from unnecessary adjustments that could affect the results of the measurement. While the equipment must be flexible for adjustments as needed before beginning the measurements, they should not be moveable during the actual process.

In the event that the equipment must be moved to another location, repaired, or stored away for future use, it must always be protected from any exterior damages that could occur without careful handling.

If a measurement device is being used that is not compliant with ISO certifications, it must first be checked against another conforming device for accuracy. Otherwise, this device will not be considered accurate or efficient and will not be used for this purpose.

When the calibration of these devices takes place before the actual measurement, the action must be performed by a provider that is certified by the ISO. Any other personnel that does not match these specifications will not be qualified to adjust or calibrate the machine in any way.

If the use of any kind of computer software is needed during the process of taking accurate measurements, it must be both confirmed and validated before it can be used correctly. Along with the initial validation of this technology, it must be maintained and re-validated as needed.

While most standard measurement equipment will be able to adhere to the guidelines explained in this section, some of these devices will not indicate specified measurement standards.

In this case, the method of calibration and verification will have to be documented and kept as a record for accuracy and future reference.

Along with the measurement traceability requirements for the machines that are used for measuring resources, there are some specific points to hit when dealing with the equipment that requires calibration.

As a quick recap from what was briefly mentioned above, the equipment that needs to be calibrated will have to follow a set of guidelines, as listed below.

Equipment That Requires Calibration:

Calibrated in specific intervals
Adjusted as needed
Showing status of calibration
Safe from adjustment
Protected from damage

As you can see, there is a very detailed process that goes into accurately and efficiently monitoring and measuring resources. However, those who choose to adhere to the guidelines will reap the benefits in their business, knowing they have full control of all operations.