The process of monitoring and measuring resources for ISO 9001 ensures conformity for all products and services. This includes making sure that all equipment is valid, up to date, clibrated and working properly.
All measurements that are taken must be accurate and recorded for monitoring purposes.
|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.|
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.
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.
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 as 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 movable 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 take 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 you can see, there is a documented 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.
The term verification refers to the confirmation that the equipment that is in question meets the standards as defined by ISO 9001. Whether this is completed by adjusting, calibrating, or testing the equipment against a confirmed device, all measurement devices must be verified before they can be used to provide reliable data.
One of the main reasons why companies will become ISO 9001 certified is to meet the requirements and needs of their customers. Due to the fact that ISO has a great reputation for keeping the quality standards of a company in line, many customers will demand certification and companies will meet the need in order to retain them.
ISO 9001, an organized and efficient Quality Management System (QMS), helps a business to be able to focus on the bigger picture and meet the goals they have established as an organization. ISO 9001 basically serves as the foundation for the company, and uses guidelines to assist them with productivity and income.
ISO 9001 Clauses - DO
- 7 Support
- 7.1 Resources
- Human Resources
- 7.2 Competence
- 7.3 Awareness
- 7.4 Communication
- 7.5 Documented information
- 8 Operation
- 8.1 Operational planning and control
- 8.2 Requirements for products and services
- 8.3 Design and development of products and services
- 8.4 Control of externally provided processes, products and services
- 8.5 Product and service provision
- 8.6 Release of products and services
- 8.7 Control of nonconforming outputs
Updated: 22nd March 2021
Author: Richard Keen
Richard is our Compliance Director, responsible for content & product development.
But most importantly he is ISO's biggest fanboy and a true evangelist of the standards.
Learn more about Richard