Tracking and measure equipment in ISO 9001:2015

Why it’s important a tracking and measuring equipment in ISO 9001:2015?

ISO 9001:2015 has the requirements that we shall comply with, by controlling the equipment that we used to carry out or produce changeable products or processes.

Why monitoring and measuring?

Everybody knows what’s a measuring device is but not the monitoring device standard. The concept of monitoring is mentioned because the equipment is used to know the state of something and control the product or process. This equipment tends to fail, and so its compliance shall be evaluated by applying similar techniques of measuring equipment (with metrological techniques).

These are some examples of monitoring and measuring equipment:

• A thermometer to control and keep the product temperature.
• A presence detector of an assembly line (tracking example).
• A Vernier Caliper to measure a piece thickness.
• A manometer to measure the pressure of production lines.

What type of equipment is influenced by ISO 9001:2015 requirements?

The equipment mentioned above is used for monitoring and measuring. It seems understandable but we shouldn’t ignore; first, we need to determine the type of monitoring and measuring we want and then what type of equipment to use.

We will use the word equipment or device to talk about the same thing. In the standard, the term device is used to differentiate from other elements of infrastructure (6.3.). This equipment comes from monitoring and measuring as we will see later, the scope, complexity or criteria to use when controlling the equipment is independent of the process and product characteristics.

The last paragraph comes from section 7.1.5. and says:

When using tracking or measuring to make evident products conformity and services with specific requirements, the organization shall determine the necessary resources to guarantee a valid and reliable control of results.

The organization shall make sure the provided resources are:

1. Suitable for the specific monitoring and measuring.
2. Maintained to guarantee continual compliance to its purpose.

When tracking the measurement of a legal requirement, a client’s requirement or interested party, or when the organization considers essential to trust in the measuring instrument’s results, it shall:

Be verified or calibrated in specific intervals or before they are used against traceable measures to national or international measure patrons.

*When there are patrons, the based for calibration or verification used, the information shall be documented.

What control demands ISO 9001:2015 for this equipment?

The standard indicates, the organization shall guarantee the results validity and reliability, also the equipment shall:

• Be calibrated or verified in programmed intervals and used international traceable patrons or register the used based to verify or calibrate.
• To be adjusted or readjusted when necessary.
• To be identified to determine the calibration state.
• To be protected against any harm.

The standard demands to maintain the equipment in perfect conditions and handle in the same way other infrastructure elements.

The difference is that to determine the conformity of this equipment, a simple visual inspection is not enough. For example, we don’t know the level of an error on a scale until we contrast results with a patron, for this, we need to use the metrology.

Metrology concept and application in the Quality Management System:

This article is not about metrology but ISO 9001:2015 requirements demand to control monitoring and measuring devices. However, metrology is used to determine the equipment state and we can’t avoid talking about some concepts.

By measuring, we can expect errors and we can improve the measurement system by a piece of better equipment or qualified staff, and a better work environment, but we will never know the real value of the item we measured. The metrology tells us the error level, which we can expect in certain conditions.

For example, when we calibrate a measuring device, a calibration certificate establishes the level of error of the measuring equipment. The task is to match the error level that we are willing to accept (tolerate) with the error level that our system has.

The error level is named uncertainty. The uncertainty establishes a gap in which you can find the true value of the thing measured (object or thing) after applying certain metrologic procedures.

The organization shall verify or calibrate the monitoring or measuring devices by hiring a specialized company. If you choose the first option, the organization could have the personnel and infrastructure to execute Metrologic procedures. Among necessary elements, we have patrons that serve to verify the measuring results. These patrons are not perfect and shall be verified in advance with a higher Metrologic level of patrons. The standards mention that the verification shall be done with international traceable patrons.

If it’s impossible to trace high-level patrons, e.g. Since we have designed our own monitoring and measuring equipment, there aren’t patrons neither procedures to verify the state then we shall create our own verification procedure or calibration as a base used to verify or calibrate.

The organization shall decide the control intensity applied to each equipment and shall establish their own verification procedures, keeping the technical exactitude to guarantee the equipment is able to fulfill their function, since the product conformity is the goal not to keep a new generation laboratory.

This last one serves to calm and lead most of the company’s which products don’t have a demanding tolerance. If your company works with small tolerance (demanding), then consider outsourcing control of this equipment to external company’s and paying attention to used methodologies to carry out measures.

When the product conformity was determined by a narrow margin it’s important that all the aspects intervene while measuring the equipment. People, equipment, and procedures make it easy to validate a measuring control name and a measurement system.

Basic elements of the control system for monitoring and measuring devices:

Stock take

As any infrastructure element, the first step is the inventory; a list shall be made of all equipment that can be used and a card (digital or printed) for each equipment, and designate a code or unique identification in each item, the codes shall be on the component or used like in any other method, by guaranteeing an easy and clear identification.

Equipment card

It describes the important characteristics of each equipment in a card that could be done in any way but associated with the corresponding equipment (s).

Reviewed controls

To determine the verification or calibration control that each equipment shall have, this could be included on the card. It indicates what to do, who shall do it (external or own service), procedures to be used (if the service is your own) and how much control to use.

To determine conformity criteria

We have said that the perfect equipment doesn’t exist. In order to use each equipment shall be determined the limits which separate a piece of nonconformance equipment to a conformance one. To analyze the result of each verification or calibration and base on that, determine if the equipment is suitable or not for the foreseen use.

To identify and register the equipment condition

To ensure product conformity, we need to ensure the measuring equipment (or monitoring) was suitable in the system. This is what ISO 9001:2015 refers to when demands a calibration condition identification. The most extended and basic method to identify the calibration condition is to add a conformity or nonconformance label to verify or calibrate the equipment. This label states the code, date of last control, foreseen date for next control and the word SUITABLE, indicating ready to be used.

Reacting to nonconformance devices detection

This last paragraph contains a requirement that most of the time got unnoticed, especially for auditors who rarely verify compliance. The question is what happens when an organization identifies nonconformance equipment? If the equipment works perfectly, there’s a possibility that some verified equipment was approved when it shouldn’t. The standard, in this case, requires an examination to evaluate the validity of the results on such equipment, register the results, and act upon verified products.

Software for monitoring and measuring

Provided information in monitoring and measuring equipment are not the only one that uses these activities. The statistics treatment of this data, a graphic representation, or estimation of the scales through the software provides essential results to determine product conformity and process. The software used in monitoring and measuring shall be summited to ISO 9001:2015 which verifies the capacity of this program. We confirm this by testing the program by a spreadsheet or software. If your case is the second one, you could request the validation records of the software.