In this article, I'm going to cover ISO 9001 clause 7.1.5.2 Measurement traceability. I’m going to break this clause down and turn it into something you can all understand and implement in your own organization or industry.
Ok, let’s get started! Let’s take a look at what Clause 7.1.5.2 wants us to do. The clause starts off by stating:
When measurement traceability is a requirement, or is considered by the organization to be an essential part of providing confidence in the validity of measurement results, measuring equipment shall be:
And then it goes on to points a, b, and c. But before I discuss those requirements, I think it is important to stop here and understand that this leading sentence is saying when measurement traceability is a requirement or is considered essential. This is where you need to identify whether you have equipment that is used to check on the final product or service that you are offering within the scope of your quality management system. This could be torque wrenches, multi-meters, measuring devices, or sound-level meters.
The list could go on and completely depends on what your activities, products, and services are.
The point is, if you do have these then you need to read on, however, if you don’t have any equipment that requires calibration then it is not a requirement to continue with this clause.
This is a great example of an area that may not be applicable within your scope – which we talked about when we covered clause 4.3 Determining the scope of the quality management system, so be sure to check that video out. I can use Auditor Training Online as an example here, we do NOT have any equipment that requires calibration for the production of our product (which is our training courses), however, if we provided training courses that required the use of say, a multi-meter, then absolutely this clause would be applicable.
Right – so now that we’ve established this let’s move on to the first point which states …
a) calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; when no such standards exist, the basis used for calibration or verification shall be retained as documented information;
This point is saying that when we do have equipment that requires calibration or verification this is to be conducted against measurement standards traceable to international or national measurement standards. You might find that your equipment needs to be sent off to a certified tester to be calibrated at the required intervals. If we use the multi-meter example again, this would need to be sent to an accredited laboratory specializing in calibrating digital multi-meters.
You would normally see these laboratories accredited to ISO 17025. While you can check for general operation, wear, and tear, or damage prior to use, you are obligated to send the device off to get calibrated at least annually – and this timeframe will depend on how and how often it is being used, so it could be more frequent.
When there isn’t an international or national standard then you should still determine what the basis for calibration or verification is. Let’s make this example simple and use a normal tape measure. Now, as far as I am aware there is no requirement to send off your tape measure to be calibrated, however, instead there is actually a tape measure calibrator that you can use yourself. This tool has a slot in it, where you place the metal tab at the end of the tape and then you can check both the push and pull measurements against the measurement marks engraved on the calibrator.
Therefore, this clause states when there is no international or national standard that the basis used for calibration or verification shall be retained as documented information. This means you should document that the tape measure calibrator is used however often you determine is necessary and even record when these checks are done. I’ve kept it simple, but I hope this has also made it clear what the differences are.
Then this clause goes on to state:
b) identified in order to determine their status;
This means that we should be able to pick up a piece of equipment and know that it has been calibrated or verified. This is normally a tag on the equipment with either the date of calibration/testing or the due date for calibration/testing or even both. Sometimes it is difficult to add a tag to a piece of equipment, so it is normally in a case with the calibration certificate included. Both ways, we are confident that when we pick it up, we can check the status of it and know whether we should use it or not.
Then this clause goes on to state:
c) safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results;
This means that we simply need to look after our equipment. Store and transport it safely. Don’t use it in any way that it could become damaged. Your organization might like to set some standards on how this equipment is treated, stored, and transported so that anyone using it understands and has been trained on these requirements.
Then finally, this clause states:
The organization shall determine if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, and shall take appropriate action as necessary.
Well, this is an interesting one. Let’s use the multi-meter example again. I mentioned that normally this would be calibrated by an accredited lab annually. Let’s say our multi-meter is sent off for calibration every July. So, we’ve sent it off and the lab comes back and tells us it has failed the test and cannot be repaired – it has to be replaced. At what point, since the previous July (when it passed the test) has the multi-meter been damaged or stopped being accurate?
This is a tricky one. It could have potentially been in August and anything we’ve been measuring since has not been accurate. In this situation, the business has to determine what has been put at risk if this multi-meter has been inaccurate for anywhere from 1-12 months.
- how often has it been used?
- what products or jobs was this used on?
- does this mean we have to recall the product?
This is why it is always beneficial to have multiple checking points throughout a process – a redundancy you could say. You might also use more than one multi-meter in a process, just to ensure the checks and verifications along the way continue to be accurate.
To finish up on this clause, while this is specific to ISO 9001 and any equipment that is used for the quality of the product or service you deliver, this is a great clause to also use for ISO 14001 environment and ISO 45001 OH&S and any equipment needed to be calibrated. ISO 9001 details this requirement far better than ISO 14001 and 45001 so if you have an integrated management system, I suggest using this clause requirement across all of your systems.
Now that you have a better understanding of these requirements, it's time to take action and implement them in your own organization and ISO 9001 quality management systems.
If you're itching to expand your knowledge on ISO 9001, make sure to check out our other articles on the topic, starting with a comprehensive breakdown of What is ISO 9001 Quality management systems?
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