The top five most common ISO/IEC 17025:2017 non-conformances

Aaron Hoare Date published: Jun 20, 23

One of the best places to start when making a plan of action for gaining ISO/IEC 17025 accreditation is to look at the most common non-conformances with the standard. Below, we have summarized some of the most common points of non-conformance in calibration and testing labs, alongside a relevant webinar for you to watch on demand to help you avoid non-conformance.

The non-conformance webinar series covers the most common non-conformances that assessors find since the publication of the most recent version of ISO/IEC 17025 in 2017. If you work in any organization that performs testing, sampling or calibration and want to be sure of the reliability of your results, you could undeniably benefit from ISO 17025 certification.

So, if you are looking for the smoothest route possible to attaining – or indeed, maintaining – ISO/IEC 17025 certification, then this webinar series is perfect for you. The series was put together in collaboration with A2LA, one of the USA’s chief accrediting bodies.

In particular, we hear from those working in forensics and environmental labs most often about their concerns, needs, and successes with ISO 17025 accreditation. But labs across a diverse range of sectors, including asbestos testing, acoustics, chemicals, fibre optics, food production, textiles, and even cannabis labs, frequently seek ISO 17025 certification as a guarantor of quality.

Non-conformance 1: equipment record and calibration requirements

Around 38% of non-conformances with ISO 17025 found by A2LA assessors concern section 6.4 of the standard. This part of the standard is all about equipment validity.

Equipment management is critical to achieving the valid results expected by customers. It is essential for labs to comply with ISO/IEC 17025:2017 standard 6.4.1, which states that correct performance of laboratory activities requires equipment that has been maintained and calibrated properly.

Proper equipment management indicates to your technicians, who are essentially your internal customers, that they are making good, reliable measurements. This instils the confidence that will help them to go out and make the measurements needed safe in the knowledge they’re not compromising their customers.

Ultimately, improper equipment management affects your ability to meet the needs of your customers. You should, therefore, focus on making sure your equipment and assets are being used to their full potential.

You can learn about non-conformances with section 6.4 of ISO/IEC 17025 by watching episode 1 of the non-conformances webinar series on demand, with A2LA WorkPlace Training’s Tim Osborne.

Non-conformance 2: Management review requirements

The next most common area of non-conformance surrounds management reviews, section 8.9 of ISO/IEC 17025. A management review ensures systematic and periodic reviews of an organization’s quality management system (QMS) are carried out. The goal is to identify opportunities for improvement and where changes need to be made.

Non-conformances with this part of the standard are when the effectiveness of that management system, its processes, provisions for the improvement of laboratory activities, and the provision of required resources are in doubt by your assessors. Powerful quality management software is one way to ensure you meet requirements for management reviews.

For a deep dive into the most common non-conformances concerning section 8.9 of ISO/IEC 17025 on management reviews, you can watch episode 2 of the webinar series on demand with Frenika Rivers.

Non-conformance 3: Externally provided products and services requirements

A2LA found that around 21% of non-conformances with ISO/IEC 17025 are related to section 6.6 of the standard and, more specifically, they are usually non-conformances with clause 6.6.2. This relates to holding appropriate records and procedures for managing “external providers” to your lab.

Where most labs fall down in this area is that their own operations meet the demands of ISO 17025, but they can’t prove that external providers are meeting the same standards of quality. This in turn brings the quality of your lab into question and means you are non-conformant with the standard. Basically, this part of the standard requires that you are holding your external providers to the same high standards as you maintain in your own facility and that, crucially, you can prove it.

To learn more about managing external providers to avoid non-conformance with section 6.6 of ISO/IEC 17025, watch episode 3 of the webinar series on demand with accreditation specialist Bibi Abdullah.

Non-conformance 4: risk management

One of the biggest changes when ISO/IEC:2017 was published was the greater focus placed on managing risk. The area of the standard where this is arguably the most applicable is section 7.7, which is all about the validity of your labs results (measurement uncertainties, equipment checks, proper calibrations etc.)

Section 7.7 is all about heading off risk so you can ensure the validity of your results. After all, the core of any testing and calibration lab is the measurements and results you produce, so it follows that all possible measures should be taken to mitigate risk and ensure the validity of those results. Consequently, labs who don’t manage the potential risks inherent in achieving reliable results are a common source of non-conformance.

For more detail on how to avoid non-conformances relating to section 7.7 of ISO/IEC 17025, watch episode 4 of the webinar series with instructor and technical trainer Roger Brauninger on demand.

Non-conformance 5: technical records

Section 7.5 of ISO/IEC 17025 is another common area of non-conformance. This section deals with technical records, and essentially requires you to record and document “sufficient information to facilitate, if possible, identification of factors affecting the measurement result and its associated measurement uncertainty and enable the repetition of the laboratory activity under conditions as close as possible to the original.”

Once again, it is essential that your lab is compliant with this part of the standard so you can demonstrate to customers the reliability and validity of your results.

You can explore in greater depth examples of errors and non-conformances with section 7.5 and get tips for avoiding them by watching the 5^th and final episode of our webinar series on demand, hosted by Pam Wright.

Avoiding non-conformances in ISO/IEC 17025: next steps

One of the best ways to avoid non-conformance with the clauses of ISO/IEC 17025 is to use powerful quality management software. Ideagen QMS helps organizations across the globe attain and maintain their ISO/IEC 17025 certification. Book a conversation with our team today to find the right quality management solution for you.

Alternatively, you may be interested in our recent ISO/IEC 17025 webinar on proficiency testing, a key element of the standard, which you can watch on demand using the link below.

Struggling with ISO/IEC 17025 compliance? Download our free compliance checklist which takes you through every clause in the standard with clear actions you should be looking to implement for compliance.

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