A Closer Look at ISO 17025 Non-Conformances: Strategies for Laboratory Improvement

One of the greatest places to start when developing a strategy for obtaining ISO/IEC 17025 certification is to examine the most prevalent nonconformances with the standard. We've compiled a list of some of the most prevalent non-conformance issues in calibration and testing laboratories, as well as a relevant webinar that you can view on demand to help you avoid nonconformance.

The non-conformance webinar series focuses on the most common nonconformances discovered by assessors since the publication of the most recent edition of ISO/IEC 17025 in 2017. If you work in an organization that undertakes testing, sampling, or calibration and want to ensure the dependability of your results, ISO 17025 accreditation might be quite beneficial.

Non-Conformance of ISO 17025

Let’s deep dive into ISO 17025 non-conformance:

Non-conformance 1 Equipment Records and Calibration Requirements: Approximately 38% of non-conformances with ISO 17025 in Section 6.4 of the standard. This section of the standard focuses on equipment validity. Equipment management is crucial to delivering the accurate outcomes that clients demand. Laboratories must comply with ISO/IEC 17025:2017 standard 6.4.1, which specifies that proper performance of laboratory tasks necessitates properly maintained and calibrated equipment.

Proper equipment management communicates to your technicians, who are your internal customers, that they are taking accurate, trustworthy measurements. This instils trust in them, allowing them to go out and take the necessary measures while remaining certain that they are not compromised by their clients.

Non-conformance 2 Management Review and Its Requirements: The second most prevalent area of nonconformance is management reviews, as outlined in ISO/IEC 17025 section 8.9. A management review guarantees that an organization's quality management system (QMS) is thoroughly and regularly reviewed. The purpose is to discover areas for improvement and adjustments that need to be implemented.

Non-conformances with this element of the standard occur when your assessors question the efficacy of the management system, its processes, provisions for improving laboratory operations, and the supply of needed resources. One method for ensuring compliance with management reviews is to use powerful quality management software.

Non-Conformance 3 Externally Provided Product and Service Needs: Approximately 21% of non-conformances with ISO/IEC 17025 are connected to section 6.6 of the standard, and more particularly, clause 6.6.2. This refers to maintaining adequate records and processes for handling "external providers" in your lab.

Most laboratories fail in this area because their internal operations fulfil the ISO 17025 requirements, but they cannot establish that external providers maintain the same quality standards. This, in turn, calls into question the quality of your lab and indicates that you are not in compliance with the standard. Essentially, this portion of the standard mandates that you hold your external providers to the same high standards that you do in your facility, and that you can demonstrate it.

Non-Conformance 4 Risk Management: One of the most significant developments since the publication of ISO/IEC:2017 has been the increased emphasis on risk management. The part of the standard where this is perhaps the most pertinent is section 7.7, which is all about the validity of your lab's results (measurement uncertainties, equipment inspections, correct calibrations, etc.).

Section 7.7 is all about mitigating risk and ensuring the veracity of your findings. After all, the measurements and findings produced by any testing and calibration lab are at the heart of the operation, thus every precaution should be taken to reduce risk and assure the validity of those results. As a result, laboratories that do not control the possible risks associated with producing accurate findings are a typical cause of nonconformance.

Non-Conformance 5 Technical Records: Section 7.5 of ISO/IEC 17025 is another major source of nonconformance. This section focuses on technical records and requires you to record and document "sufficient information to facilitate, if possible, the 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 critical that your lab adheres to this section of the standard so that you can show clients the dependability and validity of your findings.

For the ISO 17025 Audit Checklist

The ISO Audit Checklist is a crucial document for confirming ISO system requirements in organizations, aiding in planning and processing audits. It helps verify ISO management systems meet standards, reducing implementation and certification time. Global Manager Group designs checklists for over 35 standards. Certificationchecklist.com provides an ISO 17025 audit checklist which contains over 200 audit questions for department and clause-wise requirements, helping organizations achieve accreditation quickly. ISO 17025 accreditation is a globally used ISO standard in calibration and testing laboratories. The ISO 17025:2017 audit checklist is a document used to verify laboratory accreditation systems and certification.