What’s New in Latest ISO 17025 Standard?

In the periphery of International ISO standards, ISO 17025 was introduced as a comparatively new standard for the general requirements set out for the competence of testing and calibration laboratories. By now, a number of documents cited in the 17025:2005 version have been obsolete. The calibration industry was frantically waiting for a massive change. In 2017, the latest version of this standard was published. This version contains many changes and to implement these changes a lab needs to undergo through a huge transformation.

In this article, we are going to discuss the transformation a lab needs to undertake to complete the transition process and gain ISO 17025 certification.

• ISO experts have recorded no major addition of a technical section to the revised ISO 17025 version. However, it possesses a dozen of new sub-elements and several key features. The first noteworthy change is found in the numbering format. The new version has replaced the requirements section of clauses 4 and 5 in the old standard with clauses four through eight in the present version. It has become similar to ISO 9001 and ISO 17020 assessment standards with a number of other corresponding clauses.

• Second major change can be found in clause 8 where it has been clearly prioritized the laboratories, which maintain both ISO 9001 Quality Management Standard as well as ISO 17025 Standard. The conventional management elements overlap a number of considerations in each system. You will find a synergy that can enable you to receive credit for it. It will reduce future assessment times somewhat for those affected organizations.

• Thirdly, several document types and elements have become less important. Hence, these documents no longer should be maintained. Such documents include quality manual, quality policy, and preventive actions etc. In this context, it is important to note that the preventive action has been expanded and it has been replaced with the Risk and Opportunities (section 8.5). Risk consideration is added to other clauses (4.1.4-impartiality, 7.8.6-statements of conformity, 7.10.-nonconforming work, and 8.7.1-corrective actions) as well. The new version has greatly prioritized risk management. Even, it has been clearly stated in the Forward to the standard. It provides a framework required for gaining accreditation. This framework helps to identify and prioritize the risks and strategize risk management plans as well as the control and measurement tools.

 

• Clause 4 has gone through another massive transformation. Earlier, this clause was all about management requirements. Now, it has two major considerations; one is impartial while another one is confidential. The impartial consideration provides insight into the Terms and Definitions. This standard has shifted its focus from independence to impartiality. Hence, independence is no more an object that must be present in the document.

• ISO 17025:2017 standard attaches great importance to sampling. A couple of requirements associated with sampling have been introduced in the new version. In this latest version, sampling has been mentioned either directly or indirectly in many elements, such as 6.6.1 (externally provided services), 7.2.2.1 (validation of methods including uncertainty), 7.8.1, and 7.8.5 (reporting requirements). Therefore, an organization, which is willing to gain ISO 17025 certification, must consider sampling.

• Sometimes, calibration laboratories got confused over some elements from the previous version, which have been coupled with some new ones. Such combination includes subcontracting of services (old 4.5) and purchasing (old 4.6). However, the new combination is 6.6. Another instance can be found in the lab-development processes and non-standard processes, which are no longer listed uniquely. They have been mentioned only in a list of valuable method validation candidates. 

When an organization is getting ready for ISO 17025:2017 accreditation, they need to consider loads of things. First, the organization needs to gain official copies of the published standard. Next, it is important to arrange training for the staff. The lab should get the documents and forms in the right place in their management system. The latest version is in favor of a crosswalk document. This document can be achieved with the help of the accreditation body or the certification body. They will help you with the coverage of every element as well as the number system. Before asking the certification body for performing the final audit, you need to arrange a gap analysis followed by an internal audit.

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