This guide will walk you through the following: what the international standard ISO 17025 covers, its importance, the specific requirements, and how you can help ensure compliance with this global standard using a digital tool.
Published 9 Dec 2022
ISO/IEC 17025:2017 is the international standard created by the International Organization for Standardization (ISO) together with the International Electrotechnical Commission (IEC). It is comprised of various requirements and guidelines used by laboratory customers, regulation boards, accreditation authorities, and organizations to verify, recognize, and ensure the competency, impartiality, and consistent operation of laboratories in their testing and calibration processes.
The ISO/IEC 17025:2017 serves as a Quality Management System (QMS) for laboratories to improve their process of facilitating more accurate diagnostics, efficient treatment, and reduced errors in the laboratory process. This coincides with the ultimate goal in laboratory medicine which is to improve an organization’s overall QMS toward ensuring patient safety.
ISO 17025 and ISO 9001 are both intended for QMS. But what sets them apart is the scope and the requirements. The requirements for ISO 17025 are specific to testing and calibration laboratories only. Meanwhile, ISO 9001 applies to organizations in all industries.
Across industries, it’s highly encouraged to create a QMS that best fits the needs of an organization. This is to help improve the quality and efficiency of laboratory safety practices, processes, and systems. It goes hand in hand with ISO 15189:2012, the ISO standard for medical-specific laboratories.
The standard’s current version which is the ISO 17025:2017 is key to establishing guidelines and protocols that are aligned with Good Laboratory Practices (GLP). Ultimately, maintaining compliance with ISO 17025 standards can lead to creating replicable testing and calibration processes, thus eliminating the need for retesting.
While ISO 17025 isn’t required, there are numerous benefits to gaining an accreditation or certification. Following internationally recognized standards allows organizations to become at par with what’s considered competent and trusted in the industry. Hence, this helps significantly increase the public’s level of confidence and the trust of peers in the laboratories’ work.
It’s important for organizations to be aware of the various ISO 17025 requirements so that they can establish the necessary compliance protocols across the board. For starters, there have been notable changes introduced in the 2017 version from its previous 2005 version. Some of these include the following:
With these, it’s worth mentioning that the 2017 version now specifies the general requirements needed to guide laboratories in their operations, especially when it comes to ensuring their competence and impartiality.
The ISO 17025 standard is comprised of the following clauses and elements:
If you want to know more about this standard, click here to view a quick and comprehensive guide to understanding the ISO 17025 in PDF.
Even if the standards and requirements are released by the ISO and the IEC, third-party enforcement agencies are in charge of implementing and monitoring compliance. They conduct audits on how an organization’s QMS when it comes to laboratory testing and calibration aligns with industry standards set out in the ISO 17025 standard.
Why Get an ISO 17025 Certification
Gaining an ISO 17025 certification merits an organization the following benefits:
To get ISO 17025-certified, follow the practical steps outlined in our checklist guide.
Eliminate manual tasks and streamline your operations.
Making sure that your workers, managers, and leaders are well-informed and skilled in laboratory safety and quality practices is key to building a sustainable system of industry-standard processes. Provide ample training programs so that ISO 17025 compliance measures can be improved, strictly enforced, and maintained. Along the way, encourage employees to always practice putting consumer safety and legal obligations in mind and at the heart of what they do.
SafetyCulture (formerly iAuditor) is a powerful, mobile-first operations platform used in digital audits and overall compliance monitoring to help organizations standardize laboratory practices, maintain quality systems, and ensure compliance with the ISO 17025 standard. Beyond using an ISO 17025 checklist, auditors, laboratory supervisors, and leadership teams can maximize SafetyCulture’s features by doing the following:
Patricia Guevara is a content writer and researcher for SafetyCulture. With her extensive content writing and copywriting experience, she creates high-quality content across a variety of relevant topics. She aims to promote workplace safety, operational excellence, and continuous improvement in her articles. She is passionate about communicating how technology can be used to streamline work processes, empowering companies to realize their business goals.
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