ISO/IEC 17025 is the international standard that labs follow to demonstrate technical competence and quality of their testing and calibration results. For laboratory managers, quality managers, and lab owners, understanding the ISO 17025 clauses and how they are structured is essential. As a certified ISO/IEC 17025 assessor for a major accreditation body under ILAC, I…
I have dedicated my career to ensuring that laboratories meet the high standards of the ISO/IEC 17025:2017 standard. I am a certified ISO/IEC 17025 assessor for one of the largest accreditation bodies in the world. In this guide, I detail a systematic approach to conducting an ISO 17025 internal audit. I also offer a…
The ISO 17025 quality management system is a robust framework that laboratories use to ensure accurate test results and next-level cool processes. In this article, I share an all-in-one exploration of ISO 17025 standards and how they help labs maintain high performance and credibility. As a certified ISO/IEC 17025 assessor, I have firsthand experience guiding…
ISO 9001 courses online offer a flexible way to learn about quality management systems. These courses help people and companies understand how to improve their processes and meet customer needs better. Online ISO 9001 training covers topics like auditing, implementation, and maintaining certification. Many organizations offer ISO 9001 courses online. These include self-paced options and…
ISO 14971 risk management plays a big role in ensuring that medical devices are safe for patients. When you work with this standard, you are getting into a process that carefully evaluates risks and helps design safer devices. I have seen how thoroughly following ISO 14971 can provide peace of mind and build trust between…
I often receive inquiries regarding quality and testing standards, especially concerning ISO 9001 vs ISO 17025. I have seen many organizations wrestle with understanding the features of these standards and with choosing which one suits their needs. In this article I share my experience and research to explain the key aspects of each standard, their…
ISO/IEC 17025 establishes a framework for labs to show technical competence and reliability in producing test and calibration data. Many labs use this standard to improve practices and build client trust. To meet the ISO 17025 requirements, labs must implement policies and procedures covering everything from personnel to complaint management. Accuracy and consistency in data…
The ISO 17025 quality manual is an essential document for labs aiming to meet the ISO/IEC 17025 standard. This manual is a guide that explains a lab’s policies, procedures, and processes to ensure accurate and reliable testing and calibration results. In this post, I share a detailed example of an ISO 17025 quality manual example….
ISO/IEC 17025:2017 outlines the general requirements for the competence, impartiality, and consistent operation of testing and calibration laboratories. Central to achieving compliance with this standard is adhering to the ISO 17025 documentation requirements, which ensure that laboratories maintain accurate and comprehensive records of their processes, procedures, and quality management systems. This guide provides an in-depth…
ISO 17025 certification requirements are a valuable tool that lists the requirements laboratories and testing facilities must meet to show competence. I have spent years as a certified ISO/IEC 17025 assessor and have come to truly appreciate the clarity this standard brings. It serves as a guide for labs, ensuring impartiality, reliability, and technical competence…
