ISO/IEC 17025:2017 Practical Guide: Competence Requirements, Checklists & Real Nonconformity Cases for Testing and Calibration Laboratories

Book Description Master ISO/IEC 17025 with clarity, confidence, and practical insight. ISO/IEC 17025 is one of the most widely used standards for accredited testing and calibration laboratories. Yet for many professionals, the standard can feel difficult to navigate. The terminology may seem unfamiliar, the documentation structure can appear complex, and even experienced laboratories often struggle with one fundamental question: How do we turn each clause into real operational practice? This book was written to bridge that gap. Built from the author’s hands-on field experience and practical interpretation of ISO/IEC 17025, this guide helps laboratory professionals understand the standard in a way that is clear, actionable, and immediately relevant to everyday work. It is designed for the wide range of people involved in laboratory quality and accreditation, including laboratory staff, internal auditors, accreditation-response personnel, assessors, and management. Rather than presenting the standard as a rigid set of “model answers,” this book offers a more practical and usable approach. Each requirement is supported by: checklist-style review questions that help readers think through compliance logically, guidance on organizing objective evidence and documentation, and real-world examples, including sample evidence and actual nonconformity cases frequently encountered in practice. Because laboratories differ in size, scope, and technical field, this book does not force a one-size-fits-all solution. Instead, it provides a strong practical framework that readers can adapt to the needs of their own organization. This is not simply a commentary on ISO/IEC 17025. It is a working reference designed to help readers build the essential judgment, structure, and practical skill needed to operate an effective laboratory management system. For those new to ISO/IEC 17025, this book offers a clear starting point. For those already managing accredited laboratories, it serves as a reliable reference for review, preparation, and continuous improvement. Whether you are preparing for accreditation, strengthening your internal system, or improving day-to-day laboratory operations, this book will help you understand ISO/IEC 17025 in the language of real practice. About the Author Tae-Hun Kim, Ph.D. ISO/IEC 17025 Assessor (KOLAS, Korea Laboratory Accreditation Scheme) Tae-Hun Kim is an ISO/IEC 17025 assessor with extensive practical experience in laboratory quality, accreditation, and technical operations. Drawing from both scientific training and real-world fieldwork, he has developed a strong reputation for translating complex accreditation requirements into practical, understandable guidance for laboratory professionals. He earned his B.S., M.S., and Ph.D. in Biochemistry from Chungnam National University. Over the course of his career, he has contributed to laboratory quality and public-sector technical services through roles in research, education, safety, and accreditation. His professional experience includes: ISO/IEC 17025 Assessor, KOLAS Master of Local Administration Award Recipient Ministry of the Interior and Safety, 2023 Laboratory Safety Specialist Instructor, National Research Safety Management Headquarters Adjunct Professor, Daejeon Health University (Physical and Chemical Instrumental Analysis) Current Affiliation: Daejeon Metropolitan City Institute of Health and Environment Research Through this book, Dr. Kim shares the practical standards, evidence structures, and field-based lessons he has organized over years of experience, with the goal of helping laboratories build stronger systems and approach ISO/IEC 17025 with confidence. Table of Contents Chapter 1. General Requirements Chapter 2. Structural Requirements Chapter 3. Resource Requirements Chapter 4. Process Requirements Chapter 5. Management System Requirements