ISO 13485 - Foundation


This course enables participants to learn about the best practices for implementing and managing a Laboratory Management System (LMS) as specified in ISO/IEC 17025, as well as best practices for implementing quality controls. The participant will learn the different component of this standard, including the quality manual, policy, required procedures, management review, internal audit and all the factors that can influence test and/or calibration results performed by a laboratory.


Who should attend?

  • Laboratory professionals wanting to gain a comprehensive knowledge of the main requirements of ISO/IEC 17025
  • Staff involved in the implementation of ISO/IEC 17025
  • Technicians involved in operations related to LMS
  • Auditors


Learning objectives

  • To understand the implementation of a Laboratory Managements System in accordance with ISO/IEC 17025
  • To understand the requirements of ISO/IEC 17025
  • To know the concepts, approaches, methods and techniques allowing to effectively manage a Laboratory Management System
  • To acquire the necessary knowledge to contribute in implementing a Laboratory Management System (LMS) as specified in ISO/IEC 17025


Course Agenda

Day 1: Introduction to Laboratory Management System (LMS) and requirements of ISO/IEC 17025

  • Introduction to ISO/IEC 17025
  • Introduction to management systems and the process approach
  • Fundamental principles of Laboratory Management System
  • Requirements: presentation of the clauses 4 and 5 of ISO/IEC 17025
  • Implementation phases of ISO/IEC 17025 framework
  • Continual improvement of a management system
  • Conducting an ISO/IEC 17025 accreditation audit

Day 2: Implementing requirements from ISO/IEC 17025 and Certification Exam

  • Documentation of a LMS
  • Monitoring and reviewing process
  • Conducting an ISO/IEC 17025 audit
  • Steps towards accreditation
  • Certified ISO/IEC 17025 Foundation Exam




Educational approach

  • This training is based on both theory and practice:
    • Sessions of lectures illustrated with examples based on real cases
    • Review exercises to assist the exam preparation
    • Practice test similar to the certification exam
  • To benefit from the practical exercises, the number of training participants is limited

Examination and Certification

  • The “Certified ISO/IEC 17025 Foundation” exam fully meets the requirements of the PECB Examination and Certification Program (ECP). The exam covers the following competence domains:
    • Domain 1: Fundamental principles and concepts of laboratories
    • Domain 2: Laboratory Management System (LMS)
  • The “Certified ISO/IEC 17025 Foundation” exam is available in different languages (the complete list of languages can be found in the examination application form)
  • Duration: 1 hour
  • For more information about the exam, refer to PECB section on ISO/IEC 17025 Foundation Exam
  • A certificate of “Certified ISO/IEC 17025 Foundation” will be issued to participants who successfully passed the exam and comply with all the other requirements related to this credential
  • For more information about ISO certification and PECB certification process, refer to PECB section on ISO/IEC 17025 Foundation Certification

General Information

  • Exam and certification fees are included in the training price
  • A student manual containing over 200 pages of information and practical examples will be distributed to participants
  • A participation certificate of 14 CPD (Continuing Professional Development) will be issued to participants
  • In case of failure of the exam, participants are allowed to retake the exam for free under certain conditions