CERTIFIED ISO 17025 LEAD IMPLEMENTER

MASTERING THE IMPLEMENTATION AND MANAGEMENT OF A LABORATORY MANAGEMENT SYSTEM (LMS) BASED ON ISO 17025

This five-day intensive course enables the participants to develop the necessary expertise to support laboratories in implementing and managing a Laboratory Management System (LMS) based on ISO 17025. Participants will also gain a thorough understanding of all the technical requirements for the competence to perform tests and/or calibrations specified in this International Standard.

Who should attend?

  • Project managers or consultants wanting to prepare and to support laboratories in the implementation of a Management System as specified in ISO 17025
  • Laboratory managers
  • Quality managers
  • Auditors who wish to understand the ISO 17025 standard
  • Technical experts wanting to prepare for a quality function or an LMS project management function in laboratories

Learning objectives

  • To understand the implementation of a Laboratory Management System in accordance with ISO 17025
  • To gain a comprehensive understanding of the concepts, approaches, methods and techniques required for the effective management of a Laboratory Management System
  • To acquire necessary expertise to support a laboratory in implementing, managing and maintaining an LMS as specified in ISO 17025
  • To acquire necessary expertise to manage a team implementing ISO 17025
  • To understand technical requirements of ISO 17025
  • To prepare a laboratory for an ISO 17025 accreditation

Course Agenda

Day 1: Introduction to ISO/IEC 17025

  • Introduction to quality systems
  • Introduction to management systems and the process approach
  • Fundamental principles of laboratories
  • Accreditation of laboratories
  • Presentation of ISO 17025

Day 2: Management and technical requirements of ISO 17025

  • Management requirements
  • Technical requirements

Day 3: Initiating and implementing a LMS based on ISO 17025

  • Selection of the approach and implementation methodology
  • Implementation of a document management framework
  • Drafting an LMS (quality manual, procedures, records)

Day 4: Monitoring a LMS and preparation for accreditation

  • Monitoring the LMS
  • ISO 17025 internal audit
  • Management review of an LMS
  • Improvement
  • Steps towards accreditation

Day 5: Certification Exam

Educational approach

  • This training is based on both theory and practice:
    • Sessions of lectures illustrated with examples based on real cases
    • Practical exercises based on a full case study including role playing and oral presentations
    • 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 17025 Lead Implementer" exam fully meets the requirements of the PECB Examination Certification Programme (ECP). The exam covers the following competence domains:
    • Domain 1: FUNDAMENTAL PRINCIPLES AND CONCEPTS IN TESTING AND CALIBRATION LABORATORIES
    • Domain 2: GENERAL REQUIREMENTS FOR THE COMPETENCE OF TESTING AND CALIBRATION LABORATORIES BEST PRACTICES BASED ON ISO 17025
    • Domain 3: PLANNING A TCL BASED ON ISO 17025
    • Domain 4: IMPLEMENTING A TCL BASED ON ISO 17025
    • Domain 5: PERFORMANCE EVALUATION, MONITORING AND MEASUREMENT OF A TCL BASED ON ISO 17025
    • Domain 6: CONTINUAL IMPROVEMENT OF A TCL BASED ON ISO 17025
    • Domain 7: PREPARATION FOR A TCL CERTIFICATION AUDIT
  • The “Certified ISO 17025 Lead Implementer” exam is available in different languages (the complete list of languages can be found in the examination application form)
    Duration: 3 hours

  • After successfully completing the exam, participants can apply for the credential of Certified ISO/IEC 17025 Provisional Implementer, Certified ISO/IEC 17025 Implementer or Certified ISO/IEC 17025 Lead Implementer, depending on their level of experience
  • A certificate will be issued to participants who successfully pass the exam and comply with all the other requirements related to the selected credential

General Information

  • Exam and certification fees are included in the training price
  • A student manual containing over 450 pages of information and practical examples will be distributed to participants
  • A participation certificate of 31 CPD (Continuing Professional Development) credits will be issued to participants
  • In case of failure of the exam, participants are allowed to retake the exam for free under certain conditions.

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