ISO 17025 - Lead Implementer


Summary

This five-day intensive course enables participants to develop the necessary expertise to support laboratories in implementing and managing a Laboratory Management System (LMS) based on ISO/IEC 17025:2005. Participants will also gain a thorough understanding of all the technical requirements for the competence to perform tests and/or calibrations specified in ISO/IEC 17025.  This training is consistent with the project management practices established in ISO 10006 (Quality Management Systems - Guidelines for Quality Management in Projects).

 

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/IEC 17025
  • Laboratory managers
  • Quality managers
  • Auditors who wish to understand the ISO/IEC 17025 standard
  • Technical experts wanting to prepare for a quality function or a LMS project management function in laboratories

 

 Learning objectives

  • To understand the implementation of a Laboratory Management System (LMS) in accordance with ISO/IEC 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 a LMS as specified in ISO/IEC 17025
  • To acquire necessary expertise to manage a team implementing ISO/IEC 17025
  • To understand management and technical requirements of ISO/IEC 17025
  • To prepare a laboratory for an ISO/IEC 17025 accreditation

Course Agenda

Day 1: Introduction to ISO/IEC 17025 and initiation of a LMS

  • Introduction to management systems and the process approach
  • Fundamental principles of laboratory management
  • Preliminary analysis and establishment of the level of the maturity level of an existing laboratory management system
  • Initiating the LMS implementation

Day 2: Plan the implementation of LMS

  • Defining the scope of a LMS
  • Development of a laboratory management policies
  • Obtaining management decision to implement the LMS
  • Defining the organizational structure

Day 3: Initiating and Implementing a LMS based on ISO/IEC 17025

  • Implementation of a document management framework
  • Design of controls and writing procedures
  • Implementation of controls
  • Development of a training & awareness program and communication plan
  • Operations management of a LMS

Day 4: Monitoring a LMS and preparation for accreditation

  • Controlling and monitoring the LMS
  • Development of quality metrics, performance indicators and dashboards
  • ISO/IEC 17025 Internal Audit
  • Management review of a LMS
  • Implementation of a continual improvement program
  • Preparing for an ISO/IEC 17025 accreditation audit

Day 5: Certification Exam

 

 

Prerequisites

ISO/IEC 17025 Foundation Certification or a basic knowledge of ISO/IEC 17025 is recommended

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/IEC 17025 Lead Implementer” 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 Best Practice based on ISO/IEC 17025
    • Domain 3: Planning a LMS based on ISO/IEC 17025
    • Domain 4: Implementing a LMS based on ISO/IEC 17025
    • Domain 5: Performance evaluation, monitoring and measurement of a LMS based on ISO/IEC 17025
    • Domain 6: Continual improvement of a LMS based on ISO/IEC 17025
    • Domain 7: Preparing for an accreditation
  • The “Certified ISO/IEC 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
  • For more information about exam, refer to PECB section on ISO/IEC 17025 Lead Implementer Exam
  • 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
  • For more information about ISO/IEC 17025 certifications and PECB certification process, refer to PECB section on ISO/IEC 17025 Lead Implementer Certification

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.