ISO 17025 Lead implementer

Course details

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).

 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
 
 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. Updated on 23 January, 2020