CERTIFIED ISO 17025 LEAD AUDITOR

MASTERING THE LABORATORY MANAGEMENT SYSTEM BASED ON ISO 17025, IN COMPLIANCE WITH THE REQUIREMENTS OF ISO 19011 AND ISO 17021

This five-day intensive course enables the participants to develop the necessary expertise to audit a Laboratory Management System based on ISO/IEC 17025 and to manage a team of auditors by applying widely recognized audit principles, procedures and techniques. During this training, the participants will acquire the necessary knowledge and skills to proficiently plan and perform internal and external audits in compliance with ISO 19011 and certification audits according to ISO 17021. Based on practical exercises, the participants will develop the skills (mastering audit techniques) and competencies (managing audit team and audit program, etc.) necessary to efficiently conduct an audit.

Who should attend?

  • Internal auditors
  • Auditors wanting to perform audits to ISO 17025
  • roject managers or consultants wanting to master the Laboratory Management System audit process of laboratories
  • Laboratory managers
  • Quality managers
  • Laboratories seeking ISO 17025 accreditation
  • Technical experts wanting to prepare for a laboratory audit function

Learning objectives

  • To acquire expertise to perform an ISO 17025 internal audit following ISO 19011 guidelines
  • To acquire the expertise necessary to manage an LMS audit team
  • To understand the operation of an ISO 17025 conformant Laboratory Management System
  • To understand the requirements of ISO 17025
  • To improve the ability to analyze the internal and external environment of a laboratory, and audit decision-making in the context of an LMS

Course Agenda

Day 1: Introduction to Laboratory Management System concepts and requirements as specified in ISO 17025

  • Fundamental principles of laboratories and accreditation
  • Laboratory Management System (LMS)
  • Detailed presentation of the clauses of ISO 17025

Day 2: Planning and initiating an ISO 17025 audit

  • Fundamental audit concepts and principles
  • Audit approach based on evidence
  • Preparation of an ISO 17025 audit
  • Conducting an opening meeting

Day 3: Conducting an ISO 17025 audit

  • Communication during the audit
  • Audit procedures: observation, document review, interview, sampling techniques, technical verification, corroboration and evaluation
  • Audit test plans
  • Formulation of audit findings
  • Documenting nonconformities

Day 4: Concluding and ensuring the follow-up of an ISO 17025 audit

  • Audit documentation
  • Quality review
  • Conducting a closing meeting and conclusion of an ISO 17025 audit
  • Evaluation of corrective action plans
  • ISO 17025 surveillance audits
  • ISO 17025 internal audit management program

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 Auditor" 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 (TCLA)
    • Domain 3: FUNDAMENTAL AUDIT CONCEPTS AND PRINCIPLES
    • Domain 4: PREPARATION OF AN ISO 17025 AUDIT
    • Domain 5: CONDUCT OF AN ISO 17025 AUDIT
    • Domain 6: CONCLUSION AND FOLLOW-UP OF AN ISO 17025 AUDIT
    • Domain 7: MANAGEMENT OF AN ISO 17025 AUDIT PROGRAM
  • The “Certified ISO 17025 Lead Auditor” 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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