ISO-17025 -Lead-Auditor

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Mastering the Laboratory Management System based on ISO/IEC 17025

Summary

This five-day intensive course enables 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 participant will acquire the necessary knowledge and skills to proficiently plan and perform internal and external audits in compliance with the ISO 19011 and ISO/IEC 17021 standards. Based on practical exercises, the participant 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 performs audits to ISO/IEC 17025
• Project managers or consultants wanting to master the Laboratory Management System audit process
• Laboratory managers
• Quality managers
• Laboratories seeking ISO/IEC 17025 accreditation
• Technical experts wanting to prepare for a laboratory audit function

Learning objectives

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

Course Agenda

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

• Normative, regulatory and legal framework related to laboratory management
• Fundamental principles of laboratories management
• Laboratory Management System (LMS)
• Detailed presentation of the clauses 4 and 5 of ISO/IEC 17025

Day 2: Planning and Initiating an ISO/IEC 17025 audit

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

Day 3: Conducting an ISO/IEC 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/IEC 17025 audit

• Audit documentation
• Quality review
• Conducting a closing meeting and conclusion of an ISO/IEC 17025 audit
• Evaluation of corrective action plans
• ISO/IEC 17025 Surveillance audits
• Internal audit management program

Day 5: Final exam

Prerequisites

ISO/IEC 17025 Foundation Certification or 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 the exercises to assist the exam preparation
  • Practice test similar to the certification exam
• To benefit from the practical exercise, the number of training participants is limited

Examination and Certification

• The “Certified ISO/IEC 17025 Lead Auditor” exam fully meets the requirements of the PECB Examination and Certification Program (ECP). The exam covers the following competence domains:
  • Domain 1: Fundamental concepts and requirements of ISO/IEC 17025
  • Domain 2: Laboratory Management System
  • Domain 3: Fundamental Audit Concepts and Principles
  • Domain 4: Preparation of an ISO/IEC 17025 audit
  • Domain 5: Conducting of an ISO/IEC 17025 audit
  • Domain 6: Closing an ISO/IEC 17025 audit
  • Domain 7: Managing an ISO/IEC 17025 audit program
• The “Certified ISO/IEC 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
• For more information about the exam, refer to PECB section on ISO/IEC 17025 Lead Auditor Exam
• After successfully completing the exam, participants can apply for the credential of Certified ISO/IEC 17025 Provisional Auditor, Certified ISO/IEC 17025 Auditor or Certified ISO/IEC 17025 Lead Auditor depending on their level of experience. Those credentials are available for internal and external auditors
• A certificate will be issued to participants who successfully passed 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 Auditor 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