ISO 17025 Lead Auditor ( iso17025 | 35 hours )

Audience

• Project managers or consultants wanting to prepare and support an organization in the implementation of a Quality Management System (QMS)
• Quality executives
• ISO 9001 auditors who wish to fully understand the Quality Management System implementation process
• Individuals responsible for the Quality or conformity in an organization
• Members of a Quality team
• Expert advisors in Quality Management Systems
• Technical experts wanting to prepare for a quality function or for a QMS project management function

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.

Learning Objectives:

• To understand the implementation of a Quality Management System in accordance with ISO 9001
• To gain a comprehensive understanding of the concepts, approaches, standards, methods and techniques required for the effective management of a Quality Management System
• To understand the relationship between the components of a Quality Management System and the compliance with the requirements of different stakeholders of an organization
• To acquire necessary expertise to support an organization in implementing, managing and maintaining a QMS as specified in ISO 9001 and ISO 9004
• To acquire necessary expertise to manage a team implementing ISO 9001
• To develop knowledge and skills required to advise organizations on best practices in the management of quality

Introduction

• 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
• 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
• 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
• 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
  • I SO 17025 surveillance audits
  • I SO 17025 internal audit management program