Mastering the Audit of a Quality Management System (QMS) based on ISO 9001

 

Summary

This five-day intensive course enables participants to develop the necessary expertise to audit a Quality Management System (QMS) based on ISO 9001:2015 and ensure that the organization is competent in maintaining its quality management system. The Lead Auditor training will equip participants with the skills and ability to perform audits 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 ISO 19011; the certification process according to ISO 17021.
Based on practical exercises, the participant will develop the skills (mastering audit techniques) and competencies (managing audit teams and audit program, communicating with customers, conflict resolution, etc.) necessary to efficiently conduct an audit.
 

Who should attend?

  • Internal auditors
  • Auditors wanting to perform and lead Quality Management System (QMS) certification audits
  • Project managers or consultants wanting to master the Quality Management System audit process
  • Persons responsible for the Quality conformity in an organization
  • Members of a Quality team
  • Expert advisors in Quality Management Systems
  • Technical experts wanting to prepare for a Quality audit function
     

Learning objectives

  • To acquire the expertise to perform an ISO 9001 internal audit following ISO 19011 guidelines
  • To acquire the expertise to perform an ISO 9001 certification audit following ISO 19011 guidelines and ISO 17021 specifications
  • To acquire the necessary expertise to manage a QMS audit team
  • To understand the operation of an ISO 9001 conformant Quality Management System
  • To understand the relationship between a Quality Management System and compliance with the requirements of different stakeholders of the organization
  • To improve the ability to analyze the internal and external environment of an organization, and audit decision-making in the context of a QMS
     

Course Agenda

Day 1: Introduction to Quality Management and ISO 9001

  • Course objectives and structure
  • Standard and regulatory framework
  • Certification process
  • Fundamental principles of quality management
  • Quality Management System (QMS)
     

Day 2: Audit principles, preparation and launching of an audit

  • Fundamental audit concepts and principles
  • Audit approach based on evidence and risk
  • Initiating the audit
  • Stage 1 audit
  • Preparing the stage 2 audit (on-site audit)
  • Stage 2 audit (Part 1)
     

Day 3: On-site audit activities

  • Stage 2 audit (Part 2)
  • Communication during the audit
  • Audit procedures
  • Creating audit test plans
  • Drafting audit findings and non-conformity reports
     

Day 4: Closing the audit

  • Documentation of the audit and quality review
  • Closing the audit
  • Evaluating action plans by the auditor
  • Beyond the initial audit
  • Managing an internal audit programme
  • Competence and evaluation of auditors
  • Closing the training
     

Day 5: Certification Exam

Prerequisites

ISO 9001 Foundation Certification or basic knowledge of ISO 9001 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 playings and oral presentations
    • Review exercises to assist the exam preparation
    • Practice test similar to the certification exam