ISO 9001 Lead Auditor (5 days)

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

This five-day intensive course enables participants to develop the necessary expertise to audit a Quality Management System (QMS) based on ISO 9001 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 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 an 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 ISO9001 internal audit following ISO 19011 guidelines
  • To acquire the expertise to perform an ISO9001 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 System (QMS) concepts as required by ISO 9001

  • Normative, regulatory and legal framework related to Quality
  • Fundamental principles of Quality
  • ISO 9001 certification process
  • Quality Management System (QMS)
  • Detailed presentation of the clauses 4 to 8 of ISO 9001

Day 2: Planning and Initiating an ISO 9001 audit

  • Fundamental audit concepts and principles
  • Audit approach based on evidence
  • Preparation of an ISO 9001 certification audit
  • QMS documentation audit
  • Conducting an opening meeting

Day 3: Conducting an ISO 9001 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 of nonconformities

Day 4: Concluding and ensuring the follow-up of an ISO 9001 audit

  • Audit documentation
  • Quality review
  • Conducting a closing meeting and conclusion of an ISO 9001 audit
  • Evaluation of corrective action plans
  • ISO 9001 Surveillance audit
  • ISO 9001 internal audit management programme

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 roe playings 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 9001 Lead Auditor” exam fully meets the requirements of the PECB Examination and Certification Programme (ECP). The exam covers the following competence domains:
    • Domain 1: Fundamental principles and concepts of Quality
    • Domain 2: Quality Management System (QMS)
    • Domain 3: Fundamental Audit Concepts and Principles
    • Domain 4: Preparation of an ISO 9001 audit
    • Domain 5: Conducting an ISO 9001 audit
    • Domain 6: Closing an ISO 9001 audit
    • Domain 7: Managing an ISO 9001 audit program
  • The “Certified ISO 9001 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 credentials of Certified ISO 9001 Provisional Auditor, Certified ISO 9001 Auditor or Certified ISO 9001 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 pass the exam and comply with all the other requirements related to the selected credential.

General Information

  • Certification fees are included in the exam price
  • A student manual containing over 450 pages of information and practical examples will be distributed to participants
  • A participation certificate of 31 CPE(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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