QMS Lead Auditor

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Program Code: TP94

Type of Program: Competency training program

Certification: Exemplar Global

Training Outline

Course Objectives:

The objectives of a Quality Management System (QMS) Lead Auditor course aim to equip individuals with the necessary skills and knowledge to effectively conduct audits and assess the compliance and effectiveness of a QMS. Here are four key objectives typically covered in such a course:

  1. Understanding QMS Principles
    The course seeks to provide participants with a comprehensive understanding of the fundamental principles of a QMS, such as the ISO 9001 standard. This includes knowledge of the QMS structure, key requirements, and the benefits of implementing a QMS within an organization.
  2. Developing Audit Techniques
    Participants learn how to plan, conduct, and report on QMS audits. They gain proficiency in various audit techniques, including gathering evidence, interviewing stakeholders, and evaluating processes to determine conformity and identify opportunities for improvement.
  3. Learning Audit Management and Leadership
    The course focuses on enhancing participants’ leadership and management skills specific to the context of QMS audits. This includes understanding the responsibilities of a lead auditor, managing audit teams, and effectively communicating findings and recommendations to relevant stakeholders.
  4. Ensuring Compliance and Continuous Improvement
    The primary goal of QMS audits is to verify compliance with established quality standards and identify areas for continuous improvement. Participants learn how to assess QMS processes to ensure conformity, spot non-compliance, and assist organizations in their pursuit of ongoing improvement.

Training Module:

Module 1: Introduction to ISO 9001:2015 Quality Management System Standards

  • What is ISO?
  • ISO 9000 Family
  • Sector-specific applications of ISO 9001
  • ISO 9001 Journey History
  • Revision of ISO 9001:2015
  • ISO 9001:2015 – Key Objectives of Revision

Module 2: Intended Outcomes and Benefits for Certified Organizations

  • Benefits of ISO 9001
  • ISO 9001:2015 Quality management systems – Certificates issuance by Country
  • Main objectives for ISO 9001:2015

Module 3: Management Principles and QMS structure

  • 7 Principles – Customer focus. customer focus, Leadership, engagement of people, process approach, improvement, evidence-based decision making and relationship management.
  • Basic QMS Structure
  • Process Management
  • Documented information

Module 4: Overview of the ISO 9001:2015 standard requirements

  • Clause 4: Context of the organization
  • Clause 5: Leadership and worker participation
  • Clause 6: Planning
  • Clause 7: Support
  • Clause 8: Operation
  • Clause 9: Performance evaluation
  • Clause 10: Improvement
  • Relationship between clauses and their significance
  • Understanding on Annexes documents

Module 5(a): Key Principles of QMS Auditing

  • Context of the organization / interested parties.
  • Leadership & commitment
  • Documented information
  • Risk Based-Thinking

Module 5(b): Risk-Based thinking in Quality Management Systems

  • Introduction to SWOT Analysis
  • Utilization of PESTLE concept to determine the external issues.
  • Developing risk control measures and mitigation strategies
  • Incorporating risk management into the audit process

Module 6(a): Accreditation Process and ISO 17021

  • Definition and purpose of accreditation
  • Accreditation bodies and their roles
  • ISO 17021:2015 and its application to QMS audits
  • Accreditation process and requirements
  • Assessing conformity to ISO 17021

Module 6(b): Certification Process and ISO 17021

  • Certification bodies and their roles
  • ISO 17021:2015 and its application to OSH MS certification
  • Certification process and requirements
  • Certification audits and assessment methods
  • Surveillance and recertification audits

Module 7: Guidelines for auditing

  • Scope and purpose of ISO 19011:2018
  • Key principles and concepts of auditing
  • Auditing process
  • Audit program management
  • Planning and conducting audits
  • Audit reporting and follow-up
  • Team dynamics and effective leadership
  • Conflict resolution and negotiation skills
  • Time management and resource allocation
  • Continual improvement of audit performance

Module 8: Audit Reporting and Documentation Processes

  • Effective documentation practices for QMS audits
  • Audit reporting requirements and formats
  • Communicating audit findings to auditees
  • Corrective actions and follow-up processes

Module 9: Case Studies and Practical Exercises

  • Application of audit principles and techniques to QMS scenarios
  • Role-playing exercises and mock audits
  • Review of real-world audit scenarios in different industry sectors
  • Evaluation and feedback sessions
  • Final Examination and Assessment
  • Comprehensive examination to evaluate participants’ understanding.

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