Skip to main content
Mastering Quality Management System Audits and Compliance

Mastering Quality Management System Audits and Compliance

$199.00
When you get access:
Course access is prepared after purchase and delivered via email
How you learn:
Self-paced • Lifetime updates
Your guarantee:
30-day money-back guarantee — no questions asked
Who trusts this:
Trusted by professionals in 160+ countries
Toolkit Included:
Includes a practical, ready-to-use toolkit with implementation templates, worksheets, checklists, and decision-support materials so you can apply what you learn immediately - no additional setup required.
Adding to cart… The item has been added

Mastering Quality Management System Audits and Compliance

Gain expertise in Quality Management System (QMS) audits and compliance with our comprehensive course. Upon completion, participants will receive a Certificate of Completion issued by The Art of Service.



Course Overview

This interactive and engaging course is designed to provide a thorough understanding of QMS audits and compliance. The curriculum is organized into the following chapters:

Chapter 1: Introduction to Quality Management System Audits

This chapter introduces the concept of QMS audits, their importance, and the benefits of implementing a QMS.

  • Definition and purpose of QMS audits
  • Types of QMS audits (internal, external, certification)
  • Benefits of QMS audits (improved processes, reduced risk, enhanced reputation)
  • QMS audit principles (integrity, fairness, professionalism)

Chapter 2: Understanding QMS Standards and Frameworks

This chapter explores the various QMS standards and frameworks, including ISO 9001, ISO 13485, and others.

  • Overview of QMS standards and frameworks
  • Key requirements and clauses of ISO 9001
  • Industry-specific QMS standards (e.g., ISO 13485 for medical devices)
  • QMS framework components (policy, procedures, records)

Chapter 3: Audit Planning and Preparation

This chapter covers the essential steps in planning and preparing for a QMS audit.

  • Audit planning (defining scope, identifying audit criteria)
  • Audit preparation (reviewing documentation, identifying audit team)
  • Developing an audit plan and checklist
  • Communicating with the auditee

Chapter 4: Conducting QMS Audits

This chapter provides guidance on conducting a QMS audit, including interviewing techniques and evidence collection.

  • Opening meeting and audit introduction
  • Conducting audit interviews and observations
  • Collecting and documenting audit evidence
  • Identifying and documenting nonconformities

Chapter 5: Audit Reporting and Follow-up

This chapter covers the process of reporting audit findings and following up on corrective actions.

  • Audit reporting (structure, content, and clarity)
  • Presenting audit findings to the auditee
  • Developing and implementing corrective actions
  • Verifying the effectiveness of corrective actions

Chapter 6: Compliance and Regulatory Requirements

This chapter explores the regulatory requirements and compliance issues related to QMS.

  • Overview of regulatory requirements (e.g., FDA, EU MDR)
  • Compliance with QMS standards and regulations
  • Identifying and managing regulatory risks
  • Maintaining compliance through ongoing audits and reviews

Chapter 7: Risk Management and QMS Audits

This chapter discusses the importance of risk management in QMS audits.

  • Introduction to risk management principles
  • Identifying and assessing risks in QMS audits
  • Developing risk mitigation strategies
  • Incorporating risk management into QMS audits

Chapter 8: QMS Audit Tools and Techniques

This chapter introduces various tools and techniques used in QMS audits.

  • Audit checklists and templates
  • Audit software and technology (e.g., audit management systems)
  • Data analysis and statistical techniques
  • Interviewing techniques and communication skills

Chapter 9: Case Studies and Group Discussions

This chapter provides opportunities for participants to engage with real-world case studies and group discussions.

  • Case studies of QMS audits and compliance issues
  • Group discussions on QMS audit challenges and best practices
  • Sharing experiences and lessons learned

Chapter 10: Certification and Continuing Professional Development

This chapter discusses the importance of certification and ongoing professional development in QMS audits.

  • Certification options for QMS auditors
  • Continuing professional development (CPD) opportunities
  • Maintaining expertise and staying up-to-date with QMS standards and regulations
Upon completing this comprehensive course, participants will receive a Certificate of Completion issued by The Art of Service, demonstrating their expertise in QMS audits and compliance.

,
!