Learn the Requirements of ISO 9001
Gain the knowledge and skills to audit medical device quality management systems with QMII’s Exemplar Global-recognized training: Virtual & Instructor-Led
Receive post-course support and join a thriving alumni network of systems thinkers and lead auditors with QMII’s industry leading “Alumni for Life” program.
Why This Course Matters
Quality leadership begins at the top. QMII’s ISO 9001 Executive Overview course is designed specifically for senior leaders who set direction, allocate resources, and make strategic decisions that determine organizational success. It is additionally useful for those organizations looking to give their team an overview of the standard and its specific requirements.
This concise yet powerful course helps executives understand how to use ISO 9001 as a management system framework and not let it merely become a compliance burden. By focusing on your People → Processes → System, you’ll learn how to create a culture where quality, performance, and profitability are naturally aligned.
You’ll see how ISO 9001 supports risk-based leadership, performance management, and stakeholder satisfaction – enabling your organization to deliver results that build trust and growth.
Learning Objectives
- Understand how ISO 9001 integrates with your organization’s strategy and business goals.
- Recognize the senior leadership’s responsibilities for policy, objectives and organizational context under the standard. Also their accountability for the system’s effectiveness.
- Learn how to interpret QMS performance data to make informed, risk-based business decisions.
- Discover how management reviews, internal audits, and customer feedback can serve as tools for assurance, not bureaucracy.
- Identify how your leadership actions directly affect the effectiveness of the management system.
- Understand the role of continual improvement in ensuring long-term business resilience and value.
Learn to lead by example, fostering accountability, engagement, and alignment across departments.
Who Needs This Course
For Decision Makers and Strategic Leaders
- Chief Executive Officers (CEOs), Presidents, and Managing Directors
- Vice Presidents and Senior Executives responsible for quality, operations, or strategy
- Senior site management who require assurance on organizational performance
- Site Leaders and Plant Managers responsible for implementing management directives
Public Sector and Defense Executives overseeing ISO 9001 compliance programs
Skills You’ll Acquire
- Interpret and apply ISO 9001 requirements.
- Understand how to apply ISO 9001 risk based approach to your system.
- How leadership can support and enable an effective system.
- Leadership role in developing flexible and reliable systems in changing environments.
- Communicate roles, responsibilities, and resources across the organization.
- Relate QMS capabilities to customer, and shareholder expectations.
Class Agenda - Hands-On Learning
Certification & Recognition
Attendees successfully completing the training provided receive a Certificate of Participation, which includes the number of training hours attended. Those desiring this course to count towards their Exemplar Global Auditor certification can complete an associated exam.