Course Description
This course prepares you to perform effective audits of Medical Device Quality Management Systems. You’ll learn how to interpret the verbiage of the 13485 Standard and apply it to your own organization. We also cover the requirements of 21 CFR 820, the federal regulations governing medical device management systems. We’ll take you through the full audit process, including: audit planning and preparation, opening meetings, document review, interviewing auditees, closing meetings and reporting as defined in ISO 19011. Training includes easy-to-use tools to simplify the auditing process.
This is a practical, how-to course that is not bogged down in academic discussions. We use case studies, role-plays, and other real-life practice exercises to keep the training active and build competence.
This is a four-day, instructor-led, course. There are written tests on each of the competency units on days 2, 3, and 4. Days 1 and 2 will cover medical device auditing along with a corresponding competency exam (MD). Day 3 will cover management systems auditing (AU) along with a corresponding competency exam. Day 4 will cover lead auditor requirements with a competency exam (TL).
Who Should Attend
This course is designed for individuals who are responsible for planning and scheduling an audit program for ISO 13485 and those who must perform audits to ISO 13485, including: Quality Assurance Managers, Quality Assurance Professionals, ISO Project Managers, ISO Project Team Members, Compliance Managers, Regulatory Personnel, or anyone desiring an in-depth understanding of the ISO 13485 Audit Process. This course has been specifically designed to meet the needs of the Medical Device Industry.
Learning Objectives
Through training, participants will learn to:
- Fully understand and interpret the requirements of ISO 13485
- Understand the requirements contained in 21 CFR 820 and be able to compare these to the requirements in ISO 13485
- Conduct a practical audit exercise to 21 CFR 820 to ensure understanding of these requirements
- Understand how to apply the requirements of the ISO 13485 Standards during 5 practical audit exercises conducted during the class
- Understand the terminology of ISO 13485 and how these apply in a Medical Device Environment
- Apply the fundamentals of ISO 19011 to master the auditor skills required for an effective and efficient audit
- Ask audit questions that get results
- Conduct opening and closing meetings that have impact
- Construct effective audit checklists
- Generate effective corrective actions
- Write the audit report and take corrective action
- Prepare Audit report
- Audit Follow-Up
Class Outline
Day 1
- Course introduction
- History of Quality Management
- In-depth Review of the Standard
- Exercise: Audit Case Studies
Day 2
- Learning Game on Pre-assignment
- Test on Standard / Review test
- Review 21 CFR 820 & Exercise
- AU Module – Part 1. Intro to Auditing
- Test on Part 1 / Review Test
- Part 2. Preparing for an Audit
Day 3
- Test on Part 2 / Review Test
- Part 3. Conducting the Audit
- Test on Part 3 / Review Test
- Audit Role Play Exercise 1
- Part 4. Completing the Audit
- Test on Part 4 / Review Test
- Exercise: Writing Audit Findings
Day 4
- TL Unit: Leading an Audit Team
- Audit Role Play Exercise 2
- Exercise: Conducting a Closing Meeting
- Writing the Audit Report
- Test on TL Unit / Review Test
- Class Wrap-Up
Prerequisites
None. Our students range from seasoned quality professionals to novices. Our goal is to meet everyone at their current level of competence and increase it. All students are required to bring their own printed copy of ISO 13485:2016. Most students will be able to obtain a copy from their company.
Course Format
32 hours
Combination lecture and individual/group exercises
Available virtually
9:30am-7:30pm (EST) each day
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