ISO 13485:2016 Lead Auditor with 21 CFR820 Exemplar Global Recognized (5-Day)
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This five-day course has been developed to satisfy the Exemplar Global MD, AU and TL Examination Profiles and, as such, all attendees who successfully pass the exams during this course will achieve a Certificate of Attainment for the following competency units:
- Exemplar Global MD
- Exemplar Global AU
- Exemplar Global TL
Our training provides an overview, distributes knowledge, and arranges group exercises. You will be given group exercise case studies with examples from the aerospace industry will be used to help attendees gage where their QMS's has potential gaps and help meet their specific needs. Within the 5-Day ISO 13485 Lead Auditor with 21CFR820 training, you'll learn to:
- Quality management principles
- Standards and guidelines
- Interpretation of the latest revision ISO 9001 and ISO 13485
- FDA 21 CFR 820
- Introduction to quality audit
- Managing the audit process
- Audit scheduling and preparation
- Performing and reporting the audit
- Corrective action and follow-up
- Registration, Accreditation and Auditor Certification
This seminar is designed for:
- Medical device professionals
- Professionals from FDA regulated industries
- Quality professionals
- Individuals who want to become Exemplar Global (RABQSA) certified lead auditors
- ISO Managers/Management Reps
- Auditors (internal, 3rd party, and supplier)
- Systems professionals or people who want to understand how management systems work
- Improvement Specialists
- Buyers in FDA regulated industries
- Leaders/managers/professionals in the Medical Device industry
An understanding of the ISO 13485:2016 requirements and a minimum 12 months of work experience in applying or auditing quality management systems is recommended. The first 1.5 and 3 days of this class are offered separately for those new to auditing or quality management.
Day One
- Introduction to ISO 13485
- The ISO 13485 Standard Explained
- MD Written Exercise 1
- Overview of ISO 13485:2016 Requirements
- MD Written Exercises 2a, 2b (Audit Scenarios)
Day Two
- Overview of ISO 13485:2016 Requirements (cont’d)
- MD Written Exercise 2c (Audit Scenarios)
- MD Written Exercise 3
- Introduction to Management System Audit Trails
- Management of Audit Programs
- Management System Audit Planning and Preparation
- Breakout Exercise 1: Writing an Objective and Scope Statement
- Breakout Exercise 2: Documentation Review
- Breakout Exercise 3: Creating an Audit Plan
Day Three
- Performing the Audit
- Breakout Exercise 4: Performing an Audit
- Writing Nonconformity Statements
- Breakout Exercise 5: Writing Nonconformity Statements
- Closing Meeting
- Completing the Audit Report Corrective Action and Closeout
- Management Systems Auditing Exam
Day Four
- Leading Audit Teams
- Customer Specific Requirements
- Management System Certification Scheme and Auditor Qualifications
- Leading Audit Teams Mock Audit Case Study
Day Five
- Review of Audit Process and Audit Management Strategies
- Leading Audit Teams Exam
- Practical Application of Audit Principles and Instructor Interviews