ISO 13485:2016 Lead Auditor, Exemplar Global Certified

Workshop Format:
This is a four-day, instructor-led classroom 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).

Workshop Outline:

Day One
• Introduction to Quality Management Systems
• ISO 13485 family of documents
• ISO 13485 Standard
• Applying ISO 13485 Standard

Day Two
• FDA Quality System Regulation General Provisions
• Medical Device Single Audit Program (MDSAP)
• Requirements for Product Realization Methods and Documentation
• Risk Management
• ISO 13485 Audit Specifics

Day Three
• Types of Audits
• Audit Approaches
• Audit Objectives, Scope, and Criteria
• Auditor Competence
• Auditor Principles and Methods
• Audit Program
• Audit Roles and Responsibilities
• Audit Techniques
• Gather Information
• Audit Cycle

Day Four
• Team Leader Roles and Responsibilities
• Conflict Management
• Select Audit Team
• Prepare for an Audit
• Plan the Audit
• Conduct an Audit
• Opening Meetings
• Gather Information
• Closing Meetings
• Prepare Audit report
• Audit Follow-Up

Workshop Objectives:
• Fully understand and interpret the requirements of ISO 13485
• Understand the differences between ISO 9001 and ISO 13485, including the critical differences in requirements for continual improvement and customer satisfaction
• 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 ISO 9001 and the ISO 13485 Standards during 5 practical audit exercises conducted during the class
• Understand the terminology of the ISO 9001 and ISO 13485 and how these apply in a Medical Device Environment
• Learn how to develop an ISO 9001 / ISO 13485 auditing system based on the ISO 19011 auditing requirements
• Learn how to ask audit questions that get results
• Learn how to conduct opening and closing meetings that have impact
• Learn how to construct effective audit checklists
• Learn how to generate effective corrective actions

Who Should Attend?
Those responsible for planning and scheduling an audit program for ISO 13485 and those who must perform audits to ISO 13485, 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.

8:30am-4:30pm (EST) each day
4 Days – 3.6 CTUs – Competency Units MD, AU, & TL

Payment Type:
Date(s) Attending
Name(s) of Attendee(s)
Name of Company

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