
Classroom 5 Day
44648290
Learn to lead 13485:2016 and MDSAP audit teams.
Description
Using a hands-on approach, learn to lead an audit of a 13485 conformant and MDSAP regulatory compliant management system. Understand how the 2016 Version of ISO 3485:2016 links and aligns to regulatory jurisdiction requirements and a risk based approach to auditing.
The course can fulfill training requirements for Medical Device QMS Requirements, Internal QMS Auditing, and Lead Assessor QMS.
Objectives
- Concepts and principles of MDSAP-based Quality Systems
- ISO-13485: 2016 Standard Requirements
- Applicable Regulatory Aspects—US, Canada, Australia, Japan and Brazil
- Internal Quality Audits—alignment of your IQSA to MDSAP
- Regulatory aspects and recognized guidance
- Risk based approach to audit
Discuss and Learn:
- Awareness of QMS Principles and MDSAP
- Understanding of terms and definitions
- Requirements of and auditor expectations for compliance to Standards
- Awareness of roles/responsibilities of an auditor, and assessment team leader
- Different types of audits and purpose
- Scope, objectives, audit criteria
- Phases of audit and deliverables, per ISO-19011: 2018
- Objective Evidence – types of and verification aspects
- Auditing device technical documentation
- Writing and Grading a Nonconformity
- Presenting audit findings and preparing conclusions
- Communicating during an audit
- Audit reporting
- Corrective action follow up and verification
- Student exercises and activities with role playing
- Scenarios and case study
Audience
- Regulatory Affairs and QA Professionals
- Quality Assurance and Compliance Specialists
- Quality Engineers and Manufacturing Engineers
- Quality Assurance
- Management with responsibility for QMS
- Internal and external auditors of medical device manufacturing/design firms
- Consultants

Classroom 5 Day
44648290