ISO 13485:2016 and MDSAP Lead Auditor Training

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

Topics Covered:

• 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