3-Day ISO 13485:2016 Internal Auditor Training (MDM24)

This course is based on the 2016 version of the ISO 13485 Standard, providing skills necessary to perform internal process audits in the medical device industry. It features a detailed review of the standard, audit activities and techniques, required documented information, objective evidence to gather, and third-party external auditor expectations when assessing ISO 13485 management system compliance for certification.          

Content includes new or changed requirements related to:

  • Understanding the organization and its context
  • Understanding the needs and expectations of external auditors
  • Leadership and commitment
  • Actions to address risks and opportunities and the concept of risk-based thinking
  • Strengthened criteria for quality objectives
  • Documented information

TCIE’s business-centric approach prepares participants to not only assist their companies in becoming ISO compliant, but in driving efficiencies, error reduction and increased profitability through proper use and management of the ISO system. 

Hours: 24

Learning Outcomes

  • Understand concepts and vocabulary of quality systems, their benefits, and approaches to effective management of quality systems to improve company performance
  • Complete internal process audits of an organization’s Quality Management System (QMS) while ensuring it meets requirements of the standard
  • Comprehend implications of an increased focus on regulatory and statutory requirements
  • Acquire a range of skills needed to be an effective internal auditor, including audit diplomacy and communication skills, team-building skills, process assessment and continual improvement

Intended Audience

Individuals interested in planning, scheduling or performing first-party (internal) audits; outsourced team members performing second-party audits; quality assurance professionals and managers; management representatives; and ISO 13485 implementation and/or transition team members

Prerequisites

None

Course Schedule

8 a.m. to 5 p.m.

January 15-17, 2019

UB Baird Research Park

Instructor Bio: John B. Riggi

Mr. Riggi has 40 years of experience in quality assurance and regulatory affairs management at major companies, including Bausch & Lomb, Novartis and Baxter Healthcare. In each role, he has been responsible for global quality system design, manufacturing quality and regulatory compliance. He began his career with implementation of quality systems, as per requirements of the initial 21CFR820 regulation. He has overseen medical device compliance to 21CFR820, ISO-9001 and ISO-13485, as well as product regulatory compliance.

COURSE CLOSED!

Another session may be scheduled if there is enough demand. Contact Gary Simon at ggsimon@buffalo.edu if interested.