ISO 13485:2016 Internal Auditor for the Medical Field

WIOA Eligible

This course covers the fundamentals of auditing and specific techniques thereof. Included will be review and interpretation of the ISO 13485:2016 Standard as well as application of techniques during audit scenarios.

Details

Curriculum

Content Outline:

• Audit Fundamentals
• Definitions, purpose, types
• ISO 13485:2016 requirements
• GMP background and FDA requirements
• What is auditing.
• Types of audits – 1st, 2nd & 3rd party audits?
• 3rd party auditing process and certification requirements
• Definitions of key words in ISO 13485 and GMP Standards
• Review of Standard requirements and summary of key points
• General requirements
• Changes from old Standard and newly emphasized points
• General review of 5 major categories
• Quality management system
• Management responsibility
• Resource management
• Product realization
• Measurement, analysis and improvement
• Type of findings
• Minor non-compliances
• Major non-compliances
• Recommendations
• Corrective actions/follow-up
• Internal audit process

Who Should Enroll

Anyone interested in this topic. There are no prerequisites required.

Instructor

Mr. Joseph DeCarlo

Joseph DeCarlo is a senior executive with over 30 years of experience in quality, sales, business development, marketing, and operations. He has helped organizations identify and capitalized on market opportunities to build revenue, presenting over 2500 training & consulting sessions at all levels of an organization. He has implemented and provided consulting support for Quality Management Systems for 100’s of organizations and trained over 15,000 individuals. He is a registered Lead Auditor with the RABQSA and a past chairman of the ASQ. He has lectured at Harvard University, Northeastern University, Columbia University, CCSU and Fordham University.

Location

Central Connecticut State University
1615 Stanley Street
Elihu Burritt Library
New Britain, CT 06051
Room 302-04

Testimonials

“This was an excellent course that was very helpful!” Fall, 2025

“This class was very informative; I learned a lot of things that I previously didn’t understand.” Fall, 2025

“Loved the class. It gave me a better understanding of auditing and a newfound respect for auditors.” Fall, 2025

“This was a great mix of technical reading with real life industry applications of the lessons.” Fall, 2025

“This course was very engaging! It gave life to the quality management and auditing!” Fall, 2025

“Joe DeCarlo was very knowledgeable! Great class!” Spring, 2024

“Joe DeCarlo was a wonderful teacher who made the class easy and enjoyable!” Spring, 2024

“Teacher was down to earth and cared deeply for the content he was teaching.” Spring, 2024

“After taking this class I now feel comfortable with performing internal audits in the future!” Spring, 2024

“Highly enjoyed the course and learned a lot!” Spring, 2024

“Joe was very knowledgeable and informative!” Summer, 2023

“I went from knowing nothing about auditing to feeling confident in participating!” Spring, 2023

“Great instructor, very knowledgeable!” Spring, 2023

“The skills I learned will be used in each audit!” Spring, 2023