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

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

Best training I’ve had in quite some time. Fall, 2022

Joe provides a depth of experience that is clearly deep. You cannot fake this level of knowledge or experience. Fall, 2022

Instructor is fantastic – informative and entertaining. Spring, 2022

Gave me understanding of how to apply the Standard to my company’s Quality Management System. Spring, 2022

Instructor did a great job explaining the entire standard. Fall, 2021

Great course! Fall, 2021