Quality Management Systems Lead Auditor Training, Incorporating ISO 13485:2016 and MDSAP Requirements (CQI/IRCA Certified*)

San Jose, California
Monday, March 05, 2018
Quality Management Systems Lead Auditor Training, Incorporating ISO 13485:2016 and MDSAP Requirements (CQI/IRCA Certified*)
Monday, March 05, 2018 8:30 AM -
Friday, March 09, 2018 5:30 PM (Pacific Time)

Holiday Inn San Jose - Silicon Valley
1350 North 1st Street
San Jose, California 95112
United States

Map and Directions

Course Overview

This five-day course provides the skills and knowledge that have taken many experienced auditors decades to develop. During the course, you will plan and prepare audits based upon case studies that simulate both supplier and third-party audits utilizing the MDSAP audit requirements. Throughout the course, you will participate in simulated auditing exercises that include planning, preparation and evaluation of audit evidence. You will also practice the application of ISO 13845:2016 and the MDSAP requirements. Students will be assessed throughout the course and an exam will be administered on the final day.

Learning Outcomes*

After completing this course, you will understand how to:

  • Plan, conduct, report and follow up on a QMS audit in accordance with ISO 19011, ISO 13485:2016 and MDSAP

  • Apply the MDSAP audit strategies adopted by Auditing Organizations in the MDSAP program

  • Identify nonconformities, grade nonconformities and prepare an audit report in accordance with the MDSAP criteria


Students must have prior knowledge of the following concepts:

  • The plan, do, check, act (PDCA) cycle in the context of processes

  • The structure, content and requirements of ISO 19011 and ISO 13485:2016

  • The relationship between quality management and regulatory compliance

  • Regulatory requirements of at least one MDSAP participating country or the EU

  • Commonly used terms and definitions and the seven quality principles of ISO 9000

  • The process approach used in quality management


Who Should Attend?

This course is vital for medical device quality professionals with responsibility for conducting or implementing internal audits, supplier audits, corporate audits or third-party audits. Quality directors, regulatory managers and those responsible for managing internal, corporate, supply chain or registration audit programs will also benefit from this course.


James Pink, MCQI, CQP

James Pink has over 20 years of experience in the medical device industry, which includes auditing medical device manufacturers worldwide (formerly for the British Standards Institute), as well as managing development and quality assurance programs for the orthopedic, cardiovascular and dental sectors. He has been providing training and education globally on medical device technologies, quality systems and auditing for over 15 years.

*This is an IRCA-certified QMS Lead Auditor Course. Please note, successful completion of this course will fulfill the educational requirements of IRCA for its accredited Auditor/Lead Auditor schemes. Further requirements to become an IRCA Lead Auditor are found on the CQI IRCA website at www.quality.org.

Cancellation Policy: Cancellations will be accepted up to 30 days prior to the training course, subject to a 10% cancellation fee. Student substitutions will be accepted until the course start date.


Contact Information

Payment Instructions

    • Registration ​Fee ​:
    • $2,695 per person

    • 10% discount for companies registering 5 or more students

    Registration ​Fee ​Includes:

    • All resource ​material

    • All training materials

    • ISO ​13485:2016 ​Medical ​Device ​QMS ​Standard ​(hard ​copy)

    • Final Exam Administration

    • Certificate of Completion* (with Passing exam score of 70% or above)

    • Lunch daily

    Payment Methods:

    • Major credit card
    • Invoice
      • Please note: payment in full will be needed 7 business days prior to the start of the course if paying via invoice
      • If paying via invoice, all "bill to" information must be filled out.

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