3 Day Schedule: 7:30 AM- 4:30 PM MST CEU Hours: 2.4 Audience: Beginner to Advanced

Overview

This course prepares you to perform internal QMS audits using industry-proven techniques and to apply a proper interpretation of the ISO 13485 standard and MDSAP requirements to real-life audit situations. You’ll follow the full audit process including: audit tools and preparation, opening meetings, audit interviews, closing meetings, and reporting.  This is a very practical class that is not “bogged-down” with academic discussions of quality topics that have limited utility for class attendees.

This class makes extensive use of activities and case studies to help you fully understand the requirements of quality system auditing and apply MDSAP and ISO 13485 requirements. Since people “lock” new understanding into long-term memory much better when they apply it, lecture time is held to a minimum providing you time to grasp and then practice your newly acquired skills in simulated real-life audit situations.
 

Who Should Attend

Individuals who will perform audits to regulatory requirements or Quality Management Systems, individuals assisting their organizations toward ISO 13485 registration or individuals who are frequently audited should attend this training. Quality directors, managers, engineers, auditors, ISO coordinators, laboratory quality professionals, and anyone engaged in quality audits will benefit from this training.
 

Prerequisites

There are no required prerequisites, though familiarity with ISO, US, Australia, Brazil, Canada, and Japan quality system requirements for medical devices is helpful.  All attendees are required to bring their own copy of the ISO 13485 Quality Management Standard Requirements to this training course. These will not be provided for you. We strongly advise you bring a “paper” copy.
 

Course Objectives

• Prepared to conduct a solo internal audit at successful course completion
• Understand the MDSAP audit model.
• Understand and interpret the ISO 13485 requirements and review applicable MDSAP requirements.
• Apply the proper interpretation of the standard in actual audit situations.
• Understand process auditing tools leading to substantive quality system improvements
• Tailor an audit interview based on the requirements of the standard and obtain audit evidence from this interview.
• Follow-up and resolve “audit trails that present themselves during the audit interviews
• Conduct audits that result in real improvements to the quality system
• Plan and execute the entire audit process including: audit preparation, opening meetings, auditing, closing meetings, and reporting.