ISO 13485:2016 with MDSAP Internal Auditing

Course Description
Medical device auditing requires technical knowledge as well as a deep understanding of international medical device regulations. Students participating in this course will gain knowledge and skills to conduct audits of ISO 13485: 2016 management system requirements in accordance with the new MDSAP Audit Model.

ISO 13485 is a Quality Management Standard for Medical Devices. Many medical device companies are utilizing ISO 13485:2016 as a platform to build their business management systems because of its benefits or because it is a necessary step to market their products and services in certain regions. For many companies, registration to ISO 13485 is the key to securing and maintaining global business.

The Medical Device Single Audit Program (MDSAP) offers the opportunity to demonstrate compliance with the regulatory requirements of up to five participating countries in the course of a certification process: Australia, Brazil, Japan, Canada, and the United States. The advantages of the program are not only the recognition of the results in the registration of medical devices but also the reduction of on-site inspections by the participating authorities.

QSG’s ISO 13485:2016 with MDSAP Internal Auditing course will teach students to plan, conduct, report, and follow up on QMS audits in accordance with ISO 13485:2016 and MDSAP. Auditing standards include ISO 13485, MDSAP requirements, and ISO 19011.

This 3-day course teaches the concepts of the ISO 13485:2016 and MDSAP with the principles/practices of effective internal audits in accordance with ISO 19011:2018, “Guidelines on Auditing Management Systems”. Experienced instructors with decades of experience in medical device quality management systems explain the clauses of ISO 13485:2016 and MDSAP in detail and guide students through internal audits that are required for a quality management system. Instructors will also help students boost their audit capabilities with the latest developments of the new 19011 standard. Students gain necessary auditing skills through a balance of formal classroom tutorials, practical role-playing, group workshops, and open forum discussions.

This course provides extensive practical training and hands-on exercises that will help prepare medical device auditors to identify critical nonconformities and meet international regulatory requirements. It is designed for medical device professionals with the responsibility for conducting or implementing internal audits, supplier audits, or corporate audits.

Upon completion of training, participants will be capable of auditing ISO 13485:2016 and jurisdiction requirements in the countries participating in the MDSAP program.

Who Should Attend
This course is designed for Internal Auditors, Quality Assurance Managers, ISO 13485:2016 Implementation Team Members, Management Representatives, and individuals who wish to learn how to perform an audit to ISO 13485 and MDSAP.

Learning Objectives
Through training, participants will be able to:

  • Describe the ISO 13485 Medical Device Quality Management System (QMS) – Requirements for Regulatory Purposes standard and development process
  • Demonstrate awareness of MDSAP fundamentals
  • Explain the structure and scope of the MDSAP audit
  • Maintain MDSAP and organizational regulatory compliance
  • Understand MDSAP reporting and nonconformity grading methods
  • Explain the differences between MDSAP and other QMS audits such as ISO 13485:2016
  • Determine MDSAP documentation requirements
  • Prepare to host a successful MDSAP audit
  • Identify medical device QMS terms
  • Describe the intent and requirements of ISO 13485:2016
  • Determine the evidence needed to demonstrate conformity to ISO 13485:2016 and MDSAP
  • Apply the process approach and Plan-Do-Check-Act (PDCA) methodology
  • Describe the relationship between ISO 13485:2016 and applicable regulatory requirements
  • Apply the principles, processes, and methods of auditing
  • Demonstrate the activities involved in preparing for an audit
  • Determine an effective audit in the context of the auditee’s organizational situation
  • Apply effective audit skills and practice personal behaviors necessary for an effective and efficient conduct of a management system audit

Course Outline
This session includes a comprehensive review of ISO 13485:2016 and audit systems:

  • The Challenge for Top Management
  • Eight Quality Management Principles
  • The ISO Standard Explained
  • Chapter 1: MDSAP Background
  • Chapter 2: MDSAP Audit Structure
  • Family of Standards
  • Detailed read/review/explanation of ISO 13485:2016/MDSAP Requirements

Students will also learn the steps to develop, implement, and audit an internal quality system that efficiently and effectively meets the requirements of ISO 13485:2016 with MDSAP, including:

  • The auditing process and audit instruments
  • The documentation process
  • How to conduct an audit
  • How to write the audit report and take corrective action
  • Auditing case studies to develop skills for identifying nonconformance
  • Audit Trails and training on the following topics:
  • Documentation for ISO 13485:2016 and MDSAP
  • The audit cycle and ISO 19011
  • Introduction to Quality Audits
  • Management of Audit Programs

Attendees will apply their knowledge by preparing, performing, and completing an audit to ISO 13485:2016. Specific activities include:

  • Audit Planning and Preparation
  • Scope and Objectives
  • Audit Plan
  • Performing the Audit
  • Opening Meeting
  • Quality Audits
  • Conducting the Audit
  • Writing Nonconformity Statements
  • Writing Nonconformities (using CARs)
  • Closing Meeting
  • Summary Statement and Closing Meeting
  • Completing the Audit Report
  • Corrective Action and Close Out (using CARs)
  • Verification and Close Out


Course Format
24 hours
Formal classroom tutorials, practical role-playing, group workshops, and open forum discussions
Available on-site at your organization and virtually

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