ISO 13485 Internal Auditor Training

ISO 13485:2016 Internal Auditing

Course Description
ISO 13485:2016 is the quality management system that governs medical devices upon which compliance with regulatory and customer compliance can be built. It embodies an agreed upon, repeatable way of managing design, production, validation, quality, and risk management. At the heart of ISO 13485:2016 is a comprehensive risk management process meant to be implemented in all medical device-related quality management processes within an organization, including processes that occur after the medical devices are placed on the market.

QSG’s ISO 13485:2016 Internal Auditor workshop teaches the fundamental concepts of ISO 13485:2016 and will explain in detail how to integrate the requirements into a quality management system. In addition, this class will teach the principles and practices of effective internal audits in accordance with ISO 19011:2018, “Guidelines on Auditing Management Systems”. Experienced instructors explain the clauses of ISO 13485:2016 in detail and guide students through internal audits to assure value to their business and regulatory authorities. Students gain the necessary auditing skills through a balance of formal classroom tutorials, practical role-playing, group workshops, and open forum discussions.

The emphasis of ISO 13485:2016 focuses on process effectiveness, efficacy, and safety and thus requires a different approach to auditing. A “value-add” perspective for audits is needed! 

Auditing is a cost-effective means of improving the organization. To be useful, audits must be performed and presented in a meaningful approach. To change practices for the better, audit results must be in business terms and appeal to the interests of the various stakeholders.

This course is designed to enhance your understanding of process auditing techniques. Using interactive workshops, simulated audits and case studies, you will develop practical audit skills, improve evaluation and communication skills, refine reporting skills and sharpen your ability to implement corrective action programs.

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.

Learning Objectives

Through training, participants will learn to:

  • Describe the ISO 13485 Medical Device Quality Management System (QMS) – Requirements for Regulatory Purposes standard and development process
  • Understand medical device QMS terms
  • Describe the intent and requirements of ISO 13485:2016
  • Determine the objective evidence needed to demonstrate conformity to ISO 13485:2016
  • 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

Participants 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, 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

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

Course Outline
Day 1 Course Introductions and Objectives
Lecture: Overview, Auditing and the Standard Requirements
Lecture: Discuss process-approach and metrics-driven audits
Exercise: Construct a process map (inputs, outputs, measures) and assign ISO 13485 / FDA CFR 21 part 820 requirements)
Lecture: Discuss the requirements/principles of ISO 13485/FDA CFR 21 Part 820 and how to integrate in a successful audit program

Day 2 Review of Day One Activities
Lecture: Review the ISO 13485:2003 / FDA CFR 21 part 820 requirements
Discuss implications to your company
Lecture: The Audit Process (planning, performing and reporting an audit)
Lecture: Preparing/Planning the audit – key criteria of a process audit
Exercise: Developing an Audit Checklist
Lecture: Conducting a process-based and metrics-driven audit
Exercise: Auditing the Organization Case Study Scenarios
Lecture: Audit report – key elements and documentation requirements
Lecture: Audit Nonconformance
Exercise: Auditing the Evidence Sample Documents and Records

Day 3 Conduct internal mock audit
Plan, Audit, and write audit report

Prerequisites
None

Course Format
20 hours
Combination lecture and classroom exercises
Available at QSG’s training facilities, on-site at your organization, and virtually

Course instructors:
Angelo Scangas – President and CEO

8:30am-4:30pm (EST) Days 1&2
8:30am-12:30pm (EST) Day 3

Course Evaluations Set 1
Course Evaluations Set 2
Course Evaluations Set 3
Course Evaluations Set 4


Payment Type
Date Attending
Name of Attendee(s)
Name of Company




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