ISO 13485:2016 Internal Auditing

Course Description
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.

QSG’s “ISO 13485:2016 Internal Quality Systems Auditor” competency- based 2-day course teaches a general understanding of the concepts of the ISO 13485:2016 standard and 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 that are required for a quality management system based on ISO 13485:2016. Our qualified instructors will also help you to boost your 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.

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.

Leaning Objectives:

  • Describe the ISO 13485 Medical Device Quality Management System (QMS) – Requirements for Regulatory Purposes standard and development process
  • Identify medical device QMS terms
  • Describe the intent and requirements of IAO 13485:2016
  • Determine the evidence needed to demonstrate conformity to ISO 13485:2016
  • Apply the process approach and Plan-Do-Check-Act (PDCA) methodology
  • Describe the relationship between ISDO 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
  • Family of Standards
  • Detailed read/review/explanation of ISO 13485:2016 Requirements
  • Exclusions
  • Overview of ISO 13485:2016 Requirements: Clause 4
  • Overview of ISO 13485:2016 Requirements: Clause 5
  • Overview of ISO 13485:2016 Requirements: Clause 6
  • Overview of ISO 13485:2016 Requirements: Clause 7
  • Overview of ISO 13485:2016 Requirements: Clause 8

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, 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
  • ISO 13485 Internal Auditing Practice
  • ISO 13485:2016 Audit Trails and training on the following topics:
    • Documentation for ISO 13485:2016
    • 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 instructors:
Angelo Scangas – President and CEO

Course format:
8:30am-4:30pm (EST)
Location: QSG Training Facility
319 Littleton Road #206, Westford, MA 01886
VIRTUAL OPTION AVAILABLE

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


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




Always Keep Improving!