ISO 13485:2016 Internal Auditing Workshop

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.

Are you an existing auditor with knowledge of ISO 13485:2003 wishing to update your audit program in line with ISO 13485:2016? This course will refresh your auditing techniques and help you prepare to audit against the new requirements!

Some of the key changes to ISO 13485:2016 include:

  • Alignment of global regulatory requirements
  • Inclusion of risk management and risk based decision making throughout the quality management system
  • Additional requirements and clarity with regard to validation, verification, and design activities
  • Strengthening of supplier control processes
  • Increased focus regarding feedback mechanisms
  • More explicit requirements for software validation for different applications
  • Alignment of global regulatory requirements
  • Validation using pre-clinical and clinical evaluations
  • Validation of packaging and distribution requirements
  • A feedback section, including a new complaint-handling section and other guidance for customer communications
  • Additional improvement measures: adding the use of post-market surveillance, risk-based decisions, and timelines

Quality Support Group’s ISO 13485:2016 Internal Auditing course meets the training portion of the requirements for certification of individual internal auditors. The course begins with an explanation of ISO 13485:2016 and includes training on the following:

  • Making a smooth transition to ISO 13485:2016
  • The auditing process and audit instruments
  • The documentation process
  • How to conduct an audit
  • How to write an audit report and take corrective action

Who Should Attend
This course is designed for 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
Upon completion of this course, students will understand each element of ISO 13485:2016 and the registration process. Using interactive workshops, simulated audits, and case studies, participants will develop skills necessary to identify nonconformance, and prepare, perform, and complete an audit to ISO 13485:2016.

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

This session begins with an introduction to 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

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

Location: Bose Corporation, Westboro, MA
Registration Deadline: September 7th, 2017


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