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ISO 13485:2016 (Medical Devices - QMS) Awareness Training



ISO 13485:2016 is an international standard that sets out the requirements for a quality management system (QMS) specific to the medical devices industry. The standard focuses on meeting customer and applicable regulatory requirements and is intended for any organization partially or fully involved in the medical device life-cycle.

It is designed to be used by organizations throughout the life cycle of a medical device, from initial conception to production and post-production, including final decommission and disposal. It also covers aspects such as storage, distribution, installation and servicing, and the provision of associated services.

In addition, the standard can be used by other internal and external parties, such as certification bodies, to help them with their certification processes, or by supply chain organizations that are required by contract to conform.


ISO 13485 helps an organization design a quality management system that establishes and maintains the effectiveness of its processes. It reflects a strong commitment to continual improvement and gives customers confidence in its ability to bring safe and effective products to market.

This ISO 13486 awareness PPT training presentation can be used to brief your employees, new hires and potential auditees so as to create awareness of the ISO 13485:2016 standard. Alternatively, the presentation may be used to supplement your materials for the training of QA professionals and internal auditors in the medical devices industry.

It covers the what and why of ISO 13485, the QMS key clause structure, the audit approach and also offers practical tips on how to handle an audit session. When you are done teaching this material to your employees, they will be much more informed and comfortable with ISO 13485:2016.

NOTE: This training package includes:
1. ISO 13485:2016 (Medical Devices - QMS) Awareness PPT training presentation (PowerPoint format, in new 16:9 widescreen)
ISO Certification Audit poster (PDF format, in color and monochrome, printable in A3 size)


Learning Objectives​

  1. Provide background knowledge of ISO 13485:2016

  2. Gain an overview of ISO 13485:2016 structure and the certification process

  3. Understand the audit approach

  4. Gather useful tips for handling an audit session


1. Overview of ISO 13485

  • About ISO

  • ISO Standards Contribute Directly to the U.N. Sustainable Development Goals (SDGs)

  • What are Standards?

  • What Standards are Not

  • Why are Standards Important?

  • What is a Management System?

  • What is ISO 13485?

  • Who is ISO 13485 For?

  • What is a Medical Device?

  • What is a Quality Management System (QMS)?

  • The Plan-Do-Check-Act (PDCA) Process Model

  • How Does ISO 13485 Work?

  • Benefits that ISO 13485 Will Bring to the Organization

  • Advantages of Certification

  • Accreditation & Certification Bodies

  • Development of ISO 13485

  • Why Was ISO 13485 Revised?

  • Key Improvements to ISO 13485:2016


2. ISO 13485 Structure

  • The ISO 13485:2016 Structure

  • ISO 13485:2016 Approach is Based on the PDCA Cycle

  • ISO 13485:2016 Key Clause Structure (4-8)

    • Clause 4: Quality Management System

    • Clause 5: Management Responsibility

    • Clause 6: Resource Management

    • Clause 7: Product Realization

    • Clause 8: Measurement, Analysis & Improvement

  • Documentation Requirements

  • ​The PDCA Cycle is the Engine of Continuous Improvement

3. ISO 13485 Certification

  • Becoming ISO 13485:2016 Certified

  • Aligning/Transitioning to ISO 13485:2016

  • ISO 13485:2016 Certification Process

  • What Does Certification Assure?


4. Audit Approach

  • What is a Quality Audit?

  • What is an ISO Audit?

  • What Are Audits Used For?

  • Types of Quality Audits

  • Internal Quality Audit

  • Principles of Auditing

  • Audit Focus

  • Audit Approach

  • Audit Emphasis

  • Document Review

  • Audit Findings


5. Handling an Audit Session

  • Rights of Auditee

  • Rights of Auditor

  • How to Handle an Audit Session?

  • Auditee's Conduct

  • Interacting with Auditors: Do's

  • Interacting with Auditors: Don'ts


You may also be interested in the following Management System Standards (sold separately):

  1. ISO 9001:2015 (QMS) Awareness Training

  2. ISO 13485:2016 (Medical Devices - QMS) Awareness Training

  3. ISO 14001:2015 (EMS) Awareness Training

  4. ISO 19011:2018 Auditing Management Systems Training

  5. ISO/IEC 20000-1:2018 (SMS) Awareness Training

  6. ISO 20121:2012 (ESMS) Awareness Training

  7. ISO 20400:2017 (Sustainable Procurement) Awareness Training

  8. ISO 22000:2018 (FSMS) Awareness Training

  9. ISO 22301:2019 (BCMS) Awareness Training

  10. ISO 26000:2010 (Social Responsibility) Awareness Training

  11. ISO/IEC 27001:2022 (ISMS) Awareness Training

  12. ISO 31000:2018 (Risk Management) Awareness Training

  13. ISO 37001:2016 (ABMS) Awareness Training

  14. ISO 37301:2021 (CMS) Awareness Training

  15. ISO 41001:2018 (FM) Awareness Training

  16. ISO 45001:2018 (OH&S) Awareness Training

  17. ISO 50001:2018 (EnMS) Awareness Training

  18. ISO 55001:2014 (Asset Management) Awareness Training

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