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  1. Provides a framework for managing and improving the quality management system based on the ISO 13485:2016 standard for the medical devices industry.
  2. Provides a tool for creating awareness of the ISO 13485:2016 standard.
  3. Provides guidelines and practical tips for handling an audit session.


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.

This 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.


1. Provide background knowledge on 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 on handling an audit session


1. Overview of ISO 13485
•  About ISO
•  What are Standards?
•  Why are Standards Important?
•  What is ISO 13485?
•  Who is ISO 13485 For?
•  What is a Medical Device?
•  What is a Quality Management System?
•  How Does ISO 13485 Work?
•  Benefits that ISO 13485 Will Bring to the Organization
•  Advantages of Certification
•  Development of ISO 13485
•  Why Was ISO 13485 Revised?
•  Key Improvements to ISO 13485:2016
•  Relationship of ISO 13485 with ISO 9001

2. ISO 13485:2016 Structure
•  The ISO 13485:2016 Structure
•  The Plan-Do-Check-Act (PDCA) Process Model
•  ISO 13485:2016 Approach is Based on the PDCA Cycle
•  Documentation Requirements
•  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

3. ISO 13485:2016 Certification
•  Becoming ISO 13485:2016 Certified
•  ISO 13485:2016 Certification Process

4. Audit Approach
•  What is a Quality 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

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Source: ISO 13485:2016 (Medical Devices - QMS) Awareness PowerPoint document

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ISO 13485:2016 (Medical Devices - QMS) Awareness

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File Type: PowerPoint (pptx)

File Size: 9.7 MB

Number of Slides: 72 (includes cover, transition slides)

Related Topic(s): Quality Management & Assurance Healthcare

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Initial upload date (first version): Jan 13, 2021
Most recent version published: Jan 13, 2021

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