Description
 

ISO 13485:2016 is an internationally recognized standard that outlines the requirements for a quality management system (QMS) specific to the medical device industry. The standard focuses on meeting customer and regulatory requirements and is intended for any organization involved in the medical device life-cycle.

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The standard covers all stages of the medical device life-cycle, from design and development to production, distribution, installation, and servicing. It also includes the provision of associated services and the final decommissioning and disposal of the device.

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ISO 13485:2016 helps organizations establish and maintain an effective QMS, ensuring the safety and effectiveness of their medical devices while meeting regulatory requirements. It also reflects a strong commitment to continuous improvement, giving customers confidence in the organization's ability to bring safe and effective products to market.

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This ISO 13485 awareness training presentation is designed to provide an introduction to the ISO 13485:2016 standard for employees, new hires, potential auditees, and other stakeholders in the medical device industry. It can also be used as a supplement to the training of quality assurance professionals and internal auditors.

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The presentation covers the key clauses of the standard, the audit approach, and offers practical tips on how to handle an audit session. It also emphasizes the importance of meeting customer and regulatory requirements, establishing an effective QMS, and ensuring the safety and effectiveness of medical devices.

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By the end of the training, participants will be more informed and comfortable with ISO 13485:2016, enabling them to contribute to the development and maintenance of an effective QMS and the production of safe and effective medical devices.

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

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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.

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Contents
 

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

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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 20400:2017 (Sustainable Procurement) Awareness Training

7. ISO 22000:2018 (FSMS) Awareness Training

8. ISO 22301:2019 (BCMS) Awareness Training

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

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

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

12. ISO 37000:2021 (Governance of Organizations) 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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