ISO 13485 Medical Devices Quality Management System Training by Tonex
ISO 13485 Medical Devices Quality Management System Training by Tonex. Tonex offers a variety of ISO 13485 training courses, including:
- ISO 13485:2003 Foundation
- ISO 13485:2003 Lead Auditor
- ISO 13485:2016 Foundation
- ISO 13485:2016 Lead Auditor
These courses cover the requirements of ISO 13485, a quality management system (QMS) standard for medical devices. The courses are designed to help participants understand the standard, implement it in their organization, and achieve certification.
Audience:
- Management: Senior management, such as CEOs, COOs, and directors, should attend ISO 13485 training to understand the importance of quality management and how to implement a QMS in their organization.
- Quality professionals: Quality managers, engineers, and other quality professionals should attend ISO 13485 training to learn about the requirements of the standard and how to implement them in their work.
- Auditors: Internal and external auditors should attend ISO 13485 training to learn how to audit a QMS against the standard.
- Others: Anyone who is involved in the design, development, manufacturing, or distribution of medical devices should consider attending ISO 13485 training to learn about the importance of quality management and how to improve their organization’s QMS.
Learning Objectives:
- Understand the importance of quality management in the medical device industry
- Understand the requirements of ISO 13485
- Implement a QMS in accordance with ISO 13485
- Audit a QMS against ISO 13485
- Identify and mitigate risks to patient safety
- Improve an organization’s QMS
Course Outlines
ISO 13485:2003 Foundation
- Module 1: Introduction to ISO 13485
- Module 2: Quality Management Systems
- Module 3: The Requirements of ISO 13485
- Module 4: Implementation of ISO 13485
- Module 5: Benefits of ISO 13485 Certification
ISO 13485:2003 Lead Auditor
- Module 1: Introduction to ISO 13485
- Module 2: Quality Management Systems
- Module 3: The Requirements of ISO 13485
- Module 4: Auditing Principles and Concepts
- Module 5: Conducting an ISO 13485 Audit
- Module 6: Reporting the Results of an Audit
ISO 13485:2016 Foundation
- Module 1: Introduction to ISO 13485:2016
- Module 2: Quality Management Systems
- Module 3: The Requirements of ISO 13485:2016
- Module 4: Implementation of ISO 13485:2016
- Module 5: Benefits of ISO 13485:2016 Certification
ISO 13485:2016 Lead Auditor
- Module 1: Introduction to ISO 13485:2016
- Module 2: Quality Management Systems
- Module 3: The Requirements of ISO 13485:2016
- Module 4: Auditing Principles and Concepts
- Module 5: Conducting an ISO 13485:2016 Audit
- Module 6: Reporting the Results of an Audit