ISO 13485:2016 - Quality Management Systems for Medical Devices
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ISO 13485:2016 - Quality Management Systems for Medical Devices at Alison Overview
Duration | 3 hours |
Mode of learning | Online |
Difficulty level | Beginner |
Official Website | Go to Website  |
Credential | Certificate |
ISO 13485:2016 - Quality Management Systems for Medical Devices at Alison Highlights
- Earn a certificate after completion of course
ISO 13485:2016 - Quality Management Systems for Medical Devices at Alison Course details
Compare the revision of ISO 13485:2003 to ISO 13485:2016
ist the main clauses of the ISO 13485:2016 standard along with the requirements
Define important terminologies about medical devices as per ISO 13485:2016
Explain the purpose of other international and regulatory standards like ISO 14971 and FDA 21 CFR Part 820
Compare ISO 13485 with FDA 21 CFR Part 820
Describe how to manage the requirements about medical device files
Illustrate how to assimilate work environment and contamination control requirements
Describe how to manage the requirements about design and development
This online ISO 13485 certification training course will teach you about quality management systems for medical devices
You will study the ISO 13485:2016 standard, learn how it was developed, and look into the practical steps to company certification on ISO 13485.
The course explains all the requirements of ISO 13485 including specific requirements of quality management system, management responsibilities together with resource management, requirements of product realization such as planning for the QMS, design and development of product, purchasing controls and production management etc
ISO 13485:2016 - Quality Management Systems for Medical Devices at Alison Curriculum
MODULE 1:Introduction to ISO 13485:2016 (Medical Devices QMS)
Introduction to ISO 13485:2016 (Medical Devices QMS) - Learning Outcomes
Quality Management System of Medical Devices Suppliers and Manufacturers
ISO 13485:2016 Important Terminologies
Publication of ISO 13485:2016 and Context of Publication
Introduction to ISO 13485:2016 (Medical Devices QMS) - Lesson Summary
MODULE 2:Operations of Quality Management System (QMS)
Operations of Quality Management System - Learning Outcomes
Quality Management System Requirements
Management Responsibility and Resource Management
Product Realization ? Planning to Design and Development
Product Realization ? Purchasing and Production
Operations of Quality Management System - Lesson Summary
MODULE 3:Measurement, Analysis and Improvement
Measurement, Analysis and Improvement - Learning Outcomes
Monitoring and Measurement
Control of Non-Conforming Product
Analysis and Improvement
Measurement, Analysis and Improvement - Lesson Summary
MODULE 4:Course Assessment
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