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Training background

ISO 13485:2016 As the international standard of the quality management system requirements of the medical device industry, involving the design, development, production, installation and service of medical devices, the design, development and provision of related services, including the production of materials and components for medical devices. This course will combine the process and case, to thoroughly explain the medical equipment industry certification requirements for you, make you have a comprehensive grasp of the relevant requirements of ISO 13485:2016, effective internal audit system, and improve the quality management level of medical equipment production enterprises, enhance the competitiveness of medical equipment products in the domestic and international, promote the standardized management of medical equipment industry.

Training object

Internal auditor of the quality management system

Organization and senior management personnel who implement quality management system

Anyone involved who needs to learn the ISO 13485 standards

Training income

Understanding ISO 13485:2016 standards and medical device industry special requirements

Understanding the ISO 9000's relationship to the ISO 13485

Provide practical cases to improve ISO 13485 review capabilities

Training outline

ISO 13485 revision history, ISO 13485:2016 and ISO 9001:2015 relationship

New ISO 13485: The Purpose, Content, and Structure of the 2016 Standard

New ISO 13485: Scope, terms, and definitions of 2016

New Version of ISO 13485:2016, Chapter 4

New Version of ISO 13485:2016, Chapter 5

New Version of ISO 13485:2016, Chapter 6

New ISO 13485:2016 Chapter 7 focuses on changes in design control during product implementation

New Version of ISO 13485:2016, Chapter 8

New version arrangement and preparation

Purpose and principles of the audit

Planning and preparation of the audit

Implementation and reporting of the review

How to conduct the internal review in accordance with ISO 13485:2016 clause 8.2.4

How to consider the applicable laws and regulations requirements

Cases and exams

  NOA|挪亞2022年課程計劃.pdf