หลักสูตร ISO 13485:2016 Medical devices — Quality management systems — Requirements and Internal Audit

       Medical devices are products designed to detect and treat human diseases or conditions. which consists of equipment, tools, and many other appliances, which various equipment, tools, and appliances These must pass standard inspection before use. ISO 13485:2016 is an international standard designed to provide manufacturers with an understanding of quality systems within the design and development process. Production and installation of medical equipment Including related services It is a standard that replaces the ISO 13485: 2003 standard.

• Introduction

• Clause 1 Scope

• Clause 2 Normative references

• Clause 3 Terms and Definitions

• Clause 4 Quality Management System

• Clause 5 Management Responsibility

• Clause 6 Resource Management

• Clause 7 Product Realization

• Clause 8 Measurement, analysis, and improvement

• Internal audit principle, Internal Audit Plan

• Internal Audit Checklist

• Internal Audit Guidelines from ISO 19011

• NC Statement (NC grading, Q&A)

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