ISO 13485
(มาตรฐาน ISO 13485)
Definition
ISO 13485 (มาตรฐาน ISO 13485) Hard Skill
ISO 13485 is an international standard that outlines the requirements for a quality management system specific to the medical device industry, ensuring consistent design, development, production, and delivery of safe medical devices.
Expertise Level
Level 1
Basic
1. Understands the fundamental principles and purpose of ISO 13485.
2. Familiar with basic terminology and requirements of the standard.
3. Recognizes the importance of quality management in medical device manufacturing.
Level 2
Intermediate
1. Can implement key requirements of ISO 13485 in quality management processes.
2. Able to conduct internal audits based on ISO 13485 standards.
3. Supports documentation and record-keeping as per compliance needs.
Level 3
Advanced
1. Leads development and maintenance of ISO 13485 compliant quality management systems.
2. Manages risk assessment and mitigation strategies according to ISO 13485.
3. Coordinates external audits and ensures continuous improvement aligned with the standard.
