1. ISO 13485

ISO 13485 is an international standard that is based on ISO 9001 and includes additional requirements for medical devices. It defines the requirements for a quality management system for the medical device industry.

It can be applied to organizations involved in the entire lifecycle of medical devices, including design and development, production, storage and distribution, installation, and servicing. This applies not only to medical device manufacturers but also to various organizations such as suppliers, distributors, and service providers.

In addition, organizations can provide consistent medical devices and related services through ISO 13485, thereby enhancing reliability and expanding business opportunities.

< ISO 13485 >

2. Benefit of ISO 13485

• •  Expression of the intention to provide high-quality products and services to companies and consumers.
• •  Continual maintenance and improvement through a systematic approach.
• •  Increased operational efficiency and cost savings.
• •  Securing competitiveness through mandatory certification when exporting to overseas markets.
• •  Improved awareness of quality management systems among employees and the ability for proactive preventive management.

< ISO 13485 Medical Device Quality Management System >

3. “ISO 13485 Auditor” registration requirement of GPC

• check Education level beyond secondary graduation
• check Over 5 years of work experience (including at least 2 years of experience related to medical devices – quality management)
• check Completion of ISO 13485 Auditor/Lead Auditor training
• check Pass knowledge and attribution examination of GPC
• check Audit log of at least 20M/D within 3 years