System certification: necessary qualification for enterprises
The management system is developed from the concept of quality management and inherits the essence of quality management.
System certification
- Intellectual property management system
- Energy management system
- Information security management system
- Occupational health and safety management system
- Supply chain security management system
- Food safety management system
- Environmental management system
- Information technology service management system
- Social responsibility management system
- Medical device quality management system
- Quality management system
- HACCP management system
- Business continuity management system
- HSE management system
- Road vehicle network security management system
- Compliance management system
- Anti-bribery management system
- Asset management system
- Enterprise integrity management system
- Privacy information management system
- Cloud service information security management system
- Personal identifiable information protection management system in public cloud
- Personally identifiable information protection management system
Medical device quality management system
ISO13485 is a quality management system standard applicable to the medical device regulatory environment, its full name is "Medical device quality management system for regulatory requirements". While ISO 13485 is based on the Plan, Do, Check, Act (PDCA) process model concept of ISO 9001, its purpose is to ensure compliance with medical devices.
Therefore, ISO13485 is more targeted and puts forward higher documentation requirements for the quality management system. ISO 13485 is designed to help medical device manufacturers establish quality management systems and maintain their effectiveness. It ensures the safety and compliance with the intended use of medical devices at all stages of design, development, production, assembly, transportation, disposal, etc.
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