TS-EN-ISO 13485: 2003 standard The TS-EN-ISO 9001: 2008 standard is based on the international standard with special requirements for medical devices. ISO 13485: 2016 The EN 1993 Standards (EN 550 and EN 46000), the standard of which was published in 46001 and including the sterilization process transferred to the EN 46002 series for medical device manufacturers, describes the quality system requirements for all medical devices. In order to implement EN 46000 standards together with ISO 9001 quality management system, ISO 13485 has established a quality management system in the medical sector. ISO 13485 Quality Management System Standard in Medical Sector; was established with the aim of structuring manufacturers, distributors, import and exporters and organizations providing these services. This system complies with the EU medical devices directive and is applied with the CE mark.
The TS EN ISO 13485 standard is based on ISO 9001, although it is a unique standard. ISO 13485: 1996 and 13488: 1996 are old models of this standard that do not rely on the process approach. ISO / TR 14969 Medical Devices - Quality management systems - The guideline for the implementation of ISO 13485 is a Technical Report intended to provide guidance on the implementation of ISO 13485.
WHAT IS THE SCOPE OF ISO 13485 STANDARD
This Standard is almost identical to the ISO 9001 standard and the following are the ingredients:
- Introduction
- General
- Process approach
- Relations with other standards
- Compatibility with other management systems
- Scope
- General
- Application
- Cited standards and / or documents
- Terms and recipes
- Quality management system
- General conditions
- Documentation requirements
- Management responsibility
- Management's commitment
- Customer focus
- Quality policy
- Planning
- Responsibility, authority and communication
- Management review
- Resource management
- Provision of resources
- Human resources
- Infrastructure
- Working environment
- Product realization
- Product realization planning
- Customer-related processes
- Design and development
- Buy
- Production and service provision
- Control of monitoring and measuring devices
- Measurement, analysis and improvement
- General
- Monitoring and measuring
- Control of unsuitable product
- Data Analysis
- rehabilitation
