Quality Management Systems in Medical Devices UNE EN ISO 13485
It details the UNE EN ISO 13485 certification, which ensures quality and safety in the management of medical devices in accordance with European regulations
Quality in medical devices
The UNE EN ISO 13485:2018 standard is the European version of the ISO 13485:2016 standard, specifically adapted for compliance with regulatory requirements in Europe. This international standard specifies requirements for a quality management system when an organization needs to demonstrate its ability to manage medical devices and services, which consistently meet customer requirements and applicable regulations.
UNE EN ISO 13485 does not introduce substantial changes with respect to its previous version, but represents the adoption and adaptation of the ISO standard for the European context.
AENOR has been accredited by ENAC to certify quality management systems according to the UNE-EN ISO 13485:2018 Standard. The scope of AENOR's accreditation includes non-active medical devices (e.g. heart valves, breast or hip prostheses), active non-implantable medical devices (such as defibrillators), medical devices for in vitro diagnostics, as well as associated parts, parts or services. This accreditation recognises AENOR's technical competence and independence, backed by more than 100 certificates in force in several countries, and which reinforces its ability to audit with rigour and objectivity, guaranteeing safety and quality in the healthcare sector.
Quality Management System Certificate for Medical Devices
ISO 13485 sets out requirements for quality management systems in medical devices, ensuring patient safety and regulatory compliance. Promotes continuous improvement and operational efficiency
Request informationThe main elements of the UNE EN ISO 13485 standard include:
- Risk management-based approach
- Legal and regulatory compliance
- Control of Suppliers and Subcontractors
- Documentation and Records Management
- Control of Monitoring and Measurement Equipment: Approach to Software Validation
- Focus on Continuous Improvement
- Staff Training and Awareness
Brand IQNetMANAGEMENT SYSTEM
The IQNet RECOGNIZED CERTIFICATION mark guarantees that an organization complies with international standards of quality and management. This recognition facilitates confidence and competitiveness in the global market
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