ISO 13485: 2012 is an international standard that represents the needs for a comprehensive quality management system for the design and manufacture of medical devices. Though it is tailored to the industry’s quality system expectations and regulatory necessities, an organization does not require being actively manufacturing medical devices or their components to look for certification to this standard. ISO 13485: 2012 applies to the design, development, production, installation and servicing of medical devices. Compliance is a measure of your ability to meet customer and legal needs.
ISO 13485 is based on the ISO 9001:2008 procedure model approach and is a management systems standard specifically developed for the manufacture of medical devices. Its primary objective is to facilitate harmonized medical device regulatory needs.
The EN ISO 13485:2012 certification was awarded by the International Organization for Standardization, the world’s largest developer and publisher of worldwide quality and safety standards. This certification outlines specific needs to establish and execute a structured quality management system for medical devices across all areas, from development to deliver.
Benefits of ISO 13485 Certificate
- Optimization of costs – reduction of operating costs, decrease of nonconforming products costs, raw materials, energy and other resources savings,
- Simplifying the procedure of attestation of conformity to needs of EU directives and corresponding Government Orders;
- Improving trust of public and public monitoring bodies in respect of the medical devices manufacturer.
- Attestation of efficiency and helpfulness of the established quality management system by an self-governing third party;
- Guarantee of production procedure stability and thus steady and high quality of services and products supplied to clientele;