• ISO 13485:2016 defines requirements for a quality management system when an organisation needs to ability to provide medical devices and demonstrate its related services that frequently meet customer and applicable regulatory requirements.
ISO 13485 is based on the ISO 9000 family of standards but addresses specifically the needs of the medical device industry. It can be used by any organisation that has anything to do with the design , manufacture , provision for support of medical devices in any of the stages of its life cycle.
• ISO 13485: 2016 , applicable on a voluntary base , was designed in particular for medical device manufacturers.
It is the main Quality Management System standard for medical devices although several countries have their own set of regulations. Moreover , if you get certified to 13485 that means an organisation has implemented ISO 13485 Quality Management System and has successfully met all the requirements in ISO 13485.
• ISO 13485 assess whether your quality management system is appropriate and productive while highlighting the safety and effectiveness of medical devices. Medical device is a product , such as an instrument , that is intended for use in the diagnosis , prevention and treatment of diseases or other medical conditions. It is always expected from the organisations in the industry to signify their quality management processes and insured best practice in everything they do.
Benefits of ISO 13485 Certification.
1. Guarantees high quality of provided services and products
2. Reduces production loss rate
3. Increases your customer’s trust in you as a safe supplier or producer
4. Reduces operational cost
5. Increases effectiveness across the whole organisation.
• ISO 13485 standard provides globally valid guarantee over your products and helps the company attract lot of contracts. The certification is to ensure the quality management system of medical devices and present customer that the business follow International standard for improving and maintaining product quality. ISO 13485 certification is ensuring the safety of medical devices and indicates customer satisfaction through timely delivery of products.