ISO 13485:2016 (QUALITY MANAGEMENT SYSTEM FOR MEDICAL COMPANY)

 

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

The processes required by ISO 13485:2016 that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization’s quality management system by monitoring, maintaining, and controlling the processes.

One of the major requirements to prove conformity is the implementation of the Quality Management System according ISO 13485 Although the European Union Directives do not mandate certification to ISO 9001 and/or ISO 13485 the preferred method to prove compliance to such standards is to seek its official certification which is issued by certifying organizations known as “Registrars”.

Several registrars also act as NOTIFIED BODY IN EUROPE.requiring the market involvement of a Notified Body. Hence, The very careful assessment of the company Quality Management System by the Notified Body, together with the review of the required Technical Documentation, is a major element which the Notified Body takes into account to issue the certificate of conformity to the company product.

 

ISO 13485:2016 in Delhi. ISO 13485:2016 in Mumbai.

Consultants in Delhi FOR 13485:2016.

Consultants in Mumbai FOR 13485:2016

ISO 13485 for Medical Companies.

 

 

Advantages
  • The 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;
  • The 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 the production procedure stability and the steady.