![what is iso 13485 certification what is iso 13485 certification](https://www.praxiom.com/iso-13485-overview-graphic.jpg)
Moreover, at the beginning of 2017, ISO 13485 implementation into. Enhancing trust of public and public monitoring bodies in respect of the medical devices manufacturer. In 2016, Biomapas was re-certified according to the newest ISO 9001 standard version.Optimization of costs reduction of operating costs, reduction of nonconforming products costs, raw materials, energy and other resources savings,.Attestation of efficiency and effectiveness of the established quality management system by an independent third party.Simplifying the process of attestation of conformity to requirements of EU directives and corresponding Government Orders.Guarantee of production process stability and thus steady and high quality of services and products supplied to customers.Decision on withdrawal of the certificate in case of fundamental deviations from requirements of standards.
![what is iso 13485 certification what is iso 13485 certification](https://antigon.eu/wp-content/uploads/2020/12/ISO-13485.jpg)
#What is iso 13485 certification verification#
Audit: verification of facts in the following stages:.Agreement for conducting a certification audit (Note: the certification audit is conducted in two stages).The certification process consists of 3 basic phases:ģ) Certification by an accredited certification body The standard contains the requirement for quality management systems, to meet customer requirement and incorporate applicable regulatory requirements within an organization’s quality management system. We examine your quality management practices for medical devices. ISO 13485 is applicable to designers, manufacturers, and distributors of medical devices. EN ISO 13485 is the international standard for quality management systems for medical devices. ISO 13485 is Quality Management System for Medical Devices.