What is the difference between EN iso and ISO 13485 ?

Title: Understanding the Differences between ISO and EN ISO 13485 for Medical Device Quality Management

Introduction:

Quality management systems (QMS) are essential for ensuring the safety and effectiveness of medical devices. Two widely recognized standards for QMS are ISO 13485 and EN ISO 1348These standards have similar objectives, but there are significant differences in their scope, application, and certification requirements. In this article, we will explore the key differences between ISO and EN ISO 13485 and provide a better understanding of these two important standards.

Differences in Scope

ISO 13485 is a global standard that outlines the requirements for a QMS. It is specifically designed for medical devices, including prosthetic devices, cardiovascular devices, and medical devices used in orthopedic, ENT, and neurostimulation applications. ISO 13485 provides guidance for the development, implementation, and continuous improvement of a QMS.

On the other hand, EN ISO 13485 is a European standard that outlines the requirements for a QMS in the medical device industry. It is based on ISO 13485 and provides guidance for the implementation of ISO 13485 in the European Union. EN ISO 13485 is designed to ensure that medical device manufacturers can demonstrate that their QMS meets the requirements of ISO 13485 and relevant regulations.

Differences in Application

ISO 13485 is intended for manufacturers of medical devices that are subject to one or more of the following requirements:

* The final product must be CE marked.

* The final product must be performed in accordance with a medical device Directive (MD) or a related regulation (R1).

* The final product must be performed in accordance with a quality management system (QMS) that meets the requirements of ISO 13485.

In contrast, EN ISO 13485 is intended for manufacturers of medical devices that are subject to the requirements of ISO 1348EN ISO 13485 is not intended for use as a prerequisite for the achievement of the requirements of other standards.

Differences in Certification Requirements

ISO 13485 and EN ISO 13485 both require manufacturers to demonstrate that their QMS meets the requirements of the standard. However, there are some differences in the certification requirements between the two standards.

ISO 13485 requires manufacturers to demonstrate that they have implemented a QMS that meets the requirements of the standard. They must also provide evidence that their QMS is regularly reviewed and updated to ensure that it remains effective.

EN ISO 13485 requires manufacturers to demonstrate that they have implemented a QMS that meets the requirements of the standard. They must also provide evidence that their QMS is regularly reviewed and updated to ensure that it remains effective.

Conclusion:

ISO and EN ISO 13485 are both important standards for ensuring the safety and effectiveness of medical devices. While both standards have similar objectives, there are significant differences in their scope, application, and certification requirements. ISO 13485 is intended for manufacturers of medical devices that are subject to one or more of the requirements of a medical device directive (MD) or related regulation. EN ISO 13485 is intended for manufacturers of medical devices that are subject to the requirements of ISO 13485 and relevant regulations in the European Union.

FAQs:

QWhat is the difference between ISO and EN ISO 13485?

AISO 13485 is a global standard that outlines the requirements for a QMS, specifically designed for medical devices. EN ISO 13485 is a European standard that outlines the requirements for a QMS in.