What is EN ISO 13485:2015?

Introduction

EN ISO 13485:2015 is an internationally recognized standard that outlines the requirements for a quality management system specifically designed for medical devices. This article aims to provide a simplified explanation of the key concepts and objectives of this standard.

The Purpose of EN ISO 13485:2015

The primary purpose of EN ISO 13485:2015 is to facilitate harmonization in the medical device industry by establishing a globally accepted framework for quality management systems. Adherence to this standard helps organizations demonstrate their commitment to consistently meeting customer and regulatory requirements. It provides the foundation for legal compliance and enhances patient safety.

Key Requirements of EN ISO 13485:2015

EN ISO 13485:2015 sets out several key requirements that organizations must fulfill to achieve certification. These include:

Establishing a robust quality management system (QMS) that focuses on risk management and product lifecycle processes.

Implementing processes for design and development, as well as product realization, including purchasing, production, and service provision.

Ensuring strict control over the monitoring and measurement of products, as well as implementing an effective process for complaint handling and post-market surveillance.

Continuous improvement through the establishment of objectives, conducting internal audits, and taking corrective actions when necessary.

Benefits of EN ISO 13485:2015 Certification

Obtaining EN ISO 13485:2015 certification offers several advantages for medical device manufacturers and suppliers. Firstly, it improves overall efficiency and effectiveness by streamlining processes and reducing waste. Secondly, it enhances the reputation and credibility of the organization, signaling to customers, regulators, and stakeholders that the company is committed to delivering safe and high-quality products. Additionally, certification can open doors to new markets and facilitate international trade by demonstrating compliance with globally recognized standards.