What is EN ISO 13845:2018

The medical device industry plays a crucial role in ensuring the health and well-being of individuals worldwide. Quality management systems are imperative for the manufacturing, testing, and distribution of these devices. One of the most essential standards in this regard is EN ISO 13845:2018.

Understanding EN ISO 13845:2018

EN ISO 13845:2018 is an international standard specifically designed for medical device manufacturers. It provides guidelines for the establishment, implementation, and maintenance of a quality management system specific to the medical device industry. This standard aims to ensure that medical devices consistently meet regulatory requirements and meet the needs of patients and healthcare professionals.

Key Requirements of EN ISO 13845:2018

EN ISO 13845:2018 encompasses various key requirements, including:

Management Responsibility: The standard emphasizes the importance of top management commitment to quality and the development of a quality policy.

Resource Management: It mandates the allocation of necessary resources, such as personnel, infrastructure, and facilities, to ensure effective quality management.

Product Realization: This section focuses on design and development processes, purchasing, production, and service activities related to medical devices.

Measurement, Analysis, and Improvement: EN ISO 13845:2018 emphasizes the need for monitoring, measurement, and analysis of processes, product characteristics, and customer satisfaction. Continuous improvement is also highlighted.

Benefits of Implementing EN ISO 13845:2018

Implementing EN ISO 13845:2018 brings several benefits to medical device manufacturers:

Enhanced Customer Satisfaction: By complying with this standard, manufacturers can consistently meet customer requirements and enhance satisfaction.

Improved Regulatory Compliance: EN ISO 13845:2018 ensures that manufacturers fulfill regulatory obligations, reducing the risk of non-compliance penalties and product recalls.

Efficient Processes: The standard promotes effective management practices, leading to streamlined processes, reduced errors, and optimized resource allocation.

Global Market Access: Compliance with EN ISO 13845:2018 demonstrates a commitment to quality, facilitating market access in various countries that recognize this standard.

In conclusion, EN ISO 13845:2018 is an essential standard for the medical device industry. It provides guidance on implementing a quality management system tailored specifically to this sector, resulting in improved customer satisfaction, regulatory compliance, and operational efficiency for manufacturers.