ISO13485:2016 standard text

ISO13485 standard

Quality management system in medical equipment

The ISO13485 standard is focused on a quality management system in the design, development, production, assembly, after-sales service and distribution of all types of medical equipment, which helps business owners to receive the CE mark or GMP standard and promote their business in the markets. expand internationally.

Considering the importance of quality management systems and the specialization of standards in various industries, especially the medical industry, which is of particular importance in relation to the health and preservation of human life, the ISO 13485 standard is extremely important.

The requirements of ISO 13485 2016 edition are applicable to organizations regardless of their size and regardless of their type, except where expressly stated.

The main objective of ISO 13485 is to facilitate the harmonized regulatory requirements of medical devices for quality management systems. This standard is an independent standard.

This standard has many overlaps with the ISO 9001 standard, but organizations that have obtained the ISO 13485 certificate cannot claim compliance with the ISO 9001 standard.

The new edition of this standard is related to 2016 and the shortcomings of the previous edition have been resolved in this version of the standard.

The new edition states that processes should be considered to control changes and evaluate the importance and impact of these cases. It requires that a file be kept for each medical device or group of medical devices in which these changes are documented.

The ISO13485 standard has numerous advantages for organizations, which are mentioned below:

Improving the image and reputation of the organization.

Increasing customer trust and satisfaction.

Creating a culture of continuous improvement in the organization.

Using evidence-based decision making and…