ISO certification

Since September 2003, Stryker Imaging's Quality Management System has been assessed and registered by Intertek Testing Services NA Ltd. as conforming to the requirements of the ISO 13485:2003 standards.

ISO certification requires an organization to adhere to extremely well defined international quality performance standards to "enhance customer satisfaction" by meeting the customer needs and adhering to the applicable FDA medical device regulatory requirements. The overall objective of ISO standards and the certification process is to demonstrate and provide continual product performance improvement with regard to the functionality of the product and assuring maximum customer satisfaction based on adherence to international quality performance standards.

What is ISO?
ISO is a network of the national standards institutes of 147 countries, on the basis of one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system.

ISO is a non-governmental organization: its members are not, as is the case in the United Nations system, delegations of national governments. Nevertheless, ISO occupies a special position between the public and private sectors. This is because, on the one hand, many of its member institutes are part of the governmental structure of their countries, or are mandated by their government. On the other hand, other members have their roots uniquely in the private sector, having been set up by national partnerships of industry associations.

Therefore, ISO is able to act as a bridging organization in which a consensus can be reached on solutions that meet both the requirements of business and the broader needs of society, such as the needs of stakeholder groups like consumers and users.

Importance of being ISO certified
For businesses, the widespread adoption of International Standards means that suppliers can base the development of their products and services on specifications that have wide acceptance in their sectors. This, in turn, means that businesses using International Standards are increasingly free to compete in more markets around the world.

Source: International Organization for Standardization