ISO 13485 Quality Certification

ISO is the acronym for International Organization for Standardization. ISO is a network of the national standards institutes of 157 countries, on the basis of one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system. Because "International Organization for Standardization" would have different abbreviations in different languages ("IOS" in English, "OIN" in French for Organisation internationale de normalisation), it was decided at the outset to use a word derived from the Greek isos, meaning "equal". Therefore, whatever the country, whatever the language, the short form of the organization's name is always ISO.

International standardization began in the electrotechnical field: the International Electrotechnical Commission (IEC) was established in 1906. Pioneering work in other fields was carried out by the International Federation of the National Standardizing Associations (ISA), which was set up in 1926. The emphasis within ISA was laid heavily on mechanical engineering. ISA's activities came to an end in 1942. In 1946, delegates from 25 countries met in London and decided to create a new international organization, of which the object would be "to facilitate the international coordination and unification of industrial standards". The new organization, ISO, officially began operations on 23 February 1947.

Between 1947 and the present day, ISO published more than 16 000 International Standards. More than half a million organizations in more than 149 countries are implementing ISO 9000 which provides a framework for quality management throughout the processes of producing and delivering products and services for the customer.

ISO 9000 is concerned with "quality management". This means what the organization does to enhance customer satisfaction by meeting customer and applicable regulatory requirements and continually to improve its performance in this regard. Our lab complete registration in ISO 9001 in 1997.

ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.

We are proud to announce are registration for ISO 13485:2003 and click to see our certificate.