Because of our commitment to provide the very highest quality products and service, LSL has achieved the ISO 13485 with CMDCAS accreditation
The ISO 13485 standard is specifically written for medical device manufacturers while the broader ISO 9001 quality management standard is sought after by any firm committed to quality. The designations are earned from TUV Rheinland, a leading international standard, testing, registration and certification organization.
What is ISO?
The International Organization for Standardization (ISO) is a worldwide federation of national standards bodies from over 150 countries. The purpose of ISO is to promote the development of standardization and related world activities to facilitate the international exchange of goods and services, and to develop cooperation in intellectual, scientific, technological, and economic activity.
The American National Standards Institute (ANSI) represents the United States in ISO. It is a private, non-profit membership organization composed of public and private sector organizations and was a founding member of ISO. ANSI does not develop American national standards but facilitates their development by establishing consensus among qualified groups.
Why be ISO certified?
While no organization must be ISO 13485 certified, it has become a standard for conducting business in the international arena. In fact, ISO 13485 is the only quality system accepted internationally. Many companies in the European community have become ISO certified and many are requiring their suppliers to prove they have a quality system, such as ISO, in place as a condition of purchase. To keep this certification, a company must maintain this commitment and incorporate a process of continual improvement and satisfaction.