IDC is committed to providing innovative high quality products and services that consistently meet and exceed the expectations of our customers.
IDC is registered to the following ISO Standards:
ISO 9001:2008 - An international family of specifications and standards for quality assurance management systems involving a third party for inspection and registration.
ISO 9000 is a generic name given to a family of standards developed to provide a framework around which a quality management system can effectively be based.
IDC has been an ISO 9001:2000 registered member since November 2003 and was certified by a Notified Body, BSI.
ISO 9001:2000 is recognized and accepted worldwide.
ISO 13485:2003 is an ISO Standard specifically written for Medical Device Manufacturers. This standard includes the design, development, and manufacturer of medical devices and is a good base model for compliance with the CE marking Medical Devices Directive Annex II, the FDA QSR, and Health Canada CMDCAS (class III & IV devices) requirements.
ISO 13485 is recognized and accepted worldwide; IDC has been registered to this standard since November, 2003.
In addition to the ISO 9001 and 13485 registrations, IDC also holds CE Certificate No. 0086. CE marking is often referred to as a 'passport' that allows manufacturers from anywhere in the world to sell their goods throughout the European market. The letters 'CE' are an abbreviation for Conformité Européenne, French for European Conformity. The letters 'CE' on a product are the manufacturer's claim that the product meets the requirements of all relevant European Directives.
CE marking on a product also:
Office of Statewide Health, Planning and Development (OSHPD)
Aside from other regulatory requirements, IDC's X-Series 1600 and 1600 Plus were granted OSHPD (Office of Statewide Health, Planning and Development) Pre-Approval of Anchorage for Fixed Hospital Equipment in the State of California.
QVIS is an on-line documentation system used by IDC to manage its internal Quality Management System. It is specifically designed to help the employees understand, visualize, measure, and manage the processes in order to deliver superior performance against the highest international standards.
Should you have any questions in regard to IDC's quality policies, please contact us at: