ISO 13485:2003 Certification
Custom Wire technologies, Inc. is ISO 13485:2003 certified. The scope of this certification registration covers the requirements for a quality management system (QMS) “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”.
ISO 13485:2003 Quality Management Requirements
Below are the main highlights of the ISO requirements for a certified medical device manufacturer’s QMS:
- Establish Quality Management System (QMS) for Medical Devices
Identify and describe the quality management processes in your QMS. Implement and control the processes and their performance. Monitor and maintain these processes.
- Document Your Medical Device QMS
Document your QMS implementation procedures, including files for each model or type of medical device and related services. Prepare a QMS Manual that details the procedures, how your processes interact, and the scope of your quality system. Describe how your documentation is organized and list any exclusions with full justification for reduction in scope.
- Control and Maintain QMS Records
Review and approve every document. Distribute approved, current version of documents to production points where used. Collect and retain obsolete documents that are pulled from use. Ensure only current, approved revisions are in use. Use QMS records to prove requirements have been met. Retain records related to medical denices and develop a procedure to control and ensure usability of your medical device records.
The ISO 13485 Certification is based on the ISO 9001 process model approach and is becoming widely accepted as the international standard to address medical device requirements around the world. When an organization is certified, the accredited certification board confirms that the organization’s QMS satisfactorily meets the requirements of the standard. Read more about ISO certification.
Our ISO 13485 Certification demonstrates to our customers that we maintain, monitor and implement documentation records on all Quality Management processes. View Custom Wire Tech’s ISO 13485:2003 Certification (PDF)