ISO 13485 Document Procedures

ISO 13485 is often compared to ISO 9001 and is a type of quality standard. It is an international standard that has to do with the quality management system for medical devices. This is a standard that meets the requirements of the regulatory effect and ensure that medical devices are manufactured in a correct manner and are out of good quality.

ISO 13485:2003 specifies requirements of 15 additional documented ISO 13485 procedures as listed bellow for use in the planning, operation, control and monitoring:

• Procedures for Maintaining facilities and equipment that affect the quality of medical devices.
• Procedure for Managing risk in the realization of medical devices (including their distribution, installation and servicing).
• Procedure for Designing and developing medical devices and associated installation, maintenance and disposal or recycling information.
• Procedure for Purchasing goods and services for the design, manufacture and distribution of medical devices.
• Procedure for validating the use of computer software.
• Procedure for validating sterilization processes.
• Procedure for Identifying and controlling medical devices according to their status.
• Procedure for maintaining the traceability of medical devices and their components.
• Procedure for Preserving medical devices and constituent parts.
• Procedure for controlling products requiring special storage conditions.
• Procedure for Using and calibrating monitoring and measuring equipment for manufacture, installation, use and servicing of medical devices.
• Procedure for Gathering and using medical device customer feedback.
• Procedure for Inspecting and testing medical devices and their components.
• Procedure for Determining, collecting and analyzing medical device QMS data.
• Procedure for Issuing and implementing Advisory Notices.