Challenge: A small manufacturer of bar coding equipment wanted to move into the medical device industry but did not have a quality management system that met the Food and Drug Administration's good manufacturing practices, 21 CFR 820.

Outcome: A quality management system based on the ISO 13485, Medical Device Requirements was implemented in ten months. Forty Six procedures were created to document the system and provide the necessary controls to ensure medical device quality, safety, and effectiveness.

The Process
Gap Analysis: The ISO 13485, Medical Devices- Quality management systems- Requirements for regulatory purposes and the 21 CFR Part 820, Food and Drug Administration Code of Federal Regulations, Quality System Regulation was used to create a gap analysis to the current state.

Prioritization: The procedures were then prioritized based on criticality to the customer. The manufacturing processes were selected as the starting point as they are critical to product quality. The processes were observed, mapped and documented as work instructions- including pictures and appropriate detail to match the skills and competency of the current workforce.

Schedule: Approximately five procedures were documented and approved each month. The limiting factor is the amount of time that the company can spend on creating the system in addition to their day to day activities. Some critical requirements required new procedures to be created. Processes like traceability, documentation, metrics and non-conformance tracking were implemented.

After all the procedures, forms and records were created, internal audits were conducted to ensure all requirements were met.

Results:
Audits from customers and third party regulatory firms were conducted and the company certified to the requirements. A prime customer agreed to expand their business both locally and in Europe as a result. Additional sales from new products were realized in this new market.