Case Study #5

ISO 13485 CERTIFICATION PREPARATION

Neozene was approached by a component manufacturer that supplies to the medical device industry. They were preparing for their first supplier audit from their biggest client and needed to establish a robust Quality Managment System and provide training to personnel that were unfamiliar with the regulations of the medical device industry. They approached us asking for a Quality expert to generate and implement a new ISO 13485-compliant Quality Managment System.

Busienss Challenge: The company had little knowledge of the regulations for the medical device industry and had grown significantly in a very short time. Because of this they had only a couple of SOPs in place and no formal Quality System. They were under a very tight deadline to prepare for a key supplier audit from their biggest customer and were not sure of what was needed to pass this audit and achieve ISO certification.

Proposed Solution: Neozene provided experienced Senior-level Quality consultants to determine what processes were needed. Our consultants performed a Gap Assessment and determined that SOPs and the Quality System basically needed to be built from scratch since very little currently existed and what did exist needed significant modification. The following steps were proposed:

• Create a project plan to prioritize the most critical SOPs for the supplier audit and put the Quality System in place to achieve ISO certification
• Create and implement a training program to bring this facility which was not familiar with FDA and ISO regulation into compliance and have everyone understand why these changes were needed
• Define and build a Quality Department and determine key roles needed to maintain the systems and procedures once in place

Results/Value Delivered: The company agreed with the proposed solution and plan presented by Neozene and engaged us on the project. The plan was implemented over 4 months and provided the company with a solid foundation for their Quality Systems and clarity on their procedures. Neozene was also able to help them determine the appropriate Quality Department structure for the company’s size, current, and future needs. Neozene worked with the company to find the resources needed and converted one of our consultants into the company’s first Quality Manager to lead the transition for them.

The company also asked Neozene to evaluate their Manufacturing and Operations departments for possible improvements. Upon completion of this evaluation Neozene made a recommendation to add a resource that would help increase work flow efficiency and also help establish a culture of Quality in the company.