1. Robust Quality Management System
Any high end precision machine shop should have a Quality Management System constructed to meet business and customer needs. This is especially true for machine shops that provide parts for the Medical industry. The system in place for medical devices must identify the processes as well as control process performance. Furthermore the effectiveness must be monitored and maintained to ensure process control. Remember, the QSR and the CFR 21 are no walk in the park, and ISO13485 helps to address many of the compliance issues in these regulations. This is no easy task. The entire enterprise must have a culture that supports it.
The Medical industry is a high tech industry that lends itself to using new technologies in a very advantageous manner. The use of multi-axis machinery is especially helpful in reducing setup times for complex parts. Stainless steel is a major component in many medical devices and shops with the technology to efficiently and effectively process it are in high demand. Many complex medical devices, such as blood analyzing instrumentation, X-ray and CT scanning units require low-volume and high complexity component parts. Certified ISO13485 machine shops that are set up for this kind of work are rare but very valuable to the OEMs that utilize them. Clean room assembly and packaging is another asset to OEMs looking for a reliable manufacturer to make their parts.
3. Senior Management Support
Creating a viable ISO13485 environment in a precision machine shop is no simple task. Senior management teams must be willing to groom the culture of the organization and dedicate the resources it takes to incorporate such a system. The discipline to develop, manage and maintain the entire system has to be carried from the top down to the bottom. A successful shop will have a senior management team that has full buy-in to the methodology and a team of dedicated employees to help carry out the program.
A Robust Quality Management System, a wide range of capabilities, senior management support and a competent staff are 4 key aspects of a great ISO13485 machine shop. Medical manufacturing is here to stay and having a supply base full of highly qualified vendors is a great way for OEMs to get compliant parts on time. This will help profitability, time to market and quality in the long term. For more information, download our medical contract manufacturing guide by filling out the form below.