Supply chain quality challenges in low volume manufacturing for medical device manufacturers include analysis of the data measuring supplier performance in relation to product risk. Under ISO 13485:2016, section 7.4, purchasing has a higher profile and more stringent requirements for documented purchasing process and supplier management.
When most people think of Lean Manufacturing, they think of large, gleaming, gazillion square foot manufacturing spaces where every surface is clean, meticulously labelled and taped off. Happy workers reach for their conveniently placed tools on their shadow boards and work on mistake-proof assembly stations. They think of Toyota, or Boeing, or any manner of […]
As a medical product moves through development to production stage, establishing supply chain controls to ensure reliable suppliers is critical to satisfy regulatory requirements for your device. ISO 13485:2016 has specific language around supplier controls that needs to be addressed in your QMS. It includes the additional requirements of supplier performance evaluation and controls appropriate […]