Starting 1 July 2019, companies applying for a new or renewal of Korea Good Manufacturing Practice (KGMP) certification will be subject to a few new requirements. Still, this does not have to be a cause for worry.
With Design and Development (D&D) being a core process of your business, having a clear D&D work structure is important. The structure your Quality Management System provides helps with maintaining systematic business practices for maximum efficiency. Here are 5 items to be set in place at the start of your D&D work structure.
Many companies recognise that it is important and beneficial to set up a Quality Management System (QMS) while still early in product development stage, but still find it a challenge to decide when to put in place a QMS. Most often, a good gauge would be when business operations have moved from Research & Development (R&D) stage to Design & Development (D&D). But what defines that transition?
It is clear that having a Quality Management System that meets ISO 13485 standards brings many benefits. However, it is not as easy as it sounds. We spoke with Mr. Encey Yao, the Management Representative at Qritive Pte. Ltd., a medical device software company that recently completed its certification for ISO 13485:2016. He shared with us some insights to challenges faced, that would be shared by similar software companies.