JoCam
Trusted Information Resource
Hi All,
I work for a Medical Device Company in the final stages of designing our first product. I have implemented a Quality Management System to ISO 13485, which is biased towards our upcoming manufacturing, distribution and Customer feedback processes due to 2 reasons. Firstly, the Research & Development team were far too busy to change their processes and document tasks accordingly, and secondly I am by no means a design expert, and only went so far as ensuring all relevant top level documents are in place. The result was successful, as we received certification back last June.
Although quite a few Employees utilise the QMS, a vast majority (mainly the design team) avoid it like the plague, and it has recently dawned on me that this may be due to the fact that they cannot see how it benefits them. This is where I need your help: -
What areas of the Design function can I concentrate on (and how) that doesn't produce too much additional paperwork or slow the process down, but does provide visible benefits of the QMS to the design team?
Areas that are already effectively controlled via the QMS, with input from the design engineers, are drawings, specifications and design changes.
Thank you in advance, your ideas will be very much appreciated.
Jo
I work for a Medical Device Company in the final stages of designing our first product. I have implemented a Quality Management System to ISO 13485, which is biased towards our upcoming manufacturing, distribution and Customer feedback processes due to 2 reasons. Firstly, the Research & Development team were far too busy to change their processes and document tasks accordingly, and secondly I am by no means a design expert, and only went so far as ensuring all relevant top level documents are in place. The result was successful, as we received certification back last June.
Although quite a few Employees utilise the QMS, a vast majority (mainly the design team) avoid it like the plague, and it has recently dawned on me that this may be due to the fact that they cannot see how it benefits them. This is where I need your help: -
What areas of the Design function can I concentrate on (and how) that doesn't produce too much additional paperwork or slow the process down, but does provide visible benefits of the QMS to the design team?
Areas that are already effectively controlled via the QMS, with input from the design engineers, are drawings, specifications and design changes.
Thank you in advance, your ideas will be very much appreciated.
Jo