Hi, Folks
Our company has TUV surveillance audit last Dec. 2005.
And our company has good results officially (No NCR, major even minor).
But I'm still dissatisfying my effort of current QMS. Our registration was made Dec.2004 and our company is 'still young' medical device manufacturer.
I worked 7 years this medical fields, (I knew what we have to do, .. but I couldn't sustain for surrounding circumstances of situation, EWB [Extended Work Bench] from mother company) but current company does not cover or handle properly 'Risk Management' well. That is TUV lead auditors comment to me, similar to personally (like a food for thought).
I would recommend all of medical device manufacturers & quality folks in that field as following.
Clever and wise speculating on What ISO 13485;2003 title says,
Quality Management System Particulated in Medical Device Requirement for Regulatory Purpose
it means, manufacturer demonstrate his products 1.Safety 2.Stability 3.Functionality at least.
For do that, Process/Product should be verified or validated .. must be choose one from two. (if you are interesting on this, please visit FDA web-site, and seek 'Warning Letter', lots of sample for validation fail,...)
Another significant subject is 'Risk' concept. Recall what ISO 13485 title says. We are facing to Government Agency (FDA, KFDA, ...) or equivalent authority (ex. MDD) for product Safety, Stability and Functionality.
Risk concept is similar concept for PL (Product Liability) law. PL preparation should cover following 3 big basical errors, 1. Manufacturing Error / 2. Design Error / 3. Labeling Error
and most QMS should worry about and try to (especially, medical device fileds)
1. Prevent recurrence of improper (Bad) output (already happened and cared as CAPA)
2. Reduce 'Risk'. (PLwise - Safety) (Risk is base on 'Probability' (=Frequency) and 'Severity', those compounding could be measured as RPN-Risk Priority Number and should be Reduced before launching product into market))
That's it. Any comment..? Feel free..