ISO 13485:2003 + AC 2007

Quality Management System for Medical Devices

haha.. far from getting one man..

not even a good quality policy in place.. no quality manual.. with knowledge of only 50% of PDCA.. OMG! how to be certified that way?

when the course is obviously meant for the management's attention and yet the management is oblivious to the clearly stated requirements and standards.. in fact i recall the Top Management saying "i employ ppl.. they shld be able to manage themselves.. why shld i need to manage them?" LOL.. joke

wad can the employees do?

watch and see lo.. we asked and we sought already.. within our capabilities and authority.. we did wad we can.. but the whole problem lies with the management seriously.. i wonder if they realized the gravity of the situation.. yet?

haha.. actually i tink the management seem to be feel like they are doing a darn good job..

putting a project manager to handle every single matter with product development without the slightest clue on the proper methods.. not even to mention background knowledge..

then put a son (NUS year 1 engineering student wor..) to be project assistant!!!??? another joke..

best of all.. the Top Management pointed finger at the minion employees.. saying that "you all have got a lot to do now" LOL.. no we dun.. we have been doing our jobs.. within and beyond our jobscope.. it is the management that's not doing any.. madness man.. wad a joke!

in term of resource management.. they suck.. LOL

and idealistically.. they can leap over clouds and sing with the cows of coz..

continue to live in ur own world man.. we're back down here on earth.. doing our thang.. the right way..

sooner or later.. they can go play with lego.. build ur empire and castles.. continue to hope that one fine day.. everything will fall in place.. with u lifting a finger..

hopeless*