Setting up a Quality system - No medical device experience - Where to start

[qualityneel]

hi , i am a student doing internship in etherlands in new staring company ... i have no experience in QA/RA
now my job is to Set up a quality management system .. now we r zero .. whole i have to do .. i joined the company yesterday .. now on monday i have to tell my boss how to proceed to set up a quality management system based on GMP and ISO 13485 . i have just theory knowledge of ISO 13485

please guide me how should i proceed to set up the system .
what r the steps to set up the qulaity management system ..

 

[gard2372]

Welcome to the Cove!

You have quite the situation to get adjusted to. Look at this thread for starters as many others have been in your situation before.

http://elsmar.com/Forums/showthread.php?t=14013

 

[Caster]

Delegate and disappear!

hi , i am a student doing internship in etherlands in new staring company ... i have no experience in QA/RA

now my job is to Set up a quality management system .. now we r zero .. whole i have to do .. i joined the company yesterday .. now on monday i have to tell my boss how to proceed to set up a quality management system based on GMP and ISO 13485 . i have just theory knowledge of ISO 13485 please guide me how should i proceed to set up the system .
what r the steps to set up the qulaity management system ..

Wow, this may be an actual record, ISO delegated all the way down to the intern!

No doubt you will soon discover that this so called "quality management system" is just a subset of the business management system.

How in the World do they expect you to accomplish their job?

I suggest setting up a steering commmitte, getting awareness training for everyone, then doing a gap assessment. (search here for these topics)

Keep reading here, many have been in your position.

 

[Walker]

Well, you first must have an understanding of What does quality mean to the big guy/head honcho? From there then read and interpret the requirements per 13485. There are guides out there, but since you've never been in Quality this could be a biggie for ya. Good Luck!

 

[amjadrana]

ISO 13485 implementation

A good start is to get ISO 13485:2003 standard along with ISO/TR 14969:2004 Guidance on the application of ISO 13485:2003 and determine what procedures do you additionally need to write up. Your company will certainly have some procedures already in place. Some procedures or information is available on the forum.

Amjad Rana

 

[Statistical Steven]

A good start is to get ISO 13485:2003 standard along with ISO/TR 14969:2004 Guidance on the application of ISO 13485:2003 and determine what procedures do you additionally need to write up. Your company will certainly have some procedures already in place. Some procedures or information is available on the forum.

Amjad Rana

Recommend they hire a consultant. You can create a quality manual that encompasses the QSR and 13485:2003, but to create all the systems required is NOT a 1 person job.

 

[Al Rosen]

You can create a quality manual that encompasses the QSR and 13485:2003, but to create all the systems required is NOT a 1 person job.

Especially for someone who has no experience!