Hello Everyone

I am a new registered user, and I am seeking input.

I recently started a new job, for a medical company,and abruptly determined that an upgrade to 13485-2003, is required, yesterday.
Therefore I am seeking any documentation ( Quality Manual & Procedures ), to assist in my continued employment.

Regards'
Jim L.

When you say "upgrade" - it implies company is currently registered under the previous version. Is this true? Who is still with the company from when they got this registration?

If company has never been registered to ANY Standard, then "upgrade" will throw the professionals here off the track.

Do you have a copy of the most recent version of the Standatd? If not, do you know how to get it?

We need a lot more information to help you.

Company previously registered to 13488-1996.
No previous staff left.

Company previously registered to 13488-1996.
No previous staff left.

So since the last audit the company has had a complete turn over??? What documentation do they have in place now they have to have something if they were registered to 13485:96. Start by doing a gap analysis of the current documentation to the 13485:2003 standard.

Currently to 13488-1996.

Thank You for your in-put.
Jim

Welcome to the Cove, Jim.

First off, try this link (http://elsmar.com/Forums/showthread.php?t=11610&highlight=13488) and pay particular attention Post#3, please. I am not an expert on this standard, but if I am reading it correctly 13488 was phased out and replaced by 13485. So, it sounds like your company is doing an upgrade of sorts...more of a transition to 13485.

So, step 1...get a copy of 13485.

Step 2 : Take a course on it, if you are unfamiliar with the standard and its requirements.

Step 3 : Figure out what your company already has...aka gap analysis.

Step 4 : Develop a plan to address the gaps.

Step 5 : Go for registration.

Step 6 : Celebrate your success!

Ahhh...registration in 6 "easy" steps. Hope that helps.