I work for a small medical manufacturer and we need to become ISO 13485 compliant in short order. Are there any easy to understand (free to low cost) step-by-step implementation resources available?

I work for a small medical manufacturer and we need to become ISO 13485 compliant in short order. Are there any easy to understand (free to low cost) step-by-step implementation resources available?

Hello Jazzbo,

Welcome to The Cove Forums! :bigwave: :bigwave:

To get started, you may want to do a search here.
Use the search function, and you'll find a lot of good information.

To help you, I did an advanced search for you on: "Implementing ISO 13485 (http://www.google.com/custom?hl=en&client=pub-1385417534940691&channel=6124086287&cof=FORID:1%3BGL:1%3BS:http://Elsmar.com/Forums/%3BL:http://elsmar.com/png/header-G-search.png%3BLH:50%3BLW:350%3BLBGC:000099%3BT:%230000ff%3BLC:%23000000%3BVLC:%23663399%3BDIV:%23336699%3B&domains=Elsmar.com&sitesearch=Elsmar.com&oe=ISO-8859-1&q=Implementing++ISO+13485&start=20&sa=N)."

Hope this helps.

Stijloor.

Step 1: get the standard (http://www.iso.org/iso/catalogue_detail?csnumber=36786)

Step 2: understand the standard

Step 3: write your procedures to implement 13485 according to how you do business.

That's a bit of oversimplification, and there are certainly follow-on efforts (as you will learn in step 2), but that's the idea.

Warning: there are plenty of opportunities to buy a 'package' that gives you all the procedures you could ever need. These are typically quite generic and can be applied to companies with thousands of employees. Such packages rarely work well for small companies. They *can* be used as a starting point as long as you go back to step 2 (understand the standard) and tailor them to how you do business.

You can also hire contractors that already understand the standard to come in and get you compliant in short order. Again, though, be sure they are matching your business to the standard. I can certainly recommend someone that will do this and ensure it aligns with your company culture! ;-)

If you have specific questions about what specific sections mean, best practices, etc. there is a wealth of information in this forum - either already in existing threads or through feedback to new questions.

It may also help to mention what you have currently:
Any QMS?
9001?
FDA registered, reg 21 part 820 complaint?
Device licenses?

I was in a similar situation 10 months ago. The advice that everyone has given is right on. Learn the standard...very well....and write or revise procedures to address your current quality systems holes. We just got our certification this week so I can tell you from personal experiance that you can do it as long as you are willing to invest the time.

Good luck:)

I would amend Yodon's Step #1. Buy ISO/TR 14969 as well (or possibly instead of). That is the guidance document for ISO13485 and it includes the sections of ISO13485 within.

I would amend Yodon's Step #1. Buy ISO/TR 14969 as well (or possibly instead of). That is the guidance document for ISO13485 and it includes the sections of ISO13485 within.

I would add ISO 14971 (Risk Management) as well.

I work for a small medical manufacturer and we need to become ISO 13485 compliant in short order. Are there any easy to understand (free to low cost) step-by-step implementation resources available?
One of the requirements in the product realization process is the Process Validation and for this the guidelines from GHTF will be very helpful. Good luck ahead ....

Here's a link to the Global Harmonization Task Force (GHTF) document Somashekar is referring to:
http://www.ghtf.org/documents/sg3/sg3_fd_n99-10_edition2.pdf

While you're at it, there are a lot of other great guidance documents from the GHTF that you may want to take a look at while you're updating your system:
http://www.ghtf.org/documents/