Contracted to get the organisation ISO 13485 certified

youngquality · Oct 31, 2005

Hi!

I've just started at a small organisation that designs and develops a medical device, but outsources all manufacturing. I have been contracted to get the organisation ISO 13485 certified. I am actually straight out of university too and this is my first job in my field of study (operations management). I am amazed at how much information is available on this site, its proving to be extremely useful.

Just thought i'd write a post since I am using a lot of the information on this site and feel as though I should make any contributions I can.

Anna.

ps. feel free to give me your 2 cents!

Jim Wynne · Nov 1, 2005

Welcome to the Cove, Anna :bigwave:

. Although my own limited area of expertise doesn't include medical devices, we do have some able contributors here who will be glad to help. Don't hesitate to ask a question or search the site for information, and always feel free to jump into the discussions.

youngquality · Nov 1, 2005

Project Plan

Just wondering if any one has any hints as to developing a project plan to eventually obtain ISO 13485 certification.

i.e. what should we start with, etc. etc.

Thanks :biglaugh:

Al Rosen · Nov 2, 2005

Start with a search here in the cove for a implementation plan or schedule and a gap analysis checklist.

youngquality · Nov 2, 2005

On the right track?

I looked at those documents, thanks...the company i'm working for is quite a bit smaller, the only permanent employee is the CEO and there are 3 contracted workers (2 working on ISO).

Am I right in how I have interpreted ISO 13485:
- We need manuals for the processes in the company, in each of these manuals is required procedures, and for each procedure is the required documentation.
- Then all forms required for each procedure are included in the manual, as is a section to record all filled-in forms

Is this kind of right?

Anna.

Al Rosen · Nov 2, 2005

With an organization that small, you might incorporate your procedures within your manual. There is a book by Kevin R. Grimes, ISO 9001:2000 A Practical Quality Manual Explained that you might want to look at. Although it is written for ISO 9001, you can get some ideas from it.

Captain Reject - 2005 · Nov 2, 2005

youngquality said:
Hi!

I've just started at a small organisation that designs and develops a medical device, but outsources all manufacturing. I have been contracted to get the organisation ISO 13485 certified.....

Welcome to the world of Medical Devices. I have been in Quality in the Medical Device industry for the last 17 years. There is a lot of requirements and a lot of documentation. Your goal in setting up a system compliant to ISO 13485 is good and attainable but challenging for a small organization. Do not forget that you need to develope your system around the requirements of FDA 21 CFR section 820 as well.

You will be basically end up with 4 teirs within the Quality System:

Top Level Manual
Procedures
Work instruction - detailed as required
Documents - Forms.

This is a step down one to the next and so on. One tool that is good is the FDA Small Entity Compliance Guide FDA 97-4179 this will start you on the right path for gathering information.

Al Rosen · Nov 2, 2005

Captain Reject said:
Welcome to the world of Medical Devices. I have been in Quality in the Medical Device industry for the last 17 years. There is a lot of requirements and a lot of documentation. Your goal in setting up a system compliant to ISO 13485 is good and attainable but challenging for a small organization. Do not forget that you need to develope your system around the requirements of FDA 21 CFR section 820 as well.

You will be basically end up with 4 teirs within the Quality System:

Top Level Manual
Procedures
Work instruction - detailed as required
Documents - Forms.

This is a step down one to the next and so on. One tool that is good is the FDA Small Entity Compliance Guide FDA 97-4179 this will start you on the right path for gathering information.

Why? She is in New Zealand

Captain Reject - 2005 · Nov 2, 2005

I work for a European Based Orthapaedic Company with Manufacturing facilities in the United States and Switzerland. I have seen the importance of making sure that a system is set up according the the requirements of ISO 13485 but with the Global scale of Medical Devices it is extremely important that companies set up their systems with compliance to the FDA requlations. The organization I work for currently out vends some of our manufacturing to facilities in China. They as well have to show compliance the the FDA reg. So when looking at setting up a system I believe it is important to look at not only the ISO but the FDA and potentially the Canadian regulations as well. So the question that has to be asked is what is the end customer base?

youngquality · Nov 2, 2005

customer base

The current customer base is New Zealanders, although the expected result of gaining ISO certification is a greater ability to export, especially to Aussie to being with, and then US, but I realise that FDA certifications will have to be attained for this.

I have done an initial process diagram (4.1a,b) and was looking for any feedback on this. Thanks a lot for all of your information, its very useful during this process!!

Anna.

Contracted to get the organisation ISO 13485 certified

youngquality

Jim Wynne

youngquality

Al Rosen

youngquality

Al Rosen

Captain Reject - 2005

Al Rosen

Captain Reject - 2005

youngquality

Similar threads