ISO 13485 CERTIFICATION WITH REGULATORY

[Atish1999]

Good afternoon All,
I am new to this platform.
My company, in which I am currently working is already IATF 16949 Certified. They are entering into medical device manufacturing, and I had been given the responsibility to setup QMS as a different entity. I do have slight knowledge of QMS but confused. I will be applying for ISO 13485 CERTIFCATION only, but my company wants to make documents in compliant with regulatory requirements for future requirements. My company does not want to invest in consultancy and I require to take help from IATF guys, which will result in non-compliance because of there automotive mindset.
Can anybody please help me with the list of all documents required for QMS with regulatory requirements?
I would be thankful if you have any older draft of list with level 1,2,3 and 4

Thanking You In advance.

 

[QuinnM]

Hi Atish,
Welcome to the Cove.
If you search the Cove I'm sure you will find the list. Keep in mind some requirements may not be applicable to your organization. As an example, our organization does not produce implantable medical devices, so our Quality Manual includes a statement of exclusion for implants. Take a look at 13485, and search using the term "Shall" this will help define what is needed. This will identify items such as "...shall document..." The IMDF International Medical Device Regulators Form web page is another place to obtain information.
Quinn

 

[Atish1999]

Hi Atish,
Welcome to the Cove.
If you search the Cove I'm sure you will find the list. Keep in mind some requirements may not be applicable to your organization. As an example, our organization does not produce implantable medical devices, so our Quality Manual includes a statement of exclusion for implants. Take a look at 13485, and search using the term "Shall" this will help define what is needed. This will identify items such as "...shall document..." The IMDF International Medical Device Regulators Form web page is another place to obtain information.
Quinn

Thanks for your reply. Will surely try it out

 

[DanMann]

I've switched from automotive components to Medical Devices a few years ago and the big difference is the regulatory aspect goes on top of the QMS for MEdical Devices, whereas for automotive components manufacturers, there is very little regulatory oversight. On the regulatory requirements - it varies depending on product type and the countries/territories you intend to sell it to; each territory will have a regulation on medical devices and a regulatory agency that will provide guidelines. It's a tall order to ask someone from automotive manufacturing QA to move into Medical Devices without any consultant support - best of luck to you.

 

[Enternationalist]

The MDSAP Audit Model might be a helpful read. It's available online for free. People use it to audit 13485 quality systems and various related national requirements.

You'll need to read and understand ISO 13485 itself as you go, but reading MDSAP will give you what an auditor would actually look for as evidence and might give you a better sense of how it all comes together as a living system, rather than just a list of requirements.