Implementing ISO 9001 in the Services Industry

[harry]

Re: Implementing ISO 9001 in a services industry

Since you are importing medical devices, apart from the ISO requirements and what Harry has rightly pointed, you need to have a look at the regulatory aspects and FDA requirements too.



It would be ISO 13485, since Paragon would be dealing with Medical Devices.

First, this post was made under the "Implementing ISO 9001 in a service industry" thread. Next, the original poster indicate that they are working on project to implement "ISO for Importing and warehousing" (refer to introduction thread) and I guess distribution - that's why she post under the service thread.

Question is, do importers and distributors of medical devices (for local consumption) need ISO 13485? Not in my country! All they need to do is meet local laws and legislation. If the purpose is to improve service, then 13485, without the customer satisfaction and continuous improvement elements is also not relevant.

However, its good to point out to the original poster as what is really needed is very much dependent on their business scope or model.