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A device has a shelf life when some part of the device degrades while sitting before use on the shelf. If the product has a shelf life, then you need to measure it and provide the user with that information. I don't think your product has a shelf life. The warranty period is important for the customer ...

Start with Annex II, 1.2 which is about previous generations and similar devices. (The section heading has a typo.) The expectation is that you will provide an overview of these devices. Each of them will have features which will be in the overview. If your current device has a feature that other ...

I'm confused by one of sentences in your original post. It says, "Unfortunately, they are sending very good parts and we raised too many SCARs against them but things are not improving." The confusion is with the "they are sending very good parts" section. I infer it should have been something like, ...

First, you need to determine why you are auditing suppliers. Does a QMS audit add value and help ensure conforming parts? In most cases the answer is no. Suppliers fall into two categories those that have QMS to a standard with a third party certificate and those that do not. If the supplier has ...

The first question is why do you want to do this. What is the problem for which this is a solution? Start with GHTF/SG4N33R16:2007 which defines a critical supplier as, "a supplier delivering materials, components or services that may influence the safety or performance of the product". In essence ...