Originally posted by Raffy:
Hi MrPhish,
Yes, we were been audited by the registrar, however, I had so many concerns after they audit us.. What if the service provider doesn't have any quality manual to be used during audit? Not an ISO Company? What and where will be going to start? Do we have to send a checklist based on 4.11 then after a week, will going to visit them? Please comment.
Thanks in advance,
Raffy
Raffy,
You had an audit by a registrar, were you suggested for certification and are you now certified?
I am more in tune with QS requirements but the ISO standards are much less restrictive. ISO requires that you evaluate, select, and define the control required for your type of product.
What if they don't have a manual? Have you told them they need one?
What if they are not ISO? Did you require it of them?
Where do you start? Tell them what you require.
Do you have to send a checklist based on 4.11? Do you have a supplier manual that tells them they will be controlled/evaluated by a checklist for this element?
It sounds as if there is more of a deficiency in the purchasing/supplier element than 4.11.
Take the bull by the horns and control your supplier!
That said, we all have suppliers that are probably much larger than us and could buy us out if they wanted to and make our lives miserable. My suggestion would be to have your systems in place that meet the standard, follow that system, and when you run into difficulty, document all of your activities as a good faith effort to comply with the system you have developed.
This is especially difficult with cal labs considering their limited number and various interpretations. (More so QS & TS)
ASD...
