Good day, all. I have been following the forums for years, but have never posted. I am the Quality Manager for an electrical cable and harness manufacturer working toward our ISO 9001:2008 and 13485 certification. Having gone through my first ISO certification with another company in 2002, I I do have some experience. My concern is that I am working with a consultant who isn't following the process approach. We are 5 months into this and have not identified key processes. Also, he is not planning to train the internal auditors in the process approach. I was under the impression that this approach was necessary for receiving certification. I would appreciate any advice you can give me. Thanks so much.
This is a way more serious problem than most would think.
I have found that 60-80% of Registrar Auditors don't understand the process approach and 95% of consultants.
Without the understanding of the process approach you are just getting words on paper.
The processes should be defined before you do anything.
I would tell you to dump the consultant but you are unlikely to find one who does undertsand the process approach. You need to have the discussion and make sure that the procerss approach is used.
Note: I doubt that you will be penalized by the Registrar Auditor since most of them don't care. They just want to fill out their check sheets, avoid getting in trouble, and collect their check.
I did numerous surveillance audits where I had to write NCs for no description of the processes. I didn't want to punish the client but as the auditor I had no other way to get them on the right track.
YOU will pay the price in that you will not have a documented functioning system but rather lots of paperwork.
You are the customer.
