J
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.
Any 'consultant' (so-called) who is 5 months into a project and has not mentioned or discussed a process approach and presumably has neither suggested nor assisted in identifying key processes is ... well, definitely a worry at best and incompetent /misguided/out of touch at worst.
Yes, people can and alas do still get certified without really understanding what a process is. But oh how much more valuable is the whole system and the whole endeavour when one does! As you already discovered at your previous workplace. Definitely I'd be raising questions! Prepare yourself though, with suitable background reading and quotes from the Standard and its related documents.