1. Almost 90% of our procedures is referenced to the old standard. Our specs was paraphrased using ISO9001:1994. Do we need to revise or update all specs affected since we are converting to ISO9001:2000 this year?
2. How do we document quality objectives? Is this a part of management review?
3. What does the "Use of Competence" Versus "Qualified" Means?
4. What is the main focus of preventive action? Do we need to track all nonconformity history, in order for us to define the real root cause of the problem?
Any feedback would be appreciated.
Thanks in advance.
1. You’ll need to go through your system to see if your procedures cover the requirements in ISO9001:2000 (gap analysis). Then you update or write new procedures as needed. There is no need to update procedures that are still valid.
2. How you document your objectives is largely up to you. I suggest a procedure that describes how you establish, follow up, report and review your objectives. The ***DEAD LINK REMOVED*** SMART model that Jim Wade among others talk about is a good way to set them up. You will definitely have to deal with objectives in the MR.
3. Where did you find the term "Use of Competence"? I can't find it. I find the word qualified in ISO9001:1994, but not in the 2000 version, so I think that's one thing less to worry about. Anyway, english is not my native lingo...
4. The focus of preventive ation is quite literally on figuring out what may go wrong and do something about it before it happens. I would think that applying FMEA to your processes would be a good idea.
The only thing I can think of related to competence is ensuring the personnel are competent. If this is what you are referring to Vash, then you determine the competence and the criteria. You can show competence by training or experience or several other factors.
If this isn't what you were referring to and I'm way off track, sorry If you are referring to something else, let us know and I'm sure someone will step in to help.
I got Competence in 6.2.2 which was "Competence, Awareness and Training" and under that clause 6.2.2 (a), I'm sorry if I got the term"use of competence" instead of "competence"
Your right, I'm referring on how to ensure that personnel are competent. We had training with a written and actual examination, with 100% efficiency. I don't know whether that would be enough. When we speak of competence, isn't it, about Skills and Knowledge?
It seems like "Competence" covers a pretty wide spectrum. During our audit we were asked about one person operating a machine. We showed that he had been trained by the machine manufacturer when it had been installed, and that was enough to satisfy the requirements.
I don't think it really matters how it's done, as long as you can show that people know what they're doing. I hope this helps and doesn't create more confusion.