I'm not sure that's entirely accurate, Randy. Often, it's the job of a consultant to bring the nature of the gaps to the client's attention, in a manner they understand better than the awful terminology in the ISO document. Seriously, would any senior management have a clue if you told them their 'Product Realization Process' wasn't compliant...?
As a general manager I certainly would and I didn't have a quality background until I implemented first ISO9001 then TS16949 without the aid of external consultants.......
I have a bit of a problem with the "Its a consultants job to understand the standard" line you seem to be suggesting Andy. If no one within the organisation can understand ISO9001 what hope is there of following never mind maintaining, developing and improving the QMS once you pass the audit and the consultant leaves. I have audited a few potential suppliers who bought a "consultant lead" QMS. Try asking questions and the system shows for what it is - a certificate saying ISO9001 on the wall and some ring binders with words in them that no one read since the consultant left soon after the auditor. I guess the consultant will be back a bit before the next audit to earn some more money and update a few words. Needless to say it tends to be a fairly short 2nd party audit.
If you are not sure what a phrase in the standard means search this forum and you soon will. It is nearly as quick as talking to a consultant and significantly cheaper.
There is certainly a place for consultants but understanding ISO9001
[End of rant]
And to get back to the original question - I agree with Randy that the standard is the best basis for a checklist. I have used 2 approaches to an actual checklist in 2 QMS developments.
If you are basically going to write/upgrade the system on your own I would recommend a soft pencil, an eraser and make notes on your copy of the standard - which procedure you cover/are going to cover the requirement under. As you write the procedure flick through and tick them off on the standard. Quick and dirty but it works. It also makes it dead easy to do a cross reference document between your QMS and the standard.
The second approach I have used (for TS16949 but it doesn't matter) is a simple excel file with columns for Gap, Plan, Reponsible person, planned date and complete date. Doesn't work any better than the first but it is much easier to share if multiple people are writing/changing procedures and it looks a lot more proffesional if you need to show it to Customers.
Thats my experience for what it is worth as a fairly green person who has been through this twice but it worked for me with passes first time on both.
Ben
