I'm moving all of our Quality Management stuff over from ISO 9002:1994 to 9001:2000...currently I'm looking at the Quality Manual and the procedures. I've read that their are only 6 (or something like that) documented procedures required in the standard. But what ones should I have done? Here is the list of procedures I have from the old standard:

1. Quality Management System – General
2. Management Review
3. Quality System Documentation
4. Quality Planning
5. Contract Review
6. Design Control
7. Design & Process Change Control
8. Document and Data Control
9. Purchasing
10. Control of Customer Supplied Product
11. Product Identification and Traceability
12. Process Controls
13. Receiving Inspection
14. In-process Inspection
15. Final Inspection
16. Control – Monitoring Measuring Equipment
17. Inspection and Test Status
18. Control of Nonconforming Product
19. Corrective Action
20. Preventive Action
21. Customer Complaints
22. Handling, Storage, Packaging, Preservation & Delivery
23. Control of Quality Records
24. Internal Quality Audits
25. Training
26. Servicing

So from these, what ones should I delete and what should I add/merge together?

Also, in writing the Quality Manual, there are A LOT of "shall"'s. Do I write in the manual 'Company XXX shall determine....' or should it read 'Company has documented procedures...'? Does the manual say what we should ('shall') do, or what we are doing ('has')?
Any explanation or opinions on these is great. Thanks.

Mike

Hey Mike,

The 6 procedures required by the 9001:2000 standard are:

control of documents
control of records
internal auditing
control of non-conforming product
corrective action
preventive action


In the standard, these 6 sections will explicitly state that a documented procedure is required. You have variants of all of those in your old procedures - though they may need to be tweaked a bit. For example, #8 in your list combines the first two in my list - you can leave it as it is or separate them. As long as the procedures are documented, it doesn't matter how you combine them. (Example - there's a thread floating around asking who combines corrective and preventive action into one procedure and who leaves it as two.)

You don't have to delete any of them if you don't want to. You are only *required* to have six - but if your organization is of a substantial size, you wouldn't want to scrap other procedures.

In your quality manual I would use "Company XXX has documented...". You're writing the manual about your company - you want to write about what you do, not about what you should do. It's a statement of conformance to the Standard, among other things.

Cheers,
-R.

:agree1: Thanks for the info. I'll review my documents and talk with management to see what they want.

If anyone else has anything else to add, feel free to post it.

currently I'm looking at the Quality Manual and the procedures.
This topic has been discussed earlier. Concerning the manual, I suggest a look at the following threads:

HELP - Tips on updating Manual (1994 - 2000) (http://elsmar.com/Forums/showthread.php?t=6419&highlight=manual+content)
What is acceptable quality manual content? How much detail to put in here? (http://elsmar.com/Forums/showthread.php?t=6490&highlight=manual+content)
QMS Quality Manual - Boss Wants a 4 Page Manual - What to Do? (http://elsmar.com/Forums/showthread.php?t=4866)

/Claes

Claes, thanks for the links.

I have done searches in the forums, but sometimes it is hard for me to find stuff, because results are listed as most recent post, not relevance to search... :frust:

Oh well, its allows me to look at a lot of different things, especially things I wouldn't have thought to look up! :lol:

Mike