gheghe said:
Yes sir I agree with you, forms may be referred by its title or number. I wish to know if it is ok if a form (whether it is numbered or not) will be use without being referred by QMS?
Good question Ghe (I got your mail btw),
First of all, I think Wes' questions are very much on track, so I have little to add, but let's have a look at the standard. Assuming we're talking about ISO9001:2000, part of the answer to your question can be found in clauses 4.2.1 & 4.2.4:
ISO9001:2000 said:
The quality management system documentation shall include
...
e) records required by this International Standard.
That's the easy part. Obviously, you need to connect the records required by the standard to the QMS. How? Over to 4.2.4:
ISO9001:2000 said:
Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable.
A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.
In other words it's up to you to deem what is necessary, and write a procedure describing
your way of hooking the necessary records to your QMS.
Now, to answer your question: Apart from the records required in clause 4.2.1e, you also (as Rob said) have to add all other records you need in order to prove conformance to the standard, as well as the ones necessary to keep your QMS running. You will have to be the judge of which records you need. Of curse, you can also choose to add records not falling into those categories. That is up to you.
The trick is to keep track of them. We used to have a (forever outdated) written procedure contaning a list of our records. Big mistake. It was in constant need of updating and we never caught up. Today we use a database, which makes life a lot easier. Our procedures refer to the records (by title) in question and to the database.
A bit longwinded, I know, but I hope it helps?
/Claes