1.0 All documents affecting quality shall be controlled and maintained. Each department manager is authorized to approve documents, or to assign a designate.
2.0 Documents shall be released and controlled by the department having the responsibility for that document.
3.0 Detailed procedures are available for each department. Procedures shall include instructions for assuring the correct issue is in use, removal of invalid or obsolete documents, and identification of any obsolete documents that must be retained for legal and/or knowledge-preservation purposes.
4.0 Forms used for documenting activities related to this system shall contain an identification number except for any form developed and purchased prior to the release of this document and forms generated by the job system computer.
5.0 Quality Department
5.1 The Quality Department shall have control over the following documents:
6.0 Engineering Department
6.1 The Engineering Department shall have control over the following documents:
Job Packet Documents
7.0 Purchasing Department
7.1 The Purchasing Department shall have control over the following documents:
Approved Vendors List
8.0 Human Resource Department
8.1 The Human Resources Department shall have control over the following documents:
New Employee Orientation
9.0 Document And Data Changes
9.1 Changes to documents can be requested by the following methods:
9.1.2 Submitting a marked-up copy to the Department Manager
9.1.3 Product Change Request form.
9.2 Only the issuing department has the ability and authority to make changes. Changes may require a revision level change. Changes require the same review and approval as the original. Procedures are released as they are issued or revised.
Covers the basics.
Thank You to CarolX for your informative Post and/or Attachment!
Not getting at CarolX in particular (her post just triggered the thought) I have a general question....
Why is it so common for procedures to use the shall word?
It seems so stiff and formal and is a word rarely used in normal business - why not use people's everyday language?
For example: "we control and maintain our documents"; "departments release and control their own documents"
Just a thought...
That is kinda a carry over from my old days as a QM for Dept of Defense contractors. Semantics was everything with them. If you used anything less, you were not in compliance with their standard. Perhaps that is why you see it so often, especially since the 1994 version of ISO9000 was almost a duplicate of MIL-Q-9858. Many of us are using a revamped version of our old Quality Manuals.
I have a question on the subject. Something has been bothering me for a while about 4.2.3 in ISO 9001:2000
(c) to ensure that changes and the current revision status of documents are identified,
What is this subclause talking about, exactly? I see drawings with changes identified by a letter, and that letter corresponds with a log indicating changes...
I also see procedural documents listing the changes made to each revision in a document history sort of section..
ensuring the current revision status is simple enough. dash one at the end of the document number does it for me. am I reading too much into this? If I were to interpret this one way, it would stipulate a list of document revisions on every form.
I have the details of document revisions elsewhere.
what does it mean to ensure that changes and the current revision status of documents are identified, and where will these changes be recorded?
atetsade, first of all it does not say that these two items must be met by the same act. For example, you might identify the current revision status on the document itself. However, you might identify changes (on this document) are identified through training (this could be the best way for changes in the steps of a work instruction).
Different documents can use different means. As you stated, perhaps on drawings you use a letter to designate the rev level (common practice). On procedures you use a dash followed by the rev number.
The key point here is that anyone using the document knows what revision level they need and if there is a change, they must know what the change was. They should not have to disect the document, and compare it to the old document, to find out what changed.
So the two questions are:
Is the document current?
How do I know what changed?
I think the 'shall' statements are there to make the statements auditable (in a compliance sense of course), and also I think it has certain legal importance. Also maybe it is grammatically more correct to say 'departments shall control their own documents' in a sentence.