Is Level 2 Documentation required or necessary?

If the Quality Manual adequately defines an element of the standard, is a Level 2 document requried/necessary? Element 4.15 is very generic in our process and I feel that a Level 2 document would only be a restatement of what is in the Quality Manual.

I wanted to add, that I really enjoy this forum. I am an avid viewer and have learned so much. Thanks to all of you who contribute!

[Marc]

Technically, if you can 'say what you need to say' in your quality manual, there is no requirement for a level 2. I have some clients which are small companies which have done just that in several cases.

[barb butrym]

Yup I agree with marc..... there are no requirements for "level 2" anywhere in the standard.... A pet peeve of mine, writing words that don't add value to the system...Say it clear, say it once, communicate it well.

[Kevin Mader]

As I understand it, it is the difference between a Structured documentation system (using the documentation levels, pyramid) and an Unstructured documentation system (basically, levels are combined in a single document). Which works best for your organization? Use that. There isn't a specific ISO requirement driving one over the other.

[Kevin Mader]

Marc,

Good point. I guess when I presented the types I should have included choice three, a combination.

Regards,

Kevin

[Marc]

I threw that in there because I have had I don't know how many people come to me with a dazed look asking how to tell the difference and what if there are some details in a level 2 that may belong in a level 3 and such. I try to tell folks there are very few 'pure' documents. In most level 2's you can find some details which might be better classified as level 3 content and vice versa. Structured documentation is nice, but its not a Black&White issue.

[Don Winton]

Good coverage all around. Nothing to add except to say that the clauses of ISO 900x that do not require procedures are normally best covered in the level 1 document, at least in my limited experience.

Regards,
<A HREF="http://www.ficom.net/members/donwinton/home.html">Don</A>

[Marc]

Kevin: Most of my clients use a combination to some degree. I don't know 1 client which has a 'pure' document structure throughout.