posted 28 June 2001 08:18 PM               

NATA, the accrediting body in this instance, has looked at the manual and doesn't have any concerns over the structure, etc. It's the structure that's the point - the manual follows my statements over the last year on this forum that manuals need very little in them, it's the procedures that count. Or conversely, put everything in the manual and don't have any procedures.

The Manual is the same structure as the 9001:2000 manual I've nearly finished drafting. This is our "Business Systems Manual" and is the mother document. It contains the systems level procedures and references other (separate) manuals that come under it and form part of the overall system (e.g. Lab Manuals, Forms Manual, Induction Manual, External Document Manual, Job Description Manual.....).

Your lab manual should contain:
- the lab quality policy;
- reference to procedures (I put the documentation master list in the manual); and
- outline the documentation that makes up the system (a compliance matrix covers that).

The roles and responsibilities must also be included, but I include the procedures themselves within the manual, as individually identified and controlled documents.

Any help?

posted 02 July 2001 09:24 AM              

thank you,