ISO 9001: 2000 Quality Management System Design
|
19.10 Effectively Link the Reader to Referenced Documents
Once you have the reader's attention, you want to keep it. A clear reference to the associated lower tier document maintains the interest. There are a number of ways to link, for example:
-
Direct reference: "The marketing and sales process is described in Doc# 7-2-001-0206, entitled 'Standard Operating Procedure for Marketing and Sales.'"
-
Indirect reference: "The lower tier process documents for marketing and sales are listed in Appendix A, entitled 'Master List (or Document Tree) of Lower Tier Documents by Manual Section.' The related documents are found under the column (tree) denoted as marketing and sales."
-
Hyperlink: "Please use the icon entitled 'Design Control Process
-
Hybrid systems: Systems that contain both electronic and hard-copy files are the most common documentation systems in use. It is imperative to clearly define which documents and records are online and which are hard copy. Most importantly, it is vital to clearly define if electronic signatures are in use, how the software is validated, and how the electronic signatures are protected. For example, this is a critical requirement for medical devices.
|