ABSTRACT

Perhaps the most important part of the preparation for the Quality System Audit is writing the documentation that is required This may be the reason that many people view the ISO 9001 standard as strictly a documentation activity. While there are certain elements which require procedures or other documentation to be available the organization has a great deal of flexibility not only in how many procedures it writes, but in how the documentation is stored and controlled. Any docwnentation that is established should serve a purpose to your organization. If it does not, determine if it is truly required in the first place.