4.1.1 Introduction

In Part 1, our goal was to create an organizationwide, business-oriented QMS, in which the financial and quality objectives were transparent. The QMS was to be based on the canonical set of ISO 9000 texts (i.e., ISO 9000:2000, ISO 9001:2000 (the Standard), and ISO 9004:2000).

It is now necessary to establish the key components of an effective QMS in terms of the Standard's documentation requirements, both from a mandatory basis and an implied overall effective hierarchy of documentation. In this regard, all documentation requirements (SHALLS) are to be addressed. Of prime importance are the mandatory documentation requirements, summarized in Section 4.1. These requirements are explicitly required by the Standard and form the umbrella under which all the other documents are contained.

To accomplish this, it is necessary first to categorize the several sets of documentation needed to produce a fully compliant and effective QMS. The four key sets are as follows:

• The Standard's mandatory documentation;

• The Standard's implied documentation;

• The registrar's required documentation;

• Required regulatory (compliance) documentation.

Whereas the Standard's mandatory documentation is defined by the Standard's SHALLS, there is considerable disagreement over what constitutes the various other required documents.

4.1.2 Recommended Documentation Taxonomy

The so-called ISO 9000 tiers (hierarchal levels of information) originated out of industrial-military requirements and have become a de facto standard because of their usefulness. The most common set of tier documents observed consists of the quality manual as tier I, SOPs as tier II, work instructions as tier...