ISO 9001: 2000 Quality Management System Design

Chapter 6: Process Document Design

6.1 The Process Document

The tier II document is expressed in many different ways, all of which are identical. For example:

  • SOP;

  • Process document;

  • Hub document;

  • Quality-assurance procedure;

  • Quality or control plan.

The role that the process document plays in the QMS is to describe the time-dependent behavior of the system after it has been defined in terms of quality policy statements. The importance of the process document cannot be overly emphasized. It is actually the first document that should be drafted prior to any other, including the quality manual (or alternately, the quality policy manual or quality system manual).

6.1.1 The Critical Development of Processes

Because the identification of processes, their sequencing and interaction, and a description of such interactions is the most dramatic revision to the 1994 version, it requires that we carefully analyze the way in that this critical requirement can be responded to effectively.

Let us consider a typical manufacturing company and what its total marketing and sales to after-sales service process could look like as our identification of processes [refer to Par. 4.1(a) of the Standard]. This concept is shown in Table 6.1. The process is described in tabular form although we could have used a flow chart graphic.

Table 6.1: Apogee E&M, Inc., Business Process Chart [*].

4.1 Requirements Apogee has chosen to define its operational processes in terms of core competencies that represent the various phases of the business cycle. The business process is summarized in the following table.

Core Phase

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