ISO 9001: 2000 Quality Management System Design

(George) Miller (1956) showed that the individual's ability to make absolute distinctions among stimuli, to distinguish phonemes from one another, to estimate numbers accurately, and to remember a number of discrete items all seemed to undergo a crucial change at about the level of seven items. Below that number, individuals could readily handle such tasks: above it, individuals were likely to fail. Nor did this discontinuity seem accidental.
Howard Gardner, The Mind's New Science , New York: Basic Books, 1985, p. 89.
The beginning of wisdom is calling things by their right names.
Old Chinese Proverb.
A considerable effort is required by top management to produce a stand-alone ISO 9001:2000 sequenced manual that integrates business strategy with quality management. It is an iterative activity that peaks approximately one-third of the way into the process and then requires some level of maintenance up to the certification assessment. After certification, maintenance is normally required prior to a surveillance assessment and when the organizational and operational structure makes significant changes.
We can estimate to some degree the number of hours required to create a fully compliant manual if we assume there are the following:
A process manufacturing facility;
A staff of 100 employees 20% of which are managers and line supervisors;
A quality-assurance department;
A management representative who is also a full-time manager;
A full-time clerical support;
A...