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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 part-time consultant (approximately 25% of the time on site during the precertification effort);
A training program that includes documentation-writing skills for some employees;
A documentation system that already exists in the form of some basic work instructions and operational formats;
A plan that shows that the designated employees write, edit, and research for three hours for every hour that the consultant had been on site.
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