Chapter 10: The Quality Manual Scope of Effort


10.1 Estimates

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.




ISO 9001(c) 2000 Quality Management System Design
ISO 9001: 2000 Quality Management System Design
ISBN: 1580535267
EAN: 2147483647
Year: 2003
Pages: 155

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