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Six Sigma is a firm belief that we can all be nearly perfect, do near-perfect work all of the time and that we have the potential to be creative. Perhaps the industry most in need of this creativity is health care.
The purpose of this field guide is to assist organizations, step by step, in implementing a quality management system (QMS) in conformance with ISO 9001:2008, whether from scratch or by transitioning from ISO 9001:2000. It examines each sub-clause of Sections 4–8 of ISO 9001:2008, which contain the requirements, and gives a list of the documentation/documents required, internal audit questions, a summary of management’s responsibilities, and a flowchart of the steps that need to be undertaken to satisfy the requirements.
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