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Lean approaches are helpful for the development and maintenance of documentation compliant with ISO Management System Standards (MSS). These standards include ISO 9001, ISO 13485, ISO 14001, ISO 45001, and many others.
Lean approaches are beneficial for the development and maintenance of management systems compliant with ISO 9001, ISO 13485, ISO 14001 ISO 45001 standards and 21 CFR 820 FDA regulation.
This article reviews common practices for, and the positive results of, establishing measurable quality objectives for ISO 9001 and ISO 13485 quality management systems.