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. An excessive number of documents, over-detailed and over-decorated “Standard Operating Procedures” (SOPs) are ineffective and costly. On the other hand, well-written and organized procedures can lead an organization to a more efficient Lean management system. The article offers an effective tool to document and monitor the progress in the transition to a Lean ISO management system, and will be helpful to those organizations that struggle with over-documented management systems and those that are searching for assistance in optimizing their ISO procedures.
According to research by the Lean Enterprise Research Centre, 60% of production activities in a typical manufacturing operation are waste! Through my consulting and auditing career I have worked with hundreds of businesses. In various countries, in different industries, in companies large and small I keep on finding, again and again, the same problem: management systems are over documented. Very few companies, if any, apply Lean techniques to their management and documentation systems. This is bad news; the good news is that there is a simple and sophisticated solution.