Quality Works

A business consulting firm. It focuses on optimizing ISO management systems through Lean methods. Since 1998, the business has assisted companies with ISO 9001, ISO 13485, ISO 14001, and FDA 21 CFR 820 management systems. Its work includes preparing or revising system documents, validating and reviewing them, and helping teams understand and follow the documentation. The approach identifies waste in procedures, such as duplicate information or content that does not support a procedure's purpose, and aims to simplify documents. In late 2019, the company shifted its focus to promoting Lean methods for ISO management systems and began serving customers under the name Lean ISO Management Systems.