We Help Businesses Optimize their ISO Management Systems

Since 1998 Quality works assisted dozens of companies in improving their ISO 9001, ISO 13485, ISO 14001, FDA 21 CFR 820 management systems. The simpler the document, the less time it takes to:

  • Prepare or revise it
  • Validate it
  • Review and approve
  • Train your team on, and
  • Understand and follow

Our invisible and costly enemy in ISO documentation is waste.

This is where the Lean concept, often overlooked for management systems, offers a solution.

There are numerous definitions of Lean, but all of them refer to eliminating “waste” in processes. Wikipedia defines Lean as “Lean is a systematic method originating in the Japanese manufacturing industry for the minimization of waste within a … system …”. So, to transition to the Lean management system, one has to identify and eliminate waste in the system that does not add value to a process’s purpose. The purpose of a procedure is to provide steps to perform a particular process.

The Title defines the purpose of a procedure, for example:

  • Management Review Process
  • Internal Audit Procedure
  • Business Objectives Matrix, etc.
Business meeting or a presentation in modern conference room for colleagues

Waste in Procedures

Anything that does not contribute to the purpose of a procedure is WASTES!  Typical waste in procedures includes:

  • Excessive graphics
  • Document numbers for small ISO management systems
  • Duplicate information in the “Reference documents” section and the text
  • The same applies to the “Responsibilities” section
  • Repetitive use of company name in documents
  • and others.

In late 2019 Quality Works shifted its entire focus to promoting Lean methods for optimizing ISO management systems. Since then, we serve our customers under the new company name: Lean ISO Management Systems.

Visit our new site to learn how you can make your ISO management system Lean and cost effective.