Quality Works

Lean Management Systems
ISO 9001, 13485, 14001, FDA 21 CFR 820

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

If your company has been struggling with over-documented ISO 9001, ISO 14001, ISO 13485 of the FDA QSR management system, you are not alone.  You might find yourself questioning if there is a way to simplify your system.  Luckily, there is, and Lean ISO Management Systems can offer you a solution.  The symptoms of a typical over-documented system are numerous:

  • There are too many procedures
  • Procedures are too long
  • Documents contain irrelevant and duplicate information
  • There is conflicting information in various procedures
  • References to not essential documents and standards
  • Documents are not effective for training
  • Review and approval times are excessive, and many others

The solution to improve such a system is optimization!  The simpler the document, the less time it takes to:

  • Prepare or revise it
  • Validate
  • Review and approve
  • Train your team on, and
  • Easier to understand and follow

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.

Anything that does not contribute to the purpose of a procedure is WASTE!  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.

More and more companies around the World are pursuing Lean business practices in manufacturing, logistics, services, hospitality, and other industries.  Regretfully, very few companies use or even consider the Lean approach to their ISO 9001, ISO 14001, or ISO 13485 management systems.


Visit our new Website to learn how you can make your system Lean and efficient.