Looking for ISO Management Services?
If you are looking for ISO 9001, ISO 13485, ISO 14001, FDA 21 CFR 820 Services, you are at the right Place.
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
Your company is struggling with ISO Management System?
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:
Procedures are too long
There are too many procedures
Documents are not effective for training
There is conflicting information in various procedures
References to not essential documents and standards
Documents contain irrelevant and duplicate information
Review and approval times are excessive, and many others
The solution to improve your system
The solution to improve your system is optimization! The simpler the document, the less time it takes to:
- Prepare or revise it
- Review and approve
- Train your team on
- Validate it, 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.
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.