People not familiar with the ISO 9001 standard may think of it as being bureaucratic with lots of extra paperwork. In reality, this is far from the truth.
The ISO 9001:2008 standard requires that you establish controls for your business, that you monitor customer satisfaction and that you continually improve your processes. These basic elements are essential for any organization to succeed.
The ISO standard does not specify “how” these elements are to be implemented, thereby giving each organization the flexibility of complying while conducting its business in an effective manner. Using Lean concepts in the implementation of ISO 9001 enables the organization to gain all the benefits of the structure of this system without creating a bureaucratic burden. Following are some of the popular myths regarding ISO requirements that often prevent a Lean implementation.
1) Myth. The Quality Manual needs to be very detailed in describing the quality system.
Truth. The manual should briefly state the key processes and their interactions. It needs to make reference to the procedures and flow diagrams that describe the processes in more detail. The manual does not contain any proprietary information and does not have a minimum length.
2) Myth. Several “controlled” hard copies of the Manual are needed.
Truth. The entire document and records control system can be in electronic format. Although many organizations prefer having a certain number of “controlled” hard copies, the standard does not require it. The key here is control; making sure that only the latest valid information (procedures, forms, etc.) are used. Having several sets of “controlled” copies makes it more difficult to maintain the documentation. Maintaining one controlled “hard copy” set may be a good idea as a quick reference.
3) Myth. Employees must have easy access to a “hard copy” of the procedures and “work instructions” that apply to them.
Truth. Again, these procedures and work instructions can be available in a controlled electronic format. Documentation must be readily available and securely stored and a method needs to be developed for revision and approval.
4) Myth. A procedure is needed for everything.
Truth. ISO requires only six procedures which can be condensed to five: document control, records control, non-conforming product handling, internal auditing, preventive and corrective actions. Other procedures should be developed when they add value to an internal customer or external customer viewpoint or improves communications between the functions that will use it.
5) Myth. ISO prevents Lean implementation because all changes need to be documented and approved.
Truth. The ISO standard expects Continual Improvement to take place and Lean provides a set of concepts and tools to reduce waste and thereby improve processes. Lean improvements should be documented once the new procedure is confirmed to result in improved results.
6) Myth. All procedures and work instructions need to be written in a consistent format.
Truth. ISO documentation can take many forms including written procedures, pictures, drawings, flow charts, and screen shots. Procedures need not be wordy or complex. The key is that the information be understood and accessible by the people using it.
Will people with different language and cultural backgrounds be able to understand the procedure or work instruction without much need for interpretation? Dispelling these myths will allow for the implementation of a highly effective Lean Quality Management System using the ISO 9001 structure.