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ISO 9001 vs. Lean: How they compare and how they are different

Have you considered adding Lean manufacturing methodologies to your quality management system as a way of focusing the improvement activities? If so, you are amongst many companies that realize they can save time and money through process improvement. One of the key principles of the ISO 9001 standard is continual improvement, but ISO 9001 does not explain how to implement or maintain this improvement. Lean manufacturing methodologies can provide this how-to information.

What is Lean Manufacturing?

Lean manufacturing is the concept that using resources for any purpose other than creating value for the customer is waste, and waste should be eliminated, or at least reduced. In the language of Lean, the Japanese words for waste: “Muda,” and improvement: “Kaizen,” are often used. Lean sees value in any actions or processes that the customer is willing to pay for. By removing other wasted actions, you preserve the value with the expenditure of fewer resources and less work.

Lean methodologies are mainly based on the Toyota Production System, and have spread worldwide. Although different people will use a different number of types of waste, the basic set comes from the seven defined by Toyota: transport, inventory, motion, waiting, over-processing, overproduction, and defects. The use of Lean will look at these different causes of waste in the process, including some additional causes depending on the person, and try to eliminate any that are unnecessary to create the product. The chief characteristic of Lean is the focus on waste elimination.

Some of the philosophical ideas behind the implementation of Lean are:

  • There are no limits to improvement; nothing is ever thought to be perfect.
  • Get the facts from the source; people closer to the problem can have better ideas.
  • Don’t require a perfect solution; any improvement is a good start.
  • Ideas from all members of the team are equal.
  • Create a visual environment where the status of the process can be easily seen.
  • Create a culture of improvement.

What are some tools of Lean?

Here are some common tools used by many Lean practitioners (in no particular order), what they mean and what they are used for:

5S – This is a program based on five Japanese words that start with S, and are often translated as Sort, Straighten, Sweep, Standardize and Sustain. The idea is to start with a Sort of the workplace to remove any unneeded articles, then Straighten to arrange necessary items to prevent wasting time to find them, next Sweep to keep the workplace safe and easy to work in, then Standardize to help keep things in order and easy to find, and finally Sustain the workplace by making these action routine in the workday. The outcome of this activity is a clean workplace where only the necessary items and tools are present and easy to find to prevent wasting time finding what is needed to do the job.

Value Stream Mapping (VSM) – VSM is used as a method of graphically representing the flow of materials and information of a process. Included in the diagram are the times taken waiting and actually performing each step of the process. By identifying the process in this way, you can aim to reduce waiting time, as well as any unnecessary steps in the process that tie up materials, and thus cause waste.

Kanban – The Kanban tool is based on the reduction of waste in process inventory. To use this tool, a system is set up for one process step to notify the preceding process step to provide new material. This can be a tag system, empty box system or even empty space system. The key is that every time the notification is given, the process provides the required materials to the next process and no more. By using this, you can reduce the amount of in-process inventory, which is identified as a source of waste.

Key Performance Indicators (KPIs) – Many companies use KPIs to measure the performance of the most important elements of the QMS processes, but few know that this concept came out of Lean thinking. Some examples of KPIS are zero defects, customer satisfaction scores or process throughput times. Many of the KPIs used by companies are focused on measuring the areas of waste, with targets for improvement.

Shadow boards – When performing the Standardize step in 5S, it is sometimes beneficial to lay out the workspace with a labeled area for each necessary tool. This way, when a tool is missing, it is easy to see that it is not in its place and you know exactly which tool is not there. This can avoid wasting precious time trying to identify what is missing, and helps to keep the area clean and tools easy to find.

Poka-yoke – This is a Japanese term that means mistake proofing. It is any mechanism that helps operators identify and prevent mistakes from happening. Most of these are for machinery, and some ideas include a feeder to make sure that long rivets are not used in a machine, or a jig used to make sure parts are held in the proper orientation for processing.

How does Lean fit with ISO 9001?

It is not an either/or choice between ISO 9001 and Lean; both can be used. Lean can help provide the process improvements that are required by the ISO 9001 quality management system. Integrating Lean manufacturing methodologies into your ISO 9001 quality management system can help you to improve by identifying and removing waste from your processes, leading to an overall process that flows more smoothly and creates better value for you and your customer. This is a good return on your investment and a good fit to support your quality management system.

See here a  List of Quality Management Standards and Frameworks.

Advisera Mark Hammar
Mark Hammar
Mark Hammar is a Certified Manager of Quality / Organizational Excellence through the American Society for Quality and has been a Quality Professional since 1994. Mark has experience in auditing, improving processes, and writing procedures for Quality, Environmental, and Occupational Health & Safety Management Systems, and is certified as a Lead Auditor for ISO 9001, AS9100, and ISO 14001.