Quality System Implementation 101:

I may as well start with a fitting quote:
“Good order is the foundation of all things”.
(Edmund Burke)

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How do I develop an ISO 9001 based QMS?

There are many different approaches and thoughts on setting up and implementing a quality management system (QMS) based on the requirements/ structure of ISO 9001. This blog post will be a brief summary of what I believe to be a very good approach to developing one.

Below is a summary of the approach I prefer:
1) Get a copy of the standard and know it inside and out.
2) Understand the “Process based Approach” as defined in the standard as well as how it will work most effectively in your organization/ industry. One personal belief is that you should NOT aim to just meet the bare minimum requirements. Make the process and QMS work for you and add value. The “Process Based Approach” is the key to adding this value if done correctly.
3) Involve as much of the management team and work force as possible in the development and implementation process. I believe that this involvement helps with resistance and educates the team at the same time on the requirements and how the system will work.
4) Provide (or have provided) training to the management team/ steering team on the “Process Based Approach”. This will help to reduce resistance, and will get the team involved with defining the QMS processes, the measureable objectives, and involve them with the corrective action and continual improvement process as it pertains to their QMS process.
5) Provide training on the requirements of ISO 9001 to the management team and workforce to the degree needed. Not everyone needs to become an expert on the requirements, but everyone needs to know the requirements that pertain to them.
6) Involve the management team and the process owners (if they are different people) in the selection of QMS Processes as well as your chosen tool to define/ describe the process. I am a huge fan of the S.I.P.O.C (supplier-input-process-output-customer) for helping the process owner know the important aspects of their QMS process. Involve them in defining the objective (measure of effectiveness) as well as how the data will be gathered, how often, by who as well as how and when it will be reviewed and action taken if the goal is not being achieved.
7) Involve as much of the management team and work force as is feasible for the internal audit team. This has numerous benefits such as the effect of looking at their own process with the eyes of an auditor, allows different view points from different levels of employees to be gathered and allows the auditors to see how the entire QMS fits together and interacts with the other QMS processes. This is the beauty of the Process Based Approach.
8) Get to know the existing processes and system as opposed to rewriting everything and expecting everyone to “change overnight”. People will naturally resist change that affects them and their work. By keeping the parts of the existing process that are working effectively and adding the missing “ingredients” to fully comply and add the most value you will lessen the resistance to change in my experience. Spend some time within the existing processes and system and get the feedback from those doing it. Determine what obstacles they are facing and what they fell could make things more effective.
9) Hold regular status updates with the management team and the work force to keep everyone apprised of what has been completed and what is coming soon that affects them. Knowing what is coming is always helpful.

This is just a summary of the starting steps and is not meant to define all of the “little pieces of the puzzle” that also take place. As I mentioned this is just one approach but one that I have found to be most effective.

The more time that you spend in the front end of the development process, making sure to add as much value as possible, the better off you and your organization will be in the end.

Here is to improvement.
Mark