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What are the biggest challenges while setting up an ISO 9001-based QMS, and how do you overcome them?

Implementing a formal QMS (Quality Management System) in an organization that doesn’t have one, but hopes to be ISO 9001 compliant or certified, presents a unique set of challenges. I recently advised an organization on such a project, and was surprised at the variety of challenges such a project presented to a management and workforce who all wanted to improve the quality of their product and service, but had differing ideas on how this could be achieved. So, what exactly were these challenges, and how can they be successfully overcome?

The challenges: Attitudes, ideas, and cooperation

While everyone generally shares a desire for a positive outcome from the QMS results, my experience has told me you can expect many different types of challenges as you work through a project like this. Let’s examine them and the solutions together:

  • Differing opinions: Almost everyone in the organization had different opinions on what the QMS should look like, how it should be accessed, and what the expected objectives should be. The key to resolving this is having a chat with the top management team, guiding them on how best to align the QMS to meet any ISO 9001 principles, and deciding on the format and objectives of the QMS itself. Then, a presentation can be made to the employees, where any input and suggestions can also be considered and added. This is where the training and education process for the employees can begin, and the more successful it is, the smoother the implementation will be.
  • Using consultation and participation to allay fears: As stated above, using principles of consultation and participation is not only vital to the content of the QMS, but to getting the employees involved in the process, ensuring their future support and input. Therefore, giving employees input or using individuals to construct certain process maps or vital documented information can pay dividends in more ways than one.
  • Ensuring that leaders lead: One of the key challenges is to ensure that the top management understand the leadership requirements of the ISO 9001:2015 standard and behave in such a way that these terms are met. The article How to comply with new leadership requirements in ISO 9001:2015 is well worth reading, and it is recommended that you spend time with the top team ahead of the project ensuring that this critical requirement is understood, and it will pay to remember that the behavior and leadership of the top team will set an example to the employees., increasing the chances of a smooth implementation.
  • Combatting rumors, gossip, and unrest: There tends to be constant chatter amongst the workforce in terms of why a QMS is being implemented, with the most popular theory being that it will allow the management team to reduce the headcount. This type of rumor can be counteracted by clear leadership action before the project to clarify the reasons for having the QMS, and critically, excellent concise and regular communication to the workforce during the implementation. The article How to comply with new leadership requirements in ISO 9001:2015 will help you to understand how to approach this topic.
  • Ensuring resources are allocated to make the project successful: Employees will be allocated extra tasks during an ISO 9001 implementation, and this extra workload can cause unrest, stress, and bad feeling. It is vital that the resources required are scoped out with the top team and middle managers at the start of the project, and that the importance of the tasks allocated is understood, and resources “ring-fenced” to ensure there is no slippage against the implementation plan.
  • Ensuring processes are followed when the QMS is running: Again, by using the elements of communication plus consultation and participation you can establish the importance of the QMS, but you may find that employees don’t adhere to stated processes or fail to record information that may be vital to defined QMS key performance indicators. This can be influenced and rectified by asking the top team to communicate the importance of the QMS to company plans regularly to the employees, and this can also be highlighted and repaired by running an efficient internal audit process. The article Five main steps in ISO 9001 Internal Audit can assist you with this element.

So, we now have an idea of what to expect before and during an ISO 9001 implementation, but are there any other tips that can help us?

Closing the loop

In the article How to prepare your company for the ISO 9001 certification audit, certification is examined, and that will be the next consideration after the QMS is established and operating correctly. In the meantime, you will have to ensure that the QMS is working, objectives are met, and continual improvement is occurring. Achieving this can be done by a combination of the leadership, consultation and participation, and communication, but your internal audit and periodic review processes must be accurate and able to rectify any problems identified. Repeat this process and you will be on the way to ensuring continual improvement takes place, but ensure you take the appropriate steps to educate, consult, train, and get the employees on your side, and the implementation project will be significantly smoother.

Download this free Checklist of Mandatory Documentation Required by ISO 9001:2015 to learn how to handle documents needed for QMS implementation.

Advisera John Nolan
John Nolan
John Nolan is a Fellow of the Institute of Leaders and Managers in the United Kingdom, and Prince 2 accredited with a background in Engineering and Electronics and Data Storage and Transfer. Having studied and qualified as both a Mechanical and Electronic Engineer, he has spent the last 15 years designing and delivering Quality Systems and projects across many sectors in the UK, including both national and local government.