Feb 25, 2018

Why ISO 9001:2015 standard implementation fail and how to make it successful

It is challenging to implement and maintain a Quality Management System (QMS). Finding the information, person, method or time to implement the system that is suitable for your organization can be difficult.

In this article, we’ll discuss eight common challenges that are often faced when people design and implement a QMS. With each challenge discussed, we’ll also give actions you can take to overcome the problem. This will hopefully help you make the implementation of your QMS successful.

 1. Focusing on theory

People that strive for perfection often focus very strongly on the theory, rather than putting the theory into practice in an attempt to design the perfect QMS.

Actions: Nothing in life is perfect and that includes a Quality Management System. One of the principles of ISO 9001 is however that the QMS can and should be improved continuously. For a QMS to work, it should be practical for the organization. Theory on its own is useless when it is not put into practice. You need to understand the theory, but the focus should be on implementing the theory and adding value for the organization.

2. Excessive documentation

Many companies create far too many documents, often resulting in a scenario where the sheer volume is so overwhelming that it starts hampering the functionality of the QMS. Employees get lost in the documentation and there is a very real danger that they lose interest in the Quality Management System, resulting in the system not delivering the required results.

Actions: The objective of a Quality Management System should never be to create documentation, but to increase efficiency by formalizing the right information so that it is easily available when needed. The purpose of the documentation is to support the communication of information, deliver proof of compliance and share knowledge. It should not ever hamper daily operations.

3. Excessive detail

Organizations often try to include as much detail as possible in their documentation. There is however a price to pay in terms of time and resources needed. Too much detail will also make the documentation more difficult to apply.

Actions: The documentation should at least be compliant with all applicable laws and regulations. It should also support all the various activities within a company. Although it is true that some documents need a high level of detail, this is not the case most of the time. When determining the appropriate level of detail for any document, always try to ask yourself what value the specific detail will (or won’t) add to the system. This is a typical case where less is more. When in doubt, don’t add the detail if you’re not sure it will add value.

4. Too rigid

If your QMS is not flexible and too rigid, it will be very difficult to improve and change when this is required. This may result in a system that won’t deliver optimal results in the future.

Actions: We live in a world that is changing rapidly and it is logical that the organization as well as customer requirements will evolve all the time. Your Quality Management System needs to keep pace with these changes and must be improved continuously to stay consistent with the changing circumstances of the business. Only by doing this will the QMS’ performance improve and you will be able to identify and exploit new opportunities.

5. Not enough communication and involvement

Unfortunately, it often happens that the QMS is only driven and supported by the Quality Manager. Employees often think that the QMS is the responsibility of the people that created it and, as a result, don’t actively contribute to the system. Instead, they simply do as little as possible for QMS related functions. This situation is not sustainable and is a sure way to kill a QMS.

Actions: Not only should all employees clearly understand their roles and responsibilities in the QMS, but they should also understand why the QMS was implemented in the first place, and what the consequences would be if the QMS fails. If this does not happen, employees will never feel that they are part of the system and add value to it. To get the desired results from a QMS, the full support of the entire organization is needed.

It takes excellent communication skills and good leadership to get the most from a Quality Management System. If employees are informed regularly about challenges and successes, this will motivate them. Sharing lessons learned will likely encourage discussions that will prevent the same mistakes being made again.

6. Lack of motivation

When a Quality Management System is implemented only because external factors ‘forces’ management to do so, only (e.g. competitors are certified and therefore have an advantage, or customers demand a certified QMS), it will be extremely difficult if not impossible to get any worthwhile results from the QMS.

Actions: Employees, and especially top management, should fully understand the host of benefits that can be realized by implementing a QMS. This will result in a strong internal motivation that will lead to achieving the best results from the QMS. All employees should feel responsible for the overall quality of products and services, while they fully understand their role and responsibility in the QMS.

7. Not suitable for the company

Quality Management Systems are sometimes delivered as a ‘one size fits all’ solution. This is a sure recipe for disaster. A QMS that is not aligned with the company’s internal operations and overall strategy will not deliver the results that are required.

Actions: ISO 9001 specifies the results that need to be achieved with the Quality Management System, but does not define how those results should be achieved. It is up to the organization to determine how the results can best be achieved within the context of the organization. The QMS should therefore be designed and adapted to fully support staff, as well as the processes and the business objective.

8. Insufficient customer care

Companies often focus exclusively on quality, but don’t pay attention to customer satisfaction.

Actions: You will have no business if you don’t have customers. At the end of the day, a Quality Management System based on ISO 9001 is intended to enhance customer satisfaction. As one of the objectives is to achieve and maintain the customer’s confidence in your products and services, it is essential that you know your customers’ expectations and requirements so that you can continuously measure customer satisfaction.


We have discussed a number of actions that you can take to ensure that the implementation of your Quality Management System does not fail but is successful.

  • The Quality Management System should be practical for your business
  • Document management must be effective and be aligned with your activities
  • Use an appropriate level of detail for your documentation
  • Keep track of changes so that you can continually improve the QMS
  • Involve employees and regularly communicate with them
  • Ensure that all stakeholders are motivated to achieve the desired results
  • Develop a system that suits the requirements of the organization
  • Always focus on customer satisfaction

ISO 9001 quality management systems (QMS) are implemented using Effivity software in Naples (Italy), while ISO 14001 & OHSAS 18001 Health Safety Management Systems (HSE) are implemented with Effivity in Memphis (Tennessee, USA).

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