reasons of failure to implement ISO 9001 QMS

What are the reasons of failure to implement ISO 9001 QMS?


As a data-driven and observant business owner, you may have noticed that most of your competitors are ISO 9001-certified. When you are in a conversation with one of your peers, they may have described the process of acquiring ISO 9001 and implementing a Quality Management System (QMS) as difficult. In fact, you may have even heard of horror stories describing how tedious the implementation process is and how difficult it is to maintain a QMS. In this article, we will outline the reasons of failure to implement ISO 9001 QMS so that you are well prepared and your QMS is implemented smoothly.

ISO 9001 certification; Is ISO 9001 a quality management system?

Before we understand the reasons of failure to implement ISO 9001 QMS, we must understand the ISO 9001 certification process. Firstly, let us answer the question of what ISO 9001 is.

ISO 9001 (ISO 9001 quality management system) contains a set of recommendations in the form of policies and procedures that help organisations implement an effective QMS. The purpose of the QMS is to create streamlined operations that enhance the quality of products/services of an organisation. Once a company implements these recommendations in their organisation and has a working model of the QMS, they must observe it for a few months. After its testing period, organisations must conduct an internal review to check if the QMS is functioning as described in the ISO 9001 standard. If there are no differences or “non-conformances,” then the organisation is ready to undergo an external audit.

An external audit is an assessment conducted by an accreditation party that is objective, fair and unbiased. During this audit, the accreditation body checks the organisation’s documentation, evaluates the efficiency of the processes and interviews process owners to understand how the QMS is functioning. If the QMS is functioning as described, the organisation is awarded a certificate.

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Reasons for failure to implement ISO 9001

Now that you understand the certification process, let us discuss the common mistakes that cause organisations commit that lead to the failure of the implementation of the QMS. Examples of such common mistakes include:

Jumping into the process

When an organisation jumps into the certification process without spending a lot of time in the preparatory phase, they are ill-equipped or less prepared to face the external auditor. Practically, this means that the documentation is not up to the mark, their personnel are not adequately prepared or have no idea how the QMS functions and their processes are “bulky.” Essentially, they do not meet the recommendations of the standard. An easy way to deal with this situation is to spend time in the pre-certification period, really understanding what the standard wants you to do.

Bulky processes

By reading the above statement, you must be wondering what a “bulky” process is. One of the core requirements of implementing a QMS based on ISO 9001 is to have a “process approach.” This approach urges organisations to really evaluate their processes to see if there are any overlaps, redundancies or unnecessary bureaucratic clauses. The solution is to evaluate your processes so that they become “leaner.”

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Lack of engagement of employees

Engagement of employees and leadership involvement are other pertinent quality management principles that must be implemented in your organisation in order to achieve certification. When an external auditor comes to your organisation and interviews your process owners, they will be able to find out if the employees have been appropriately engaged. This will lead to a compliance failure. To address this issue, leaders must be appropriately involved, and employee engagement should be done. This means that leaders should create quality policies and invest resources in appropriately training their personnel to interact with the new QMS.

Organisational resistance

Sometimes, the failure of the QMS is not related to the external audit but to internal reasons. Employees are hesitant whenever changes are being made to how tasks are being done and, therefore, can create organisational resistance towards the QMS. To mitigate this issue, managers must explain how the QMS will reduce the workload and its other benefits.

Not hiring an ISO 9001 consultant

The biggest obstacle in implementing a QMS is thinking that you can do it alone. Business owners simply don’t have the experience to understand the technical terms of the standard. Hiring a consultant is extremely helpful as they provide customised guidance that will prevent QMS failure and allow the certification process to be successful.

An expert ISO 9001 consultant will guide you to implementing  ISO certification without any difficulty.

ISO 9001 cost; The cost depends on the type of industry

The cost of ISO certification is always variable and depends on factors such as your industry and complexity. However, a good estimate is $15,000 per annum for a medium-sized organisation with approximately 1000 employees.

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Edara Systems consultants help you to skip ISO implementation failure

There are many reasons why reasons of failure to implement ISO 9001 QMS happens, and it can include not spending enough time in the preparatory phase, not hiring an ISO consultant, not preparing for upcoming organisational resistance, improper leadership involvement, lack of employee engagement, and not implementing a process approach. The solution to all these problems is simple; you must spend time understanding the standard’s recommendations. Therefore, if your QMS is compliant, it will not fail. If you are interested in getting more information about ISO 9001 cost, call the Edara Systems phone number or fill out the pop-up message form and the Edara Systems consultants will contact you.

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