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You might have thought how ISO 9001:2015 many often do not have sufficient impact in an organization even it is an international standard. The problem is not with the standard but the way the organizations looks at it and implements it. ISO 9001:2015 standard has been implemented in many organizations and is one of the most popular standards of the International Organization for Standardization (ISO). It has proven records of adding values to many other organizations in the world, especially in their product and service as well as reputation in the market by enhancing customer satisfaction.

There are multiple factors we found that the ISO 9001:2015 certificate or the Quality Management System is not adding any values to the organizations. In this article we will explain our experience of consulting 100 different organizations on ISO 9001:2015. However, the factors can vary in industry sector, local or multinational organization, the culture and values of the organization etc. Also, this is to add that our experience is with the organizations located in Bangladesh only. So, this may vary in other country based on the knowledge, values and culture of the organizations.

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Leader

Factor 1: Leadership

The main factory what we found is the lack of seriousness among the leaders or top management of the organization in the management system. If the top management do not give importance in the implementation of the QMS, many often the employees who work for different activities and implementation of the standard could not do what it requires. They get very few times from the management for working and implementing the requirements of QMS and gradually it becomes a pain in the ass for them. Also, when there is a lack of awareness and understanding of the standard in the top managements, they usually are not interested to implement it effectively.

Role of Top Management for making QMS effective:

  1. First of all, the top management need to have solid knowledge on the requirements of the standard.
  2. Secondly, they have to have good vision of implementing the standard and how it is going to impact the organization in a good way.
  3. They need to assign appropriate person to manage the QMS.
  4. Their commitment should be reflected in their actions for the QMS.
  5. They should be able to explain how they are committed in the clauses mentioned in ISO 9001:2015 standard clause 5.1 “Leadership and Commitment”. They should also be able to explain what initiatives they have taken for each requirement.
  6. The top management needs to be honest, sincere and proactive to make sure the QMS will ad value to the organization.
  7. Top management need to engage all the employees in the organization to the implementation of the management system. They have to understand that it is not a duty for some employee but for all the employees.
  8. The top management need to make all the employees accountable for the effective implementation of the quality management system.
  9. The top management need to do the management review very seriously and follow up the decisions made during the review meeting.
  10. Finally, a well reputed and experienced consultant need to be onboarded who have sound knowledge in the relevant standards of QMS to teach them on the implementation of the standard and explain the effectiveness to the employees.

Read this article to know “How to choose your QMS Consultant”.

Factor 2: Management Representative/Coordinator/Implementor:

The Management Representatives, QMS coordinator and the implementers play a vital role in the effectiveness of the implemented QMS. One of the most important factors what we found is the seriousness in the MR, QMS Coordinator or implementor. Sometimes they do not involve or even restrict other employees to the QMS and makes it just a routine work for themselves. In such cases, the QMS do not have any impact in the organization and the certificate becomes just a piece of paper

Competent Person

Role of the Management Representative (MR) in the Quality Management System effectiveness:

The following role of an MR described here is not a top management but a senior managerial role working directly with the employees (i.e. QMS Manager, QMS Coordinator).

  1. The MR need to be accountable for the QMS, not only responsible. This is a highly self-driving role he/she needs to play for the effectiveness of the QMS.
  2. He/she needs to understand the vision of the organization and the top management to understand how the QMS implementation will be aligned with it.
  3. He/she needs to regularly report to the top management proactively on different issues of the QMS implementation regularly and consistently.
  4. The MR needs to engage all the employees of all the processes and departments based up on their roles and ranks. For example, a cleaner will have much smaller role than a production manager or sales manager in the QMS.
  5. He/she should know all the requirements and must have a deep understanding how these will be implemented in his/her organization.
  6. The MR needs to have good knowledge on the legal requirements and compliance. He needs to know these requirements need to be implemented.
  7. If the MR works is going to work directly with the employees, he/she needs to have capability of taking critical decisions based on the problems he/she faces during implementing the ISO 9001:2015 standard.
  8. The MR needs to understand that QMS is not a thing which is implemented once and it will be reviewed only in certain time of the year (i.e. before surveillance audit or internal audit) but a system which needs to be maintained all the time the organization is operating in producing its product or service.
  9. The MR needs to understand that the Quality Management System is more a mindset than some paper works or activities.
  10. The MR will be able to demonstrate each requirement’s importance to any employee or top management by giving practical example from the organization he/she is working in.
Consultancy
Consultancy
Achieve Goal

Factor 3: Purpose of ISO 9001:2015 certification

Many organizations get the ISO 9001:2015 certification for the purpose of getting a project, applying for tender, attracting buyers, fulfill the requirements of the customers etc. They think the certificate as a medium of their other purpose to be fulfilled. Many often the organizations do not have any idea how the effective implementation of this international standard can benefit them. When the primary purpose of getting the certificate is different than the proper implementation and develop an effectiveness quality management system, the certificate does not bring any benefit to the organization.

These 3 factors are the major factors when an organization can get the indented benefit of implementing the standard ISO 9001:2015. There are many other reasons but these are the main reasons for organization are not getting benefits from this international standard.

Factor 4: Not analyzing the customer feedback and satisfaction

Many cases organizations collect the feedbacks but do not do necessary analysis. Sometimes, they do the analysis wrong and take decisions or actions which are not according to the customers expectations. This causes the organizations to lose faithful customers and fall behind the competition. Even the interested parties’ needs and expectations are also not collected appropriately many often. This leads to business interruption and operation process becomes more complicated. Competent suppliers and vendors move out and poor-quality product and service gets into the system.

Customer Rating
Risk & Opportunity

Factor 5: Failing to identify the organization Risks and Opportunities

Each business has its own type of risks and opportunity based on industry type, location, community, stakeholders etc. Each kind of business is usually build based on the business opportunity which the owners think of. With the opportunity, there are risks factor as well for every business. Reducing the risks and increasing the opportunity is the main goal of all business owners. Failing to identify these risks and opportunity time to time is a major factor business fall. Even the risks and opportunity identified during building the business may drastically change in a matter of time. So regularly doing risk and opportunity assessment is a must for any organization. This is a requirement of ISO 9001:2015 standard.

Every requirement of the ISO 9001:2015 standard is very important and nonconforming to any requirement can lead to have negative consequences in the business. It’s wise to look deeply into each clause and implement in according to the organizational context.