What is ISO 9001? Quality management system explained

Last Updated at: Dec 03, 2020
ISO 9001
What is ISO 9001_ Quality management system explained
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ISO 9001 is an international standard, which every company has to look forward to achieve. It is important for all companies to have a strategic plan to meet the quality principles and guidelines that are essential for efficient business practice. Also, there should be important on customer satisfaction, efficiency and more.

ISO 9001 standard is much more than a standard and should be a part of every company’s strategic plan rather than just a certification. The guidelines and quality principles in ISO 9001 certification are essential for good business practices.

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All the companies strive to increase their efficiency, customer satisfaction and profitability but all of them rarely think about the standard and rarely tap into the real power of ISO 9001. 

ISO 9001

The value of ISO 9001 Certification has been subject to a great debate in recent years. Organizations that continue to debate rather than take action are registered to the prospect of poor business growth and being incapable of competing with organizations that have moved beyond debating the topic.

One of the most important benefits of this standard is the principle of employing the process which is the approach to management. ISO 9001 results in a reduction in waste, enhanced quality, productivity, improved attention to detail and also improved standards of health and safety performance. Thus ISO 9001 should be thought of as a business management tool for the organization to drive and understand the real value and results.

The process

ISO 9001  being a complete guide is meant to be used as a business tool by the management which is of great benefit to the management which ultimately results in the profitability of the company. It is necessary that every employee in the organization should have a basic understanding of how the organization functions, about the revenues, the flow of cash, the various processes followed as without knowing such important things it will be difficult for the employees to diagnose the problems. This process identification involves four principles.

    • Understanding and meeting requirements
    • Considering the process in the terms of added value
    • Obtaining the result of the process and the effectiveness
    • Continual improvement of processes on the measurement of the objectives.

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Meeting the requirements of ISO 9001

Most of the problems in the organization occur due to minimal knowledge about the ISO 9001 requirements and it often results in the underperformance of the employees as they are not aware of what their job requires which results in the dissatisfaction of the customers. Understanding the requirements is the responsibility of both the parties involved. Both the employees and the customers must be educated on the standard requirements.

Processes in terms of added value

The organization should add value internally and externally, all through the way starting from capturing the customer requirements till the final delivery.

This will become possible only when the ISO 9001 is seen as a quality management tool and not as a marketing tool to attract customers. This process helps in the transformation of the raw materials into the desired output. Without the proper utilisation of the ISO 9001, the organisation will fail to add value when the output of the process is delivered.

New standard

The ISO 9001 latest version was published in 2015 and all the organizations having ISO 9001: 2008 certification were to be transformed to 2015 standard, if not the certification is void.

The important amendment made in the year 2015 was in the Annex SL. It had a gap analysis performed to identify any potential nonconformities so that it can be addressed to the certification audit. It includes the concept of risk-based thinking, new leadership requirements etc…

The audit process is both internal and external. Audits are the key component for becoming ISO certification.

On-site audits: These are performed in full days, the number of days depends upon various factors like the size, complexity, nature of the organization.

Remote audits: this is done via web meetings, teleconferencing or electronic verification of process but this type is not very common

A certification audit is an audit where the selected registrar will conduct to verify conformance against the ISO 9001 certificate; the auditor will interview the staff, and also review the documented information to make sure all ISO 9001 requirements are fulfilled.


Some of the documents required are the quality manual, policy, objectives and records and it also includes the six procedures which are control of documents, records, internal audit, control of nonconforming product, corrective and preventive action


A company needs to understand its processes in order to monitor its performance and to assess effectiveness. A quality management system should be a strategic part of the overall business plan, so it’s important to determine if the process is assisting the organization of why the process was initially created.

Continuous improvement based on objective measurement.

Many organizations may not reach their full potential and remain stagnant and the reason being is that they don’t have a mechanism to drive continual improvement. They simply run by tackling the surface issues, putting up with firesand responding to day to day problems rather than addressing the process performance issues based on objective measures. This is the main reason as to why the small and medium-sized companies remain in the same level and the large companies don’t achieve the maximum profitability.  ISO 9001 provides objective measures to continually drive improvement.

Here are the list of documents required for ISO Certification

ISO Certification


 Therefore, ISO 9001 is a  quality management system standard and should be used as a business management tool. Focusing on implementing this process approach will lead to a systematic method of identifying and controlling the process to ensure requirements are understood and met in an effort to add real value. Once the processes are mentioned through objective measurements, an organization can focus on the actual cause of process performance issues. 

Click here to know how ISO certification can boost your sales.

ISO 9001 should be used an effective business management tool to ensure the company and its products adhere to this international standard. Once you understand the requirements of this quality standard, you will be able to make an effort to add value to your products and services. So, ensure to adhere to ISO 9001 certification and take your business to the next level.