ISO 9001 is an international standard published by the International Organization for Standardization (ISO) that specifies the requirements for a quality management system. ISO 9001 standards were first created in 1987 and were updated over time as business needs changed. The last update was made in 2015. Updating ISO 9001 according to new needs has enabled it to gain a flexible structure. Today, ISO 9001 is among the most popular and widely used quality management system standards worldwide.
ISO 9001 standards provide a number of criteria for companies to implement and maintain effective quality management practices. ISO 9001 aims to improve all areas and processes of a company and increase customer satisfaction. For this reason, it is a standard preferred by companies that want to create a culture of continuous improvement, increase customer satisfaction and make radical changes.
ISO 9001 certification reassures customers that the company has established a quality management system based on the seven core quality management principles of ISO 9001. For this reason, many companies demand ISO 9001 certification from their suppliers.
In short, companies can improve quality by applying ISO 9001 and provide products/services that meet customer needs. At the same time, ISO 9001 applications have the ability to increase customer confidence, streamline processes and increase efficiency.
The requirements of ISO 9001 consist of a total of 10 mandatory and non-mandatory items. In order for an enterprise to receive a certificate in accordance with the ISO 9001 standard, it must meet the mandatory ones from the 10 items. These requirements ensure the successful implementation of the company’s quality management system.
The ISO 9001 standard is basically divided into 10 parts. The first 3 items contain non-mandatory requirements. These 3 articles are an introduction to the standard and only explain the scope, terms and references of the standard. Articles 4 to 10 contain the mandatory requirements of the Quality Management System that the company must certify.
This clause defines the scope of the objectives of the quality management system, underlining that it does not contain any mandatory requirements. It clearly expresses the basic objectives of a quality management system, such as increasing customer satisfaction and providing quality products or services.
This article clarifies in detail the definitions and terminology used in the ISO 9001 standard.
The third article aims to detail the basic concepts, explanations and glossary related to the ISO 9001 standard.
This article includes aspects that provide a full understanding of the company. The fourth item provides to define the purpose of the company, the factors affecting the quality of the service or product, its customers and stakeholders, the requirements for determining the scope of the quality management system.
One of the mandatory requirements under ISO 9001 is leadership. This clause emphasizes that top management should take responsibility for establishing a quality management system by performing tasks such as maintaining customer focus, defining a quality policy, and assigning company-wide responsibilities.
The purpose of this article is to establish a structure for recording the potential risks and opportunities faced by the company, with the ultimate goal of developing strategies that will minimize negative impacts and increase positive outcomes.
This clause deals with the management of all resources necessary for the company to successfully implement its quality management system, such as human resources, work environment, infrastructure, buildings, monitoring and measurement.
This clause summarizes the company’s objectives for creating, launching and delivering products or services, taking into account the risks and opportunities identified in the previous sections.
The ninth item describes the requirements to ensure the good functioning of the quality management system. In order to understand that the changes made are permanent and beneficial, it is necessary to monitor and measure the processes and evaluate customer satisfaction in order to fulfill these requirements.
This last item focuses on the continuous improvement of the quality management system, which includes the assessment of process irregularities and the implementation of corrective actions. Continuous improvement is essential for the quality management system to have a long-term impact and ensure success.
As can be seen, continuous improvement is one of the basic and mandatory requirements of ISO 9001. Within the scope of Article 10 of ISO 9001, companies must effectively manage their improvement processes in order to successfully implement quality management system standards.
The efficient implementation of the QMS within the scope of ISO 9001 also depends on the participation of the employees. Employees make the best contribution to the improvement processes as they know the job they do and the company they work for in the best way possible. For this reason, it is very important to collect suggestions, ideas and feedback from employees for the successful execution of improvement processes. The Suggestion System, one of the four modules of the Continuous Improvement Solution, provides the digital gathering and evaluation of the feedback received from the employees regarding the problem areas.
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