ISO 9001 explained

What is “ISO” and what does “ISO 9001” mean?

The International Organization for Standardisation (ISO) is a global association of national standardisation bodies. It defines international standards, norms and guidelines for various sectors for quality and safety, with which products, services or similar can be certified. ISO certification thus describes the process by which a company, institution or authority obtains proof of conformity – product compliance.

ISO 9001 is a globally recognized standard for quality management systems that focuses on continuous improvement and customer satisfaction. It helps companies to optimise internal processes and minimise risks.

Development of the standard

ISO 9001 was created in 1987 and is continuously adapted to respond to technical and legal changes such as digitalization. The current version dates from 2015 and initially consists of the chapters Scope, Normative references and Terms and Definitions, which form the basis for the areas of the organisation to be certified. These areas are defined in the following chapters 4 to 10 and include the context of the organisation, leadership, planning for quality management, support, operation, performance evaluation and improvement.

This version of the standard was preceded by several versions. Initially, there were actually three different quality assurance standards, ISO 9001, ISO 9002 and ISO 9003. When these were introduced, a company could decide which standard it wanted to be certified to: ISO 9001 for all areas of the company (design, development, production, assembly and customer service), ISO 9002 for production and assembly or ISO 9003 for inspection and testing, depending on the industry in which the company was active.

The standards were revised in 2000. At that time, there was only one standard, ISO 9001:2000, in which all three standards are now summarised. The latest version is known as ISO 9001:2015 and is currently being revised. A first draft (CD1) was published in April 2024 and submitted to the members of the ISO committee ISO TC 176 for review, who initiated the revision to a second draft (CD2). The revision of the standard focuses on harmonising the structure of the standard with other management system standards and considering topics such as ethics, integrity, vision, mission and values and includes sustainability as part of the ESG-aspects, for example.

Purpose and function of the standard

ISO 9001 is a standard for quality management systems and is used to ensure the quality of a company’s products and services. For example, customer requirements or legal requirements are considered. ISO 9001 serves as the foundation for further sector-specific quality standards.

Sector-specific quality standards are, for example, ISO 13485 in the healthcare sector, ISO/IEC 27001 in the information security sector (details can be read here) or IATF 16949 in the automotive industry. Depending on the different standards, different requirements must be met, including proof of conformity in addition to quality standards such as environmental regulations.

Principles of the standard

ISO 9001 is based on the basic principles of ISO 9000, which comprises the descriptions of the fundamentals of quality management systems and the associated terminology. These seven basic principles form the basis for various quality management standards and are described below.

1. Customer Focus

The success of a company depends largely on the satisfaction of its customers. In order to gain the trust of customers and all stakeholders involved, it is crucial to precisely understand the needs of users. This is the only way to develop products or services that fulfil or even exceed customer expectations.

2. Leadership and Responsibility

Managers of an organisation should act as role models for their employees and develop a clear vision. It is their responsibility to communicate this vision and the underlying values and ethical standards in such a way that they are embedded in the corporate culture and at all levels of the organisation. To achieve this, leaders need to lead by example, take responsibility, encourage open communication and utilise performance indicators that support ways of working that contribute to the achievement of organisational goals and are in line with established targets. They should build trust and reduce fears.

3. Engagement of people

Employees should not only see their work as a means of receiving a salary or wage. This is achieved when they feel emotionally and personally connected to the organisation and are motivated by intrinsic rewards such as recognition or the promotion of knowledge and skills. Motivation also increases when employees are given more responsibility and a say. By giving them authority, they can actively contribute to the further development and shaping of the organisation.

4. Process approach

To pursue a process-orientated approach, all relevant processes of the quality management system must be described and documented in detail. This makes visible which processes are required to achieve the defined objectives and how these processes interact with each other. Measures are defined to measure whether the processes have achieved their objectives, thereby deepened the understanding of the processes and ultimately improving the result.

5. Continuous improvement

Continuous improvement and adaptation are necessary to ensure quality in the long term. Performance is regularly evaluated in order to recognize problems at an early stage and identify potential for improvement. Employees should take part in targeted training to apply the tools of continuous improvement at all levels of the organisation and to be able to respond better to changes and challenges in the future.

6. Evidence-based decision making

One of the aims of quality standards is to ensure comparability. To make decisions on quality levels as objectively as possible, key performance indicators are defined and measurements are carried out. It is essential that the data and information collected is precise, reliable and easily accessible. On this basis, well-founded and comprehensible decisions can be made.

7. Relation management

The success of a company depends on the people within the organisation as well as on external partners and interested parties such as suppliers. It is therefore essential to build trust and maintain strong relationships with everyone involved. A shared understanding of goals and values creates the basis for actively involving and successfully bringing together customers, employees, suppliers and all stakeholders.

Why YOUR company should be „ISO 9001“ certified

ISO 9001 is the most widely used standard in quality management. If companies are ISO 9001 certified, they are perceived as reliable and can benefit from various advantages, which are listed below.

• Transparency: Internal processes, steps and responsibilities are clearly and transparently presented. This means that responsibilities are clearly defined, and problem identification is simplified.
• Costs and time: Quality management procedures can increase the efficiency, productivity and profitability of your company.
• Risk minimization: By meeting the specified standards, the products and services fulfil a certain level of quality and the probability that customer expectations will be met increases.
• Market acceptance: The world-leading quality management system helps to position the company as a supplier, for example, when entering a new market.
• Competitiveness: With the help of a quality seal, investors can be attracted and trade barriers broken down. At the same time, customer trust and employee satisfaction are strengthened.
• Error reduction: Through continuous improvements, errors can be avoided and, if necessary, found and thus corrected more quickly.

Conclusion

The success of a company depends largely on customer satisfaction. Companies that are certified according to ISO 9001 demonstrate reliability and quality, strengthen the trust of their customers and increase their satisfaction. At the same time, the standard facilitates international trade, minimises misunderstandings and increases competitiveness. EFS Consulting supports you in developing the necessary processes and strategies to fulfil the requirements of ISO 9001. This will position your company as a reliable and competitive partner on a global level and ensure your long-term sustainable success.