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Successfully introduce and certify DIN EN ISO 9001: 2015

What is ISO 9001 about?

DIN EN ISO 9001: 2015 specifies the requirements for implementing a quality management system. These requirements support companies in setting up processes that, on the one hand, predictably increase customer satisfaction and, on the other hand, support the stability and success of the company.

Starting with the requirements for processes and process management, through tasks of leadership and management as well as aspects of the planning of the management system to specific requirements for the value-adding processes, control loops and improvement measures, DIN EN ISO 9001: 2015 covers all aspects of a modern management system.

A company certified according to DIN EN ISO 9001: 2015 shows externally that it has met the minimum of these requirements and is therefore a reliable partner for customers, authorities, suppliers and other organizations.

What are the challenges during the implementation?

The DIN EN ISO 9001: 2015 is written as a standard in a very formal language. Understanding these takes practice and experience. So the first challenge is to avoid misunderstandings.

DIN EN ISO 9001: 2015 introduces the risk-based approach. This means that the standard does not make any concrete specifications for the implementation of the requirements. These implementations must be determined in the company on the basis of the industry requirements as well as the risk for the company, customers and society. So the second challenge is to find the right level in implementation; As much as necessary, as little as possible.

DIN EN ISO 9001: 2015 is a process-oriented standard. This means that the individual requirements must not be interpreted separately from the overall standard. The relationship between the requirements is what makes the standard so strong. Recognizing these relationships and knowing their typical implementation in the company is difficult, especially at the beginning, for the quality departments and management. The third challenge is to understand the overall logic of quality management according to DIN EN ISO 9001: 2015 and to align it with the company's strategic approach.

The final challenge is to ensure that the quality management system does not become a paper tiger. It's not about just creating documents, but about supporting employees and managers in the company in doing their day-to-day work for the satisfaction of customers.

Selected case studies

ISO 9001: 2015 - mechanical engineering

initial situation

As part of the ISO 9001 certification, our customer relied on a management system made up of a wide variety of document templates. Rapid growth meant that the management system and the real company structure, with its processes, differed more and more from each other. The result was that some discrepancies were found in the recertification audit.

After DECURA got involved, we first got an overview of the risks and problems at the customer with our own GAP audit. We were able to identify the customer's understanding of his QM system as the core cause. There was specific QM documentation that differed from the operational reports and documents. So a parallel structure was built for QM.

Unternehmen für Maschinenbau
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ISO 9001: 2015 - software development

initial situation

Our customer is an established software developer with 12 employees and a network of around 20 freelance developers.

Due to the requirements for a public tender, an ISO 9001 certification had to be proven within five months.

The management wanted to use this impulse not only to prove the certification, but also to improve the business processes and the software validation process.

IATF 16949: 2016 - Motor and Battery Production

initial situation

Due to a legal change in China, our customer had to prove the certification of one of his production lines according to IATF 16949 within four months. At this point in time, the plant was exclusively certified according to ISO 9001.

Market approval for an entire product category was in jeopardy.

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