Quality management in SMEs: Erwin Halder KG

CONTENTS

• ISO 9001 - A standard in transition
• The major revision of 2015
• Quality Managemenent - Indispensable for SMEs
• Quality management in SMEs - Interview with Erich Rosmer, Erwin Halder KG
• Quality management in SMEs - Conclusion
• DQS - Pioneer in the certification of management systems

ISO 9001 - A standard in transition

ISO 9001 was first published in 1987 as a standard for classic quality assurance; the first drafts for the ISO 9000 series were available two years earlier. At that time, a certification audit was still characterized by the schematic processing of 20 elements; at that time, it was not yet possible to speak of a genuine management system standard.

While the first revision of the standard in 1994 was still limited to editorial and conceptual adjustments, and continued to focus on procedures and documentation, the second revision of the quality standard in 2000 offered a decisive change: away from elements and towards process orientation - quality assurance finally became quality management and thus inevitably a matter for top management.

Continuous improvement (CIP) was also officially incorporated into the standard with the 2000 revision. Finally, integrating ISO 9002 and ISO 9003 into ISO 9001 was a major step, which also laid the foundation for a new structure for the content of the standard. The 2008 revision merely added some clarifications; the structure and requirements remained the same.

The major revision of 2015

With the High Level Structure, the major revision of 2015 introduced a new structure for the requirements, with common basic texts and terms across all ISO management system standards. This also meant numerous fundamental changes to the content of ISO 9001. These included, for example, the topic of the context of the organization, taking into account the interested parties.

Top management was now held much more responsible for the management system with the so-called accountability, and the introduction of the risk-based approach brought the concept of risks and opportunities into the organizations. In addition, the organization's knowledge was declared an important resource and a new, more efficient form of documentation was created, which has since been referred to as documented information.

The major revision initially caused some headaches for the users of the standard - in both SMEs and large organizations. After a certain period of familiarization, the new requirements, which were initially described as a "real challenge", ultimately became second nature to them - especially since the major revision actually brought certified organizations a number of advantages and management benefits for their products and services via the quality management system.

Quality Managemenent - Indispensable for SMEs

Erwin Halder KG is a medium-sized company based in Bronnen (Germany) that was founded 85 years ago as a manufacturer of hand tools. Today, in addition to hand tools, the company's portfolio includes a large number of standard parts and products for the aviation industry.

Halder has been certified to ISO 9001 for about 30 years, with the 1994 version marking the company's entry into the world of ISO 9001. The management system is scheduled to be re-certified for the tenth time in September 2024 - and has thus experienced almost the entire development of the quality standard - from its beginnings as a quality assurance standard to the complex management system standard of today.

• How has the family business experienced the sometimes extensive revisions of the standard?
• Why is it considered a prime example of successful quality management?

We talked to Erich Rosmer, Quality Management Representative at Halder from the very beginning, about three decades of quality management.

Quality management in SMEs

Interview with Erich Rosmer, Erwin Halder KG

DQS: Mr. Rosmer, you were there 30 years ago when Halder first introduced a "system for the presentation of quality assurance" in accordance with ISO 9001 and had it certified by DQS. Do you still remember the reasons for this step?

Erich Rosmer: The impetus came from our sales department and from the increasing number of inquiries, for example in the form of questionnaires from our customers on the subject of quality assurance. As a result of this and our own drive to improve processes, the management of Erwin Halder KG decided to obtain ISO 9001 certification. There were no defined customer requirements for certification. DQS was already a leading certification provider at the time and was selected as a partner.

DQS: What role does your quality management system (QMS) currently play - also with regard to market orientation?

Erich Rosmer: The management system is now a central point of our structural and process organization. The original documentation in paper form has been transferred to a corresponding digital documentation tool, which has simplified access, searching and administration. With a view to market orientation, the management decided in 2012 to have our company additionally certified according to the aerospace standard EN 9100.

DQS : When you think of your interested parties, how great is their need for information and can you cover this with the help of the QMS?

Erich Rosmer: Documented processes and definitions in the QMS are extremely helpful and important when answering many questions during regular customer audits. In addition to questions about the QMS, these audits also cover other topics such as corporate social responsibility, guidelines, regulations such as the European Chemicals Regulation or the EU RoHS Directive for hazardous substances, as well as compliance in general.

DQS: Your workforce is a key interested party. How well is the QMS accepted there? What is your experience with internal audits, for example?

Erich Rosmer: After more than 30 years of experience, acceptance among all employees is very high and the significance and importance of the QMS has been internalized. Nevertheless, internal audits are extremely important. In a constantly changing environment, definitions and processes are constantly being adapted. These must be checked for conformity in the audits and corrected if necessary.

DQS: In the past, the issue of conformity had absolute priority, but today the focus has shifted to the active responsibility of management - how does the company benefit from this development?

Erich Rosmer: We very much welcome the fact that the focus today is on actual practice and the goals achieved, as opposed to "fulfilling formalities". This increases the benefits for our company enormously and gives us more freedom in implementing the standard.

DQS: Since the 2015 revision at the latest, risks and opportunities have played a central role in ISO 9001. Let's think, for example, of vulnerability management as an active lever for identifying and exploiting opportunities. What role do external audits play in this context?

Erich Rosmer: They are an important "sparring partner" for the management. Risk management is a central component of operational management. Risks must be known, aware and controlled. Critical external control ensures the quality of risk management. Opportunities often arise through risk mitigation measures.

DQS: What is the balance between risk and opportunity management in your QMS?

Erich Rosmer: Experience shows that risk management clearly predominates.

DQS: In February 2024, ISO published the new ISO amendments on climate change and called for their inclusion in 31 currently published standards. How are you dealing with this in regard to ISO 9001?

Erich Rosmer: The ISO requirement to consider climate change issues in the context of the organization is a valuable impulse that we will also use in the QM system. To support the climate targets as well as for our own "benchmark", we will also introduce an environmental management system in accordance with EMAS this year, and have it validated by an environmental auditor.

DQS: Mr. Rosmer, thank you very much for the interesting interview!

Quality management in SMEs - Conclusion

The practical example of Erwin Halder KG shows impressively how a medium-sized company can achieve sustainable success over three decades by consistently applying the ISO 9001 standard. The continuous adaptation to the standard, which has been revised several times, and the integration of new requirements, have not only increased the internal process quality, but also strengthened the company's market position. Erich Rosmer's experience underlines the importance of flexible and future-oriented QM in medium-sized companies.

DQS - Pioneer in the certification of management systems

The Deutsche Gesellschaft zur Zertifizierung von Managementsystemen (DQS) was founded in 1985 by DGQ (Deutsche Gesellschaft für Qualität e.V.) and DIN (Deutsches Institut für Normung e.V.) as Germany's first management system certifier.

We are the only major certifier to focus on management systems and processes. We have played a pioneering role in this for many years. In 1986, DQS issued Germany's first certificate in accordance with ISO 9001, the world's most important standard for management systems.

In 1991, DQS was the first certification body in Germany to be accredited for ISO 9001/2/3 by what was then TGA GmbH (today: Deutsche Akkreditierungsstelle GmbH, DAkkS). Today, our range of services covers around 200 international regulations and national standards. Our claim always begins where checklists end. Take us at our word!

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