Quality management for microenterprises and start-ups – is the ISO 9001 suitable?

Abstract

Purpose Quality management systems are well established in multinationals and SMEs. For establishing and improving such systems, there is a variety of guidelines. Furthermore, there are software tools allowing a self-assessment of the current state of the implemented systems. However, these approaches do not fit for micro-enterprises and start-ups. Their processes are rather informal or not yet specified. Moreover, these companies are often in a phase of strong growth and have only one person in charge. Hence, they face the difficulty to decide if and how a (quality) management system should be implemented. This paper aims to show a first guideline for implementation. Design/methodology/approach The first step comprises a definition of microenterprises and start-ups and an analysis of their specific characteristics. Following, an overview of the DIN EN ISO 9001:2015 and its requirements is given. Next, it is analysed which requirements are relevant for or can be implemented in microenterprises and start-ups. Based on this, a guideline for decision-making is developed to examine if an application of the analysed standard is useful or necessary for the regarded companies. Also, the guideline illustrates how the requirements can be implemented. Findings A literature review, an analysis of the DIN EN ISO 9001:2015, the standards for project management, microenterprises and start-ups have been carried out. Thereby, the need to decide whether to implement implement a quality management system and assistance for the implementation process has been revealed as essential for the companies considered. Literature mostly deals with implementing a quality and/or project management system in multinationals and SMEs but not in very small companies. Furthermore, first practical examples have shown that microenterprises face difficulties when choosing and implementing a quality management system. A practical implementation guideline for these companies is lacking. Originality/value Although there is a lot of research dealing with quality management in SME, research about quality management in microenterprises and start-ups is scarce. This paper offers a first approach for a guideline of implementing an appropriate quality and possibly an additional or alternative project management in microenterprises and start-ups. This should facilitate the process of deciding if and how to implement an adequate management system for the regarded companies.

An evaluation of documentation requirements for ISO 9001 compliance in scrum projects

“…Lemos et al , 2012; Fernández et al , 2017). Moreover, preserving innovative capabilities are difficult when implementing ISO 9001 documentation since these formally laid out documents require continuous monitoring that can cause tensions (Klute-Wenig and Refflinghaus, 2020). We therefore propose that software organizations pursuing Agile/scrum projects alongside ISO 9001 compliance should review their current level of documentation with concerned software professionals.…”

“…Chiarini et al (2019) are of the view that QMS documentation (e.g. ISO 9001) can introduce “red tape” and bureaucracy that can result in “higher time consumption and additional daily work for employees, as well as for top management” (Klute-Wenig and Refflinghaus, 2020, p. 440). Further, certain concepts are ambiguously stated in the text of ISO standards, which can at the very least complicate or distort its implementation and impact the auditing process (Anttila and Jussila, 2017).…”

“…Our study further affirms that Scrum professionals consider much of the ISO 9001 documentation tasks to be cumbersome requiring extraneous effort. While some documentation is necessary, the auditors focus should be on addressing operational risks and plans on preventing them in the given business context (Klute-Wenig and Refflinghaus, 2020). That is, documentation for agile/Scrum projects should be linked to core processes that focus on preserving innovative capabilities and improving performance in the long-term rather than rigidly reviewing some documented control procedure.…”

“…However, the process documentation is often overstated, especially for Scrum projects, which mainly rely on face-to-face communication during daily stand-ups and sprint retrospectives (Hanssen et al , 2018). This has made some practitioners question if the practice of maintaining documentation outweighs their potential benefits (Rüeping, 2003; Zhi et al , 2015; Klute-Wenig and Refflinghaus, 2020).…”

Efficient Quality Management in MedTech Start-Ups (Based on ISO 13485)

“…This paper describes the documentation to be established for the QMS of an ISO 13485 certified start-up by highlighting the established processes, procedures, and forms to fulfil these ISO standard requirements. The study by Klute-Wenig and Refflinghaus 8 confirmed that the processes in start-ups and micro-enterprises, which may constitute of few developers, are rather informal or not yet specified, even though these companies are often in a phase of strong growth. According to the same study, these small companies face the difficulty to decide if and how a QMS should be implemented, how the corresponding requirements can be fulfilled, and which requirements are relevant.…”