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This study aims to develop a novel diagnostic methodology for implementing ISO13485:2016 and test its applicability to improve quality management systems (QMS) in the medical devices industry context.

First, a literature review on the topic was conducted. Second, insights gained from the literature and expert interviews were employed to develop the new maturity assessment methodology. Subsequently, the methodology was tested on a medical device manufacturer. Next, based on the evaluation of the intervention, actions were recommended to improve the QMS.

Research findings have developed a maturity assessment methodology comprising 52 certifiable requirements structured into four macro-requirements derived from ISO 13485:2016. Findings show that the methodology is valuable for aiding QMS implementation, and the diagnosed maturity levels corresponded with the company’s empirical perceptions of the requirement’s maturity.

Empirical evidence validates the significance and practical utility of the proposed methodology, as evidenced by the company’s attainment of FDA (US Food and Drug Administration) approval after the intervention. Findings suggest that the methodology could be replicated within the medical products industry or adapted to assess other QMS, leveraging the organizational alignment with the international regulations of the sector and the ISO 9000 requirements.

The developed methodology fills existing gaps in both literature and practice within the medical devices industry, providing a valuable contribution by addressing the limited research on diagnostic methodologies designed for ISO 13485:2016 implementation. The article assists medical device enterprises in addressing QMS maturity levels as a metric for evaluating QMS requirements, which is an underexplored avenue in existing QMS evaluation approaches.

Small retail stores in the luxury market face significant challenges due to fluctuations in market demand. This task turns challenging as it requires effectively coordinating and translating customer needs into specific requirements that align with retail goals and available resources. However, limited empirical research exists investigating how managers can address service value and quality attributes in small retail stores. This article aims to bridge this gap by investigating the role of quality function deployment (QFD) in improving market and quality requirements management in small retail stores.

Based on the case study, a customer survey was initially conducted to gather information on critical characteristics valued in the luxury retail segment. QFD was used to assist the company in identifying and prioritizing key quality attributes to meet customer requirements effectively.

The findings demonstrate that implementing QFD in small luxury retail stores empowers managers to identify previously neglected product and service quality aspects. The article shows that QFD informs organizational adaptations that align with the demands of the retail market, leading to an improved ability to meet customer expectations and enhance customer value through the development of enhanced products and services. The study showcases the efficacy of the tested methodology in effectively capturing and prioritizing both tangible and intangible customer needs in retail.

Findings offer valuable insights to retail managers of small luxury stores, providing actionable market-oriented strategies. By implementing the recommended practices, managers can improve the store’s competitiveness and better cater to the customer base.

This study contributes to bridging persistent knowledge gaps by addressing the unique context of small luxury retail stores and introducing the application of QFD in this setting. The insights gained from this research are relevant to both retailing and quality management literature. Considering the growing prevalence of transformations in the retail industry, the study provides practical implications for retail managers in effectively navigating these changes.