A maturity assessment methodology for ISO 13485 implementation in the medical devices industry

Abstract

Purpose

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.

Design/methodology/approach

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.

Findings

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.

Practical implications

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.

Originality/value

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.

Citation

Linck, W., Tinoco, M.A.C., Bonato, S.V., Grochau, I.H., Pacheco, D.A.d.J. and Ten Caten, C.S. (2024), "A maturity assessment methodology for ISO 13485 implementation in the medical devices industry", International Journal of Quality & Reliability Management, Vol. ahead-of-print No. ahead-of-print. https://doi.org/10.1108/IJQRM-05-2024-0163