Suitability of ISO 9001:2015 standard in the digital transformation context: literature review

Purpose – The last revision of the ISO 9001 standard (quality management systems) was carried out in 2015 when Industry 4.0 was still in its infancy, and the concept of Quality 4.0 was only introduced after that revision. This study aims to review the literature focusing on the suitability of ISO 9001 considering the current context of Digital Transformation (DT). The literature review intended to identify articles that discuss gaps, or outdated features of ISO 9001, or misalignments with current needs, or contributions to the debate on updating ISO 9001, or mentions of the need to update ISO 9001, or proposals for revising its requirements, or references to a future research agenda.
Design/methodology/approach – A systematic literature review was accomplished using the PRISMA methodology to summarise the literature published between 2011 and 2023, available on Web of Science and Scopus. The search query was “ISO 9001” or “quality management system” and terms related to DT or synonyms. The list was imported into Rayyan software to analyse the data from the relevant literature.
Findings – After using a set of predetermined inclusion and exclusion criteria, the literature review revealed few articles investigating changes or future approaches to ISO 9001 because of DT. Only less than 1% of the articles were selected with data relevant to the study. The literature has provided some insights in approximately a quarter of the articles included, but more details are needed toidentify possible changes to ISO 9001. Approximately 50% of the articles identified refer to integrating ISO 9001 and Industry 4.0 as a future research agenda.
Originality/value – The main topics of the articles that identified gaps, obsolescence, misalignments of ISO 9001 with current needs, contributions to discussions on updating ISO 9001, references to the necessity of its revision, and proposals for revising its requirements were sustainability, innovation, risks (especially with analytics, predictive software and artificial intelligence (AI)), Stakeholder identification accompanied by objectives, measures and monitoring, dynamic inter-organisational relationships, cyber-security (data protection and security aspects), validation of quality control equipment based on AI and decision-making and problem-solving processes, including a more simplified language and writing style of ISO 9001:2015 requirements.

ISO 9001:2015, Digital Transformation, Quality 4.0, Industry 4.0