Radu-Marian BUJDOIU1, Mihai DRAGOMIR2, Aurel Mihail TITU3,4, and Constantin OPREAN5,6
ABSTRACT: The ISO 9001 standard remains the most widely implemented framework for Quality Management Systems (QMS), with its revisions reflecting the need to adapt to technological, economic, and organizational change. This study provides a critical analysis of recent updates to ISO 9001, with a focus on the 2015 revision, which introduced a risk-based approach, strengthened leadership responsibility, and emphasized the role of organizational context and knowledge management. By examining the historical evolution of ISO 9001 and comparing previous versions with current requirements, the research highlights the shift from a document-oriented model to a strategic management framework that fosters continual improvement, resilience, and integration with other ISO standards. The findings suggest that while these updates enhance relevance and flexibility across industries, they also introduce challenges in implementation, requiring significant organizational alignment, resource commitment, and cultural adaptation. Future implications for digitalization and sustainability are also discussed.
KEYWORDS: ISO 9001, Quality Management System, Risk-Based Approach, Organizational Context, Continuous Improvement.
DOI 10.56082/annalsarscieco.2025.4.60
1National University of Science and Technology POLITEHNICA Bucharest, 313 Splaiul Independenței, București, Romania,, ORCID No. 0009-0003-3986-2812, radubujdoiu101099@gmail.com
2Technical University of Cluj-Napoca, 103-105 Muncii Blvd, 400641, Cluj Napoca, Romania; ORCID No. 0000-0003-0561-4274; mihai.dragomir@muri.utcluj.ro
3Lucian Blaga University of Sibiu, 10 Victoriei Street, Sibiu, Romania, Corresponding author, ORCID No. 0000-0002-0054-6535, mihail.titu@ulbsibiu.ro
4Academy of Romanian Scientists, 3 Ilfov Street, Bucharest, Romania
5Lucian Blaga University of Sibiu, 10 Victoriei Street, Sibiu, România,, 0000-0002-1710-0660, constantin.oprean@ulbsibiu.ro
6Academy of Romanian Scientists, 3 Ilfov Street, Bucharest, Romania
PUBLISHED in Annals Academy of Romanian Scientists Series on Economy, Law, Sociology, Volume 8 no 4, 2025