Findings and Implications of ISO 9001:2015 Transition Audit in Manufacturing Related Industry

제조 관련 산업의 ISO 9001:2015 전환심사 시 발견사항과 시사점

The International Organization for Standardization published ISO 9001 Quality Management System– Requirements in 1987 and has revised four times since then. ISO 9001:2015 is the latest edition. This latest edition has two most noticeable changes. The first major change of new edition focuses on performance with an emphasis on Risk-Based Thinking (RBT) to enhance the process approach. The new edition consists of ten clauses whose first three clauses are largely same as older edition but risks are clearly stated and stressed in last seven clauses, emphasizing on Plan-Do-Check-Act cycle at all levels in the organization. The second major change is that the new edition has the same overall structure as other ISO management system standards known as High Level Structure with Annex SL. In this article we aim to statistically analyze minor nonconformities found in different types of transition audits. We try to interpret the findings and summarize the implications of the statistical results.