ISO 9001:2015 is the latest version of the Quality Management System (QMS) standard developed by the International Organization for Standardization (ISO). It provides a globally recognized framework for organizations to consistently deliver products and services that meet customer and regulatory requirements while continually improving overall performance.

Key Features of ISO 9001:2015

• Risk-Based Thinking

  Unlike earlier versions, ISO 9001:2015 emphasizes identifying, evaluating, and addressing risks and opportunities to enhance resilience and prevent nonconformities.

• High-Level Structure (HLS)

  It follows a common structure (Annex SL) used across ISO management system standards.

• Leadership Commitment

  Greater emphasis is placed on top management to demonstrate leadership, accountability, and commitment to the QMS, ensuring quality objectives align with business strategy.

• Context of the Organization

  Organizations are required to understand internal and external factors (business environment, stakeholders, industry trends) that may affect the QMS.

• Process Approach

  Encourages viewing activities as interconnected processes, focusing on inputs, outputs, monitoring, and continual improvement.

• Performance Evaluation

  Stronger focus on measurement, analysis, and evaluation of processes and customer satisfaction.