DIFFERENCE ISO 9001:2015 AND QMS

ISO 9001:2015 and QMS (Quality Management System) are closely related but not identical concepts. Here's the distinction:

ISO 9001:2015

• Definition: ISO 9001:2015 is a specific international standard for quality management systems, published by the International Organization for Standardization (ISO).

• Purpose: It provides a framework for organizations to ensure they meet customer and regulatory requirements and strive for continuous improvement.

• Key Features: Focus on risk-based thinking and process-based approaches. Emphasis on leadership, customer focus, and continual improvement. Contains detailed requirements for establishing, implementing, maintaining, and improving a QMS. Certification is available, demonstrating compliance with the standard.

• Applicability: ISO 9001:2015 applies to organizations of all types and sizes.

Quality Management System (QMS)

• Definition: A QMS is a generic term for the structured system organizations use to manage and improve the quality of their processes, products, and services.

• Purpose: Helps organizations achieve consistent quality, meet customer requirements, and enhance satisfaction.

• Key Features: Includes policies, procedures, processes, and resources required for quality management. Can be tailored to specific organizational needs, industry standards, or regulatory requirements. Not always aligned with ISO standards—an organization can have a QMS without adhering to ISO 9001:2015.

• Applicability: A QMS can exist without being tied to any specific standard like ISO.

Comparison

Aspect ISO 9001:2015 QMS

Nature A standard to follow A system to implement

Scope Specific framework for QMS Broader concept encompassing any quality-focused system

Certification Organizations can get certified No formal certification; varies by design

Focus Global benchmark for QMS Organizational-specific goals and needs

Requirements Defined explicitly in the standard Determined by the organization

Requirements

Defined explicitly in the standard

Determined by the organizationIn short, ISO 9001:2015 is a specific standard that provides guidelines for implementing a QMS, while a QMS is a broader concept that may or may not align with ISO 9001:2015.