BS EN ISO 9001:2015

With more than a million organizations certified to it globally, ISO 9001 is the most widely recognized standard in the world. It sets out what’s needed to implement a quality management system – the purpose of which is to improve overall performance and provide a sound basis for sustainable development initiatives. 

It’s suitable for all types of organization, irrespective of size, location or sector. 

ISO 9001:2015:

• Enables you to better align and integrate multiple management standards
• Takes a risk-based approach, becoming a tool for preventive action
• Moves away from prescriptive paperwork
• Helps organizations of every kind to improve customer satisfaction and build a sustainable future

This fifth edition of the standard cancels and replaces the 2008 version, which has been technically revised through the adoption of a revised clause sequence and adoption of revised quality management principles and new concepts.

The 2015 version reflects many changes in the way we do business now – using new technology, with greater access to information, higher customer expectations, globalization and the increasing importance of service industries.  

The standard has lost none of the rigour of earlier versions, but cuts bureaucracy by being less prescriptive and focusing more on the context of each organization. It guides organizations to build a management system suited to specific organizational needs without imposing irrelevant paperwork or requirements which add no value.

Contents                                                                                                          

Foreword

Introduction

• Scope
• Normative references
• Terms and definitions
• Context of the organization
  • Understanding the organization and its context
  • Understanding the needs and expectations of interested parties
  • Determining the scope of the quality management system
  • Quality management system and its processes
• Leadership
  • Leadership and commitment
    • General
    • Customer focus
  • Policy
    • Establishing the quality policy
    • Communicating the quality policy
  • Organizational roles, responsibilities and authorities
• Planning
  • Actions to address risks and opportunities
  • Quality objectives and planning to achieve them
  • Planning of changes
• Support
  • Resources
    • General
    • People
    • Infrastructure
    • Environment for the operation of processes
    • Monitoring and measuring resources
    • Organizational knowledge
  • Competence
  • Awareness
  • Communication
  • Documented information
    • General
    • Creating and updating
    • Control of documented information
  • Operation
    • Operational planning and control
    • Requirements for products and services
      • Customer communication
      • Determining the requirements for products and services
      • Review of the requirements for products and services
      • Changes to requirements for products and services
    • Design and development of products and services
      • General
      • Design and development planning
      • Design and development inputs
      • Design and development controls
      • Design and development outputs
      • Design and development changes
    • Control of externally provided processes, products and services
      • General
      • Type and extent of control
      • Information for external providers
    • Production and service provision
      • Control of production and service provision
      • Identification and traceability
      • Property belonging to customers or external providers
      • Preservation
      • Post-delivery activities
      • Control of changes
    • Release of products and services
    • Control of nonconforming outputs
  • Performance evaluation
    • Monitoring, measurement, analysis and evaluation
      • General
      • Customer satisfaction
      • Analysis and evaluation
    • Internal audit
    • Management review
      • General
      • Management review inputs
      • Management review outputs
    • Improvement
      • General
      • Nonconformity and corrective action
      • Continual improvement

Annex A (informative) Clarification of new structure, terminology and concepts

Annex B (informative) Other International Standards on quality management and quality management systems developed by ISO/TC 176

Bibliography

This standard BS EN ISO 9001:2015 Quality management systems. Requirements is classified in these ICS categories:

• 03.120.10 Quality management and quality assurance
• 03.100.70 Management systems