EN ISO 9000 standards - Quality Management Systems

Standards EN ISO 9000 family is the most applied quality management systems standard in the world. It is applied by companies of any size and sector

The EN ISO 9001 Family

The EN ISO 9000 family standards include:

• EN ISO 9001:2015 - Quality management systems - Requirements (ISO 9001:2015)
• EN ISO 9004:2018 - Quality management - Quality of an organization - Guidance to achieve sustained success (ISO 9004:2018)
• EN ISO 9000:2015 - Quality management systems - Fundamentals and vocabulary (ISO 9000:2015)

One of the most applied standards worldwide

EN ISO 9001:2015 establishes the requirements for quality management systems and can be used by any organization, large or small, regardless of its sector of activity. The International and European standard EN ISO 9001 is the world's most applied Quality Management System standard, with more than 1 million companies certified according to this standard all over the world.

The EN ISO 9001 quality management systems standard is also the most required standard in the context of Public Procurement, both at the European and at the national level, in Europe.

Content of EN ISO 9001

The main sections of the EN ISO 9001 standard are:

• 4 Context of the organization - 4.1 Understanding the organization and its context; 4.2 Understanding the needs and expectations of interested parties; 4.3 Determining the scope of the quality management system; 4.4 Quality management system and its processes.
• 5 Leadership - 5.1 Leadership and commitment; 5.2 Policy; 5.3 Organizational roles, responsibilities and authorities.
• 6 Planning - 6.1 Actions to address risks and opportunities; 6.2 Quality objectives and planning to achieve them; 6.3 Planning of changes.
• 7 Support - 7.1 Resources; 7.2 Competence; 7.3 Awareness; 7.4 Communication; 7.5 Documented information.
• 8 Operation - 8.1 Operational planning and control; 8.2 Requirements for products and services; 8.3 Design and development of products and services; 8.4 Control of externally provided processes, products and services; 8.5 Production and service provision; 8.6 Release of products and services; 8.7 Control of nonconforming outputs
• 9 Performance evaluation; 9.1 Monitoring, measurement, analysis and evaluation; 9.2 Internal audit; 9.3 Management review.

Bibliography to consult when implementing a Quality Management System (QMS) in an organisation

EN ISO 9004 - Managing for the sustained success of an organization — A quality management approach
ISO 10001 - Quality management — Customer satisfaction — Guidelines for codes of conduct for organizations
ISO 10002 - Quality management — Customer satisfaction — Guidelines for complaints handling in organizations
ISO 10003 - Quality management — Customer satisfaction — Guidelines for dispute resolution external to organizations
ISO 10004 - Quality management — Customer satisfaction — Guidelines for monitoring and measuring
ISO 10005 - Quality management systems — Guidelines for quality plans
ISO 10006 - Quality management systems — Guidelines for quality management in projects
ISO 10007 - Quality management systems — Guidelines for configuration management
ISO 10008 - Quality management — Customer satisfaction — Guidelines for business-to-consumer electronic commerce transactions
ISO 10012 - Measurement management systems — Requirements for measurement processes and measuring equipment
ISO 10013 - Guidelines for quality management system documentation
ISO 10014 - Quality management — Guidelines for realizing financial and economic benefits
ISO 10015 - Quality management — Guidelines for training
ISO 10017 - Guidance on statistical techniques for ISO 9001:2000
ISO 10018 - Quality management — Guidelines on people engagement
ISO 10019 - Guidelines for the selection of quality management system consultants and use of their services

Other standards of interest include

ISO 14001 - Environmental management systems — Requirements with guidance for use - See also EN ISO 14000 family standards
ISO 19011 - Guidelines for auditing management systems
ISO 31000 - Risk management — Principles and guidelines
ISO 37500 - Guidance on outsourcing
ISO/IEC/IEEE 90003:2018 - Software engineering — Guidelines for the application of ISO 9001:2015 to computer software
EN 60300-1:2014 - Dependability management - Part 1: Guidance for management and application (identical adoption of IEC 60300-1 - Dependability management — Part 1: Guidance for management and application)
EN 61160 - IEC 61160 - Design review

Quality management principles

  The Quality Management Principles, as defined by ISO are:

• Customer focus: The primary focus is to meet customer requirements and to strive to exceed customer expectations
• Leadership: Leaders at all levels establish unity of purpose and direction and create conditions in which people are engaged in achieving the organization’s quality objectives
• Engagement of people: Competent, empowered and engaged people at all levels throughout the organization are essential to enhance the organization’s capability to create and deliver value
• Process approach: Consistent and predictable results are achieved more effectively and efficiently when activities are understood and managed as interrelated processes that function as a coherent system
• Improvement: Successful organizations have an ongoing focus on improvement
• Evidence-based decision making: Relationship management
• Relationship management: For sustained success, organizations manage their relationships with relevant interested parties, such as providers, customers, authorities, etc

High-level structure for Management Systems

The EN ISO 9001 standard follows the Harmonized Structure (HS) so that most of the management standards are structured in the same way, regardless of the topic of application (e.g. quality, environment, occupational health and safety, energy management, information security, food safety, etc). This brings particular benefits for companies because users who are familiar with one MSS will immediately understand the structure of another Management System (MS) and will be able to use it in an easy way.

The use of the Harmonised Structure also improves coherence and recognition, simplifies use, and often consider many of the same terms and definitions. 

Particular Sector or Topic applications of a QMS

Particular standards have also been developed for quality management systems in different sectors, such as aerospace, defence, rail, transport services, medical devices, automotive sector, amongst others.

More information can be found on the Topic: #QualityManagement