The ISO 9000 family addresses various aspects of quality management and contains some of ISO’s best known standards. The standards provide guidance and tools for companies and organizations who want to ensure that their products and services consistently meet customer’s requirements, and that quality is consistently improved.

ISO 9001:2015

ISO 9001:2015 sets out the criteria for a quality management system and is the only standard in the family that can be certified to (although this is not a requirement). It can be used by any organization, large or small, regardless of its field of activity. In fact, there are over one million companies and organizations in over 170 countries certified to ISO 9001.

This standard is based on a number of quality management principles including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement. These principles are explained in more detail in the pdf Quality Management Principles. Using ISO 9001:2015 helps ensure that customers get consistent, good quality products and services, which in turn brings many business benefits.

Requirements of ISO 9001:2018

ISO 9001:2015 specifies requirements for a quality management system when an organization:

a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and

b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

All the requirements of ISO 9001:2015 are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.

Quality management principles

See the Document at the Link.

This document introduces the seven quality management principles that ISO 9000, ISO 9001 and other related quality management standards are based on.

Sector-specific applications of ISO 9001

ISO has a range of standards for quality management systems that are based on ISO 9001 and adapted to specific sectors and industries. These include:

ISO 13485 – Medical devices 
ISO 17582 – Electoral organizations at all levels of government
ISO 18091 – Local government
ISO/TS 22163 – Business management system requirements for rail organizations
ISO/TS 29001 – Petroleum, petrochemical and natural gas industries
ISO/IEC 90003 – Software engineering 

A management system is the way in which an organization manages the inter-related parts of its business in order to achieve its objectives. These objectives can relate to a number of different topics, including product or service quality, operational efficiency, environmental performance, health and safety in the workplace and many more.

The level of complexity of the system will depend on each organization’s specific context. For some organizations, especially smaller ones, it may simply mean having strong leadership from the business owner, providing a clear definition of what is expected from each individual employee and how they contribute to the organization’s overall objectives, without the need for extensive documentation. More complex businesses operating, for example, in highly regulated sectors, may need extensive documentation and controls in order to fulfil their legal obligations and meet their organizational objectives.

The ISO model: agreed by experts

ISO management system standards (MSS) help organizations improve their performance by specifying repeatable steps that organizations consciously implement to achieve their goals and objectives, and to create an organizational culture that reflexively engages in a continuous cycle of self-evaluation, correction and improvement of operations and processes through heightened employee awareness and management leadership and commitment.

The benefits of an effective management system to an organization include:

• More efficient use of resources and improved financial performance,
• Improved risk management and protection of people and the environment, and
• Increased capability to deliver consistent and improved services and products, thereby increasing value to customers and all other stakeholders.

MSS are the result of consensus among international experts with expertise in global management, leadership strategies, and efficient and effective processes and practices. MSS standards can be implemented by any organization, large or small.

MSS and related standards: the big picture

This picture explains what are the different types of ISO documents supporting the management of an organization and what these documents deal with. Examples of standards for each quadrant are also provided.

Management standards, management systems standards and related standard

Audits

Audits are a vital part of the management system approach as they enable the company or organization to check how far their achievements meet their objectives and show conformity to the standard.

In order to help the auditing related to these standards, ISO has released ISO 19011:2011 providing specific guidance on internal and external management system audits.

Certification

Certification to management system standards is not a requirement. You can benefit from implementing these standards without being certified to them.

However, if you are looking to get certified to one or more of our management system standards, then you need to get in touch with an external certification body.

That's because ISO does not perform certification.

Read more about certification to ISO standards.

Certification is not the only way to show conformity to standards.