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Neuro Inclusive Standards 2024

Quality management systems — Requirements
This publication was last reviewed and confirmed in 2021. Therefore this version remains current.

Neuro Inclusive Standards 2024

Quality management systems — Requirements
This publication was last reviewed and confirmed in 2021. Therefore this version remains current.

What is ISO 9001?

ISO 9001 is a globally recognized standard for quality management. It helps organizations of all sizes and sectors to improve their performance, meet customer expectations and demonstrate their commitment to quality. Its requirements define how to establish, implement, maintain, and continually improve a quality management system (QMS).

Implementing ISO 9001 means your organization has put in place effective processes and trained staff to deliver flawless products or services time after time.

Why is ISO 9001 important?

With more than one million certificates issued to organizations in 189 countries, ISO 9001 is the most widely used quality management standard in the world. Within the ISO 9000 family, which defines seven quality management principles including a strong customer focus and continual improvement, ISO 9001 is the only standard that can be certified to (though certification is not mandatory).

Business benefits include:

  • Customer confidence: The standard ensures that organizations have robust quality control processes in place, leading to increased customer trust and satisfaction.
  • Effective complaint resolution: ISO 9001 offers guidelines for resolving customer complaints efficiently, contributing to timely and satisfactory problem-solving.
  • Process improvement: The standard helps identify and eliminate inefficiencies, reduce waste, streamline operations, and promote informed decision-making, resulting in cost savings and better outcomes.
  • Ongoing optimization: Regular audits and reviews encouraged by ISO 9001 enable organizations to continually refine their quality management systems, stay competitive, and achieve long-term success.

Benefits of ISO 9001

  •  Increased customer trust and satisfaction
  •  Sound quality control processes
  •  Cost savings and productivity gains
  •  Culture of continuous improvement

FAQ

Any organization that wants to improve its quality management system, meet customer and applicable statutory and regulatory requirements, and enhance customer satisfaction can use the ISO 9001 standard. It is suitable for organizations of any size, and applies to all sectors, including manufacturing, services, healthcare, education, government, and non-profit organizations. ISO 9001 can also be used by certification bodies or other third parties to assess an organization’s conformity with this International Standard.

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:

The ISO 9001 standard specifies requirements for the establishment, maintenance, and continuous improvement of a quality management system, covering a wide range of topics including:

  1. Context of the organization: ISO 9001 requires organizations to determine the external and internal factors that affect their ability to achieve the intended results of their quality management system.
  2. Leadership: The standard emphasizes the importance of leadership in implementing and maintaining a quality management system.
  3. Planning: The quality management system must include measures designed to achieve an organization’s quality objectives and continuously improve the system’s effectiveness.
  4. Support: ISO 9001 addresses issues such as resources, competence, awareness, communication and documented information.
  5. Operation: The processes necessary to meet customer requirements and increase customer satisfaction must be planned, implemented and controlled.
  6. Performance evaluation: The standard requires organizations to monitor, measure, analyze and evaluate the performance and effectiveness of their quality management system.
  7. Improvement: ISO 9001 emphasizes the importance of continuously increasing the effectiveness of the quality management system based on the results of performance evaluation and other data sources.

Overall, ISO 9001 helps organizations address all aspects of managing the quality of their products and services, with an emphasis on customer satisfaction and constant enhancement of the quality management system.

The most recent revision of ISO 9001 was finalized in 2015. Ensuring that all ISO standards remain current and relevant for the marketplace is crucial. After extensive international consultation, a consensus was reached in August 2023 that revising the standard would add value. This revision aims to align ISO 9001 with the current needs of standard users and the communities they serve.

The revised version of ISO 9001 is expected to be published at the end of 2025.

General Information

Status:
Published
Publication date:
2015-09
Corrected version (fr):
2015-09
Stage:
International Standard to be revised [90.92]
Edition:
5
Number of pages:
29
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