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.
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Benefits of ISO 9001
- Increased customer trust and satisfaction
- Sound quality control processes
- Cost savings and productivity gains
- Culture of continuous improvement
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:
- 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.
- Leadership: The standard emphasizes the importance of leadership in implementing and maintaining a quality management system.
- Planning: The quality management system must include measures designed to achieve an organization’s quality objectives and continuously improve the system’s effectiveness.
- Support: ISO 9001 addresses issues such as resources, competence, awareness, communication and documented information.
- Operation: The processes necessary to meet customer requirements and increase customer satisfaction must be planned, implemented and controlled.
- Performance evaluation: The standard requires organizations to monitor, measure, analyze and evaluate the performance and effectiveness of their quality management system.
- 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.
ISO 9001 and ISO 14001 are both International Standards for organizational management but they have different goals. ISO 9001 helps organizations improve their quality management and customer satisfaction. ISO 14001 helps organizations reduce their environmental impact and promote sustainability. ISO standards that look at different types of management systems, such as ISO 9001 for quality and ISO 14001 for environmental management, are all structured in the same way. This means that companies using one ISO management standard will find it easy to integrate other aspects of organizational management into their existing management system.
The International Standards ISO 9001 and ISO 13485 both define requirements for quality management systems, but one has a much broader user group than the other. ISO 9001 provides a quality management framework that can apply to organizations of any size or sector. ISO 13485, on the other hand, has been developed specifically for the medical device industry with a focus on regulatory compliance. The standard helps ensure the safety and effectiveness of medical devices, including risk management, traceability and process validation. Compared to ISO 9001, it contains additional requirements specific to organizations involved in the life cycle of medical devices, whereas elements of ISO 9001 that are not relevant as regulatory requirements are not part of ISO 13485.
In short, while ISO 9001 sets out a general framework for quality management, ISO 13485 provides specific guidance for the medical device industry.
Support on auditing quality management systems can be found on the website of the ISO 9001 Auditing Practices Group. This is an informal group of quality management system experts, auditors and practitioners from ISO/TC 176 and the International Accreditation Forum.
Certification to ISO 9001 is one way to demonstrate to stakeholders and customers that you are committed and able to consistently deliver high quality products or services. Holding a certificate issued by an accredited conformity assessment body may bring an additional layer of confidence, as an accreditation body has provided independent confirmation of the certification body’s competence.
As with other ISO management system standards, companies implementing ISO 9001 can choose whether they want to go through a certification process or not.
Checking that the system works is a vital part of ISO 9001. The standard recommends that an organization performs internal audits to check how its quality management system is working. An organization may decide to invite an independent certification body to verify that it is in conformity with the standard, but there is no requirement for this. Alternatively, you might invite your clients to audit the quality system for themselves.
As in other contexts, standards should always be referred to with their full reference in statements on certification such as “certified to ISO 9001:2015” (not just: “certified to ISO 9001). If you wish to use a logo to demonstrate certification, please contact the certification body that issued your certificate. See full details about use of the ISO logo.
Status: PublishedPublication date: 2015-09
Corrected version (fr): 2015-09Stage: International Standard to be revised [90.92]
Edition: 5Number of pages: 29
Technical Committee :ISO/TC 176/SC 2
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A standard is reviewed every 5 years
Stage: 90.92 (To be revised)
Corrigenda / AmendmentsUnder development
Will be replaced byUnder development