ISO 9001 was first published in 1987 by the International Organization for Standardization (ISO), which includes national standards bodies from over 170 countries.
It has since been revised in 1994, 2000, 2008, and 2015. The most recent version is ISO 9001:2015.
It was built on the success of BS5750, which was originally geared towards manufacturing businesses. Created to extend the reach of quality management internationally, ISO 9001 was designed to be used for quality management across all products, services and industries.
With over 1 million certified users, it’s the most popular ISO standard and the only one in the ISO 9000 series that organisations can be certified for.
ISO 9001 requirements guide businesses in setting up an effective quality management system. The standard focuses on several key areas to help deliver quality products and services, which include:
These requirements help businesses to build a framework that maintains high-quality standards which can boost customer satisfaction.
ISO 9001 certification shows that your Quality Management System (QMS) meets internationally recognised standards – and that you are committed to consistently delivering great products or services.
The certification looks specifically at how your QMS operates, rather than your entire business. An independent certification body reviews your processes, policies, and procedures. If they meet the ISO 9001 standards, you’ll be awarded a certificate – which needs to be renewed periodically to keep your certification active.
Getting certified can help you build trust with customers and stakeholders, meet contract requirements, and stand out in your industry as a business that puts quality first.
Key steps to becoming certified include:
Though certification may seem challenging, proper preparation can make it manageable, achievable and beneficial for your business. For more guidance, explore our useful resources about achieving ISO 9001 certification.
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A Quality Management System (QMS) is a structured framework of policies, processes, and procedures used by an organisation to help deliver products or services that consistently meet customer and regulatory requirements.
It focuses on improving efficiency and effectiveness across all business areas, with the goal of enhancing customer satisfaction.
A QMS helps organisations streamline operations, reducing waste and the risk of errors, while maintaining continual improvement. ISO 9001 is one of the most widely recognised standards for implementing a QMS.
The ISO 9001 family of standards, also known as the ISO 9000 series, includes several standards related to quality management systems.
Their main focus is to help organisations consistently meet customer and regulatory requirements while enhancing customer satisfaction.
However, only ISO 9001 is a certifiable standard.
To achieve certification, your QMS must meet the ISO 9001 standard’s requirements through an external audit by a certified body.
The other standards in the family, such as ISO 9000, ISO 9004, and ISO 19011, serve as guidance documents.
ISO 9001 is not a legal requirement. It is a voluntary standard that organisations and businesses can choose to implement to improve their quality management systems.
However, some businesses may require or request ISO 9001 certification from their suppliers or partners to help deliver consistent quality, making it a practical necessity in specific industries or markets.
Any industry focusing on quality management and customer satisfaction can benefit from ISO 9001.
Industries that often seek ISO 9001 certification include:
The key principles of ISO 9001 include:
These principles guide organisations in implementing an effective Quality Management System (QMS).
Yes, ISO 9001 can be useful for very small businesses. It helps improve process efficiency, reduce waste, and enhance customer satisfaction, which are crucial for small businesses competing in the market.
The standard’s flexibility means it can be tailored to fit the scale and needs of smaller operations. It provides a structured approach to quality management that can lead to better consistency and reliability in products or services.
Additionally, ISO 9001 certification can enhance a small business’s credibility and open up new opportunities by meeting customer and market expectations.
Implementing a Quality Management System (QMS) can require a significant amount of work, especially initially. It involves documenting processes, training staff, and possibly changing existing procedures to align with the QMS framework.
The extent of the effort depends on the organisation’s current practices and the complexity of its operations. However, the long-term benefits, such as improved efficiency, reduced errors, and increased customer satisfaction, often outweigh the initial effort.
Additionally, the process can be scaled to fit the organisation’s size and needs, making it manageable for businesses of all sizes.
ISO 9001 is designed to easily integrate with other ISO standards, making it suitable for organisations aiming to cover various quality and compliance areas.
This compatibility comes from a shared framework called Annex SL, which aligns structures and terms across ISO management systems. As a result, ISO 9001 works well with standards like ISO 14001 for environmental management, ISO 27001 for information security, and ISO 45001 for health and safety.
Implementing ISO 9001 allows you to expand your system to include other standards, streamlining processes and enhancing your business’s efficiency and adaptability.
