How many clauses are there in ISO 9001:2015?

ISO 9001:2015 is the globally recognised Standard for Quality Management Systems, designed for organisations of all sizes and sectors to enhance their entire management process, operational efficiency, and customer satisfaction.

The Quality Management System Standard supports organisations in improving the quality of goods and services, maintaining consistency, and increasing stakeholder confidence. But what are the main ISO 9001 clauses, and how do these apply to your business? 

In this blog, we’ll dive into the ISO 9001:2015 clauses, allowing you to be prepared for the Standard’s certification process.

What are the main clauses of ISO 9001:2015? 

By understanding the Standard’s key elements, you can ensure compliance with its requirements, improve service delivery, and create a robust quality management framework. 

The ISO 9001:2015 Standard requires you to address a total of 11 clauses. However, the first four clauses (clauses 0 – 3) aren’t mandatory for the implementation of ISO 9001 but will provide a comprehensive breakdown of the Standard’s purpose, benefits, scope, and key terms. This will allow you to have a better chance of using the framework effectively throughout your organisation. 

Clause 4: Context of the organisation

Here is where you’ll define your business goals and any areas (from both an internal and external perspective) that are impacting the quality of your goods or services. At this stage, you’ll pinpoint what your business is trying to achieve, your key stakeholders, and your customers’ needs. 

Understanding where your business lies in its market environment and identifying key influencers will provide you with a better understanding of any strengths, risks, and areas for improvement, thus allowing you to develop an optimised quality management system.

Clause 5: Leadership

Here you’ll identify senior members of management who will take responsibility for creating and managing the different areas of the quality management system. 

By actively involving your leadership team in the development of the quality management system and ensuring it’s appropriately communicated throughout your organisation, this will support the successful implementation of the framework, its application, and its evolution as your business grows. 

Clause 6: Planning

Planning is the key to the success of your organisation’s new quality management system. By operating with a risk-based approach, you’ll implement measures to document potential risks, their severity and likelihood, mitigation actions, and set measurable objectives. This allows you to be prepared to address any emerging risks and opportunities, improving decision-making, and maintaining your quality management system’s success.

Of course, changes in your business are bound to happen, and as part of the ISO 9001:2015 Standard, it’s required to document any potential modifications or new processes. This ensures that changes are effectively managed, minimises operational disruption, and maximises the benefits they bring. 

Clause 8: Operation 

Here, you’ll set the ISO 9001 requirements and processes your business must follow to develop and deliver optimal goods or services to your customers. This is the largest and most substantial part of the ISO 9001 Standard, as you’ll address the entire production and operational process.

Clause 8 highlights the importance of meeting client expectations and ensures you maintain consistency in your overall quality. Not only will this boost your client satisfaction and retention, but will also ensure your operations process is streamlined, your resources are utilised effectively, and improves collaboration. 

Clause 9: Performance evaluation 

Evaluating and measuring performance metrics is essential for making well-informed decisions that will drive your business forward. Clause 9 of ISO 9001:2015 outlines how to generate valuable data and conduct management reviews. 

By effectively generating and analysing performance data, you can improve your quality management and customer satisfaction based on evidence-based insights. 

Clause 10: Improvement

The final clause highlights the importance of continuous improvement within your business operations and quality management. At this stage, you’ll document potential areas for improvement, opportunities, and embed preventative measures that ensures excellence with your goods or services.

Clause 10 is all about setting your business up for success, by creating a robust quality management system that allows you to demonstrate excellence with your customers, suppliers, and stakeholders. 

Become certified with Citation ISO Certification

ISO 9001 is a powerful business improvement tool, providing the framework and guidance you need to help you consistently meet your customers’ expectations and regulatory requirements. 

With Citation ISO Certification by your side, we can help get your business certified in as little as 45 days. Our ISO consultants will help create a QMS that works for your business, improving quality and efficiency in areas across your organisation. We’ll conduct an ISO 9001 audit to assess your current processes and see how we can get your business to reach the ISO 9001 requirements.

Take a look at our ISO 9001 checklist to help you pass any audit.

Ready to get certified? Get your free quote today or contact us on 0330 127 5121 to chat to our team.