ISO 9001 Clauses Explained

ISO 9001 is the standard regarding quality management, specifically the implementation of Quality Management Systems (QMS). As one of the most popular ISO standards, it can be applied to a wide range of industries and sectors and used by organisations of all sizes. The latest iteration is ISO 9001:2015.

There are ten ISO 9001 clauses that provide a framework for organisations looking to implement an effective QMS. These need to be thoroughly understood to become successfully ISO 9001-certified.

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Clause 1 describes the applicability of ISO 9001:2015.

It outlines the purpose and the limitations of the standard and establishes its fundamental goal – to provide a framework that supports organisations’ products or services in meeting high-quality standards, customer expectations, and statutory and regulatory requirements.

Find out more about defining the scope of your organisation.

The second clause refers to the supportive documents and standards that are indispensable for the application of ISO 9001. ISO 9000, which covers fundamentals and vocabulary, is the only normative reference in this standard.

Clause 3 outlines the key terminology and definitions used throughout the standard.

To understand and apply ISO 9001 effectively, it’s critical to have a strong understanding of these terms, as they provide a common language for all parties involved in the QMS.

This clause focuses on the importance of understanding the unique circumstances – the ‘context’ of the organisation – including its culture, objectives, complexities and the needs and expectations of its ‘interested parties’. These are the customers, suppliers, regulators and employees of the organisation.

• 4.1 Understanding the organisation and its context – This subclause requires organisations to identify internal and external issues that could affect the QMS’s purpose and strategic direction. These could include legal, technological, competitive, market, cultural, social and financial issues.
• 4.2 Understanding the needs and expectations of interested parties – Here, organisations must determine the relevant stakeholders for their QMS and understand their requirements. This understanding can help the organisation manage relationships, meet expectations and improve customer satisfaction.
• 4.3 Determining the scope of the Quality Management System – This part focuses on defining the boundaries and applicability of the QMS. This is based on the identified external and internal issues, requirements of relevant interested parties and the products and services offered by the organisation. The scope must be maintained as documented information.
• 4.4 Quality Management System and its processes – This final subclause requires organisations to establish, implement, maintain and continually improve their QMS. This includes defining necessary processes and their interactions. It operates under the process approach principle, emphasising the importance of understanding and controlling interrelated processes as a cohesive system.

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Clause 5 requires an organisation’s leadership to take responsibility for the effectiveness of the QMS, establishing quality policies and objectives, and promoting a culture that focuses on quality by encouraging employee engagement throughout the organisation.

• 5.1 Leadership and commitment – This subclause emphasises the role of leaders in promoting a customer focus and engaging employees in the QMS principles. Leaders must demonstrate their commitment by aligning the QMS with strategic objectives, incorporating QMS requirements into business processes, promoting risk-based thinking and driving continual improvement.
• 5.2 Quality policy – Top management must establish, implement and maintain a quality policy that aligns with the organisation’s purposes and context. This policy should provide a framework for setting and reviewing quality objectives, and be communicated and understood throughout the organisation.
• 5.3 Organisational roles, responsibilities and authorities – The assignment and communication of relevant roles’ responsibilities should be maintained as documented information. This subclause emphasises the need for clarity surrounding roles and responsibilities to support effective implementation and maintenance of the QMS.

Clause 6 focuses on planning for the implementation of the Quality Management System (QMS), emphasising risk-based thinking and its alignment with the organisation’s strategic direction.

• 6.1 Actions to address risks and opportunities – This subclause requires organisations to identify risks and opportunities when planning their QMS and develop actions to address them. The intent is to enhance desirable outcomes, prevent or reduce undesired consequences and achieve improvement.
• 6.2 Quality objectives and planning to achieve them – Organisations need to set measurable quality objectives to support the conformity of products and services and to enhance customer satisfaction. These objectives will also need to be monitored, communicated and updated as necessary. They should outline any required actions, resources, KPIs, timeframes and responsible team members.
• 6.3 Planning changes – This subclause provides a structured approach for organisations to manage changes that can impact their QMS. Changes must be pre-planned and made systematically to minimise potential negative impacts and maximise successful implementation.

The seventh clause deals with the resources required for the successful implementation and maintenance of the QMS. This includes human resources, infrastructure and the work environment. It also covers the importance of competence, awareness, communication and documented information to support the effectiveness of the QMS.

It recognises that a successful QMS depends on having the appropriate support in place.

Clause 8 is the heart of the standard. It covers operational planning and control, product and service requirements, design, control of external providers, production, release of products and services and nonconformity controls. This is where written policies are turned into effective actions.

• 8.1 Operational planning and control – This subclause requires the organisation to plan, implement, and control its processes to meet QMS requirements. It includes:
  • The determination of product and service requirements
  • The design and development of the products and services
  • The control of externally provided processes, products and services
  • The implementation of production and service provision under controlled conditions
• 8.2 Requirements for products and services – This focuses on customer communication, determining the requirements for products and services, conducting a review of these requirements and ensuring that they are met.

Continual improvement is a core tenet of many ISO standards, particularly in the ISO 9000 family. But in order to continually refine, improve and strengthen your QMS over time, you will need data to guide your efforts.

Clause 9 focuses on monitoring, analysing and evaluating the performance of a QMS. It involves measuring customer satisfaction, conducting internal audits, monitoring and measuring processes, and conducting management reviews. This data can indicate the efficiency of your QMS and whether customer satisfaction is at optimum levels. It can also tell you whether resources and budget are being used effectively and identify where support is needed in your QMS.

Read about creating a culture of continuous improvement with ISO 9001.

The final clause emphasises the importance of continual improvement in a QMS. It requires organisations to correct and prevent any unwanted actions and reduce the likelihood of mistakes. The goal is to learn from past mistakes and successes to drive future improvements and deliver better products and services.

• 10.1 General – This subclause encourages organisations to identify improvement opportunities and implement actions to meet customer requirements and enhance satisfaction. This involves improving products and services, correcting and preventing undesired actions and improving the performance and effectiveness of the QMS.
• 10.2 Nonconformity and corrective action – This subclause requires organisations to react appropriately to any nonconformities and take action to control and correct them. This also involves dealing with the consequences. This subclause is broken down into two subsections.
  • 10.2.1 calls for the organisation to take action when something goes wrong, respond appropriately to any negative impact, evaluate the situation and mitigate its chances of it happening again.
  • 10.2.2 requires organisations to keep detailed records of all improvement actions, including the initial issue, how it occurred and how it was rectified. This a new clause for ISO 9001:2015.
• 10.3 Continual improvement – This section requires organisations to continually improve the suitability, adequacy and effectiveness of the QMS. This implies an ongoing effort to improve all elements of the QMS, from its overall performance to its individual processes.

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