- ISO 9001 and its 10 clauses are universally adaptable across all sectors and business sizes, from manufacturing to service-oriented businesses.
- ISO 9001 emphasises the leadership’s role in implementing and upholding ISO 9001 and the importance of understanding the organisation’s context, planning, and ensuring adequate support for successful implementation.
- Operational planning and control, performance evaluation through audits and management reviews, and an unwavering commitment to continual improvement are essential aspects of ISO 9001.
“Quality is not an act, it’s a habit” – Aristotle. In the business world, ISO 9001 is the codification of this habit. Understanding its ten clauses is paramount for businesses seeking sustainable quality management success.
ISO 9001, a globally recognised standard for quality management systems (QMS), represents universal best practices to enhance customer satisfaction and internal efficiencies. Its reputation stems from its universal adaptability across all sectors, from manufacturing to service-oriented businesses.
For those just beginning their journey, our what is ISO 9001 page provides a comprehensive introduction.
Now, let’s dive into The Ten Clauses of ISO 9001.
Defining ISO 9001 and Its Importance
The ISO 9001 standard is structured into ten clauses, each containing a distinct set of requirements. As a framework, ISO 9001 is based on ten clauses, each leading seamlessly into the next, culminating in a holistic approach towards quality management.
From defining the scope to continuous improvement, these clauses cover all aspects a robust QMS should address. And getting ISO 9001 certification provides assurance that a company’s QMS adheres to these standards.
Clause 1 Scope
The scope of ISO 9001:2015 quality management system standard sets out the boundaries to which the standard applies. In this case, the limits are as wide as possible, stating that the standard is generic and applies to all organisations irrespective of size, type, or the products or services it provides.
This means that ISO 9001 can be applied to a micro business of one person to a global enterprise with hundreds and thousands of employees.
Clause 2 Normative References
Normative References, the second clause, serves as a compass, directing users to supplemental documents. A normative reference means you cannot apply the quality management standard without using the referenced source, ISO 9000:2015 Quality management systems — Fundamentals and Vocabulary.
ISO 9000 defines the fundamental concepts and principles of quality management. However, it is not mandatory to purchase or read ISO 9000; it is a good prerequisite as it will help understand ISO 9001 requirements.
Clause 3 Terms and definitions
This clause states that the terms and definitions given in ISO 9000:2015 apply. You can also view terms and definitions online using the BSI Online Browsing Platform.
Clause 4 Context of the organisation
ISO 9001:2015 Clause 4, “Context of the Organization,” requires an organisation to identify and understand the external and internal issues relevant to its purpose and strategic direction.
External issues may include the environment, market, political landscape or other external factors that may impact the ability to achieve its objectives, such as the Russia-Ukraine war and Brexit.
Internal factors such as culture, processes, and resources that can impact business performance should also be identified.
By understanding the context in which it operates, businesses can establish their objectives and the processes needed to achieve them and identify improvement opportunities.
Conducting a SWOT or PESTLE analysis is a practical method of determining internal and external issues.
Additionally, it’s essential to identify interested parties and their needs and expectations.
Interested parties can include clients, end-users, subcontractors, employees, shareholders, members of the public and so on.
By considering the needs and expectations of interested parties, an organisation can ensure that its products and services meet their requirements.
Clause 5 Leadership
Clause 5 requires leadership to take responsibility for the quality management system’s effectiveness and provide the necessary support and resources for its implementation and maintenance.
Leaders must develop and communicate a quality policy and objectives and ensure they are understood throughout the organisation and externally when relevant to do so.
Leadership is also responsible for promoting a continuous improvement culture and encouraging employee participation in the quality management system. This can be achieved in several ways, such as off-site meetings with management, briefing the workforce and walking the site or shop floor to engage with the workforce.
Leadership must take responsibility for the quality management system and provide the necessary support and resources for its effective functioning. This doesn’t mean they should build or maintain the management themselves, but they must contribute and ultimately lead it. This will ensure that the quality management system is aligned with the strategic direction of the business.
Clause 6 Planning
Clause 6 requires an organisation to develop and implement plans that support the quality management system and its processes. This includes:
- Plans to mitigate risks and exploit opportunities.
- Plans to achieve business objectives.
- Strategies to manage change.
Risks and opportunities should be evident by fully understanding the internal and external issues identified throughout clause 4. The next step would be for the leadership and management teams to plan to address them proactively.
Additionally, the business must set quality objectives at relevant functions, levels and processes needed for the quality management system to be effective.
Objectives should be relevant, aligned with the policy and measurable. Using a framework such as SMART or OKRs (objectives and key results) is beneficial to ensure objectives are planned appropriately.
ISO 9001 also requires planning for implementing any changes to the quality management system and evaluating the impacts of those changes (change management).
Managing changes should include: assessing the risks, availability of resources and determining responsibilities.
Planned changes do not have to be complex most businesses already informally plan for change. For example, investing in new machinery would require a location, training, maintenance programme, cost-benefit analysis, etc.
Clause 7 Support
Adequate resources are essential for a business to operate effectively. Clause 7 outlines the requirements for an organisation to determine and provide adequate resources. Resource requirements are broken down into three main categories:
People – ensuring employees have the necessary education, training, and experience to perform their responsibilities.
Infrastructure – ensuring that buildings and equipment are suitable for their intended use and maintained in a safe, usable condition.
Environment – ensuring human and physical factors are taken into consideration. For example, equality, diversity and inclusion (ED&I), working time or shift patterns, and working conditions such as temperature and lighting.
Other resource requirements include:
- Ensuring all monitoring and measuring equipment is fit for purpose, suitably calibrated and maintained.
- Organisation knowledge is maintained and available to the necessary people.
- Effective communication channels are established to ensure that information is communicated internally and externally.
Documented information is also an essential pillar of a successful management system. Without controlled documentation, a business could not operate efficiently.
Information that is controlled reduces mistakes significantly. Imagine relying on word of mouth to get a job done. It makes sense to maintain records of all your quality management system documentation to achieve consistent performance.
Clause 8 Operation
The heart of ISO 9001, the eighth clause, revolves around operation. Clause 8 outlines several requirements for the processes an organisation should utilise to produce and deliver its products and services successfully. Quality management principles are brought to life in this clause, translating plans into action.
Operational requirements include:
- Establishing how and what you will communicate to and from your customers.
- Determining a customer’s requirements
- Verifying that the products and services meet those requirements.
- Designing and developing products or services.
- Controlling externally provided processes, products, and services.
- Delivering and completing products and services.
- Monitoring and measuring activities to ensure that they are being carried out effectively.
- Post-delivery activities.
- Controlling nonconforming outputs.
Clause 9 Performance Evaluation
Here, ISO 9001 requires a business to monitor, measure, and analyse its performance to determine the effectiveness of its Quality Management System and identify opportunities for improvement.
Processes for evaluating customer satisfaction and measuring the performance of its suppliers and other external parties that provide products or services must also be established, implemented, and maintained.
Additionally, conducting internal audits of the management system is crucial and mandated to ensure that business processes are being implemented in accordance with the organisation’s objectives, and the requirements of ISO 9001.
A management review is also another mandatory activity in clause 9. This activity consists of reviewing the QMS’s performance to ensure its suitability, adequacy, and effectiveness.
Clause 10 Improvement
The final clause, improvement, outlines the organisation’s commitment to continual improvement requirements. The idea here is that a good QMS does not just rest on its laurels but is always striving towards enhancing its effectiveness and efficiency.
Using the information gathered throughout performance evaluation activities, the organisations leadership must determine and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction.
Clause 10 also requires the management of non-conformities. Requirements include:
- Taking action to control the nonconformity.
- Evaluating the need for action to eliminate the cause(s).
- Corrective action(s).
- Reviewing the effectiveness of corrective action(s).
- Updating the risk register and;
- Making changes to the quality management system, if required.
As we uncover the ten clauses of ISO 9001, we discover their impacts on modern businesses. From fostering customer satisfaction to improving operational efficiency, ISO 9001 shapes how businesses operate.
Understanding ISO 9001 clauses is essential for achieving quality management success and fostering a culture of continual improvement. The strength of ISO 9001 lies in its universality – its clauses provide a best practice path towards sustainable business excellence.