Want the Helicopter view of ISO 9001? If yes, start here.
ISO 9001 offers a comprehensive framework for establishing a solid Quality Management System (QMS). The key to this lies within its core clauses, a set of specific requirements that form the backbone of this standard. Let’s look at each in turn to understand how they can transform your organization’s approach to managing your business.
List of ISO 9001 Clauses
- ISO 9001 Clause 0: Introduction: This clause introduces the overall purpose of ISO 9001. It explains how the standard can help organizations achieve consistent customer satisfaction and meet regulatory requirements. It also highlights the key quality management principles that underpin the standard, such as customer focus, continual improvement, and leadership commitment.
- ISO 9001 Clause 1: Scope: This clause defines the applicability of the standard. It clarifies that ISO 9001 can be implemented by organizations of any size and industry, regardless of their product or service offerings. The Scope clause also emphasizes that the entire QMS, not just specific departments or activities, is subject to the standard’s requirements.
- ISO 9001 Clause 2: Normative References: This clause lists any other ISO standards that must be applied when implementing and maintaining an ISO 9001-compliant QMS. By including these references, the standard avoids redundancy and ensures that everyone involved is using the same terminology and definitions.
Tip: For ‘Normative,’ read ‘Mandatory’.
- ISO 9001 Clause 3: Terms and Definitions: This clause defines key terms used throughout ISO 9001. Understanding what these terms mean is crucial for effective communication and implementation of the standard. For example, the clause defines terms like “nonconformity” and “corrective action,” ensuring everyone involved in the QMS uses these terms correctly and consistently.
- ISO 9001 Clause 4: Context of the Organization: Clause 4 emphasizes understanding the big picture for your organization. Internally, your organization must analyze factors like employee skills and infrastructure that affect quality goals. Externally, it asks you to consider market trends and regulations.
Aside from that, it also asks you to identify the needs of all interested parties, from customers (contractual requirements) and employees to investors and regulators (applicable statutes and regulations). Lastly, it requires defining the QMS scope and outlining which locations and activities of the organization are covered by the system.
- ISO 9001 Clause 5: Leadership: Clause 5 outlines the significant role that top management plays in effectively managing the QMS. This includes setting a clear direction through a documented quality policy, allocating necessary resources, and actively participating in QMS reviews. It also underscores the importance of ensuring the organization understands and prioritizes customer needs and expectations.
- ISO 9001 Clause 6: Planning: Clause 6 emphasizes proactive planning when implementing a QMS. This involves identifying potential risks and opportunities that could impact achieving quality goals so organizations can implement measures to mitigate threats and capitalize on favorable opportunities. It also requires establishing measurable quality objectives aligned with the organization’s strategic direction.
- ISO 9001 Clause 7: Support: Clause 7 emphasizes the need for a suitable infrastructure, including physical and technological resources, to support QMS processes. This means ensuring staff competency through training and awareness programs. Effective communication with both internal and external providers is also crucial.
- ISO 9001 Clause 8: Operation: Clause 8 emphasizes meticulously managing all the processes that affect quality. This means carefully planning, operating, and controlling each step to achieve consistent quality. Everything from production planning and strict control of incoming materials to well-defined service delivery processes falls under this clause. Design and development activities are also included here.
- ISO 9001 Clause 9: Performance Evaluation: ISO 9001’s Clause 9 takes a data-driven approach to achieving continuous improvement. It requires organizations to set up methods for monitoring and measuring the critical parts of their Quality Management System (QMS). This includes things like processes, customer satisfaction, and other important metrics. It also covers how regular internal audits ensure the system continues to function well and how your organization can use customer feedback to measure customer satisfaction and identify areas where the organization can go the extra mile.
- ISO 9001 Clause 10: Improvement: Clause 10 emphasizes addressing nonconformities or instances where products or services fall short of requirements. It goes beyond fixing the issue and requires finding and eliminating the root cause so that it won’t happen again. Furthermore, it encourages organizations to actively seek opportunities to improve the effectiveness of their QMS across the board.
ISO 9001 Mandatory Clauses
There are no specific mandatory procedures outlined in the ISO 9001 standard itself. However, seven clauses (out of a total of 10) contain requirements for a Quality Management System (QMS) that must be met to achieve certification. These clauses essentially define the framework for the QMS.
These include:
- Clause 4: Context of the Organization
- Clause 5: Leadership and Commitment
- Clause 6: Planning for the QMS
- Clause 7: Support
- Clause 8: Operational planning and control
- Clause 9: Performance evaluation
- Clause 10: Improvement actions
Note that while there aren’t specific procedures mandated by ISO 9001, you will need to develop documented procedures and records to address how you meet the requirements within these clauses. This documentation will then form the foundation of your evidence of compliance with ISO 9001 requirements.
