ISO9001 Quality Management Systems Clause Overview
The clauses of ISO 9001 are the requirements that organizations must meet in order to be certified compliant with the ISO 9001 Quality Management System. These requirements cover all aspects of quality management, from leadership and customer focus to quality control and continual improvement. ISO 9001 requires organizations to create quality management systems, document processes and improve processes to enhance customer satisfaction, reduce waste and increase efficiency. The clauses provide the framework for organizations to develop a practical quality management system that has been proven to improve organizational performance and customer satisfaction.
Each clause is outlined below:
1. Scope: This clause outlines the purpose and context of the ISO 9001 standard, including its intended use and the applicable fields of application.
2. Normative References: This clause defines the standards (e.g., ISO 9000) and other documents (e.g., corporate policies) that the organization must refer to and have access to when implementing the requirements of ISO 9001.
3. Terms and Definitions: This clause sets out the definitions of technical terms and concepts related to ISO 9001.
4. Quality Management System: This clause describes how an organization should go about establishing, implementing, and maintaining its own quality management system (QMS). It outlines the necessary elements of a Quality Management System, including the documentation requirements, management responsibilities, and the requirements for improving the QMS.
5. Management Responsibility: This clause outlines the responsibilities of the top-level management in ensuring that a Quality Management System is established, implemented, and maintained. It also outlines the management’s responsibility in setting up the necessary infrastructure and making sure that organizational goals are met.
6. Resource Management: This clause outlines the resources (people, systems, support services, etc.) required for the successful implementation and maintenance of a Quality Management System. It also covers the requirements for training personnel and providing the necessary infrastructure for supporting the Quality Management System.
7. Product Realization: This clause describes the processes for ensuring that the desired quality is achieved for all products and services. This includes the processes for design control, purchasing and servicing, and verification and validation. 8. Measurement, Analysis and Improvement: This clause describes the processes for monitoring, measuring, and assessing the effectiveness of the Quality Management System. It also covers processes for analysing data, dealing with nonconformities, and taking corrective and preventive actions.
8 – Measurement, Analysis and Improvement This clause outlines the importance of monitoring product performance and customer satisfaction, as well as detailed requirements for the implementation of processes like corrective and preventive action and continual improvement. It also describes the need for measuring and monitoring processes in order to provide accurate data to base decisions on and to continuously improve the QMS.
9 – Control of Nonconforming Product This clause specifies the responsibilities of personnel when dealing with products that do not conform to the specified requirements of the organization and/or customer. These requirements involve the facility, personnel and procedures to isolate/identify nonconformities, to remove them from further processing, to take appropriate action and to ensure follow-up.
10 – Improvement This clause outlines the importance of continual improvement as one of the core principles of a QMS. It lays out detailed requirements for setting goals and objectives, and making continual improvements to the system. It also pertains to the process of reviewing the QMS to ensure that it is working properly and that the processes are effective.
Whatever your requirements, NDC can guide you through the standard, offering continued support and training as part of an agreed maintenance contract or pay-as-you go support. Our team of consultants are qualified ISO 9001 lead assessors. They have extensive experience in auditing to a number of standards and in many industry sectors across Wiltshire, Hampshire, Dorset, Avon and Somerset.
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