WHAT ARE THE ISO 9001 REQUIREMENTS?
ISO 9001 is a widely recognized standard for quality management systems (QMS) and provides a framework for organizations to establish, implement, maintain, and continually improve their quality management system. The requirements for ISO 9001 are outlined in the standard document, which consists of ten sections:
- Scope: The scope of the standard specifies the requirements for a QMS that an organization can use to enhance customer satisfaction and meet applicable regulatory requirements.
- Normative References: This section lists the other documents referenced in the standard that must be followed to implement a QMS compliant with ISO 9001.
- Terms and Definitions: This section defines key terms and concepts used in the standard.
- Context of the Organization: This section requires organizations to determine the internal and external issues that are relevant to their QMS and to understand the needs and expectations of interested parties.
- Leadership: This section requires top management to demonstrate leadership and commitment to the QMS by establishing a quality policy, defining quality objectives, and ensuring the QMS is integrated into the organization’s business processes.
- Planning: This section requires organizations to identify risks and opportunities related to the QMS, establish quality objectives, and plan to achieve them.
- Support: This section requires organizations to provide the resources, infrastructure, and environment necessary to support the QMS, including human resources, infrastructure, and work environment.
- Operation: This section requires organizations to establish and implement operational controls to ensure products and services meet customer requirements.
- Performance Evaluation: This section requires organizations to monitor, measure, analyze, and evaluate the performance of the QMS and to identify opportunities for improvement.
- Improvement: This section requires organizations to continually improve the effectiveness of the QMS by taking corrective actions, implementing preventive actions, and making changes to the QMS as needed.
These ten sections provide a comprehensive set of requirements that organizations must meet to establish and maintain a QMS that meets the requirements of ISO 9001.
