ISO 9001:2015 is an international standard that specifies requirements for quality management systems. The purpose of ISO 9001:2015 is to guide organizations seeking to develop and implement a quality management system.
The ISO 9001:2015 standard applies to all types of organizations, including small businesses, medium-sized companies, large corporations, government agencies, and educational institutions.
The standard is intended to ensure that organizations meet certain minimum requirements for implementing a QMS. These requirements are designed to improve the effectiveness of the organization's processes and procedures, thereby improving its ability to deliver high-quality products and services.
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There are ten top-level requirements in the standard. A brief description of each of these requirements is listed below:
1. Scope
When/why should an organization adopt this standard?
2. Normative references
Use ISO 9000 for terms and definitions
3. Terms and definitions
Definitions of various terms referred to in the standard.
4. Context of the organization
Determine the purpose and the direction of the organization.
5. Leadership
The commitment of the top management, quality policy, roles and responsibilities.
6. Planning
Planning to address risks and opportunities and achieving quality objectives.
7. Support
People, infrastructure, knowledge, communication, documented information.
8. Operation
Finding out customer requirements, designing, external providers, delivering, post-delivery support.
9. Performance evaluation
Customer satisfaction, analysis, internal audit and management review.
10. Improvement
Nonconformity, corrective action and continual improvement.
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