ISO 9001 - Clause 8.3.1 General
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ISO 9001:2015 Clause 8.3.1, "General," serves as the introduction to the design and development section, emphasizing the organization's need to establish, implement, and maintain a design and development process that is capable of meeting requirements for products and services. This clause underlines the importance of considering the nature, duration, and complexity of design and development activities, ensuring these processes are appropriately planned and carried out in controlled conditions. It sets the stage for more detailed requirements in subsequent clauses, focusing on how organizations should manage and execute the design and development of their products and services to ensure quality and conformity to customer and regulatory requirements.