What does 'product realization' entail in ISO 9001?

'Product realization' in ISO 9001 encompasses a comprehensive approach to planning and establishing processes aimed at delivering products that satisfy both customer expectations and regulatory requirements. This concept is central to ensuring that an organization's outputs are consistent, reliable, and compliant with necessary standards.

The focus of product realization is on understanding customer needs and aligning product specifications to meet those needs effectively. This involves several stages, including planning, design, development, production, and monitoring the performance of the product throughout its lifecycle. By emphasizing the importance of meeting requirements, product realization helps organizations maintain quality standards, improve customer satisfaction, and reduce the likelihood of product non-conformity.

While eliminating waste, forecasting, and minimizing costs are important aspects of operational efficiency, they do not fully encompass the framework of product realization within ISO 9001. These activities may contribute to quality management, but they do not capture the holistic approach of ensuring that products are developed and delivered in alignment with established quality objectives and requirements.