ISO 9001 is a standard for quality management systems (QMS) that was developed by the International Organization for Standardization (ISO). It provides a set of requirements that organizations can use to establish, implement, maintain, and continually improve their QMS. The goal of ISO 9001 is to help organizations improve the quality of their products and services, and to ensure that they are meeting the needs and expectations of their customers.
ISO 9001 has an impact on design reviews in several ways. First, the standard requires organizations to establish a process for reviewing and approving design outputs, such as drawings, specifications, and other documents. This helps to ensure that the design meets the agreed-upon requirements and that it is fit for its intended purpose. Second, ISO 9001 requires organizations to conduct regular reviews of their QMS to identify any areas that need improvement. This can include design review processes, and can help to identify opportunities for making the design review process more efficient and effective. Finally, the standard requires organizations to involve their customers in the design review process, either directly or through a representative, to ensure that the design meets the customer's needs and expectations.