The information between the organization and its customers is related to products, inquiries, contracts, order handling, changes, complaints and feedback. Additional requirements have been added to further ensure that organizations clearly understand what their customers' requirements are before they begin the design process. Organizations will be required to consider the effect of design changes on the constituent parts and delivered products and document the changes and any associated actions. Organizations will still need to consider what criteria they use for supplier selection and how often their suppliers should be evaluated. Overall, the purchasing section is still designed to ensure that purchased product conforms to specifications and that purchasing documents clearly describe what is being ordered.
Organizations are still completely responsible when handling customer property.
In particular, these practices should clearly address conforming and nonconforming product to prevent the shipment of nonconforming product. 4.9 Process Control Organizations are still required to maintain operations in a controlled environment and provide work instructions for personnel where necessary. There are several new requirements, however, that expand on some of the basic requirements in the 1994 version. Organizations must now consider how they validate and revalidate special processes where the resulting output can't be verified by subsequent measuring. The revision doesn't explicitly specify inspection and testing activities for incoming, in-process and final product, although they are implied.