ISO 10005:2018 pdf download – Quality management — Guidelines for quality plans.
4 Using a quality plan 4.1 Introduction A quality plan describes how an organization will provide an intended output, whether that output is a process, product, service, project or contract (termed the “specific case” in this document). Quality plans are developed where they are considered necessary to meet needs and expectations related to a specific case. Where the organization has an established management system, quality plans might be necessary if requested by a customer or considered useful for other reasons. On the other hand, where no established management system exists, quality plans can provide a framework for meeting the requirements of the specific case. They can also assist the organization to develop its own management system and its processes. The organization should decide where there is need for quality plans. There are a number of situations where quality plans can be useful or necessary, for example: a) to show how the organization’s quality management system applies to a specific case; b) to meet customer, other interested parties or the organization’s own requirements; c) to develop and validate new products, services or processes; d) to demonstrate, internally and/or externally, how requirements will be met; e) to organize and manage activities to meet requirements and quality objectives; f) to optimize the use of resources in meeting quality objectives; g) to minimize the risk of not meeting requirements; h) to control the establishment of a new or modified organization, site or partnering arrangement; i) as a basis for monitoring and assessing compliance with the requirements for quality; j) in the absence of an established management system. 4.2 Requesting external provider quality plans An organization may choose to request that an external provider or a prospective external provider submit a quality plan related to a specific case (this can relate to external providers who are part of the same organization, e.g. a separate division).