ISO 10005:2018 pdf download.Quality management一Guidelines for quality plans
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;
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). Both the organization requesting a quality plan and the prospective external provider should consider the reasons for using a quality plan and the benefits that might be achieved through its use.
The organization requesting an external provider quality plan should apply risk based thinking to the nature of the specific case, the evaluation and selection of external provider(s) and opportunities for benefits. There can be benefits to both the organization and potential external providers in using risk-based thinking.
Consideration of risks related to the specific case can increase the options for requesting quality plans from external providers, for example:
a) specifying intended results rather than the methods and resources to be applied to the specific case (such as in performance-based contracts) can allow external providers to introduce innovation in methods, practices and resources;
b) specifying minimum requirements for controls and documented information allows an external provider to apply their own processes and experience;
c) defining quality plan requirements for the specific case rather than requiring conformity with a management system standard, such as ISO 9001, can enable participation by a broader range of potential external providers with different levels of maturity of their management systems.ISO 10005 pdf download.