ISO 10005-2018 pdf free.Quality management – Guidelines for quality plans.
This document gives guidelines for establishing, reviewing, accepting, applying and revising quality plans.
This document is applicable to quality plans for any intended output, whether a process, product. service, project or contract, and any type or size of organization.
It is applicable whether or not the organization has a managenlent system in conformity with ISO 9001. This document provides guidance and does not specify requirements.
It is focused primarily on the provision of outputs and is not a guide to the planning of quality management system development.
NOTE To avoid undue repetition of “process, product, service, prolect or contract, this document uses the term speclflc case.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 9000:2015, Quality management systems — Fundamentals and vocabulary
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 9000:2015 and the
following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at
— IEC Electropedia: available at httpJjwww,
3.1 documented information
information required to be controlled and maintained by an organization and the medium on which it is contained
Note ito entry: Documented information can be in any format and media and from any source. Note 2 to entry: Documented information can refer to:
— the management system, including related quality plans (12) and processes;
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 caseTM 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;
1) 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). 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.ISO 10005 pdf free download.