ISO 10005:2018 download free.Quality management – Guidelines for quality plans.
3.2
quality plan
speci1icaton o[the actions, responsibilities and associated resources to be applied to a specific object
(SOURCE: ISO 9000:201S. 3.8.9. modified — The phrase procedures and associated resources to be applied when and by whom has been replaced by “actions, responsibilities and associated resources”, and the notes to entry have been deleted I
3.3
specific case
<quality plans> subject of a quality p1w, (L2)
Note I to entry The specific case can be a process, product, service, project, contract or other Intended output for the quality plan.
4 Using a quality plan
4.1 Introduction
A quality plan describes how an organization well provide an intended output, whether that output isa process, product, service, protect or contract (termed the “specific case in ISO 10005).
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 obfrctives:
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.
Audits may he used for several purposes, such as:
a) to monitor the Implementation and effectiveness olquallty plans:
b) to monitor and verify conformity with specified requirements
c) for surveillance of external providers to the organization:
d) to provide Independent objective assessment, when required, to meet the needs of customers or other interested parties.
NOTE ISO 19011 provides guidance for the auditing of management systems.
7 Oper.ition and control of the quality plan
7.1 RevIew and acceptance of the quality plan
The quality plan should be reviewed for adequacy and effectiveness, and should be formally approved by an authorized person or a group that includes representatives from relevant functions within the organization.
In contractual situations, a quality plan might need to be submitted to the customer by the organization for review and acceptance, either as part of a pre-contract consultation process or after a contract has been awarded. Once a contract Is awarded, the quality plan should be reviewed and, where appropriate, revised to reflect any changes In requirements.
Where a project or contract Is conducted in stages, the organization might be expected to submit a quality plan to the customer for each stage, prior to the start of that stage.
7.2 Implementation and monitoring of the quality plan
In the implementation and monitoring of the quality pbn. the organization should consider the following issues:
a) distribution of the quality plan to all relevant people: care should be taken to distinguish between copies that are distributed under the control provisions for documented information (to be updated as appropriate), and those that are supplied for information only;
b) training in the use of quality plans; In some organizations (e.g. those engaged In project management) quality plans may be used as a routine part of the quality management system, while in others, quality plans may be used only occasionally (in this case, special training could be needed to assist users in applying the quality plan correctly);
c) monitoring conformity with quality plans: the organization is responsible for monitoring conformity with each quality plan that it operates, which can include:
1) operatIonal supervision of the planned arrangements;
2) milestone reviews;
3) audits.
Audits are generally undertaken on a sampling basis, especially where many short-term quality plans are used
Where quality plans are submitted to customers or other Interested parties, these interested parties might establish provisions for monitoring conformity with the quality plans.
Whether carried out by internal or external interested parties. such monitoring can assist in:
— assessing the commitment of the organization to the effective implementation of the quality plan;
— evaluating the practical Implementation of the quality plan:
— determining where risks can arise in relation to the requirements of the specific case;
— taking corrective action where appropriate;
— finding opportunities for improvement in the quality plan and associated activities.
7.3 RevIsion of the quality plan
The organization should revise the quality plan:
a) to reflect any changes to quality plan inputs or risks, including:
1) the specific case for which the quality plan is established;
2) the processes far production and service provision;
3) the organization’s management system;
4) statutory or regulatory requirements;
5) to incorporate agreed improvements to the quality plan.
An authorized person or persons should review changes to the quality plan for impact, adequacy and effectiveness. Revisions to the quality plan should be made known to users, customers, interested parties and/or external providers. Communication with customers and other interested parties should be consistent with the requirements for externally provided products and services. Any documented information that is affected by changes in the quality plan should be revised as necessary.
The organization should consider how and under what circumstances the organization would authorize a deviation from the quality plan, including:
— who will have the authority to request such devtations;
— how such a request will be made;
— what Information will be provided and in what form;
— who will be identified as having the responsibility and authority to accept or reject such deviations.
7.4 Feedback and improvement
Where appropriate, experience gained from the application of a quality plan should be reviewed and evaluated. The organization can also review the application of the quality plan in consultation with customers, external providers and other relevant Interested parties.
Lessons learned should be used to improve the organization’s quality plan(s) and the respective management system(s).