ISO 10005 pdf download – Quality management systems 一—Guidelines for quality plans.
Much of the generic documentation needed may already be contained in the organization’s quality management system documentation, including its quality manual and documented procedures. This documentahon may need to be selected, adapted an&or supplemented. The quality plan should show how the organization’s generic documented procedures are applied, or alternatively modified or overridden by procedures in the c.iaIity plan.
A quality plan may be included as part of another document or documents, for example protect quality plans are often induded in project management plans (see ISO 10006).
4.4.3 Responsibilities
In preparing the quality plan, the organization should agree and define the respective roles, responsdilities and obligations both within the organization and with the customer, regulatory authorities or other interested parties. Those administering the quality plan should ensure that the persons it refers to are aware of the quality obeclives and any specific quality issues or controls requited by the quality plan.
4.4.4 Consistency and compatibility
The contents and format of the quality plan should be consistent with the scope 01 the quality plan, the inputs to the plan and the needs of the intended users. The level of detail in the quality plan should be consistent with any agreed customer requirement, the organizations method of operation and the complexity of the activities to be performed. The need lot compatibility with other plans should also be considered.
4.4.5 Presentation and structure
The presentation of the quality plan may have any of several forms, for example a simple textual description, a table, a document matrix, a process map, a work flow chart or a manual. Any or all of these may be presented In electronic or hard-copy formats.
NOTE Examples of quality plans are provided in Annex A
The quality plan may be broken up into several documents, each of which represents a plan for a distinct aspect Control of the interfaces between the different documents needs to be clearly defined. Examples of these aspects include design, purchasing. production, process control or parlicutar activities (such as acceptance testing).
An organization may wish to prepare a quality plan that conforms to applicable requirements of ISO 9001. A cross-reference matrix is provided in Annex B for guidance.
5 Content of the quality plan
5.1 General
The examples and lists provided in this clause should not be considered comprehensive or limiting in any way.
The quality plan for a specific case should cover the topics examined below as appropriate. Some topics in this guidance may not be applicable, for example where design and development are not involved.
Where the work environment has a direct effect on product or process quality, the quality plan may need to specify the particular environmental charactenstics, for example
a) the air-borne particle content for a clean room:
b) electrostatic sensitive device protection;
c) biological hazard protection:
d) the temperature profile of an oven;
9) ambient light and ventilation.
5.9 Requirements
The quality plan should incluae or make reference to the requirements to be met br the specific case. P simple overview of the requirements may be included to help users to understand the context of their work, for example an outline of a project. In other cases, there may be a need br a comprehensive list of requirements. developed from input documents.
The quality plan should state when, how and by whom the requirements specified for the specific case will be reviewed. The quality plan should also state how the resulls of this review will be recorded and how conflicts or ambiguities in me requirements will be resolved.
5.10 Customer communication
The quality plan should stale the following:
a) who is responsible for customer oommuriication in particular cases:
b) the means to be used for customer communication;
C) where applicable, communication pathways and contact points for specific customers or functions:
d) the records to be kept of customer communication:
e) the process to be followed when a customer compliment or complaint is received.
5.11 Design and development
5.11.1 DesIgn and development process
The quality plan should include or make reference to the plan(s) for design and development.
The quality plan should take account of applicable codes, standards, specifications. quality characteristics and regulatory requirements, as appropriate. It should identity the criteria by which the design and development inputs and outputs should be accepted, and how, at what stage(s), and by whom, the outputs should be reviewed, verified and validated.
ISO 10005 pdf download – Quality management systems 一—Guidelines for quality plans
