ISO 10005 pdf download – Quality management-Guidelines for quality plans.
An organization may decide to prepare a quality plan that conforms to applicable requirements of Iso 9001. A correlaflon matrix to ISO 9001:2015 is provided in Annex C for guidance.
5.4.4 Presentation and structure
A quality plan may be formally defined and presented using different methods, for example;
a) graphical representations (e.g. process map, work flow charts);
b) written work instructions (e.g. textual description, table, document matrix, checklists, manual);
c) visual media, electronic methods;
d) software applications;
e) combination of methods.
These methods should be appropriate to the application and users of the quality plan.
The quality plan may contain a number of distinct plans, for example br particular aspects, processes or functions. Control of the interlaces between the different plans needs to be clearly defined.
NOTE Examples of quality plans are provided In Ana&A.
6 Content of the quality plan
6.1 General
The guidance in 6.3 to 6.17 indicates what should be considered tar inclusion in a quality plan. Documented information necessary for the intended users of the quality plan may be contained within the quality plan or, where available from other sources (e.g. an intranet or extranet), may be referenced or linked electronically.
Some topics not mentioned In 62 to 61.7 could be added depending on the nature and the scope of the specific case. Where a customer requires specific topics or a specific structure, the quality plan should be prepared in accordance with those requirements.
The quality plan for a specific case should cover the topics examined in 6.2 to 6.17 as appropriate. Some topics In this guidance might not be applicable, for example where design and development are not involved.
6.2 Scope of the quality plan
The scope should he clearly stated in the quality plan (see 5.3). This should include:
a) a simple statement of the purpose and expected output of the specific case;
b) the aspects of the specific case to which it will be applied, including particular restrictions to its applicability;
c) the conditions of its validity (e.g. dimensions, temperature range, hardware platform/operating system, market conditions, resource availability or quality management systems certilication/ registration status).
6.3 Quality plan inputs
It can be necessary to list or describe the inputs to the quality plan (see 5.2). to facilitate. for example:
a) reference to Inputs by users of the quality plan;
e) the documented information that should be retained from communications and/or on complaints received from customers and other interested partIes.
6.9 Design and development
6,9.1 Design and development process
The quality plan should reference applicable plan(s) for design and development.
The quality plan should take account of applicable specifications, codes, industry standards, qLlality characteristics, statutory and regulatory requirements.
It should specify the criteria by which the design and development inputs and outputs should be accepted, and how, at what stagefs), and by whom, the outputs should be reviewed, verified and validated.
In some cases, design and development Is a complex process and guidance should be sought from appropriate sources, including internal documented information an design and development. In others. the level of complexity will be low but still require a planned process to ensure that risks associated with the use of design and development outputs are controlled. For projects, the design and development process can be applied to the establishment and subsequent change control of prolect plans, as well as to the intended result of the project.
In the service sector, the design and development process can apply to the development of a service specification which forms the basis for subsequent service provision. However, where services are unique to a specific customer transaction, for example research and advisory services, the design and development process can be applied to the entire service provision process.
NOTI ISO/TS 9002 provides general guidance on the design and development process. isolia 904)03 and I5O/IEC/IEEE 24748.5 provide specific guidance for the software sector.
6.9.2 Control ol design and development changes
The quality plan should state:
a) how requests for changes to the design and development outputs will be controlled;
b) who is authorized to initiate a change request:
c) how changes will be reviewed In terms of their impact;
d) who is authorized to approve or re)ect changes.
ISO 10005 pdf download – Quality management-Guidelines for quality plans
