ISO 10005:2018 pdf download – Quality management—- Guidelines for quality plans.
5 Development of a quality plan
5.1 Context of the quality plan
Understanding the context of the quality plan and its intended results provides a basis for determining risks and opportunities to be addressed.
The context of the quality plan can include:
a) existing management plans or processes which will support the quality plan, whether or not these processes are part of an established management system;
b) Internal Issues that can affect the ability of the organization to achieve the intende’d results, suuh as constraints on resources, how the quality plan will be communicated to its users and whether Work will be carried out at different sites;
c) external issues related to the specific case, such as statutory and regulatory requirements, competitive and market issues;
d) the aspects of both the internal and external issues of the organization that relate to the specific case, for example quality and market objectives;
e) the needs and expectations of relevant interested parties, including customers, employees, external providers, etc.
NOTE I linderstandrng the external context can be facilitated by considering issues arising from legal, technological, competitive, market, cultural, social, environmental and economic factors, whether international, national, regional or local.
NOTE 2 UnderstandIng the Internal context can be facilitated by considering Issues related to values, culture, knowledge and performance of the organization
Risks should be determined and addressed. In order to provide confidence that intended results will be achieved and undesired effects will be prevented or reduced.
Opportunities for improvement should be considered, for example to meet customer expectations or increase effectiveness and efficiency. Opportunities for innovation can also be important, for example where draft quality plans are submitted as part of a tendering process for provision of products and services.
Once the context for the quality plan and its intended results are understood, the scope and objectives of the quality plan can be defined. The format and level of detail needed for the quality plan can also be decided.
5.2 Inputs to the quality plan
The organization should determine the inputs to the quality plan, for example:
a) customer requirements, statutory, regulatory and industry specifications;
b) information on the needs of users of the quality plan;
c) other relevant quality plans;
d) requirements of the specific case;
e) assessments of risks and opportunities related to the specific case;
f) requirements for and availability of resources;
g) management system requirements of the organization;
h) documented information relevant to the quality plan;
I) communication requirements for the quality plan.
5.3 DefIning the scope of the quality plan
The organization should determine what is to be covered by the quality plan. The scope of the quality plan will depend on several factors, including:
a) the requirements of customers and other relevant interested parties;
b) the types of products and services to be provided;
c) the organizatwns processes and their quality characteristics;
d) the resources needed to achieve the intended results;
e) the extent to which the quality plan is supported by an established quality management system.
There can be benefits from reviewing the scope of the quality plan with the customer or other relevant
interested parties.
5.4 Preparation of the quality plan
5.4.1 InItiation
In preparing the quality plan, the organization should determine the respective rules, responsibilities and authorities within the organization and, where applicable, the relevant responsibilities and aLithorities of external parties.
The quality plan should be prepared with the participation of people who are involved in the specific case, both within the organization and, where appropriate, relevant interested parties. Where a particular resource has limited availability, the quality plan might need to specify how the demand for resources will be satisfied.
5.4.2 DefinIng the quality plan
The quality plan should Indicate how the required activities will be carried out, either directly or by reference to appropriate documented information (e.g. project plan, work instruction, checklist. software application).
Where an organization has an established management system, it may select, adapt, or supplement existing documented information for use in, or reference by, the quality plan.
Where a requirement results in a deviation from the organization’s management system the resulting risks and opportunities associated with the deviation should he considered; such deviations should be justified, agreed and approved.