AS ISO 10005:2018 pdf free.Quality management—Guidelines for quality plans.
The organization requesting an external provider quality plan should apply risk-based thinking to the nature of the specific case, the evaluation and selection of external provider(s) and opportunities for benefits. There can be benefits to both the organization and potential external providers in using risk- based thinking.
Consideration of risks related to the specific case can increase the options for requesting quality plans from external providers, for example:
a) specifying intended results rather than the methods and resources to be applied to the specific case (such as in performance-based contracts) can allow external providers to introduce innovation in methods, practices and resources;
b) specifying minimum requirements for controls and documented information allows an external provider to apply their own processes and experience;
c) defining quality plan requirements for the specific case rather than requiring conformity with a management system standard, such as ISO 9001, can enable participation by a broader range of potential external providers with different levels of maturity of their management systems.
Examples of specifications of requirements for external provider quality plans relevant to particular sectors can often be found in industry codes of practice, requests for offers of products and services or other publicly available sources. However, care should be taken to ensure that such examples are appropriately adapted to the specific case.
Requirements for external provider quality plans can be included in specifications for other management plans such as service management plans, project management plans, construction management plans or production and installation plans.
NOTE 1 Understanding 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.AS ISO 10005 pdf download.