Questions relating to specific clauses in the standard
15. What is meant by the context of the organization?
This is the combination of those internal and external factors that affect an organization's approach to the way in which it provides products and services that are delivered to its customer.
External factors can include, for example, cultural, social, political, legal, regulatory, financial, technological, economic, and competitive environment, at the international, national, regional or local level.
Internal factors typically include the organization’s corporate culture, governance, organizational structure, technologies, information systems, and decision-making processes (both formal and informal).
16. What are the needs and expectations associated with interested parties?
The organization will need to determine the interested parties that are relevant to the quality management system and the requirements of those interested parties, as outlined in clause 4.2. This does not extend past the quality management system requirements and the scope of this International Standard.
As stated in the scope, this International Standard is applicable where an organization needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and aims to enhance customer satisfaction.
17. What is meant by organizational knowledge?
Organizational knowledge is knowledge specific to the organization; it is generally gained by experience. It is information that is used and shared to achieve the organization’s objectives. Requirements regarding organizational knowledge were introduced for the purpose of safeguarding the organization from loss of knowledge and encouraging the organization to acquire new knowledge as its business context changes.
