CAN/CSA-ISO 9000:16 Quality management systems一Fundamentals and vocabulary.
2.2 Fundamental concepts
2.2.1 Quality
An organization focused on quality promotes a culture that results in the behaviour, attitudes, activities and processes that deliver value through fulfilling the needs and expectations of customers and other relevant interested parties.
The quality of an organization’s products and services is determined by the ability to satisfy customers and the intended and unintended impact on relevant interested parties.
The quality of products and services includes not only their intended function and performance, but also their perceived value and benefit to the customer.
2.2.2 Quality management system
A QMS comprises activities by which the organization identifies its objectives and determines the processes and resources required to achieve desired results.
The QMS manages the interacting processes and resources required to provide value and realize results for relevant interested parties.
The QMS enables top management to optimize the use of resources considering the long and short term consequences of their decision.
A QMS provides the means to identify actions to address intended and unintended consequences in providing products and services.
2.2.3 Context of an organization
Understanding the context of the organization is a process. This process determines factors which influence the organization’s purpose, objectives and sustainability. It considers internal factors such as values, culture, knowledge and performance of the organization. It also considers external factors such as legal, technological, competitive, market, cultural, social and economic environments.
Examples of the ways in which an organization’s purpose can he expressed include its vision, mission, policies and objectives.
2.2.4 Interested parties
The concept of interested parties extends beyond a focus solely on the customer. It is important to consider all relevant interested parties.
Part of the process for understanding the context of the organization is to identify its interested parties. The relevant interested parties are those that provide significant risk to organizational sustainability if their needs and expectations are not met. Organizations define what results are necessary to deliver to those relevant interested parties to reduce that risk.
Organizations attract, capture and retain the support of the relevant interested parties they depend upon for their success.CAN/CSA-ISO 9000 pdf download.