Quality Management System Auditing

The adoption of a quality management system should be a strategic decision of anorganization. The design and implementation of an organization's quality managementsystem is influenced bya) its organizational environment, changes in that environment, and the risksassociated with that environment,b) its varying needs,c) its particular objectives,d) the products it provides,e) the processes it employs,f) its size and organizational structure.It is not the intent of this International Standard to imply uniformity in the structure ofquality management systems or uniformity of documentation.The quality management system requirements specified in this International Standard arecomplementary to requirements for products. Information marked "Note" is for guidance inunderstanding or clarifying the associated requirement.This International Standard can be used by internal and external parties, includingcertification bodies, to assess the organization's ability to meet customer, statutory andregulatory requirements applicable to the product, and the organization's ownrequirements.
The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization's quality management system is influenced by

a) its organizational environment, changes in that environment, and the risks associated with that environment,

b) its varying needs,

c) its particular objectives,

d) the products it provides,

e) the processes it employs,

f) its size and organizational structure.

It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation. The quality management system requirements specified in this International Standard are complementary to requirements for products. Information marked "Note" is for guidance in understanding or clarifying the associated requirement.

This International Standard can be used by internal and external parties, including certification bodies, to assess the organization's ability to meet customer, statutory and regulatory requirements applicable to the product, and the organization's own requirements.

This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements.

For an organization to function effectively, it has to determine and manage numerous linked activities. An activity or set of activities using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process. Often the output from one process directly forms the input to the next.

The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the "process approach".

An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as over their combination and interaction.