4.1 General requirements

The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard.
The organization shall

  1. determine the processes needed for the quality management system and their application throughout the organization (see 1.2)
  2. determine the sequence and interaction of these processes
  3. determine criteria and methods needed to ensure that both the operation and control of these processes are effective
  4. ensure the availability of resources and information necessary to support the operation and monitoring of these processes
  5. monitor, measure where applicable, and analyse these processes
  6. implement actions necessary to achieve planned results and contitinual improvement of these processes

These processes shall be managed by the organization in accordance with the requirements of this International Standard.

Where an organization chooses to outsource any process that affects product conformity to requirements, the organization shall ensure control over such processes. The type and extent of control to be applied to these outsourced processes shall be defined within the quality management system.

NB Processes needed for the quality management system referred to above include processes for management activities, provision of resources, product realization, measurement, analysis and improvement.

NB an “outsourced process” is a process that the organization needs for its quality management system and which the organization chooses to have performed by an external party.

NB Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory and regulatory requirements. The type and extent of control to be applied to the outsourced process can be influenced by factors such as

  1. the potential impact of the outsourced proces on the organization’s capability to provide product that conforms to requirements
  2. the degree to which the control for the process is shared
  3. the capability of achieving the necessary control through the application of 7.4
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