Guidance

Act to improve

The ISO Navigator™ database hyperlinks the ISO 9000 principles and the ISO 9001 requirements; and explains them in plain English with practical guidance.

ISO 9001: Improve the QMS (4.1 f)

Implement actions necessary to achieve the planned results, and the continual improvement of those processes. Auditors expect to see evidence that corrective action taken, when measurable objectives fall below target or defined action level.

A formal corrective action is not, however, always required; 'corrections' can be made through improvement plans and other methods though, a significant departure from the objectives should always invoke formal correction actions. This is the 'Act' part of the PDCA process. Act to achieve planned results and continual improvement.

Outsourced Processes

Outsourced processes must be controlled by the organization and the control methods must be defined within the QMS. Organizations should identify the controls they apply for any outsourced processes. The QMS manual must identify if outsourced processes are applicable. In addition, written documentation on the methods used to control the outsourced processes. Examples of some outsourced processes are:

1. A process completed wholly or partially by a sister facility outside the scope of registration. Such as corporate performing design, purchasing or customer related processes, this includes management activities i.e. business planning, goal setting, resources, data analysis, budgeting, etc. This may include the entire element or a subsection i.e. corporate completes supplier evaluation and re-evaluation of suppliers and the registered site initiates purchase orders.

This may include the entire element or a subsection i.e. corporate completes supplier evaluation and re-evaluation of suppliers and the registered site initiates purchase orders.

2. A processes completed by an outside vendor or subcontractor such as heat treating, plating, calibration, painting, powder coating, etc. These types of processes may be controlled by the purchasing process where a formal contract or purchase order may be the controls. If this is the case, written documentation would be the purchasing documentation and records however; these processes are required to be documented in the quality manual.

If an outsourced process is controlled through purchasing information, there must be documented objective evidence to ensure that these processes are being controlled beyond the basic purchasing requirements, which are focused on controlling products not processes.

The organization should ensure that each outsourced process meets the applicable requirements to ISO 9001:2008. Outsourced processes may be controlled through such methods as, but not limited to:

  1. Auditing
  2. Contractual agreements
  3. Process performance data review on an on-going basis
  4. Purchasing process

Ensuring control over outsourced processes does not absolve the organization of the responsibility for conforming to 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:

The potential impact of the outsourced process on the organization’s capability to provide a product or service that conforms to requirements, the degree to which the control of the process is shared and the capability of achieving the necessary control through the application of the purchasing process