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ISO 9001:2008: Quality system planning 5.4.2

It is the responsibility of top management to ensure that quality management system is implemented and properly maintained. They should undertake quality management system planning to ensure:

  1. The on-going development of the QMS to meet the requirements of 4.1
  2. The on-going development of policies and objectives 5.4.1 & 5.4.2
  3. Processes and resources exist to identify characteristics at different stages 6.1, 6.2, 7.1, 7.3.1 & 7.5.1
  4. The ability to proactively review and improve the QMS 5.6 & 8.5.1
  5. Verification activities, determine criteria for acceptability 7.6 & 8.1

Each department manager should develop and maintain a process map, flow chart, quality plan, operating procedure, etc., that show the workflow of the department as well as referencing evidence of compliance with the requirements of the management system.

If your organization outsources certain processes or has a requirement for strict control over its supplied product, it might be appropriate to establish a quality plan. This defines the quality practices, resources and activities relevant to the product to be designed or supplied whilst also establishing how the requirements for quality are to be met.

The quality assurance requirements are then implemented through the use of this plan in conjunction with the manufacturer’s quality manual and operating procedures.

This plan further includes, but is not limited to the following key activities, as appropriate, in meeting the specified requirements for the products, projects or contracts. The preparation of the quality plan might include:

  1. The identification of processes, resources and skills to achieve quality
  2. The identification of suitable verification criteria at appropriate stages
  3. Demonstrating compatibility of design, production, inspection and testing
  4. The clarification of standards of acceptability for all features/requirements
  5. Details of calibration of any special measuring or test equipment to be used