Risk Management Part 4 – Quality Management System and its processes

Once the organization has determined the Pertinent requirements of the relevant concerned parties and has understood the Context of the organization in which it must carry out its operations, it needs to establish the necessary processes that will make up the Quality Management System. Risk management is based on the analysis of these processes and their interactions.


The quantity and complexity of the processes that make up the Quality Management System in the organization will depend on its organizational structure and its own management model. The following are some of the processes that organizations commonly determine to be necessary:

  • Production / Manufacturing / Product realization
  • Design and development of new products
  • Management review
  • Purchases / Supplies / Materials / Logistics
  • Calibration and testing laboratory
  • Training
  • Document control
  • Maintenance
  • Sales / Marketing
  • Shipping / Transportation / Distribution
  • Internal audits


For each of the necessary processes, the following must be determined:

  • Required inputs and expected outputs
  • Sequence and interaction with other processes
  • Resource requirements:
    • People
    • Infrastructure
    • Environment
    • Documented information
  • Responsibilities and authorities
  • Indicators for monitoring and measuring performance


Once the necessary processes of the Quality Management System have been determined, Risks and Opportunities must be addressed in all of them.


◄Part 3 – Part 5 ►

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