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Processes, Procedures, and Work Instructions: Tips From ISO 9001:2015 

Nicole Radziwill

“The procedural approach is about doing a task, conforming to the rules, doing what we are told to do, whereas the process approach is about understanding needs, finding the best way of fulfilling these needs, checking whether the needs are being satisfied and in the best way and checking whether our understanding of these needs remains valid.” -- David Hoyle in ISO 9000 Quality Systems Handbook, 7th Ed. (p.129) 

Quality management systems (QMS) are process-based, and QMS software systems help organizations document, manage, and update those processes -- in many cases, to demonstrate compliance with standards such as ISO 9001. The terminology can be confusing because processes, procedures, and work instructions are related: 

  • A process covers what we need to accomplish to add value, and is outcome-based 
  • A procedure articulates how the process will be executed, and is task-based 
  • A set of work instructions describes exactly how each person will contribute 

When technology changes, work instructions will change, but procedures may remain the same. Work instructions may need to be translated into multiple languages to meet the needs of the frontline workforce. When a new technique is adopted (say for measurement or calibration), the procedure will change and the work instructions will need to be updated. When the needs of internal or external customers change, the process itself might change, leading to changes in both procedures and work instructions. 

The more complex the procedure, the less valuable work instructions are likely to be. For example, it would be pointless to write documents or create videos providing work instructions for identifying the source of a cyberattack. A documented process, however, could help guide first responders through the high-level steps of an investigation. 

Do people in your organization know what needs to be done, and how to do it? When there are changes in customer needs, staff needs, personnel, or technologies, how does your organization adapt? How do you train people on the changes, and can you demonstrate that effective training was provided? 

Additional Reading: 

Hoyle, D. (2017). ISO 9000 Quality Systems Handbook-updated for the ISO 9001: 2015 standard: Increasing the Quality of an Organization’s Outputs. Routledge. 


September 12, 2018 @ 10:16 AM EDT Quality

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