Process vs. Procedure vs. Work Instruction
Process (Not a document)
Process – any activity or set of activities that uses resources to transform inputs into outputs can be considered a process. ISO 9001 has a process approach.
Processes must have defined (but not necessarily measurable) objective(s), input(s), output(s), activities, and resources. You should be able to ask these when defining a process:
- What are the basic jobs carried out in your department?
- Can you explain to me your operations here?
- What information do you need to start your work?
- Where does it come from?
- Who receives the result of your work?
- How do you know if you’ve done your job correctly? (meet objectives)
Procedures (Level 2 Documents)
Procedure – A procedure outlines how to perform a process, such as “Purchasing“:
- Who performs what action
- What sequence they perform the steps in the task
- The criteria (standard) they must meet
Your procedures (along with your ISO 9001 quality manual and required forms) make up your quality management system (QMS). Your procedures will describe how you operate and control your business and meet the ISO 9001 requirements.
Procedures are used for all of the Quality System Processes. You need to have all of the ISO 9001 required Procedures to ensure that the quality management system or QMS runs correctly and consistently.
Work Instructions (Level 3 Documents)
Work Instructions – A work instruction describes how to perform a task, which is a more detailed portion of the procedure such as “Completing a PO” or “Ordering supplies”.
You may need more detail than that described in the procedures. Many businesses
include work instructions to aid in training, to reduce mistakes, a point of reference for jobs, etc.
Processes, procedures and work instructions are all part of the general ISO requirements package. The 9000 Store provides a complete set of the required ISO 9001 procedures. We also have general information such as ISO training, ISO standards and more. ISO requirements