Process Approach Auditing FAQs
What is process approach auditing?
Using the process approach, you audit your company's processes instead of individual
elements of the quality system. The criteria and scope of the audit are basically
the same, but the sequence, approach and focus changes from the ISO 9001 standard
to the actual organization and processes of your company.
What are the advantages of process approach auditing?
In process approach the flow and focus of the audit is on the organization (company)
rather than the ISO 9001 standard. It considers the effectiveness and efficiency
of processes, such as purchasing, and how the process interfaces with other processes.
Process auditing is more natural and logical, and adds more value to your company
than the element (compliance) approach.
What are the drawbacks of the process approach?
The process approach is more difficult and time consuming to implement than element
based auditing. The additional steps in implementing process approach auditing involve
developing a process map and associating all major processes with relevant ISO 9001
How is compliance with ISO 9001 verified using the process approach?
Compliance is verified by associating all ISO 9001 requirements to relevant processes
and verifying whether the process and its implementation meet these requirements.
For example, the purchasing process in your organization, in addition to being effective,
efficient, and meeting your other internal requirements, must also meet all requirements
of ISO 9001 Clause 7.4, Purchasing, and other relevant clauses.
What additional steps are required to implement process approach auditing?
First you must define your processes and establish your process map (which you should
have anyway in order to comply with ISO 9001 Clause 4.1). Then associate each process
with all relevant ISO 9001 requirements (sections, clauses and sub clauses). Finally,
organize the checklist into sections representing your processes, and for each process
list the corresponding requirements and audit questions. The scope of the checklist
remains the same as for the element approach (all ISO 9001 requirements) but the
basic unit of the audit is now a real process instead of an arbitrary clause in