ISO 9001 Process Auditing Requires Knowledge of the Standard

There is general agreement among Quality Managers and Quality Auditors that process auditing is more beneficial than clause based auditing.

In clause based auditing, an organization or a segment of an organization is audited to verify it complies with a particular clause of the ISO 9001 QMS Requirements.

With process auditing, a particular process or group of processes is audited to ensure that it complies with any part or clause of the standard that applies to it.

For example, corrective action is a clause in the standard, but corrective action should also be a continual improvement process.   If you are doing a clause based audit, you would audit aspects of corrective action that are covered in the corrective action clause (8.5.2).  If you are doing a process audit of corrective action, then you would verify that the corrective action process is in compliance with all applicable sections of the standard, not just clause 8.5.2.  It could include things such as Customer focus (5.2) and Customer satisfaction (8.2.1), Competence, training and awareness (6.2.2), Control of documents (4.2.3) and records (4.2.4), Analysis of data (8.4), and (definitely) Management review (5.6).

But effective process auditing requires a good grasp of the standard, so the auditor or audit team knows which clauses of the standard apply to a particular process.  While new auditors or a newly established QMS may start with clause based auditing, the goal should be to move to process auditing as soon as the auditors and the quality team feel familiar with the standard.

As the above example demonstrates, process auditing provides a much more comprehensive and in-depth measurement of the Quality Management System, and thereby provides better value for your internal auditing efforts.

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Originally published in 2009 by Bizmanualz, Inc. under the title ISO 9001 Process Auditing Requires Knowledge of the Standard. All rights reserved. Reproduction permitted with attribution only. www.bizmanualz.com