Understanding the ISO 9001 Audit Checklist
If an organization has recently embarked on the journey of implementing ISO 9001:2008, a
generic ISO 9001 audit checklist can be very helpful in determining gaps in compliance. As
the system matures however, generic audit checklists lose their effectiveness and it becomes
critical for the organization to delve deeper in terms of conformance when assessing the
effectiveness of operational controls and specific processes.
Why use an ISO 9001 Audit Checklist?
Internal auditors often use an ISO 9001 audit checklist to determine compliance since the ISO
9001 audit checklist covers each requirement of the standard as a question. This type of
questionnaire is very useful for internal auditors, because it helps them to discover how a
specific requirement is implemented. The auditor has only to check that the defined procedure
meets the requirements and if the procedure is preformed correctly.
The shortcoming of this approach is that the audit often fails to evaluate the effectiveness and
efficiency of the process being audited. What happens if the process does not meet
procedure? Should you change the process to be compliant with the procedure, or should you
verify whether the process is effective and change the procedure? These are questions to
consider in any procedure-based audit.
Instead, use the ISO 9001 audit checklist only as a guide and allow the auditor to delve freely
into whatever process is deemed critical. This model will produce more meaningful findings,
but, there is a risk that auditors focus on auditing processes that are familiar to their particular
specialty. Furthermore, as time goes by, completing the audit checklist could become
mandatory and overburdened with detail resulting in less time for in-depth auditing.
Process Auditing and Checklists
Process audits are undertaken to verify whether a process meets the planned goals and
objectives and to identify opportunities for improvement. The main thing to understand when
auditing a process is the actual process concept. One does not need to know or understand
the details of a specific process to be able to audit it, although it does help. A good auditor
should be able to audit any process without knowing anything about it by monitoring the
process inputs to determine whether the desired process outputs have been achieved.
As with other ISO standards which require internal auditing, audit checklists based on the
standard have minimal benefit when it comes to auditing a process. It is best to develop a
specific audit questionnaire based on actual management system policies, processes and
procedures. This allows a more in-depth approach that identifies not only failures in the
processes but also potential failures, while also ensuring the internal auditors are much more
rigorous during their enquiries.
Controlling the Audit Checklist
The basic ISO 9001 audit checklist template should be controlled but the actual audit
checklist for each process is subject to change and should not be controlled.
Download a free ISO 9001 audit checklist example courtesy of ISO 9001 Checklist.
Sometimes the ISO 9001 audit checklist and auditing in general are treated as a separate
agenda items which are often put back in the closet until the next internal audit or registration
audit. An effective internal audit process can prevent that from happening by maintaining
visibility throughout the organization. To learn more please visit ISO 9001 Checklist:
You have permission to republish the above article free of charge (in Print and on the
Internet) as long as the article title, body and resource box remain intact (with no changes)
and the hyperlinks active.
Telephone: 020 8144 1863
About ISO 9001 Checklist
ISO 9001 Checklist has grown from a project started in 2002 by ISO Auditors and Quality
Manager Trainers to freely share their knowledge and experience with the ISO community
online. The free ISO 9001 training section is an essential resource for any organization aiming
to achieve ISO 9001:2008 accreditation through PDCA.
Registered in England No. 7175526. Registered office: 2 Woodberry Grove, North Finchley,
London. N12 0DR.