Iso 9000 auditing

1. Iso 9000 auditing
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 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
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

2. 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 checklist template should be controlled but the actual audit checklist
for each process is subject to change and should not be controlled.
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