ISO 9001:2915 Clause 9.2 Internal Audit

ISO defines audits as “Systematic, independent and a documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.”

We understand that Internal Audit Programs and Business interruptions can negatively impact your Quality Management System.

More and more organizations have to address a current and real concern of organizations facing challenges with regards to the integrity of their Internal Audit Program in face of an upcoming 3^rd Party verification audit.

These challenges can range from;

products not going out to customers
service has come to a still stand
trained internal auditors or key process owners has been laid off
training has been out on ice
Quality meetings or circles has stopped
records are not maintained
the Internal audits has been put on hold
calibration of instrumentation has expired

The list goes on. The cost not to maintain the integrity of your Quality Management System can be enormous during these uncertain times.

Leaderships in most Post Covid-19 business environments will be faced with similar dilemmas. Serious consideration should be given to the fact that Internal audits, can be conducted by, or on behalf of the organization. Turn the potential threat to your organization’s Quality Management System into an opportunity.

Outsourcing your Internal Audit Program presents the following advantages and assistance in;

maintaining the integrity of the QMS
management of existing resources
receive guidance and direction from an experienced lead auditor while at the same time maintaining significant involvement in the internal audit process
address the gap in Quality records
cost effectiveness, the Internal Audit function can be outsourced to an external experienced auditor on a periodic basis
storing of finished products for longer than anticipated time periods
If expiry dates were exceeded then you’d want to demonstrate that appropriate actions were taken to segregate/disposition those items so that they never reached the Customer
cost and time saving because of conducting off site / Table Top internal audits
the potential lack of key personnel’s availability is largely being minimized
assess and determine the impact of calibration cycle’s
review existing procedures and protocols with regards to outsourced suppliers
keep record of all documented information regarding related to the internal audit program for external / 3^rd party audits
a fresh independent pair of eyes always brings new opportunities whilst providing an independent and objective assessment to management
keeping your QMS active and effective
lessen the impact of future business interruptions
satisfying Internal Audit requirements (Clause 9.2)

If your Internal Audit Program’s integrity is under threat, PlanBee is there to assist. For more information, please contact us.

ISO 9001:2915 Clause 9.2 Internal Audit