Auditing
We have IRCA certified lead auditors
available to conduct audits at your facility or your suppliers.
See below types of Audits we can complete for you.
QSIT style Inspection
Expecting an FDA inspection at your site?
We can complete a mock FDA inspection at your facility to determine
your level of compliance with US regulations.
The mock FDA inspection usually take 4 days and follows the
Quality System Inspection Technique that an FDA inspector would follow.
You will receive a detailed report after completion of the inspection.
This report will include identification of any deficiencies in your
Quality Management System, what is being done well and
any potential areas of improvement for
hosting FDA inspections.
ISO 13485 Audit
We can complete an audit of your quality management system against ISO 13485:2016
MDSAP Inspection
What to be MDSAP ready. We can complete a MDSAP style audit of your facility. This can be a great tool in helping your company get ready for MDSAP.
Supplier Audits
We can conduct audits of your supplier. Many of our clients do not have adequate resources to conduct audits of their high risk suppliers. We can perform this service, and provide you with a report detailing the results. If required we can generate these reports in your own templates.
This will help ensure that your organization
does not receive a 483 or an FDA warning letter.
The benefits of this to your organization are:
Gain experience hosting a QSIT style inspection
Identify who in your organization is comfortable
defending your quality system
Identify issues before the FDA identify them.
This gives you the opportunity to correct these or
have corrective action plans in place in advance of
the FDA inspection.
