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We have developed over the years a complete Internal Audit System that includes an
ISO 13485:2003 compliant audit procedure, annual audit schedule, management summary,
opening and closing meeting checksheets and attendance logs, and a set of 16 comprehensive
checklists for process-oriented system auditing. With this resource, we will also be including
a PowerPoint slideshow explaining the entire system in complete detail.
Our Audit System will be delivered in a combination of Microsoft Word and Excel documents that
will enable your organization to effectively audit your entire business
process relative to the requirements of ISO 13485:2003. Each Audit Report includes a
series of questions to drive your auditors to successful completion of a system-wide
compliance audit. The complete package of documents will be bundled in a compressed zip file for fast download.
The reports are designed to audit processes within your organization assisting with the
recognition of inputs and outputs used to show effectiveness. This enables your ISO
Management Representative to schedule your internal audits with frequency based upon
the importance and status of each area and quickly determine the results of audits to
make additional frequency adjustments as necessary.
This system can be used as both a gap analysis tool and a quality management system
compliance validation and improvement tool. After implementing our Audit System, your
organization will be equipped with a better understanding of all ISO 13485:2003
requirements and be able to breeze through your next 3rd party Registrar’s Audit.
Get a copy of our Audit Report System for your organization as soon as it's available, and begin reaping the
benefits of a comprehensive system tool and a more relational perspective of ISO 13485:2003!
If you are interested in this resource, please contact us to help us prioritize our development efforts!
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ISO 13485:2003 - Internal Audit Procedure and Audit Report [Checklists] System