Prior to a Quality Management System Certification, GMED offers manufacturers the chance to schedule a Pre-Assessment Audit or Diagnostic Audit. As an optional service, one of our auditors will visit your site to perform a mock audit prior to your actual Certification Cycle.
Benefits
The Diagnostic Audit is a convenient, economical way for you to discover and correct any non-conformities, prior to the actual certification audit cycle.
Your diagnostic audit can be scheduled quickly and is completely confidential; only your company will receive audit results.
The Diagnostic Audit:
- Determines your readiness for certification by an actual registrar (GMED)
- Reveals your strong points as well as the weaknesses to clarify unmet requirements
- Familiarizes your organization with GMED and its auditors’ assessment method
- Optimizes your resources by allowing you to focus on the gaps to be bridged
- Applies to Quality Management System applicable standards, including:
- ISO 9001 General, ISO 13485 Medical Devices, ISO 15378 Primary Packaging Materials for Medicinal Products
- European directives for the CE marking of Medical Devices (MDD), Active Implantable Medical Devices (AIMD) and In Vitro Diagnostics(IVD)
- Quality, Security and Environment (QSE) integrated management systems
If you are preparing for your first audit, have any concerns about your readiness or face critical deadlines, a Diagnostic Audit is a great way to get early feedback on any issues you need to address and maximize your opportunity for successful certification.
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