ISO 13485 document template:
SOP-824-02
FDA Inspections
This SOP outlines the process for managing a USA FDA facility inspection and describes activities that should be carried out to facilitate and manage the inspection. Applies to all personnel involved in the implementation and coordination of the Quality Management System. This procedure covers the preparation, reporting, and procedures to follow prior to, during, and following an inspection by the U.S. Food and Drug Administration (FDA).
The document is fully editable that you can customize to suite your prduct and companies QMS.
Blue font areas indicate where some customization may be required.
Each SOP purchase includes unlimited email support for any assistance you may need.
US $149
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OVERVIEW
Price
US$ 149.00
Compliant with
FDA Regulations
Format
Microsoft Word All Versions compatible
Number of pages
6
Document language
English
Content
Includes ISO 13485 as well as Best Practice recommendations
USABILITY
Can I edit the document?
Yes. The document is fully editable – just enter information specific to your company.
Can I use this to become certified?
Yes. The documentation template may be used for ISO 13485 certification audit purposes.
Compatible for all companies
Formated for start-up companies to mature companies
Want to see what the documents look like?
DOCUMENT FEATURES
F.A.Q
BUYING INDIVIDUAL ISO 13485 DOCUMENT TEMPLATES
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