About:
I will create your quality manual and associated quality management documentation for ISO 22716
I am an experienced regulatory affairs specialist on medical devices and healthcare products. I have extensive experience preparing QMS documentation for ISO 13485, ISO 9001 and ISO 22716 processes and procedures for implementation.
- Management System according to ISO 22716
- I will compile, review and generate your company QMS documents
- Establish processes and procedures documentation
- I will create form templates for use by your company
- I will provide audit consulting for preparation by third party
- I will support your compliance response to third party audits
- I will advise and generate documentation for your CAPA system
- Standard Operating Procedure, Work Instructions
- Your company and current QMS
- Any special features of your organizational operation
- One location or multi site organization
Basic: 3000 words, 2 technical illustrations, 1 revision, delivery in 5 days.
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