SFDA’s Quality Management System Auditing Organizations
November 19, 2020
SFDA has published a new implementing rule on how Quality Management Auditing Organizations can comply with SFDA’s requirements; Click here to read the official document.
Highlights from this Document
SFDA will perform (if needed) auditing for QMS of the establishment and overseas manufacturer
Any auditing organization applying for this designation, shall submit the required information mentioned in this article
SFDA’s role starts with reviewing the information submitted by the auditing organization, certify and audit whenever necessary
These articles mainly discuss the role and responsibilities of the Auditing Organization in terms of: Resources, Independence and Impartiality, Confidentiality and due professional care, Quality management procedures, Legal requirements and Liability Insurance
Listed here; are all the requirements to be provided upon applying for the designation to be an Auditing organization with SFDA.
This information applied to the personnel:
Conducting the application review
Reviewing audit reports
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