ISO 13485 Standard has been based on the requirements of ISO 9001 standard and has the same structure in terms of clauses. Even some clauses of ISO 13485 have been referred to ISO 9001. The main objective of the standard is to facilitate harmonized quality management system requirements for regulatory purposes within the medical devices sector. ISO 13485 is an internationally published standard that defines requirements within quality management systems for manufacturers, suppliers, contract service and distributors of medical devices and equipment.
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