7.5.3.1 Identification

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You are here: Home Compliance Master Compliance ISO 13485:2012-11 Quality management 7 Product realization 7.5 Production and service provision 7.5.3 Identification and traceability 7.5.3.1 Identification 7.5.3.1 Identification

General :
Version:	1.0

Project :
Author:	Wolfgang Kern
Created:	07.03.2014
Modified:	12.09.2017 16:02:50

Diagram Elements :

Store sterilized modules

Store approved modules

Store approved device

Article master data

File product identification of incoming parts

File product identification before delivery

File modules build into device

Label lot number

Label STERILE MEDICAL DEVICE

Label module with serial number

Label device and affix CE mark

Label MEDICAL DEVICE

Label MODULE

Label service module as customer property

Label module as customer property

Label CUSTOMER PROPERTY

7.5.3 Identification and traceability : 7.5.3 Identification and traceability

7.5.3.1 Identify the product and establish documented procedures for such product identification

7.5.3.1 Establish procedures to identify products returned to organization and are distinguished from conforming product

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