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7.5 Production & Service Provision [7.5.7 to 7.5.11] (ISO 13485:2016)
7.5 Production & Service Provision [7.5.7 to 7.5.11]
(ISO 13485:2016)
7.5.7 Particular Requirements for Validation of Processes for Sterilization & Sterile Barrier Systems
Validate processes before implementation & following product/process changes (as appropriate)
Maintain records of validation results, conclusions & necessary actions
Document procedures for the validation of processes for sterilization & sterile barrier systems
7.5.8 Identification
Document a system to assign unique device identification to the medical device (if required by regulatory requirements)
Document procedures to ensure medical devices returned are identified & distinguished from conforming product
Identify product status with respect to monitoring and measurement requirements
Maintained throughout production, storage, installation & servicing of product
Document procedures for product identification
7.5.10 Customer Property
If any customer property is lost, damaged or unsuitable for use, report to customer & maintain records
Identify, verify, protect & safeguard customer property provided for use or incorporation into the product while it is under organization's control or being used by the organization
7.5.11 Preservation of Product
Apply to constituent parts of a medical device
Protect product by:
designing & constructing suitable packaging & shipping containers
documenting requirements for special conditions needed if packaging alone cannot provide preservation
Document procedures for preserving conformity of product to requirements during processing, storage, handling & distribution
Control and record special conditions (if they are required)
7.5.9 Traceability
7.5.9.1 General
Document procedures for traceability
Procedures and records to define extent of traceability in accordance with regulatory requirements
7.5.9.2 Particular Requirements for Implantable Medical Devices
Require suppliers of distribution services/distributors maintain records of medical devices distribution & that these records are available for inspection
Maintain records of the name & address of shipping package consignee
Require records of components, materials & conditions for the work environment used if these could cause the medical device not to satisfy its safety & performance requirements