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7.5 Production & Service Provision [7.5.1 to 7.5.6] (ISO 13485:2016)
7.5 Production & Service Provision [7.5.1 to 7.5.6]
(ISO 13485:2016)
7.5.1 Control of Production & Service Provision
Production controls to include, but not limited to, items (a-f)
For each medical device or batch of medical devices
Establish & maintain a record that provides traceability to the extent in 7.5.9
Record to be verified and approved
Identifies amount manufactured and amount approved for distribution
P&S to be planned, carried out, monitored and controlled to ensure product conforms to specifications
7.5.3 Installation Activities
If agreed customer requirements allow installation of medical device to be performed by external party
Provide documented requirements for medical device installation & verification of installation
Maintain records of medical device installation & verification of installation performed by the organization/supplier
Document requirements for medical device installation and acceptance criteria for verification of installation (as appropriate)
7.5.2 Cleanliness of Product
Document requirements for product cleanliness or contamination control if (a-e) occurs
If product is cleaned in accordance with a) or b), requirements in 6.4.1 do not apply before the cleaning process
7.5.4 Servicing Activities
If servicing of medical device is a specified requirement
Document servicing procedures, reference materials & reference measurements (as necessary) for performing servicing activities & verifying that product requirements are met
Analyse records of servicing activities:
to determine if information is to be handled as a complaint
for input to improvement process (as appropriate)
Maintain records of servicing activities
7.5.5 Particular Requirements for Sterile Medical Devices
Maintain records of sterilization process parameters used for each sterilization batch
Sterilization records to be traceable to each batch of medical devices
7.5.6 Validation of Processes for Production & Service Provision
Document procedures for validation of processes including items (a-g)
Document procedures for validation of application of computer software used
Validated before initial use
Validated after changes to software/application
Specific approach & activities associated with software validation & revalidation to be proportionate to risk associated with use
Validation to demonstrate ability of processes to achieve planned results consistently
Maintain records of validation results & conclusions and necessary actions
Validate any processes where resulting output cannot be/is not verified by subsequent monitoring or measurement
As a consequence, deficiencies become apparent only after product is in use/service has been delivered