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7 Product Realization (ISO 13485:2016) (7.5 Production and Service…
7 Product Realization
(ISO 13485:2016)
7.1 Planning of Product Realization
To document 1 or more processes for risk management
To determine items (a-d)
To be consistent with requirements of other processes of QMS
Output to be documented in a suitable form for operations
Maintain records of risk management activities
7.3 Design & Development
7.3.5 Review
7.3.6 Verification
7.3.4 Outputs
7.3.7 Validation
7.3.3 Inputs
7.3.8 Transfer
7.3.2 Planning
7.3.9 Control of Changes
7.3.1 General
7.3.10 Files
7.4 Purchasing
7.4.1 Purchasing Process
Plan the monitoring and re-evaluation of suppliers
Non-fulfilment of purchasing requirements -> supplier proportionate to risk associated with purchased product and regulatory requirements
Establish criteria for evaluation and selection of suppliers based on items (a-d)
Document procedures to ensure purchased product conforms to specified purchasing information
Maintain records of results of evaluation, selection, monitoring & re-evaluation of supplier capability or performance & any necessary actions
7.4.2 Purchasing Information
Ensure adequacy of specified purchasing requirements before their communication to the supplier
Include a written agreement that the supplier notify the organization before implementing changes that affect the ability of the purchased product to meet purchase requirements
Describe/reference product to be purchased including items (a-d)
Maintain purchasing information in the form of documents and records (to the extent required for traceability in 7.5.9)
7.4.3 Verification of Purchased Product
Extent of verification activities to be based on supplier evaluation results & proportionate to risks associated with the purchased product
Determine whether the product realization process or medical device is affected (if there are any changes)
Establish and implement inspection or other activities necessary to ensure purchased product meets purchasing requirements
State intended verification activities & method of product release in purchasing information (if organization/its customer intends to perform verification at supplier's premises)
Maintain records of the verification
7.5 Production and Service Provision
7.5.6 Validation of Processes for Production and Service Provision
7.5.7 Particular Requirements for Validation of Processes for Sterilization & Sterile Barrier Systems
7.5.5 Particular Requirements for Sterile Medical Devices
7.5.8 Identification
7.5.4 Servicing Activities
7.5.9 Traceability
7.5.9.1 General
7.5.9.2 Particular Requirements for Implantable Medical Devices
7.5.3 Installation Activities
7.5.10 Customer Property
7.5.2 Cleanliness of Product
7.5.11 Preservation of Product
7.5.1 Control of Production and Service Provision
7.6 Control of Monitoring and Measuring Equipment
7.2 Customer-related Processes
7.2.2 Review of Requirements related to Product
Ensure items (a-e)
When customer provides no documented requirement statement
Confirm customer requirements before accepting
Conducted before organization's commitment to supply product to customers
When product requirements are changed
Ensure relevant documents are amended & relevant personnel are aware of changed requirements
Maintain records of review results & actions arising from review
7.2.3 Communication
Plan and document arrangements for communicating with customers in relation to items (a-d)
Communicate with regulatory authorities in accordance with regulatory requirements
7.2.1 Determination of Requirements related to Product
Determine items (a-e)