7 Product Realization
(ISO 13485:2016)
7.1 Planning of Product Realization
7.3 Design & Development
7.4 Purchasing
7.5 Production and Service Provision
7.6 Control of Monitoring and Measuring Equipment
7.2 Customer-related Processes
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
7.2.2 Review of Requirements related to Product
7.2.3 Communication
7.2.1 Determination of Requirements related to Product
Determine items (a-e)
Ensure items (a-e)
When customer provides no documented requirement statement
Conducted before organization's commitment to supply product to customers
When product requirements are changed
Confirm customer requirements before accepting
Ensure relevant documents are amended & relevant personnel are aware of changed requirements
Plan and document arrangements for communicating with customers in relation to items (a-d)
Communicate with regulatory authorities in accordance with regulatory requirements
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
7.4.1 Purchasing Process
7.4.2 Purchasing Information
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
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)
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
7.5.3 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
7.5.9.1 General
7.5.9.2 Particular Requirements for Implantable Medical Devices
Maintain records of review results & actions arising from review
Maintain records of results of evaluation, selection, monitoring & re-evaluation of supplier capability or performance & any necessary actions
Maintain records of the verification
Maintain records of risk management activities