Aligning the Requirements of ISO 13485:2003 to ISO 9001:2008 (Part 4 of 5: Product Realization)

By: Mona Elkahatib


A major additional requirement stated in the ISO 13485:2003 and not in ISO 9001 is establishing and maintaining documented requirements for risk management throughout the product realization processes (7.1).


For this section of the standard, there are many additional documentation requirements for product realization. Emphasis is based on validation, sterile medical devices and implantable devices.


Below is a summary of the key differences between the two standards:


ISO 9001 ISO 13485 Changes
7.1 Planning of Product Realization P Documented requirements for risk management and records
7.2.1 Determination of Requirements None No Changes
7.2.2 Review of Requirements 7.2.2(a) Requirements defined and documented
7.2.3 Customer Communication 7.2.3(d) Advisory notices
7.3.1 Design and Development Planning 7.3.1(b) Documented procedureDesign transfer activitiesPlanning output shall be documented
7.3.2 Inputs 7.3.2(a)7.3.2(e) Safety requirements for intended useOutput of risk managementInputs shall be reviewed and approved
7.3.3 Outputs P Records shall be maintained
7.3.4 Reviews P Shall include specialist personnel
7.3.5 Verification None No changes
7.3.6 Validation P Deleted intended use “where known” and “wherever practicable” validation shall be completed prior to delivery.
7.3.7 Changes None No changes
7.4.1 Purchasing Process P Documented procedure
7.4.2 Purchasing Information P Traceability requirements
7.4.3 Verification P Records shall be maintained
7.5.1 Control of Production and Service Provision Documentation requirementsLabeling and packagingMaintain verified and approved batch records Cleanliness of product and contamination control Installation activities Servicing activities Requirements for sterile devices
7.5.2 Validation of Processes Documented procedures-Software Requirements for sterile devices
7.5.3 Identification and Traceability Identification Traceability-general Requirements for implantable devices Status identification
7.5.4 Customer Property P Property includes health information
7.5.5 Preservation of product P Documented proceduresShelf-life and storage conditions control
7.6 Control of Monitoring and Measuring Devices P Documented procedures


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