Quality Management Systems for Drugs and Devices
7
ISO 13485:2003 ISO 13485:2016
***7.3.1 General
7.3.1 Design and Development Planning 7.3.2 Design and Development Planning
7.3.2 Design and Development Inputs 7.3.3 Design and Development Inputs
7.3.3 Design and Development Outputs 7.3.4 Design and Development Outputs
7.3.4 Design and Development Review 7.3.5 Design and Development Review
7.3.5 Design and Development Verification 7.3.6 Design and Development Verification
7.3.6 Design and Development Validation 7.3.7 Design and Development Validation
***7.3.8 Control of Design and Development Transfer
7.3.7 Control of Design and Development Changes 7.3.9 Control of Design and Development Changes
***7.3.10 Design and Development Files
7.4 Purchasing 7.4 Purchasing
7.4.1 Purchasing Process 7.4.1 Purchasing Process
7.4.2 Purchasing Information 7.4.2 Purchasing Information
7.4.3 Verification of Purchased Product 7.4.3 Verification of Purchased Product
7.5 Production and Service Provision 7.5 Production and Service Provision
7.5.1 Control of Production and Service Provision 7.5.1 Control of Production and Service Provision
7.5.1.1 General Requirements ***
7.5.1.2 Control of Production and Service Provisions -Specific
Requirements ***
7.5.1.2.1 Cleanliness of Product and Contamination control 7.5.2 Cleanliness of Product
7.5.1.2.2 Installation Activities 7.5.3 Installation Activities
7.5.1.2.3 Servicing Activities 7.5.4 Servicing Activities
7.5.1.3 Particular Requirements for Sterile Devices 7.5.5 Particular Requirements for Sterile Devices
7.5.2 Validation of processes for production and service
provision
7.5.6 Validation of processes for production and service
provision
7.5.2.1 General Requirements ***
7.5.2.2 Particular requirements for sterile medical devices
7.5.7 Particular requirements for validation of processes for
sterilization and sterile barrier systems
7.5.3 Identification and Traceability ***
7.5.3.1 Identification 7.5.8 Identification
7.5.3.2 Traceability 7.5.9 Traceability
7.5.3.2.1 General 7.5.9.1 General
7.5.3.2.2 Particular requirements for active implantable
devices and implantable devices 7.5.9.2 Particular Requirements for Implantable Devices
7.5.3.3 Status Identification ***
7.5.4 Customer Property 7.5.10 Customer Property
7.5.5 Preservation of Product 7.5.11 Preservation of Product
7.6 Control of Monitoring and Measuring Equipment 7.6 Control of monitoring and Measuring Equipment
8 Measurement, Analysis and Improvement 8 Measurement, Analysis and Improvement
8.1 General 8.1 General
Table 1-3. Comparison of ISO 13485:2003 and ISO 13485:2016 (cont.)
7
ISO 13485:2003 ISO 13485:2016
***7.3.1 General
7.3.1 Design and Development Planning 7.3.2 Design and Development Planning
7.3.2 Design and Development Inputs 7.3.3 Design and Development Inputs
7.3.3 Design and Development Outputs 7.3.4 Design and Development Outputs
7.3.4 Design and Development Review 7.3.5 Design and Development Review
7.3.5 Design and Development Verification 7.3.6 Design and Development Verification
7.3.6 Design and Development Validation 7.3.7 Design and Development Validation
***7.3.8 Control of Design and Development Transfer
7.3.7 Control of Design and Development Changes 7.3.9 Control of Design and Development Changes
***7.3.10 Design and Development Files
7.4 Purchasing 7.4 Purchasing
7.4.1 Purchasing Process 7.4.1 Purchasing Process
7.4.2 Purchasing Information 7.4.2 Purchasing Information
7.4.3 Verification of Purchased Product 7.4.3 Verification of Purchased Product
7.5 Production and Service Provision 7.5 Production and Service Provision
7.5.1 Control of Production and Service Provision 7.5.1 Control of Production and Service Provision
7.5.1.1 General Requirements ***
7.5.1.2 Control of Production and Service Provisions -Specific
Requirements ***
7.5.1.2.1 Cleanliness of Product and Contamination control 7.5.2 Cleanliness of Product
7.5.1.2.2 Installation Activities 7.5.3 Installation Activities
7.5.1.2.3 Servicing Activities 7.5.4 Servicing Activities
7.5.1.3 Particular Requirements for Sterile Devices 7.5.5 Particular Requirements for Sterile Devices
7.5.2 Validation of processes for production and service
provision
7.5.6 Validation of processes for production and service
provision
7.5.2.1 General Requirements ***
7.5.2.2 Particular requirements for sterile medical devices
7.5.7 Particular requirements for validation of processes for
sterilization and sterile barrier systems
7.5.3 Identification and Traceability ***
7.5.3.1 Identification 7.5.8 Identification
7.5.3.2 Traceability 7.5.9 Traceability
7.5.3.2.1 General 7.5.9.1 General
7.5.3.2.2 Particular requirements for active implantable
devices and implantable devices 7.5.9.2 Particular Requirements for Implantable Devices
7.5.3.3 Status Identification ***
7.5.4 Customer Property 7.5.10 Customer Property
7.5.5 Preservation of Product 7.5.11 Preservation of Product
7.6 Control of Monitoring and Measuring Equipment 7.6 Control of monitoring and Measuring Equipment
8 Measurement, Analysis and Improvement 8 Measurement, Analysis and Improvement
8.1 General 8.1 General
Table 1-3. Comparison of ISO 13485:2003 and ISO 13485:2016 (cont.)