ISO 13485 差異分析 - twap.sgs.com

1 ISO 13485 2016 Mar 1/7 ISO 13485 Medical devices Quality management systems Requirements for regulatory purposes ISO 13485 :2016 2003 (medical device file) (software validation) Regulatory Validation Sterile Software Proportionate to the risk associated with the medical device 8 3 2019 2 2003 2016 2003 2016 Foreword Foreword 0 Introduction Introduction -- General General -- Process approach Clarification of concepts -- Relationship with other standards Process approach -- Relationship with ISO 9001 -- -- -- Relationship with ISO/TR 14969 -- -- -- ISO 13485 2016 Mar 2/7 2003 2016 Compatibility with other management systems Relationship with ISO 9001

2 ISO 9001 -- -- Compatibility with other management systems -- 1 Scope 1 Scope 6 8 General -- -- -- Application -- -- -- 2 Normative references 2 Normative references -- 3 Terms and definitions 3 Terms and definitions 8 20 ( 1) 13/ 5 / 3 4 Quality management system 4 Quality management system -- General requirements General requirements ( ) Documentation requirements Documentation requirements -- General General Quality manual Quality manual -- -- -- Medical device file Control of documents Control of documents -- Control of records Control of records 5 Management responsibility 5 Management responsibility -- Management commitment Management commitment -- ISO 13485 2016 Mar 3/7

3 2003 2016 Customer focus Customer focus -- Quality policy Quality policy -- Planning Planning -- Quality objectives Quality objectives -- Quality management system planning Quality management system planning -- Responsibility, authority and communication Responsibility, authority and communication -- Responsibility and authority Responsibility and authority -- Management representative Management representative -- Internal communication Internal communication Management review Management review -- General General Review input Review input 12 Review output Review output 4 6 Resource management 6 Resource management -- Provision of resources Provision of resources -- Human resources Human resources General.

4 Competence, awareness and training -- -- -- Infrastructure Infrastructure Work environment Work environment and contamination control -- -- -- Work environment -- -- Contamination control 7 Product realization 7 Product realization -- Planning of product realization Planning of product realization ISO 13485 2016 Mar 4/7 2003 2016 Customer-related processes Customer-related processes -- Determination of requirements related to the product

5 Determination of requirements related to product Review of requirements related to the product Review of requirements related to product -- Customer communication Communication Design and development Design and development -- -- -- General Design and development planning Design and development planning 6 Design and development inputs Design and development inputs (IEC 62366-1) Design and development outputs Design and development outputs -- Design and development review Design and development review Design and development verification Design and development verification / / Design and development validation Design and development validation / / -- -- Design and development transfer Control of design and development changes Control of design and development changes -- -- Design and development files

6 Purchasing Purchasing -- Purchasing process Purchasing process / Purchasing information Purchasing information Verification of purchased product Verification of purchased product Production and service provision Production and service provision Control of production and service provision Control of production and service provision ISO 13485 2016 Mar 5/7 2003 2016 General requirements Cleanliness of product 5 Control of production and service provision Specific requirements -- -- -- Cleanliness of product and contamination control -- -- -- Installation activities Installation activities -- Servicing activities Servicing activities Particular requirements for sterile medical devices Particular requirements for sterile medical devices -- Validation of processes for production and service provision Validation of processes for production and service provision 7 / / General requirements -- -- -- Particular requirements for

7 Sterile medical devices Particular requirements for validation of processes for sterilization and sterile barrier systems Identification and traceability -- -- -- Identification Identification (unique device identification) Traceability Traceability -- General -- -- -- Particular requirements for active implantable medical devices and implantable medical devices -- -- -- Status identification -- -- -- Customer property Customer property -- Preservation of product Preservation of product Control of monitoring and measuring devices Control of monitoring and measuring equipment -- 8 Measurement, analysis and improvement 8 Measurement.

8 Analysis and improvement -- General General -- Monitoring and measurement Monitoring and measurement -- Feedback Feedback ISO 13485 2016 Mar 6/7 2003 2016 Internal audit Complaint handling Monitoring and measurement of processes Reporting to regulatory authorities Monitoring and measurement of product Internal audit -- General requirements Monitoring and measurement of processes -- Particular requirement for active implantable medical devices and implantable medical devices Monitoring and measurement of product Control of nonconforming product Control of nonconforming product -- -- General -- -- Actions in response to nonconforming product detected before delivery -- -- Actions in response to nonconforming product detected after delivery (2003 )

9 -- -- Rework -- Analysis of data Analysis of data - Improvement Improvement -- General General -- Corrective action Corrective action Preventive action Preventive action Annex A (informative) Correspondence between ISO 13485 :2003 and ISO 13485 :1996 Annex A (informative) Comparison of content between ISO 13485 :2003 and ISO 13485 :2016 ISO 13485 2003 -- Annex B (informative) Explanation of differences between ISO 13485 :2003 and ISO 9001:2000 Annex B (informative) Correspondence between ISO 13485 :2016 and ISO 9001:2015 ISO 13485 :2016 ISO 9001:2015 -- Bibliography Bibliography 15 13 ( 2) 11/ 2/ 13 ISO 13485 2016 Mar 7/7 1 - 8 20 1.

10 Advisory notice 2. authorized representative (GHTF/SG1/N055:2009, ) 3. clinical evaluation (GHTF/SG5/N4:2010, 4) 4. complaint 5. distributor (GHTF/SG1/N055:2009, ) 6. implantable medical device 7. importer (GHTF/SG1/N055:2009, ) 8. labelling (GHTF/SG1/N70:2011, Clause 4]) 9. life-cycle (ISO 14971:2007, ) 10. manufacturer (GHTF/SG1/N055:2009, ) 11. medical device (GHTF/SG1/N071:2012, ) 12. medical device family 13. performance evaluation 14. post-market surveillance 15. product 16. purchased product 17. risk (ISO 14971:2007, ) 18. risk management (ISO 14971:2007, ) 19.