YY/T / ISO 13485:2016

Transcription

1 Translated English of Chinese Standard: YY/T Buy True-PDF Auto-delivery. YY ICS ; C 30 PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE S REPUBLIC OF CHINA YY/T / ISO 13485:2016 Replacing YY/T Medical Devices Quality Management Systems Requirements for Regulatory Purposes (ISO 13485:2016, IDT) 医疗器械质量管理体系用于法规的要求 Issued on: January 19, 2017 Implemented on: May 01, 2017 Issued by: China Food and Drug Administration Buy True-PDF Auto-delivery. Page 1 of 58

2 Table of Contents Foreword... 6 Introduction Scope Normative References Terms and Definitions Quality Management System General requirements Documentation requirements General Quality manual Medical device file Control of documents Control of records Management Responsibility Management commitment Customer focus Quality policy Planning Quality objectives Quality management system planning Responsibility, authority and communication Responsibility and authority Management representative Internal communication Management review General Review input Buy True-PDF Auto-delivery. Page 2 of 58

3 5.6.3 Review output Resource Management Provision of resources Human resources Infrastructure Work environment and contamination control Work environment Contamination control Product Realization Planning of product realization Customer-related processes Determination of requirements related to product Review of requirements related to product Communication Design and development General Design and development planning Design and development inputs Design and development outputs Design and development review Design and development verification Design and development validation Design and development transfer Control of design and development changes Design and development files Purchasing Purchasing process Purchasing information Verification of purchased product Buy True-PDF Auto-delivery. Page 3 of 58

4 7.5 Production and service provision Control of production and service provision Cleanliness of product Installation activities Servicing activities Particular requirements for sterile medical devices Validation of processes for production and service provision Particular requirements for validation of processes for sterilization and sterile barrier systems Identification Traceability Customer property Preservation of product Control of monitoring and measuring equipment Measurement, Analysis and Improvement General Monitoring and measurement Feedback Complaint handling Reporting to regulatory authorities Internal audit Monitoring and measurement of processes Monitoring and measurement of product Control of nonconforming product General Actions in response to nonconforming product detected before delivery Actions in response to nonconforming product detected after delivery Rework Analysis of data Buy True-PDF Auto-delivery. Page 4 of 58

5 8.5 Improvement General Corrective action Preventive action Appendix A (Informative) Comparison of Content between YY/T and YY/T Appendix B (Informative) Correspondence between YY/T and GB/T Bibliography Buy True-PDF Auto-delivery. Page 5 of 58

6 Medical Devices Quality Management Systems Requirements for Regulatory Purposes 1 Scope This Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). This Standard can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations. Requirements of this Standard are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization. The processes required by this Standard that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization s quality management system by monitoring, maintaining, and controlling the processes. If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity to this Standard reflect any exclusion of design and development controls. If any requirement in Clauses 6, 7 or 8 of this Standard is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system. For any clause that is determined to be not applicable, the organization records the justification as described in Buy True-PDF Auto-delivery. Page 11 of 58

7 Bibliography [1] GB/T Quality Management Systems Requirements (GB/T , ISO 9001:2015, IDT) [2] ISO Measurement Management Systems - Requirements for Measurement Processes and Measuring Equipment [3] GB/T Packaging for Terminally Sterilized Medical Devices - Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems (GB/T , ISO :2006, IDT) [4] ISO Packaging for Terminally Sterilized Medical Devices - Part 2: Validation Requirements for Forming, Sealing and Assembly Processes [5] ISO (all parts) Cleanrooms and Associated Controlled Environments [6] ISO (all parts) Cleanrooms and Associated Controlled Environments - Biocontamination Control [7] YY/T Medical Devices - Application of Risk Management to Medical Devices (YY/T , ISO 14917:2007, modified edition, IDT) [8] ISO Guidelines for Auditing Management Systems [9] IEC Medical Devices - Part 1: Application of Usability Engineering to Medical Devices [10] GHTF/SG1/N ) Definition of the Terms Manufacturer, Authorized Representative, Distributor and Importer [11] GHTF/SG5/N ) Post-Market Clinical Follow-Up Studies [12] GHTF/SG1/N ) Label and Instructions for Use for Medical Devices [13] GHTF/SG1/N ) Definition of Terms Medical Device and In Vitro Diagnostic (IVD) Medical Device END 2) Available from website: 3) Available from website: 4) Available from website: 5) Available from website: Buy True-PDF Auto-delivery. Page 58 of 58