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DOCUMENT NUMBER91-QM-13485PRODUCT RESOURCESNEWBURYPORT, MAREVISIONCTITLEREV DATEProduct Resources QualityManual ISO 13485Page09/20191 of 30NOTICE: THIS DOCUMENT IS PROPRIETARY, AND ITS CONTENTS ARE THE EXCLUSIVE PROPERTY OF PRODUCTRESOURCES. THIS DOCUMENT MAY NOT BE REPRODUCED IN ANY FORM WHATSOEVER, WITHOUT PRIORWRITTEN PERMISSION FROM PRODUCT RESOURCES.Quality ManagementSystem Manualfor ISO 13485:2016
DOCUMENT NUMBERREVISION91-QM-13485PRODUCT RESOURCESNEWBURYPORT, MACTITLEREV DATEProduct Resources QualityManual ISO 13485Page09/20192 of 30NOTICE: THIS DOCUMENT IS PROPRIETARY, AND ITS CONTENTS ARE THE EXCLUSIVE PROPERTY OF PRODUCTRESOURCES. THIS DOCUMENT MAY NOT BE REPRODUCED IN ANY FORM WHATSOEVER, WITHOUT PRIORWRITTEN PERMISSION FROM PRODUCT RESOURCES.TABLE OF CONTENTSTABLE OF CONTENTS. 2Figure 1: Process Linkages, ISO 13485:. 61Scope. 61.1General. 7Scope. 71.2Application. 82Normative references . 83Terms and definitions . 84Quality management system . 954.1General requirements. 94.2Documentation requirements . 114.2.1General [91-6001, 91-9001, 91-9002, 91-9004]. 114.2.2Quality manual [91-9001, 91-9003] . 114.2.3Medical device file [91-6004]. 124.2.4Control of documents [91-6001]. 124.2.5Control of records [91-6002, 91-6005] . 13Management responsibility . 135.1Management commitment [91-9002, 91-9005] . 135.2Customer focus [91-1003, 91-9005] . 135.3Quality policy [91-9002, 91-9005] . 14Product Resources’ Quality Policy is documented in 91-9002. 145.4Planning . 145.4.1Quality objectives [91-9004, 91-9005] . 145.4.2Quality management system planning [91-9001, 91-9005] . 145.5Responsibility, authority and communication. 145.5.1Responsibility and authority . 14
DOCUMENT NUMBER91-QM-13485PRODUCT RESOURCESNEWBURYPORT, MACTITLEREV DATEProduct Resources QualityManual ISO 13485Page09/20193 of 30NOTICE: THIS DOCUMENT IS PROPRIETARY, AND ITS CONTENTS ARE THE EXCLUSIVE PROPERTY OF PRODUCTRESOURCES. THIS DOCUMENT MAY NOT BE REPRODUCED IN ANY FORM WHATSOEVER, WITHOUT PRIORWRITTEN PERMISSION FROM PRODUCT RESOURCES.5.5.2Management representative [91-9001]. 155.5.3Internal communication. 155.66REVISIONManagement review [91-9005]. 155.6.1General . 155.6.2Review input . 155.6.3Review output . 16Resource management . 166.1Provision of resources [91-9005]. 166.2Human resources [91-8002]. 166.3Infrastructure [91-4004, 91-7005, 91-8001] . 176.4Work environment and contamination control . 176.4.1Work environment [91-4004] . 176.4.2 Contamination control . 177Product realization. 177.1Planning of product realization [91-6004, 91-7006] . 187.2Customer-related processes . 187.2.1Determination of requirements related to the product [91-1001] . 187.2.2Review of requirements related to the product [91-1002] . 187.2.3Communication [91-1003] . 197.3Design and development . 19Note that these elements of the standard are excluded from Product Resources’ scope. . 197.4Purchasing . 197.4.1Purchasing process [91-3001, 91-3002]. 197.4.2Purchasing information [91-3002]. 207.4.3Verification of purchased product [91-3003] . 217.5Production and service provision. 217.5.1Control of production and service provision [91-1004, 91-4001, 91-6004] . 217.5.2Cleanliness of product. 217.5.3Installation activities . 217.5.4Servicing activities [91-5001]. 217.5.5Particular requirements for sterile medical devices . 227.5.6Validation of processes for production and service provision [91-7006] . 22
DOCUMENT NUMBER91-QM-13485PRODUCT RESOURCESNEWBURYPORT, MA7.5.7REVISIONCTITLEREV DATEProduct Resources QualityManual ISO 13485Page09/20194 of 30NOTICE: THIS DOCUMENT IS PROPRIETARY, AND ITS CONTENTS ARE THE EXCLUSIVE PROPERTY OF PRODUCTRESOURCES. THIS DOCUMENT MAY NOT BE REPRODUCED IN ANY FORM WHATSOEVER, WITHOUT PRIORWRITTEN PERMISSION FROM PRODUCT RESOURCES.Particular requirements for validation of processes for sterilization and sterile barrier systems. 22Note that this element of the standard is not applicable to Product Resources’ products or services. . 237.5.8Identification [91-6003] . 237.5.9Traceability [91-6003] . 237.5.9.1General. 237.5.9.2Particular requirements for implantable medical devices . 237.5.10Customer property [91-1003] . 237.5.11Preservation of product [91-4003] . 247.68Control of monitoring and measuring devices [91-7004] . 24Measurement, analysis and improvement . 258.1General [91-4001, 91-7001, 91-9004] . 258.2Monitoring and measurement. 258.2.1Feedback [91-9004]. 258.2.2Complaint handling [91-1003]. 268.2.3Reporting to regulatory authorities [91-1003] . 268.2.4Internal audit [91-7001] . 278.2.5Monitoring and measurement of processes. 278.2.6 Monitoring and measurement of product [91-4001]. 278.3Control of nonconforming product . 278.3.1General [91-4002]. 288.3.2Actions in response to nonconforming product detected before delivery [91-4002]. 288.3.3Actions in response to nonconforming product detected after delivery. 288.3.4Rework [91-4002]. 298.4Analysis of data [91-9004] . 298.5Improvement . 298.5.1General [91-7002, 91-7003, 91-9005]. 298.5.2Corrective action [91-7002] . 308.5.3Preventive action [91-7003]. 30Introduction
DOCUMENT NUMBER91-QM-13485PRODUCT RESOURCESNEWBURYPORT, MA0.1REVISIONCTITLEREV DATEProduct Resources QualityManual ISO 13485Page09/20195 of 30NOTICE: THIS DOCUMENT IS PROPRIETARY, AND ITS CONTENTS ARE THE EXCLUSIVE PROPERTY OF PRODUCTRESOURCES. THIS DOCUMENT MAY NOT BE REPRODUCED IN ANY FORM WHATSOEVER, WITHOUT PRIORWRITTEN PERMISSION FROM PRODUCT RESOURCES.GeneralProduct Resources is a product design, engineering and manufacturing company with expertise in designing andbui
ISO 9001-approved for engineering design, development, manufacturing, and service 0.2 Process Approach This Manual has adopted the process approach to quality management. Figure 1, is a conceptual illustration of the process approach of the system aimed towards Consistent Compliance to the Standard and illustrates the process linkages presented in clauses 4 to 8 of ISO 13485. For
