中國醫療器材GMP對比. 國際標準化組織 13485:2016: 終極逐條指南

國際標準化組織 13485:2016 與. 中國醫療器材GMP比較 | 技術參考

ISO 之間的比較 13485:2016 和中國新醫療器材GMP

基於最新 NMPA 檢查原則的國際製造商詳細技術圖譜.

		並確定各部門設計開發的活動及介面,職責分工明確.
		審查設計和開發規劃文件時, 應根據產品的特性來規劃設計和開發活動, 規劃結果應記錄在案. 這至少應包括以下內容:內容:
		1.設計開發專案目標及意義說明
		敘述,Technical indicator analysis;
		2.確認設計和開發階段並適合每個設計和開發階段。審查, 確認, 驗證和設計轉移活動;
		3.The design and development of each department should be identified and determined.Activities and Interfaces,clearResponsibilities of personnel or organizations at each stage,Composition of the review panel,as well asExpected output results at each stage;

		4.Planning and arranging main tasks and phased tasks in relation to the entire projectConsistent;

		5.SureProduct Technical RequirementsofFormulate, verify, confirmandMeasuring devices required for production activities;

		6.Risk ManagementActivity.
		The design and development should be implemented in accordance with the plan.Deviation from PlanWhen it is necessary to modify the plan, it should be done as follows:The plan will be reviewed and approved again..
	7.3.3 Design and development input	5.3.1	1)13485Emphasis on usabilityRequest, and require that it meets the following conditions.IEC 62366-1Requirements; 而檢查的原則沒有明確強調.
	應確定與產品相關的要求，輸入並維護記錄(See4.2.5)These inputs should include:	設計和開發輸入應包括預期用途規範特定功能, 表現, 和安全要求, 及監理要求、風險管控措施及其他要求.	2)13485適當的時候, 設計開發輸入包括以前類似設計提供的信息, 但未提出檢查原則.
	一個)in accordance withIntended Use,功能, 表現,可用性和安全性要求;	5.3.2
	乙)適用法規要求和標準;	應分析設計和開發輸入。审查并获得批准,保留相關記錄.
	c)ApplicableRisk management output;
	d)適當的時候, 先前提供類似設計訊息;
	e)The design and development of products and processes are necessaryOther requirements;
	Requirements shouldComplete and clear, can beVerify or confirm,
	And it cannot be self-contradictory.
	筆記: Further information can be found at [link/reference].IEC 62366-1.
	7.3.4 Design and development outputDesign and development outputs should:	*5.4.1	Inspection principles are relatively13485 More detailedbody
	一個)satisfyDesign and development inputRequirements;	Design and development outputs shouldMeets input requirements,includeProcurement, production and serviceRequired relevant informationProduct Technical Requirementswait.
	乙)GiveProcurement and productionandService providedAppropriate
ISO 13485:2016		New versionGMP/Inspection principles	A Brief Analysis of Differences
	information;	Review the design and development output materials; they should at least meet the following requirements.The following requirements are made:
	c)包含或參考產品驗收標準;	1.採購資訊,喜歡原料, 包裝材料, 集會
	d)產品規定安全正常使用必填產品特點;	零件技術要求;
	設計開發輸出形式應適合設計開發輸入驗證且應在發布前批量允許.	2.生產及服務需求資訊, 例如產品圖紙
	應保留設計和開發輸出的記錄(看	(包括組件圖))工藝制定, 工作指導書, 環境要求等等;
	4.2.5).	3.產品技術要求;
		4.產品檢驗程序或說明;
		5.指定產品安全和正常使用所需的產品特性，例如產品使用說明書,包裝及標籤要求等. 產品使用說明書與備註是否相符?
		The registration application and approval are consistent;
		6.Identification and traceabilityRequire;
		7.Submit toRegistration and approval departmentFiles, such asResearch data, product technical requirements, registration test reports, clinical evaluation data (if any))List of basic requirements for the safety and effectiveness of medical deviceswait;
		8.prototype or sample;
		9.Biological evaluation results and records,includeMain performance requirements of materials.
		5.4.2
		The design and development outputs should be receivedapproveMaintain phasecloseRecord.
	7.3.5 Design and development review	5.6.1	13485 Emphasis was placed on design and development reviewsThe participants.
	existAppropriate stageThe design and development should be systematically carried out in accordance with the planned and documented arrangements.Review,so that:	It should be arranged at an appropriate stage of design and development.CommentsTrial,KeepReview resultsand anyNecessary measuresThe recordrecord.
	一個)Evaluation of design and developmentThe results meet the requirements.ofability;	Review relevant documents and records, ensuring at least the following requirements are met.beg:
	乙)Identify and proposeNecessary measures.	1.It should be based on the results of the design, development, and planning.suitable
	ReviewParticipantsThis should include the design and development phases being reviewed.Representatives of relevant functionsOtherofexpert.	stageConduct design and development reviews;
	ReviewResults and any necessary measuresofRecordShould be	2.Design and development reviews should be maintained.Record,includeReviewresultand the review adoptedNecessary measuresThe recordrecord.
	Keep(See4.2.5).
	7.3.6 Design and development verification	5.6.1	1)13485Emphasis was placed on the method and reception.Criteria, and the statistical techniques and principles used to determine the sample size;
	To ensure that the design and development outputs meet the design and development requirements	Design and development should be carried outverifyTo ensure that the design and development outputs meet the input requirements and maintainVerification resultsand anyNecessary measuresShi’s records.	2)13485Emphasizing other medical devicesSpecial validation requirements for medical devices that are mechanically connected or joined;
	Input requirements should be based on the planned and documented arrangements for design and development.verify.	Review relevant documents and records, ensuring at least the following requirements are met.beg:	3)The inspection principle emphasizes the availability of options.
	The organization should include a validation plan.Create document,includesquare	1.The results of the planning should be considered in conjunction with the actual situation.Appropriate stage
	Law, Acceptance CriteriaWhen appropriate, to determineSampling sizeThe adoptedStatistical Techniques and Principles.
ISO 13485:2016		New versionGMP/Inspection principles	A Brief Analysis of Differences
	If the intended use requires medical devices to be used in other medical fieldsMedical devicesConnection or engagementThe verification should include the following:Connection or engagementAt that time, it was confirmedThe design output satisfies the design input.The content.	Conduct design and development verification to ensure that the design and development outputs meet the input requirements;	The calculation method or the method of comparison with the proven design should be used.Appropriateness of the methods used in the reviewSexuality, whether the confirmation method is scientific andefficient.
	Verification resultsandin conclusionas well asNecessary measuresofRecord	2.Design and development verification should be maintained.Record,verify
	It should be maintained.(See4.2.4 and4.2.5).	resultand anyNecessary measuresRecords;
		3.If the design and development verification usesAvailableCalculation methodorComparison of proven designsMethodThe methods used should be reviewed.suitablesexTo confirm whether the method is scientific and effective.
	7.3.7 Design and development confirmation	5.8.1	1)13485Emphasis on methods and receiving accuracyTherefore, when appropriate, the statistical techniques used to determine the sample size should be consistent with the original principles.reason;
	To ensure the product canMeets the applicable requirementsor requirements for intended useIt should be based on the planned and writtenComponent-based arrangements for design and developmentconfirm.The organization should confirm the plan.Create document,includesquareLaw, Acceptance CriteriaWhen appropriate, forDetermine the sample sizeStatistical techniques and principles employed.	Design and development should be carried outconfirmTo ensure productionProduct satisfactionSpecified usage requirements or intended useRequirementsAnd keep confirmingresultand anyNecessary measuresofRecord.	2)13485Clearly require representative samplesProduct design confirmation;
	responseRepresentative productsDesign confirmation was conducted, with representative products includingThe initial production unit, batch, or other equivalentThe information used for confirmation should be recorded.Product Combinationreason(See4.2.5).	Review relevant documents and records, ensuring at least the following requirements are met.beg:	3)13485Explicitly require recording forVerify the product’s suitability;
	As part of design and development verification, the organization shouldaccording toApplicable laws and regulationsRequired to conductClinical evaluation orPerformance Evaluation.	1.Should be inSuitable stageDesign and development	4)13485Clearly for clinical evaluationMedical devices that have undergone performance evaluation should not be considered as released for customer use.
	ForClinical evaluation or performance evaluationofmedical devices	Recognize and ensure product quality.Requirements for meeting the specified usage or intended use;	5)13485Emphasizing other medical devicesSpecial validation requirements for medical devices that are mechanically connected or joined.
	This should not be considered as permission for customers to use..	2.Design and development validation activities should be conducted during product development.Before delivery and implementationconduct;
	If the intended use requires medical devices to be used in other medical fieldsMedical devicesConnection or engagementConfirmation should include this linkWhen connecting or joining, confirm the applicable requirements or pre-defined conditions.	3.Design and development verification records should be maintained, includingClinical evaluation or clinical trialRecord the results and any necessary actions taken.
	The intended use has been fulfilled.	5.9.1
	Confirmation should be made on the productBefore delivery to the customeroverbecome.	Confirm that clinical or performance evaluation methods are suitable.When conducting clinical trials,Compliant with medical device clinical trialsTesting regulationsRequirements.
	confirmresultandNecessary measuresofRecordShould be maintained	CheckClinical evaluation reportand its supporting materials. If open
	(See4.2.4 and4.2.5).	For clinical trials to be conducted, the clinical trials must comply with the law.The regulations require and corresponding supporting documentation must be provided. For those requiring…
		Medical devices requiring clinical or performance evaluationThe equipment should be able to provide an evaluation.Reports and/or materialsmaterial.
	7.3.8 Design and development conversion	5.5.1	1)The inspection principles have further refined the specific content of design and development transformation activities.Allow;
	Organizations should transfer design and development outputs to manufacturing.changeChangeThe procedures are documented. These procedures should ensure the design…	Design should be carried out during the design and development process.From development to productionConversionActivities to enable design and developmentThe output was developed before becoming the final product specification.Verification ensures that the design and development outputs are validated.Suitable for life	2)The inspection principles emphasize product technology.beg.
	The output of development becomes the final production specification.PreviouslySuitable for productionthroughverify,andProduction capacity can meet product requirements.	Produce.
	Transformedresultandin conclusionIt should be recorded.(看	The relevant documents must meet at least the following requirements:
	4.2.5).	1.Design should be carried out during the design and development process.conversionActivityTo solveManufacturability, Componentsand the availability of materials, the required production facilities
ISO 13485:2016		New versionGMP/Inspection principles	A Brief Analysis of Differences
		Training of equipment and operatorswait;
		2.Design transformation activities should incorporate the product’s…Each technical requirementCorrectly translate into product realizationRelatedSpecific process or procedure;
		3.Records of design conversion activities should indicate that the design conversion activities were completed.Design and development output in becomingFinal product specificationsFan Qian’s statement has been verified.and retainVerification records,To ensure the design and developmentOutput suitable for lifeProduce;
		4.Special processes should be addressed.Confirm conversionIndeed
		Ensure the results are applicable to production and retain confirmation records.record.
	7.3.9 Control of design and development changes	5.10.1	The inspection principles have been further refined in design and development.The revised review record requirements.
	The organization should control design and development changes.programCreate documentThe organization should determine the relationship with medical devices.Functionality, 表現, usability, securityandApplicable medicalMedical device regulations requireand itsIntended use relatedofHeavyTo change.	The design and development should beChangePerform identification andKeep a record.
	Design and developmentchangeIt should be identified before implementation.,thisThese changes should be:	5.10.2
	一個)go throughReview;	Design and development changes should be made when necessary.CommentsReview, verification and confirmationand obtained before implementationapproveView design and development.ChangeofReview Record,At least
	乙)go throughverify;	The following requirements must be met:
	c)適當的時候,confirm;	1.It should include changes to theProduct components andImpact of delivered products;
	d)go throughapprove.	2.The implementation of design and development changes should comply withmedicalMedical device product registrationThe relevant regulations;
	The review of design and development changes should includeDuring the processOr already deliveredofComponents and productsChanges andwindRisk ManagementandProduct realization processof	3.The content and results of the design changes involve modifying…ChangeMedical Device Product Registration Certificate (Filing CertificateThe certificate statesWhen discussing content, enterprises should conduct…Risk AnalysisAnd in accordance with the relevant regulations, apply for a change of registration (filing) to meet the requirements.
	Evaluation of the impact of changes in input and output, and modification.ofReview resultsand anyNecessary measuresofRecordShould be maintained(See4.2.5).	It meets the requirements of the regulations.
	Design and development changesReviewIt should include evaluations.Modify product components and work-in-process or delivered	*5.10.3
	The impact on the product, and the evaluation changes.Risk ManagementInput/Output andProduct realizationThe impact of the process.	When selectedMaterials, parts, or product functionsChanges may affect medical device products.Safety and effectivenessWhen making changes, the potential consequences should be evaluated.riskTake measures to mitigate risks when necessary.Reduce to acceptableSubject to levelAt the same time, shouldCompliant with relevant regulationsThebeg.
	7.3.10 Design and development documents	none	Although the inspection principles do not explicitly emphasize maintaining the design and development documentation for each type or family of medical devices in this chapter.However, the actual regulatory process in China requires…It should cover all product models.
	The organization should maintainEach type of medical device or medicalMachine familyThe design and development documents, this document should includeInclude or cite to demonstrate compliance with design and development requirements
	The resulting records, as well as design and development changesRecord.
ISO 13485:2016		New versionGMP/Inspection principles	A Brief Analysis of Differences
	none	5.11.1	Although13485 The style was not clearly defined in a separate chapter.Risk management requirements, but in the preceding section “7.1”Product Realization Planning” clearly requires:”During the product realization process, the organization should…”One or more processes of risk management”Create a document”.
		Product implementation, including design and development, should be included.Throughout the entire process, the following was formulated.Risk ManagementThe requirements should be documented and relevant records maintained.
		CheckRisk Management DocumentsandRecordAt least meet the following requirementsThe following requirements are made:
		1.Risk management should cover the realization of the products developed by the enterprise.The whole process;
		2.Documentation for risk management of medical devices should be established and relevant records should be maintained.RecordTo determine the certificate of implementationaccording to;
		3.The risks of medical device products should be controlled withinAcceptable level.
7.4 purchase	7.4.1 Procurement process	*6.1.1	採購流程中的檢驗原則更加詳細。內容和供應商審核的要求.
	組織應記錄程序(見4.2.4),透過確保所採購的產品符合要求的採購訊息，組織應建立評估和選擇機制。供應商指南,允許	應建立採購控製程序.
	那麼應該是:	採購流程至少應包括以下內容:Procurement process, 選擇, 合格供應商的評估和再評估, 採購物品檢驗或驗證的要求, 採購記錄要求.
	一個)基於供應商提供滿足組織需求的產品;	*6.1.2
	乙)基於供應商績效;	要保證採購的貨物符合要求, 且不低於法律法規的相關規定和國家實力監管標準的相關要求.
	c)基於產品採購對醫療器材品質的影響環;	6.2.1
	d)與醫療器材相關風險一致.	應該根據購買的物品對產品的影響,確保對採購物品的控制方法和程度。檢查對採購物品實施的控制方法和程度。依照規定, 驗證控制方法和程度符合要求。產品要求.
	組織應對供應商的監督和再評估行為進行政策計劃，對採購的產品符合要求的供應商的績效應給予監督，監督的結果應作為供應商的 [資源/資源].Inputs to the re-evaluation process.	6.3.1
	Should be statedUnmet procurement requirementsandCorrespondingly there areSuppliers of products corresponding to risksand in complianceApplicable regulatory requirements.	It should be establishedSupplier audit systemSuppliers should be audited and evaluated. On-site audits should be conducted when necessary.nuclear.
	Supplier evaluationResults, 選擇, 監控, and reassessmentpriceRecords or actions taken as a result of these activitiesanyNecessary measuresRecords should be kept.	Does it meet the requirements?Guidelines for Supplier Auditing of Medical Device ManufacturersRequirements.
	(See4.2.5).	6.3.2
		When retainSupplierEvaluationresultand the evaluation processRecord.
	7.4.2 採購資訊	6.5.1	No significant differences
	The procurement information should describe or reference the products to be procured, 和, where appropriate, 包括:	When procuring, 明確採購訊息，明確採購細節。採購要求, 包括購買商品的類別, 驗收標準,規格, 程式, and drawingsContent such as…
	一個)產品規格;	從採購清單中抽查相關物品的採購情況.
	乙)Product AcceptanceGuidelines, 程式, 製程及設備
ISO 13485:2016		New versionGMP/Inspection principles	A Brief Analysis of Differences
	要求;	採購要求, 並確認是否符合本條款的要求.
	c)供應商人員資格要求;	6.5.2
	d)Quality Management SystemRequirements.	應建立採購記錄, includingPurchase contract, 原料清單, supplier qualification documents, 品質標準, 檢驗報告及驗收標準等.
	與供應商溝通前, the organization should ensure that…Regulations on procurement requirementsIt is sufficient and appropriate.	*6.5.3
	Where appropriate, any actions that affect the ability of purchased products to meet the prescribed procurement requirements.changeBefore implementation, procurement information should be…Includes a written agreementThe supplier shall inform you.	Procurement records should meet the following requirementsTraceableRequire.
	Changes in the organization’s procurement of products.	*6.4.1
	according to7.5.9 RegulationsTraceabilityRequired process	Should be withMajor raw material suppliersSignQuality AssociationDiscussionClearly define the quality responsibilities undertaken by both parties.
	The organization should use documents to determine the degree of organization.(見4.2.4)and records(See4.2.5)To maintain relevant procurement information in a specific format.
	7.4.3 Verification of purchased products	6.6.1	13485 Verification requirements for purchased productsPlease be more specific.
	The organization should establish and implementtestOr other necessaryActivities to ensure procurementThe products meet the specified procurement requirements.Verification activitiesScope and extentShould be based onThe supplier’sEvaluation resultsand the purchase of productsriskConsistent.	The purchased items should be inspected.Inspection or verification,make sureMeet production requirements.
	When an organization becomes aware of any changes in the products it procures…At that time, the organization should determine theseDoes the change affect the product realization process or medical device?.	Check the purchased itemsInspection or verification records.
	When an organization or its customers intend to use the supplierOn-site implementation
	verifyAt that time, 組織應將其包含在採購資訊中。應建立擬議的驗證安排和產品放行方法法規. 這個應該維護.verifyRecord(See4.2.5).
7.5產品服務	7.5.1 生產和服務提供的控制	*7.1.1	1)檢驗原則強調確保產品符合強制性標準並進行註冊。或要註冊的產品技術;
	確保產品符合法規, [應採取以下措施]提供生產和服務行為規劃, 執行, 監控和控制（如適用）, 生產管制應包括, 但不限於, [下列].:	生產應依照既定的品質管理系統進行。生產保證產品符合強制性標準並註冊或備案的產品技術要求.	2)檢查原則強調要明確關鍵工序和特殊程序;
	一個)用於生產控製程序/方法文件	*7.2.1	3)檢查原則進一步細化了生產記錄的具體內容.
	(見4.2.4);	生產應準備工藝規範及作業指導書等,明確關鍵流程與特殊流程.
	乙)發現基礎設施;	審查相關文件，看看關鍵流程和特殊程序是否有明確規定, 是否有驗證或確認關鍵工序和特殊程序重要參數的規定.
	c)rightProcess parametersandProduct FeaturesconductSurveillanceandMeasurement;	2.1.1
	d)Acquisition and useSurveillanceandMeasuring device;	Factory buildings and facilitiesIt should conform to the productProduction requirements.
	e)In accordance with regulationsLabelandPackageoperate;	5.2.1
	f)Release,deliverandAfter deliveryImplementation of the activity. The organization should establish and maintain [the necessary procedures].Each (or batch) of medicalinstrumentofRecord(See4.2.5)to provide7.5.9 middleRegulationstraceabilityRecord the scope and extent, and indicateProduction quantityandApproved for saleThe quantity.RecordShould go throughValidation and approval.	5.Determine product technical requirementsFormulate, verify, confirmrecognizeandProduction activitiesRequiredMeasuring device;

		*5.4.1
		5.Regulations necessary for the safety and proper use of the product.
ISO 13485:2016		New versionGMP/Inspection principles	A Brief Analysis of Differences
		Product Featuressuch as productsInstruction Manual,Packageand
		Labeling requirementsEtc. 產品使用說明書與備註是否相符?
		The registration application and approval are consistent.
		8.3.2
		需要日常控制的來料檢驗過程檢驗和
		原則, 成品檢驗專案不應外包.
		測試. 對於測試條件和設備要求較高的, [以下是必要的]:
		對於需要測試外包的項目, 可委託有資格的檢測機構.
		機構進行檢驗證明產品符合強制標準.
		標準及註冊或備案的產品技術
		求.
		*8.5.1
		產品應指定發布程序,條件和發布批次
		標準要求.
		檢查產品發布流程，查看發布流程是否明確定義.
		發布批准的條件和要求. 應明確權限.
		授權發布產品的人員及其職責和權限必須受到保護.
		Hold approved records.
		*9.1.1
		Products should be establishedSaleRecord and satisfyTraceable
		Require
		9.3.1
		It should possess the necessary capabilities appropriate to the products it produces.After-sales service
		Service capabilitiesEstablish and improve the after-sales service system.
		*7.6.1
		Each batch (units) of productsAll should haveProduction Records,和
		satisfyTraceableRequirements.
		7.6.2
		Production RecordsIt should include:Product Name, 規格
		Number, raw material batch number, production batch number or product number
		Production date, quantity, main equipment, process parameters,
		營運商, etc.content.
		*8.4.1
		Each batch (units) of productsAll should haveBatch inspection record,
		and satisfyTraceableRequire.
	7.5.2 Product cleaning	7.3.1	13485 Further details on which situations require
	The organization should make the productcleanorProduct contamination controlof	During the production process, it is necessary to…Raw materials, intermediate products, ETC.	產品清潔或產品污染控制要求
	需要建立文檔,如果:	進行清潔處理時應明確規定清潔方法和	請建立一個文檔.
	一個) 存在滅菌和/或使用前組織製造的產品	要求並對清潔效果進行驗證.
	乾淨的;
	乙) 以非無菌形式提供並進行滅菌或
	應先進行清潔。產品;
	c)使用前無法消毒或清潔的產品
	品嚐,使用過程中清潔。是重要的;
ISO 13485:2016		New versionGMP/Inspection principles	A Brief Analysis of Differences
	d)由非無菌形式提供的產品, 他們的清潔是必不可少的。;
	e)在產品製造過程中從產品中移除加工助劑.
	如果產品如上所述)球體)如果需要清潔, 然後進行清洗處理。無需滿足6.4.1要求.
	7.5.3 安裝活動	9.4.1	沒有重大差異, 檢查原則稍詳細，由使用者或其他企業安裝、維護的特定要求.
	適當的時候, 組織應將醫療設備安裝和安裝驗證驗收標準的要求記錄在案.	需要企業安裝的醫療器材應確定安裝要求和安裝驗證驗收標準,建立安裝驗收記錄.
	如果客戶請求許可, 除了…組織或其供應商以外的外部安裝醫療設備小時,	9.4.2
	組織應辦理醫療器材的安裝和安裝驗證。提供文件化要求.	依賴用戶單位或其他公司進行安裝和維修, 應提供以下內容:安裝要求, 標準, 維修零件, 文件, 密碼, etc.and conductguide.
	It should be maintained that the work is done by the organization or its supplier.Installand
	Verification records(See4.2.5).
	7.5.4 Service Activities	9.3.1	13485 The service records have been further refined.Requirements for tolerance.
	Where service requirements are specified, and when necessary,Organizations should establish [equipment/systems] forService provision activitiesandverifyDocumentation confirming whether the service meets the specified requirements.ofProcedures and Reference MaterialsandMeasurement Procedure.	It should possess the necessary capabilities appropriate to the products it produces.After-sales serviceService capabilitiesEstablish and improveAfter-sales service system.
	The organization should analyzeThe organization or its suppliersImplement service activities	9.3.2
	movingRecord:	應售後服務要求並建立售後服務記錄並滿足可追溯要求.
	一個)確定該資訊是否用作投訴處理;
	乙)適當的時候,作為改進過程的進入。應保存組織或其供應商所進行的服務活動的記錄(See4.2.5).
	7.5.5 無菌醫療器材的具體要求	《無菌醫療器材現場檢驗GMP指導原則》”:	1)No significant differences. 無菌醫療器材的詳細具體要求可參見”GMP無菌醫療器材相關規定, 文件, 和標準, 例如 “現場檢查指南”;
	組織應保持每個滅菌批次的滅菌製程參數記錄(See4.2.5),滅菌記錄答案可追溯到達醫療器材每個生產批次.	7.21.1	2)《無菌醫療器材GMP》 “現場檢查指南” 進一步細化滅菌過程控製文件內容.
		有必要製定滅菌過程控製文件,保留每個滅菌批次的滅菌製程參數應記錄, 並應有滅菌記錄…可追溯至產品每個生產批次.
	7.5.6生產和服務交付流程的驗證	7.5.1	13485 流程確認進一步細化。要求.
	組織應識別其生產和服務提供過程的輸出。不能或不遵循持續監視或測量來驗證該過程, 因為	生產應經過特殊工藝確認, 並保存記錄,包括確認計劃, 方法, 營運商, 結果評價, 和重新確認.內容.
	所以, 產品使用過程中或服務交付後出現缺陷.	7.5.2
ISO 13485:2016		New versionGMP/Inspection principles	A Brief Analysis of Differences
	只有稍後才會變得明顯.	Used in the production processComputer software for products Quality is affectedYes, it should be carried outVerify or confirm.
	confirmIt should be able to demonstrate the ability of these processes to consistently achieve the planned results.
	The organization should include the processConfirmation procedure document,Baginclude:
	一個)forProcess reviewandApproval stipulationsofallowbut;
	乙)equipmentofIdentificationandPersonnel Qualifications;
	c)Use specificmethod,programandAcceptance criteria;
	d)適當的時候, to determineStatistical techniques and principles used in sampling;
	e)RecordRequirements(See4.2.5);
	f)Confirm againIncluding reconfirmationGuidelines;
	g)Process Changeofapprove.
	Organizations should allocate funds for production and service provision.Computer softwareofconfirmThis creates a documented procedure.Software verification should be conducted withinConfirm before first use,appropriateAt this time, 這裡軟體變更或應用後與軟項確認和再次確認的具體方法和活動答案與應用本軟體相關風險一致, 包括對產品合規能力的影響.
	結論中確認措施和確認結果的必要性
	ofRecord應該被維護(See4.2.4 and4.2.5).
	7.5.7 滅菌和無菌屏障系統的過程驗證特殊要求	《無菌醫療器材現場檢驗GMP指導原則》”:	1)13485提到了具體的滅菌方法。無菌屏障系統的製程有具體要求, 請參閱相關文件。 ISO11607-1和ISO 11607-2;
	組織應將滅菌和無菌屏障系統的過程確認程序形成文件(見4.2.4).	7.20.1	2)其他與無菌醫療器材相關的具體要求, 請參閱文件。 GMP無醫療器材現場檢查指南原則”.
	Where appropriate, the sterilization process and aseptic barrier system should be implemented.Before implementationas well asBefore subsequent product or process changesgo throughconfirm.	Sterilization of sterile medical devices should be established.The process is verified and documented..
	confirmresultandin conclusionAnd the measures taken as confirmed	Check the sterilization process confirmation procedure documents to see if they conform to…Meets the requirements.
	Necessary measuresRecords should be kept.(See4.2.4 and	*7.20.2
	4.2.5).	The sterilization process should be carried out in accordance with relevant standards.Before the first implementationconductconfirmWhen necessaryConfirm again,andMaintain a record of the sterilization process confirmation.
	筆記: Further information can be found at [link/reference].ISO 11607-1 andISO 11607-2.	existFirst timeBefore sterilizing the product, is the sterilization process monitored?confirm.existProducts, sterilization equipment, process parameterswaitWhen changes occurShould the sterilization process be carried out?Confirm again.
		Validation of sterilization or aseptic processing proceduresComplies with relevant standards,likeGB18278~GB18280Sterilization Validation and Routine of Medical and Healthcare ProductsRegulation and control requirementsWhether the record or report has been reviewed and approved.
		If aseptic processing technology is used to ensure the sterility of the product, then…
ISO 13485:2016		New versionGMP/Inspection principles	A Brief Analysis of Differences
		Whether or not in accordance with relevant standards, such asYY/T0567″medicalAseptic processing of therapeutic productsPerformedProcess simulation testTest.
		Has the sterilization process been maintained?Record.
		Sterilization confirmation was used to determine the quality of the initial packaging and the product.Initial contaminant bacteriaandacceptable levels of particulate pollution.
	7.5.8 logo	7.7.1	13485It was emphasized that if applicable regulations apply.The requirements stipulate that organizations should allocate medical equipmentSystematic documentation for the unique identification of mechanical devices;And only in theGMPImplantable medical devicesThe “現場檢查指南” mentions uniqueness.Logo.
	The organization shouldProduct IdentificationofProgram documentation,andUsed throughout the entire product realization processAppropriate methodsIdentify the product.	Products should be establishedIdentification control program,useAppropriate methodsProducts should be labeled for identification purposes to prevent misuse and confusion.
	In product implementationThe whole processIn China, the organization should, according toMonitoring and measurementRequirementsIdentify product statusThroughout the productProduction, storage, and installationandServeDuring the process,KeepProductsStatus indicatorTo ensure that only those who passNecessary inspections and tests or authorized concessions OKOnly products can beSend, use or installIf there isApplicable regulatory requirementsThe regulations stipulate that organizations should respond.System for assigning unique identifiers to medical devicesForming text	*7.8.1
	Item.	Products should be labeled during the production process.Inspection status,preventSubstandard intermediate products flow to downstream processessequence.
	Organizations should establish documented procedures to ensureReturn to organizationAll medical devices can beIdentificationAnd can be withDistinguishing qualified products.	Check whether there are regulations on the method of marking the inspection status, and inspect the inspection status markings in the production process on-site to see if they comply with the regulations.
		*7.9.1
		The product should be establishedTraceabilityProcedures, regulations for productionProduct traceability scope and extentlogoAnd necessary records.
		《GMP On-site inspection guidance for implantable medical devicesin principle”:
		*7.22.1
		A traceability procedure should be established and documented, specifying the scope and extent of traceability for implantable medical devices.Unique identifierAnd the required records.
		Check the traceability procedure documents to see if they specify the scope, extent, unique identification, and required records for traceability of implantable medical devices.
	7.5.9Traceability	*7.9.1	none
	7.5.9.1General Principles	The product should be establishedTraceability proceduresRegulations on productionTasteScope, extent, identification, and necessary records of traceability.
	The organization shouldTraceability proceduresThese procedures should be documented and specified to conform toApplicable regulatory requirementsofCan Scope of traceability, proceduresand placeRecords maintained,
	(See4.2.5).
	7.5.9.2Specific requirements for implantable medical devices	《GMP On-site inspection guidance for implantable medical devicesin principle”:	none
	The records required for traceability should include, but are not limited to, those that may be necessary.guideMedical devices that fail to meet their safety and reliability requirementsCan be requiredofComponents, materials and working environmentenvironmental conditionsThe record.	7.22.1
	The organization should requireResale serviceSuppliers or distributors maintainMedical device distribution recordsso thatTracingWhen inspect	When specifying traceability requirements for records, it should includeIncluding the possibility of finalThe product does not meet its specifications.The required raw materials, production equipment, and operatorsPersonnel and production environmentRecords, ETC.
ISO 13485:2016		New versionGMP/Inspection principles	A Brief Analysis of Differences
	This record can be obtained when needed.	Check the product’s labeling, production records, and inspection records to see if the raw materials, production equipment, 營運商, and production environment used in the product’s production can be traced.content.
	Freight Packaging RecipientofnameandaddressRecordsIt should be maintained(See4.2.5).	9.6.1
		It should be required thatAgents or distributorssaveMedical device distribution recordsso thatTracing.
		9.6.2
		Should be preservedFreight Packaging RecipientofnameandaddressThe record.
	7.5.10 Customer property	none	The inspection principles do not emphasize customers in a separate chapter.Property requirements.
	當客戶財產處於組織的控製或使用之下時, 組織應確定, verify, 保護, 並維護可用的資源。使用或構成產品客戶財產的一部分.
	如果客戶材料發生遺失, 損壞的, 或當時發現不適合, 應向客戶報告並保存記錄.
	(See4.2.5).
	7.5.11 Product Protection	7.11.1	檢查原則進一步細化，納入防護用品的實體要求.
	存在處理, storage, 處理和銷售這個過程, 組織記錄保護程序，以確保產品符合要求。保護適用於醫療器材組件加工過程中, storage, 處理, and distribution, 當產品暴露於…預計當時的情況和危害, 該組織應透過	Products should be establishedProtectionThe procedure specifies the protection requirements for products and their components, includingPollution protection, electrostatic protection, dust protection, corrosion protection, transportation protection, etc.Requirements. Protection should include…Labeling, transportation,包裝, storage and protectionwait.
	Protect your product in the following waysAvoid alteration, contamination, 或者	On-site inspection to verify whether the product protection procedures meet the requirements of the specifications; on-site inspection and spot checks of relevant records to confirm that the product protection meets the requirements.
	damage:
	一個)Design and constructionAppropriate packagingandFreight Capacityinstrument;
	乙)If packaging alone cannot provide protection, then necessary measures should be taken.Special conditions require documentation..
	If there are special requirements, then it should be…controlandremember
	record(See4.2.5).
7.6Surveillanceand measurement equipmentEquipment control	The organization should determineMonitoring and measurementAnd the necessary monitoring and measurementDeviceTo ensure that the product meets the specified requirementsProvide evidence.	*3.3.1	1)The inspection principles have further refined the requirements for the content of the usage records of inspection instruments and equipment;
	The organization shouldProgram documentationTo ensure surveillance andMeasurement activities are feasible and require monitoring and measurement.begConsistentImplemented in this manner.	It should be equipped withProduct inspection requirements are compatibleofInspectionTesting instrumentsandequipmentThe main testing instruments and equipment shouldWhen haveClear operating procedures.	2)檢驗原則強調測量儀器的要求;
	確保結果的有效性, 測量設備應, 必要時, 包括:	透過與產品檢驗要求和方法對比，驗證企業是否擁有相關檢測設備. 檢查主要檢測設備是否建立操作規程.	3)13485強調比較可以溯源。以國際和/或國家標準計量數量標準.
	一個)比較可以追溯到國際和/或國家標準測量標準,根據規定的時間間隔或使用前進行校準或驗證.	3.4.1
	如果沒有上述標準, 應記錄校準或檢查.	應建立檢測儀器和設備的使用記錄該記錄應包括使用情況, 校準, 以及維護和修理等條件.
ISO 13485:2016		New versionGMP/Inspection principles	A Brief Analysis of Differences
	判定依據(See4.2.5);	3.5.1
	乙)必要時進行調整重新調整; 此類調整或進一步調整應進行記錄(See4.2.5);	應配備適當的設備、測量儀器、測量儀器的測量範圍和準確度應滿足使用要求、測量儀器應標明其使用範圍和準確度。…校準有效期限保存對應記錄record.
	c)取得標誌,透過確定其校準狀態state;	檢查測量儀器的校準記錄，以確定其是否在有效期內使用.
	d)防止測量結果因調整而失效;	8.1.1
	e)存在運輸及維護及儲存期限防止損壞或故障.	It should be establishedQuality control proceduresRegulations for productsInspection departments, personnel, operations, etc.Require.
	The organization should perform calibration or verification in accordance with the documented procedures.	Check the quality control procedures to see if they specify the responsibilities of the product inspection department, personnel qualifications, and inspection operating procedures.
	In addition, whenThe equipment was found to be non-compliant.At that time, the organization	8.1.2
	Addressing previous measurement resultsValidityconductevaluateandRecord.	It should be stipulatedTesting instrumentsandequipmentofUse, CalibrationRequirements, and procedures for product release.
	The organization should take appropriate measures regarding the equipment and any affected products.measure.	檢查品質控製程序是否規定了測試儀器和設備的使用和校準.
	應保存校準和驗證結果的記錄。(看	8.2.1
	4.2.5).	應定期對試驗儀器和設備進行校準或檢驗並給予標誌.
	組織回應電腦軟體的監控和測量要求應用確認過程被記錄. 這類…軟體應該可以初次使用，使用前確認一下，適當的時候, 在此類軟體變更後或應用過程中確認	檢查檢測儀器、設備是否依要求進行校正或驗證，是否有標識。 8.2.2
	認出.	應規定檢測儀器、設備應符合…運輸, 維護
	The specific methods and activities related to software verification and re-verification should be aligned with the risks associated with software use.This includes the impact on the product’s ability to conform to specifications.Internal risks.	During protection and storageProtection requirements,Preventing inspection resultsIf inaccurate.
	Results and confirmed conclusions, and measures taken as a result of confirmation.Records of necessary measures should be kept.(See4.2.4and4.2.5).	8.2.3
	筆記: Further information can be found at [link/reference].ISO 10012.	whenThe testing instruments and equipment were found to be non-compliant.At that time, previous test results should be reviewed.evaluate, and saveVerification records.
		Review equipment usage and maintenance records to see if previous test results were evaluated and relevant records were kept when testing instruments and equipment failed to meet requirements.record.
		8.2.4
		For usetestofComputer softwareIt should be carried outConfirmrecognize.
8 TestQuantification, analysis and improvement	The organization should plan and implement the following aspects as requiredMonitoring, measuring, analyzing and improving processes:	*11.2.1	The inspection principles have been further refined to improve the monitoring system.Specific requirements.
8.1	一個)Confirm product conformity;	Medical devices should be established in accordance with relevant regulations.Adverse event monitoring systemConduct adverse eventsMonitoring and re-evaluationWork, maintain relevantRecord.
General Principles	乙)ConfirmQuality Management SystemofCompliance;	查看企業建立的不良事件監控系統,
	c)維持品質管理系統的有效性.	有沒有規定?可疑不良事件管理人員
	這應該包括 [下列]統計技術包括適當的方法
ISO 13485:2016		New versionGMP/Inspection principles	A Brief Analysis of Differences
	以及應用程式層級的確定.	職責, 報告原則, 報告程序, 和報告截止日期,制定醫療器材上市計畫並實施再評估流程訂單和文件, ETC。, 和符號合規要求審查相關記錄以確認是否發生任何不良事件, 並相應地執行所需的程序.
		11.3.1
		應建立與產品品質相關的數據分析程序進行收集和分析, 不良事件, 客戶回饋, and the operation of the quality management system.Data verificationProduct safetyandValidityAnd keep relevant records.
		Review the implementation records of the data analysis to see if it was conducted according to the prescribed procedures and if the required technologies were applied.Statistical TechniquesThe data analysis results were also recorded.
8.2	8.2.1 feedback	9.5.1	No significant differences
Monitoring and measurementquantity	As a measure of the performance of the quality management system, the organization should address the relevant organizational…Have the customer’s needs been met? begInformation should be collected and monitored.Methods of acquiring and utilizing this informationCreate a document.	It should be establishedCustomer feedback handling procedureTo process customer feedback informationTracking analysis.
	The organization shouldFeedback systemThe program forms a file. ThisSuch a feedback process should include collecting feedback from…Productionand post-production activity dataAccording to the regulations.	Check whether the program documentation specifies the implementation of the above activities and whether customer feedback information is tracked and analyzed.
	The information collected during the feedback process should be able to provideMonitoring and maintaining product requirementsand providing product realization or improvement processesRisk Management PotentialInput.	11.3.1
	ifApplicable regulations requireThe organization received fromProductionPost-activity specific experienceThe review of this experience should constitute	A data analysis procedure should be established to collect and analyze data related to product quality, 不良事件, andCustomer feedbackData related to the operation of the quality management system, verificationProduct safety and effectivenessAnd keep relevant records.
	It becomes part of the feedback process.	Review the implementation records of the data analysis to see if it was carried out according to the prescribed procedures, whether statistical techniques were applied, and whether records of the data analysis results were retained.
	8.2.2 Complaint handling	11.1.1	13485 Further refine the complaint handling proceduresSpecific requirements and responsibilities.
	The organization should base its decisions onApplicable laws and regulationsRequires timely handlingThe complaint procedure is documented..	Relevant departments should be designated to be responsible for receiving, investigating, evaluating, and processing the information.Customer complaintsand maintain relevantRecordReview relevant documents regarding responsibilities and authority to determine if the above activities are stipulated.
	These programs should include at least the followingRequirements and Responsibilities:	11.4.1
	一個)Receive and record information;	It should be establishedCorrective action proceduresTo determine the cause of the problem, effective measures should be taken to prevent the problem from recurring.
	乙)Evaluation information to determine whether feedback constitutes a voteLawsuit;
	c)Investigate complaints;
	d)SureReport the information to the appropriate regulatory authorities.demand;
	e)Processing andComplaints about related products;
	f)Determined to carry outThe need for correction or corrective action.ifThe complaint was not investigated.The reasons for such actions should be documented. Any corrections arising from the complaint handling process…
	Or corrective measures should be documented.
	If the investigation confirmsComplaints are activities outside the organization
ISO 13485:2016		New versionGMP/Inspection principles	A Brief Analysis of Differences
	ToThe relevant information should be inOrganizations and relevant external partiesInterchange.
	Complaint handling recordShould be maintained(看
	4.2.5).
	8.2.3 Report to regulatory agencies	*11.5.1	No significant differences
	Complaints that comply with the prescribed adverse event reporting guidelines are required by applicable regulations.Issue notices or advisory noticesThe organization shouldNotify appropriate supervisionDocumented procedures of the organization.	For medical devices that pose safety hazards, they should be handled in accordance with relevant regulations.Regulations require measures such as recalls.Measures, and in accordance with regulations, toReport from relevant departments.
	Reporting regulatory agency recordsShould be maintained	11.6.1
	(See4.2.5).	Products should be establishedInformation notification procedurePromptly deliverTasteChanges, UseWaiting for supplementary information notificationUser unit, related enterprise or consumer.
	8.2.4 Internal audit	11.7.1	13485The selection of auditors and the implementation of audits should be clearly defined to ensure the audit process is effective.Objectivity and impartiality; auditors should not auditCheck your own work.
	The organization should follow the plan.Time intervalconductInternal auditTo determine whether the quality management system is:	An internal audit procedure for the quality management system should be established, stipulating…The audit criteria, scope, frequency, participants, 方法, record requirements, and assessment of the effectiveness of corrective and preventive actions.This includes ensuring that the quality management system complies with…This specificationRequirements.
	一個)conform toPlanning and documented arrangements,This standardRequirements and the organization’s establishedQuality Management SystemRequirements andApplicable laws and regulationsRequire;	Check whether the internal audit process includes the above.Content. Review internal audit documents.Personnel conducting internal auditsyesnoAfter training,Internal audit recordsDoes it meet the requirements?Request: Have any measures been taken regarding the issues identified in the internal audit?correctPositive measures,whetherefficient.
	乙)getEffective implementation and maintenance.
	The organization should document the procedures to describe them.Planning, implementation review, and reporting review resultsDuties andRequire.
	The audit program should be planned taking into account the status and importance of the areas and processes to be audited, as well as the results of previous audits. Audit procedures should be defined and documented.GuidelinesScope, Interval and Method(See4.2.5)AuditorThe selection and implementation of audits should ensure that the audit process is…Objectivity and impartiality.Auditors should not audit themselves
	My work.
	Records of the audit and its results, includingProcess identificationandAudited Areaandin conclusionThe record should be madeKeep.(See4.2.5).
	ResponsibleManagers of the audited areaAny necessary actions should be taken in a timely manner.Correction and corrective actionsTo eliminateThe identified nonconformities and their causes. Follow-up activities should…Including the measures takenVerification and verification resultsReport.
	筆記: Further information can be found at [link/reference].ISO 19011.
	8.2.5 Process monitoring and measurement	8.3.2	13485Emphasizing that when the planned goals are not achievedAs a result, corrective measures should be taken where appropriate.Corrective measures.
	Organizations should adopt appropriate methods toQuality Management SystemSystem processconductSurveillanceWhen appropriate, quality managementSystem processMeasurementThese methods should be verified.Pass	Incoming inspection that requires routine controlProcess inspectionIn principle, finished product inspection items should not be outsourced for inspection. For inspections with high requirements for conditions and equipment, it is advisable to…
ISO 13485:2016		New versionGMP/Inspection principles	A Brief Analysis of Differences
	Cheng’s ability to achieve the planned results.whenThe planned results were not achieved.When appropriate, measures should be taken.Correction and corrective actions.	For items requiring commissioned testing, a qualified institution can be commissioned to conduct the testing to prove that the product meets mandatory standards and the registered or filed product technical requirements.beg.
		8.4.2
		Inspection records should include incoming inspection,Process inspectionInspection records, inspection reports or certificates for finished products.Books, ETC.
	8.2.6 Product monitoring and measurement	*8.3.1	1)The inspection principles clarify that product technical requirements should be formulated in accordance with mandatory standards and registered or filed product technical requirements to develop product inspection procedures;
	Organizations should monitor and measure the characteristics of products to verify them.Product requirements have been met.Such monitoring and measurement should be based on the planned, documented arrangements and procedures during the product realization process.suitable	According toMandatory standardsand those that are registered or filedProduct Technical RequirementsDevelop product inspection procedures and issue corresponding certificates.Inspection report or certificate.checkCheck whether the product inspection procedures cover mandatory standards.In addition to verifying the performance indicators of the registered or filed product technical requirements; confirming whether the inspection records can prove that the product meets the requirements; and checking whether the corresponding inspection reports or certificates have been issued in accordance with the inspection procedures and inspection results..	2)The inspection principles have further refined the inspection requirements for the products;
	At this stageconduct.	8.3.2
	Should maintain complianceAcceptance CriteriaEvidence.Identification of personnel authorized to release productsIt should be recorded.(看	Requires routine controlIncoming inspection, process inspectionandFinished product inspectionProject in principleOutsourcing inspections is not allowed.TestFor testing conditions and equipment with high requirements,對於需要測試外包的項目, a qualified testing agency can be commissioned.The agency conducts inspections to prove that the product complies with mandatory standards.Standards and technical requirements for registered or filed products.	3)Although13485not yetThis section emphasizes that each batch (unit) of products should have a batch inspection record. Record and meet traceability requirements.But in the previous section “7.5.1 Production and
	4.2.5)Where appropriate, records should identify the activities used to conduct the measurement.Test equipment.	*8.4.1	The phrase “control over service delivery” is mentioned.
	Only when the planned and documented arrangements have been successfully completedOnly when it is completedRelease products and delivery services.forImplantable medical devicesThe organization should keep recordstestand the identity of the test personnel.	Each batch (units)All products should haveBatch Inspection Recordrecordand satisfyTraceableRequire.	4)The relevant requirements for implantable medical devices should be referred to.
		8.4.2	《GMP Implantable medical devicesOn-site inspection guidelines.
		Inspection records should include the incoming…Goods inspection, process inspection and finished product inspectionTestRecords, inspection reports or certificatesBooks, ETC。.
		《GMP On-site inspection of implantable medical devicesGuiding Principles:
		*1.5.2
		It should have the correspondingQuality inspection agencyorfull-time inspectors.
		Check the organizational chart, departmental responsibilities, and personnel appointment documents to confirm whether they meet the requirements.
8.3	8.3.1 General Principles	10.1.1	No significant differences
Non-conforming productscontrol	The organization should ensureProducts that do not meet product requirementshave toarriveIdentificationandcontrolTo prevent itUnexpectedUse	It should be establishedNon-conforming product control proceduresThe regulations are not in complianceQuality controlResponsibilities and authority of departments and personnel.	No significant differences
ISO 13485:2016		New versionGMP/Inspection principles	A Brief Analysis of Differences
	Or delivery. The organization shall stipulate.Non-conforming product controland regulationsNon-conforming product identification, 文件, isolation,evaluateandDisposal of substandard productsRelevant duties and authorities The program forms a file.	*10.2.1
	Unsatisfactory evaluationIt should include decisionsThe need to conduct an investigationand notification regarding thisAny external party responsible for non-compliance.	Non-conforming products should be inspected.Identification, recording, isolation,ReviewBased on the review results, appropriate measures should be taken against non-conforming products.Disposal measures.
	Should be maintainedNon-conforming natureAnd subsequentlyTake anyWhat measuresRecords, includingEvaluation, any surveyandRecord of the reasons for the decision(See4.2.5).	On-site inspections were conducted to verify whether the labeling and isolation of non-conforming products complied with the procedural documents, and random checks were performed on the non-conforming product handling records to ensure that the review was conducted in accordance with the document requirements.
	8.3.2Response measures for non-conforming products before delivery	*8.5.1	13485 More detailed pre-delivery non-conformitiesProduct response measures.
	Shi	產品應指定發布程序,conditionandRelease batchStandard requirements.
	The organization should follow the followingOne or moreThe method of handling is notqualified products:	檢查產品發布流程，查看發布流程是否明確定義.
	一個)takeMeasures to eliminate identified nonconformities;	Conditions and release approval requirements. The regulations should specify the conditions for releasing products.Personnel and their duties and authorityand should maintainapproveThe record.
	乙)Take measuresTo prevent its original intended use or shoulduse;	8.5.2
	c)Authorization to use concessions,ReleaseorAccepting unqualifiedTaste.	The released products should be accompanied byCertificate of Conformity.
	The organization should ensure that non-conforming products are only produced after they have been supplied.combinereason,ApprovedandTo meet applicable regulationsbegIt can only be implemented under certain circumstances.Concession Acceptance.
	Concession Acceptance and Authorization of ConcessionsPersonnel identification records
	It should be maintained(See4.2.5).
	none	*9.1.1	1)13485Not separatelyCheng Zhang emphasized the requirements of sales, onlyIn the7.2.3 The communication chapter mentionsSome terms;
		Products should be establishedSales recordsand satisfyTraceableRequire.	2)Direct within ChinaSelling self-produced products or choosing medical device distributors must also comply with the requirements of the “Administrative Measures for the Operation of Medical Devices” and the “Good Manufacturing Practice for Medical Devices”.
		9.1.2
		Sales records should include at least:Medical device nameName, specifications, model, quantity, production batch number, and availability.
		Expiry date, sales date, name and address of the purchasing unit,Contact information, etc.content.
		9.2.1
		Direct sales of self-produced productsOr chooseMedical device distribution companiesIt should comply withMedical device related regulations and standards.
		9.2.2
		Medical device distributors were found to haveillegal and irregular Business activitiesAt that time, it should be reported toReport from the local food and drug administration department.
	8.3.3Response measures for non-conforming products after delivery	10.3.1	13485 The definition of advisory notices has been clarified.
	Shi	In productsAfter saleDiscover ProductsUnqualifiedAt that time, it should be done promptly.
ISO 13485:2016		New versionGMP/Inspection principles	A Brief Analysis of Differences
	whenAfter delivery or commencement of useWhen nonconforming products are discovered, the organization should take measures appropriate to the impact or potential impact of the nonconformity.Take measuresThe records should beTo maintain(See4.2.5).	Take action at the timeCorresponding measures,likeRecall, DestructionMeasures such as on-site inspection of products.When defects are found after sale
	The organization shouldComplies with applicable regulatory requirementsPublishedofAdviceThe program forms a fileThese processesThe procedure should be readily implementable. This differs from issuing advisory notices.	ofDisposal measures,whetherRecall and Destructionwait.
	ClosedMeasures RecordThis should be maintained.(See4.2.5).
	8.3.4 Rework	10.4.1	The inspection principles clearly state that items that cannot be reworked should be…When relevant handling systems are established.
	Considering the potential adverse effects of rework on the product consider,The organization should be based onDocumented proceduresImplementationReworkThese (rework) procedures should go through andSame as the original programofReview and approval.	Defective products canReworkYes, enterprises should preparereturnWork control documentsRework control documentation should include…doIndustry guidelines, re-inspection and re-verification, etc.content.
	After rework, the product should undergo…verifyEnsure itsComplies with applicable acceptance criteria and regulatory requirements..	Check the rework control documents to see if any rework is permitted.Regulations on non-conforming productsRandomly check rework activity records to confirm whether they comply with the requirements of the rework control documents.
	Rework should be maintainedRecord(See4.2.5).	10.4.2
		No reworkYes, it should be establishedRelated handling system
		Spend.
8.4	Organizations should identify, collect, and analyze appropriate data.According to, to confirmThe suitability and effectiveness of the quality management systemefficacyThe program should be documented.statisticsTechnology and its application scopeanddegreeIncludingAppropriate methodsThe determination.	11.3.1	13485 The data analysis has been further refined.Specific input content.
Data Analysis	Data analysis should include…The monitoring measurement generateddataandData from other relevant sourcesAt least including	A data analysis program should be established to collect and analyze data.Related to product quality, 不良事件, 客戶回饋, and the operation of the quality management system.The data is used to verify product safety and effectiveness, and relevant records are maintained.
	The following inputs are required:	Review the implementation records of the data analysis to see if it was conducted according to the prescribed procedures and if the required technologies were applied.Statistical TechniquesThe data analysis results were also recorded.
	一個)feedback;
	乙)andProduct compliance;
	c)Processes and productsCharacteristics and Trendsincluding takingPreventive measuresOpportunity;
	d)Supplier;
	e)Review;
	f)適當的時候,Service Report.
	If data analysis showsInadequate quality management systemshould,Inadequate or ineffectiveThe organization should follow80.5 ofThis analysis should be used as input for improvement.
	Records of data analysis results should be kept.(See4.2.5).
8.5	8.5.1 General Principles	*1.3.2	No significant differences.13485 The knowledge was slightly refined.Don’t implement any necessary changes.
improve	Organizations should utilizeQuality policy, quality objectives, audit	The management representative shall be responsible for establishing, implementing, and maintaining [the system/system].
ISO 13485:2016		New versionGMP/Inspection principles	A Brief Analysis of Differences
	Results, post-market surveillance, data analysis, corrective andPreventive measures and management reviewComeIdentificationandImplementationAny necessaryChangeTo ensure and maintain quality controlTheoretical systemSustained suitability and adequacyandValidityas well asSafety and performance of medical devices.	Quality management system, reporting on the operation of the quality management system andImprovement requirementsThis will raise employees’ awareness of meeting regulations, rules, and customer requirements.	Use the method.
		Check whether the above responsibilities are clearly defined. Review the management representative’s report on quality management.System operation ConditionandimproveRelated records.
		*11.8.1
		Management reviews should be conducted regularly to evaluate and audit the quality management system to ensure its effectiveness.Sustained suitability and adequacyandValidity.
		Review management review documents and records, including the management review plan, management review report, 和…Related improvement measuresDoes the management review report include a review of the law?
		Evaluation of compliance. Whether a management review was conducted within the stipulated timeframe, whether improvement measures were proposed and specific responsibilities and requirements were implemented, and whether the plan was followed.Shi.
	8.5.2 Corrective measures	11.4.1	No significant differences.13485 Slightly refinedRequirements for corrective actions.
	The organization should takemeasureTo eliminate the non-conforming original	It should be establishedCorrective action procedures,SureThe cause of the problem,takeEffective measures,preventRelatedThe problem occurred again..
	所以, to prevent the recurrence of nonconformities, any necessary corrective actions should be taken promptly. The corrective actions should be commensurate with the severity of the impact of the nonconformity.	11.7.1
	Organizations shouldDocumented procedures, in order to stipulate	An internal audit procedure for the quality management system should be established, specifying the audit criteria, scope, frequency, participants, 方法, and record requirements.correctpreventionEvaluation of the effectiveness of measures, etc.Content to ensure that the quality management system complies with the requirements of this specification.
	The following requirements:	Check if the internal audit procedures include the above. Review the internal audit documents and identify the personnel who conducted the internal audit.
	一個)Unsatisfactory review(includeCustomer complaints);	Whether training was conducted, whether internal audit records meet requirements, and whether issues identified during internal audits were addressed.Corrective measures were taken.,Is it effective?.
	乙)SureReasons for non-compliance;
	c)Evaluation ensures failureMeasures to prevent it from happening againofneed;
	d)Plan and take the necessary measuresCreate document,Implementation measuresWhen appropriate, includingUpdate files;
	e)verifyCorrective measuresFailure to meet applicable regulatory requirementsorAdverse effects on the safety and performance of medical devices;
	f)ReviewThe measures takenCorrective measuresofValidity.anyinvestigationandTake measuresofRecordShould be maintained
	(See4.2.5).
	8.5.3 Preventive measures	11.4.2	No significant differences.13485 Slightly refinedRequirements for preventive measures.
	The organization should identify measures to eliminateReasons for potential non-complianceTo prevent nonconformities from occurring, preventative measures should be appropriate to the severity of the potential problem.	It should be establishedPreventive measures procedures,SurePotential problemsReasons,takeEffective measures,To prevent problems from occurring.
	The organization should establish documented procedures to describe the following:求:	11.7.1
	一個) SurePotential nonconformities and their causes;	An internal audit procedure for the quality management system should be established, specifying the audit criteria, scope, frequency, participants, 方法, record requirements, and corrective actions.Preventive measures include
ISO 13485:2016		New versionGMP/Inspection principles	A Brief Analysis of Differences
	乙)evaluatePreventing non-conformitiesmeasuresneed;	Evaluation of effectiveness, etc.Content to ensure that the quality management system complies with the requirements of this specification.
	c)planAnd the necessary measuresCreate document,Implementation measuresWhen appropriate, includingUpdate files;	Check whether the internal audit procedures include the above-mentioned content. Review internal audit documents to verify whether the personnel conducting the internal audit have received training and whether the internal audit records meet the requirements.
	d)verifyPreventive measuresIt does not adversely affect the ability to meet applicable regulatory requirements or the safety and performance of the medical device.;	Request: Regarding the issues identified in the internal audit,Corrective measures were taken
	e)適當的時候,ReviewThe preventive measures takenValidity.	Positive measures,Is it effective?.
	anyinvestigationand the measures takenmeasureofRecordShould be protected
	hold(See4.2.5).