7 Product realization
7 產品實現
7.2 Customer-related processes 與顧客有關的過程
7.2.1 Determination of requirements related to product 與產品有關的要求的確定
The organizationshall determine: 組織應當確定
a) requirementsspecified by the customer, including the requirements for delivery andpost-delivery activities;
顧客規定的要求，包括對交付及交付后活動的要求;
b) requirementsnot stated by the customer but necessary for specified or intended use, asknown;
顧客雖然沒有明示，但規定的用途或已知的預期用途所必需的要求;
c) applicableregulatory requirements related to the product;
與產品有關的法律法規要求;
d) any usertraining needed to ensure specified performance and safe use of the medicaldevice;
任何用于保證醫療器械安全使用和特定性能的用戶培訓需求；（新增）
e) anyadditional requirements determined by the organization.
組織確定的任何附加要求。
7.2.2 eview of requirements related to product 與產品相關的需求的審核
The organizationshall review the requirements related to product. This review shall beconducted prior to the organization’s commitment to supply product to thecustomer (e.g. submission of tenders, acceptance of contracts or orders,acceptance of changes to contracts or orders) and shall ensure that:
組織應當審核與產品有關的要求。審核應在組織向顧客作出提供產品的承諾之前進行（如:提交標書、接受合同或訂單及接受合同或訂單的更改），并應確保:
a) productrequirements are defined and documented;
產品需求必須得到明確并形成文件；
b) contract ororder requirements differing from those previously expressed are resolved;
與以前表述不一致的合同或訂單的要求得到解決；
c) applicableregulatory requirements are met;
符合相應的法律法規要求；
d) any usertraining identified in accordance with 7.2.1 is available orplanned to be available;
按照7.2.1項要求確定的任何用戶培訓是可行的或是計劃可行。（新增）
e) theorganization has the ability to meet the defined requirements.
組中有能力符合確定的需求；
Records of theresults of the review and actions arising from the review shall be maintained(see 4.2.5).
審核結果和因審核而產生措施的記錄應當予以保留（見4.2.5）
When the customerprovides no documented statement of requirement, the customer requirements shallbe confirmed by the organization before acceptance.
若顧客提供的要求沒有形成文件，組織在接受顧客要求前應對顧客要求進行確認。
When productrequirements are changed, the organization shall ensure that relevant documentsare amended and that relevant personnel are made aware of the changedrequirements.
若產品要求發生變更，組織應確保相關文件得到修改。并確保相關人員知道已變更的要求。
YY/0287備注項目（刪除）
7.2.3 Communication 溝通
The organizationshall plan and document arrangements for communicating with customers in relationto:
組織應對以下有關方面確定并實施與顧客溝通的有效安排:
a) productinformation;
產品信息；
b) enquiries,contracts or order handling, including amendments;
問詢、合同或訂單處理、包括修訂；
c) customerfeedback, including complaints;
顧客反饋，包括抱怨；
d) advisorynotices.
忠告性通知。
The organizationshall communicate with regulatory authorities in accordance with applicable regulatoryrequirements.
組織依據相應的法規要求與藥監局進行溝通。
總結:風險管理描述略有差異。7.1產品實現策劃b）項中強調了資源和環境；c）中強調了處理，存儲、分配（銷售）和可追溯性措施；新增注意事項。7.2.1中d）項新增培訓、7.2.2中d）項新增培訓，且備注項刪剪。