7 Product realization
7 產(chǎn)品實(shí)現(xiàn)
7.2 Customer-related processes 與顧客有關(guān)的過程
7.2.1 Determination of requirements related to product 與產(chǎn)品有關(guān)的要求的確定
The organizationshall determine: 組織應(yīng)當(dāng)確定
a) requirementsspecified by the customer, including the requirements for delivery andpost-delivery activities;
顧客規(guī)定的要求，包括對(duì)交付及交付后活動(dòng)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(guī)定的用途或已知的預(yù)期用途所必需的要求;
c) applicableregulatory requirements related to the product;
與產(chǎn)品有關(guān)的法律法規(guī)要求;
d) any usertraining needed to ensure specified performance and safe use of the medicaldevice;
任何用于保證醫(yī)療器械安全使用和特定性能的用戶培訓(xùn)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(chǎn)品相關(guān)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(yīng)當(dāng)審核與產(chǎn)品有關(guān)的要求。審核應(yīng)在組織向顧客作出提供產(chǎn)品的承諾之前進(jìn)行（如:提交標(biāo)書、接受合同或訂單及接受合同或訂單的更改），并應(yīng)確保:
a) productrequirements are defined and documented;
產(chǎn)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(yīng)的法律法規(guī)要求；
d) any usertraining identified in accordance with 7.2.1 is available orplanned to be available;
按照7.2.1項(xiàng)要求確定的任何用戶培訓(xùn)是可行的或是計(jì)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(jié)果和因?qū)徍硕a(chǎn)生措施的記錄應(yīng)當(dāng)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(yīng)對(duì)顧客要求進(jìn)行確認(rèn)。
When productrequirements are changed, the organization shall ensure that relevant documentsare amended and that relevant personnel are made aware of the changedrequirements.
若產(chǎn)品要求發(fā)生變更，組織應(yīng)確保相關(guān)文件得到修改。并確保相關(guān)人員知道已變更的要求。
YY/0287備注項(xiàng)目（刪除）
7.2.3 Communication 溝通
The organizationshall plan and document arrangements for communicating with customers in relationto:
組織應(yīng)對(duì)以下有關(guān)方面確定并實(shí)施與顧客溝通的有效安排:
a) productinformation;
產(chǎn)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(jù)相應(yīng)的法規(guī)要求與藥監(jiān)局進(jìn)行溝通。
總結(jié):風(fēng)險(xiǎn)管理描述略有差異。7.1產(chǎn)品實(shí)現(xiàn)策劃b）項(xiàng)中強(qiáng)調(diào)了資源和環(huán)境；c）中強(qiáng)調(diào)了處理，存儲(chǔ)、分配（銷售）和可追溯性措施；新增注意事項(xiàng)。7.2.1中d）項(xiàng)新增培訓(xùn)、7.2.2中d）項(xiàng)新增培訓(xùn)，且備注項(xiàng)刪剪。