5 Management responsibility
5 管理職責
5.5 Responsibility, authority and communication 職責，權限和溝通
5.5.1 Responsibility and authority 職責和權限
Top managementshall ensure that responsibilities and authorities are defined, documented and communicatedwithin the organization.
最高管理者應當保證組織內的職責和權限清晰的被界定、文件化和溝通。
Top managementshall document the interrelation of all personnel who manage, perform andverify work affecting quality and shall ensure the independence and authoritynecessary to perform these tasks.
最高管理者應當文件化所有從事影響質量的管理、執(zhí)行和驗證工作的人員的相互關系。最高管理者還應當保證其完成這些任務所必須的獨立性和權限。
其中沒有YY/T0287的備注項目。（刪減）
5.5.2 Management representative 管理者代表
Top managementshall appoint a member of management who, irrespective of otherresponsibilities, has responsibility and authority that includes:
最高管理者應當制定一名管理者，不管他是否有其他責任，他都應具有以下的職權：
a) ensuring thatprocesses needed for the quality management system are documented;
保證質量管理體系所需的過程都被文件化；
b) reporting totop management on the effectiveness of the quality management system and anyneed for improvement;
向最高管理者報告質量管理體系的業(yè)績和任何改進的需要；
c) ensuring thepromotion of awareness of applicable regulatory requirements and quality managementsystem requirements throughout the organization.
確保貫穿于組織內部的質量管理體系需求和適應的法規(guī)需求意識的提升。
其中沒有YY/T0287的備注項目。（刪減）
5.5.3 Internal communication 內部溝通
Top managementshall ensure that appropriate communication processes are established within theorganization and that communication takes place regarding the effectiveness ofthe quality management system.
最高管理者應保證在組織內部建立適宜的溝通程序，并保證對質管理體系的有效性進行溝通。
5.6 Management review 管理評審
5.6.1 General 總則
The organizationshall document procedures for management review. Top management shall review theorganization’s quality management system at documented planned intervals toensure its continuing suitability, adequacy and effectiveness. The review shallinclude assessing opportunities for improvement and the need for changes to thequality management system, including the quality policy and quality objectives.Records from management reviews shall be maintained (see 4.2.5).
最高管理者應建立管理評審的程序。最高管理者應當在規(guī)定策劃時間間隔內審核該組織的質量管理體系，從而保證質量管理體系持續(xù)的適宜性、充分性和有效性。評審應包括評估質量管理體系改進的機會和變更的需要，包括質量方針和質量目標。應保持管理評審的記錄(見4.2.5)。
5.6.2 Review input 審核輸入
The input tomanagement review shall include, but is not limited to, information arisingfrom: 管理評審的輸入應當包括但不限于以下信息：
a) feedback; 反饋
b) complaint handling; 抱怨的處理
c) reporting to regulatoryauthorities; 向藥監(jiān)部門報告
d) audits; 審計
e) monitoring and measurement ofprocesses;過程的控制和測量；
f) monitoring and measurement ofproduct; 產品的控制和測量；
（新增部分）
g) correctiveaction; 糾正措施；
h) preventive action;預防措施；
i) follow-upactions from previous management reviews; 以往管理評審的跟蹤措施；
j) changes thatcould affect the quality management system;可能影響質量管理體系的變更；
k) recommendationsfor improvement;改進的建議；
l) applicablenew or revised regulatory requirements. 新的或修訂的法規(guī)要求。
5.6.3 Review output 評審輸出
The output frommanagement review shall be recorded (see 4.2.5) and includethe input reviewed and any decisions and actions related to:
管理評審的輸出應當被記錄（見4.2.5），并且應當包括經審核輸出和任何與下述有關的決定和措施：
a) improvement needed to maintain thesuitability, adequacy, and effectiveness of the quality management system andits processes;
維持質量管理系和其過程適宜性、有效性和充分性所需的改進；
b) improvementof product related to customer requirements;
與顧客要求有關的產品的改進；
c) changesneeded to respond to applicable new or revised regulatory requirements;
適應新的和修訂的法規(guī)所需的變更；（新增）
d) resourceneeds. 資源需求。
總結：管理職責變化不大，只是略微調整。其中5.5.1和5.5.2去掉了注意項；5.6.2管理評審輸入增加了幾個輸入內容；5.6.3管理評審輸出增加了一項輸出內容。