5 Management responsibility
5 管理職責
5.5 Responsibility, authority and communication 職責，權(quán)限和溝通
5.5.1 Responsibility and authority 職責和權(quán)限
Top managementshall ensure that responsibilities and authorities are defined, documented and communicatedwithin the organization.
最高管理者應(yīng)當保證組織內(nèi)的職責和權(quán)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(yīng)當文件化所有從事影響質(zhì)量的管理、執(zhí)行和驗證工作的人員的相互關(guān)系。最高管理者還應(yīng)當保證其完成這些任務(wù)所必須的獨立性和權(quán)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(yīng)當制定一名管理者，不管他是否有其他責任，他都應(yīng)具有以下的職權(quán)：
a) ensuring thatprocesses needed for the quality management system are documented;
保證質(zhì)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(zhì)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(nèi)部的質(zhì)量管理體系需求和適應(yīng)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(nèi)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(yīng)保證在組織內(nèi)部建立適宜的溝通程序，并保證對質(zhì)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(yīng)建立管理評審的程序。最高管理者應(yīng)當在規(guī)定策劃時間間隔內(nèi)審核該組織的質(zhì)量管理體系，從而保證質(zhì)量管理體系持續(xù)的適宜性、充分性和有效性。評審應(yīng)包括評估質(zhì)量管理體系改進的機會和變更的需要，包括質(zhì)量方針和質(zhì)量目標。應(yīng)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(yīng)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(chǎn)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(zhì)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(yīng)當被記錄（見4.2.5），并且應(yīng)當包括經(jīng)審核輸出和任何與下述有關(guān)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(zhì)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(guān)的產(chǎn)品的改進；
c) changesneeded to respond to applicable new or revised regulatory requirements;
適應(yīng)新的和修訂的法規(guī)所需的變更；（新增）
d) resourceneeds. 資源需求。
總結(jié)：管理職責變化不大，只是略微調(diào)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(nèi)容；5.6.3管理評審輸出增加了一項輸出內(nèi)容。