M05.03 Documentation requirements QMS
The quality management system documentation shall include質(zhì)量管理體系文件應包括
a) Documented statements of a quality policy and quality objectives, a)形成文件的質(zhì)量方針和質(zhì)量目標
b) A quality manual,質(zhì)量手冊
c) Documented procedures required by this International Standard,形成的程序文件要符合國際標準
d) Documents needed by the organization to ensure the effective planning, operation and control of its processes, d)本組織為確保有效的規(guī)劃、運作和控制其過程所需的文件
e) Records required by the International Standard (see 4.2.4), and e)國際標準所要求的記錄 (見4.2.4)，和
f) Any other documentation specified by national or regional regulations. f)任何其他國家或區(qū)域的規(guī)例所指定的文檔。
M05.12 QMS is adequate
The Quality Management System that the organization has implemented must support the strategy. Suppliers in the industry of medical devices are expected to have ISO 13485 or equivalent. 組織實施質(zhì)量管理體系必須支持的戰(zhàn)略。在醫(yī)療器械行業(yè)供應商預計將有ISO13485或等效。
M05.13 Solving findings previous audits
Auditors will ask for objective evidence to show that findings from previous audits are solved timely and effectively. 審計將要求提供客觀證據(jù)顯示及時有效地解決以往審核的結(jié)果。
M06.01 Management Commitment
Top management shall provide evidence of its commitment to the development and implementation of the quality management system and maintaining its effectiveness by最高管理應致力于發(fā)展與實施提供證據(jù)的質(zhì)量管理體系和保持其效力
a) Communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements, a)向組織傳達滿足客戶以及法律、法規(guī)要求的重要性
b) Establishing the quality policy,建立質(zhì)量方針
c) Ensuring that quality objectives are established, c)確保質(zhì)量目標的制定
d) Conducting management reviews, and d)進行管理審查，和
e) Ensuring the availability of resources. 確保資源的可用性。
NOTE For the purposes of this International Standard, statutory requirements are limited to the safety and performance of the medical device only注意為此國際標準、法定要求的目的僅限于安全和性能的唯一的醫(yī)療器械。
M06.03 Quality policy
Top management shall ensure that the quality policy最高管理層應確保質(zhì)量方針
a) Is appropriate to the purpose of the organization a)適合于組織的宗旨
b) Includes a commitment to comply with requirements and to maintain the effectiveness of the quality management system b)包括致力于符合要求，維護的有效性質(zhì)量管理體系，
c) Provides a framework for establishing and reviewing quality objectives, c)為建立和評審質(zhì)量目標提供了框架
d) Is communicated and understood within the organization, and d)得到溝通和理解本組織內(nèi)和
e) Is reviewed for continuing suitability. e)審查其持續(xù)適用性。
M06.04 Planning: Quality Objectives.
Realizing a strategy requires that objectives have been set for quality. These objectives are made measurable via performance indicators. A well deployed strategy will show positive trends and meeting targets for a time frame of 3 years. 實現(xiàn)戰(zhàn)略需要定為質(zhì)量目標。這些目標是可衡量的業(yè)績指標通過。好已部署的戰(zhàn)略將顯示積極的趨勢和3年時間內(nèi)的達到目標。
M06.07 Responsibility and authority
The organizational charts of a company should show how many people are working in the various functional areas (development, quality, etc). The interrelation of the functions must be clear. Authorities and responsibilities should support the deployment of the strategy. 公司的組織結(jié)構(gòu)圖應顯示究竟有多少人正在在各個功能領(lǐng)域 (開發(fā)、質(zhì)量等)。必須明確職能之間的相互關(guān)系。當局和責任應該支持戰(zhàn)略的部署。
Top management shall establish the interrelation of all personnel who manage, perform and verify work affecting quality and shall ensure the independence and authority necessary to perform these tasks最高管理層應建立管理、執(zhí)行和驗證工作影響質(zhì)量和應保證的獨立性和權(quán)威性執(zhí)行這些任務所需的所有人員的相互的關(guān)系。
NOTE National or regional regulations might require the nomination of specific persons as responsible for activities related to monitoring experience from the post-production stage and reporting adverse events注意國家或地區(qū)法規(guī)可能要求特定的人，作為負責監(jiān)測經(jīng)驗從后期制作階段和報告不良事件相關(guān)的活動提名。