【正文】 文件要求Documentation requirements 總則General 質(zhì)量體系文件包括:Documentation of the quality management system consists of A. 質(zhì)量方針和質(zhì)量目標(biāo)。Quality Manual C. 《ISO9001: 2008質(zhì)量管理體系要求》所要求的程序文件和本公司確定的其它程序文件, 見附件4:《質(zhì)量手冊(cè)和程序清單》。Documents needed by our pany to ensure the effective planning, operation and control of its processes, and QMS Manual and Procedure ListE. 《ISO9001: 2008質(zhì)量管理體系要求》所要求的記錄()Records required by ISO9001:2008 Quality Management System (see in this Manual F. 文件的形式: 紙質(zhì)或電子文件.Media of documents: paper or electronic carrier 質(zhì)量手冊(cè)Quality Manual A. 本公司編制和保持本《質(zhì)量手冊(cè)》, 且包括:We shall establish and maintain this Quality Manual that includes a) 質(zhì)量管理體系的范圍,包括任何刪節(jié)的細(xì)節(jié)和合理性,見本手冊(cè)第1章節(jié): “范圍”。The documented procedures established for the quality management system, or reference to them, and c) 質(zhì)量管理體系過程的相互作用的表述.A description of the interaction between the processes of the quality management system B. 本《質(zhì)量手冊(cè)》由管理者代表編制、總經(jīng)理審核。Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in B. 建立《文控程序》, 以規(guī)定以下方面所需的控制:Document Control Procedure shall be established to define the controls needed a. 文件發(fā)布前得到批準(zhǔn), 以確保文件是充分與適宜的。 to review and update as necessary and reapprove documents c. 確保文件的更改和現(xiàn)行修訂狀態(tài)得到識(shí)別。 to ensure that relevant versions of applicable documents are available at points of usee. 確保文件保持清晰、易于識(shí)別。 to ensure that documents of external origin are identified and their distribution controlled, andg. 防止作廢文件的非預(yù)期使用, 若因任何原因而保留作廢文件時(shí), 對(duì)這些文件進(jìn)行適當(dāng)?shù)臉?biāo)識(shí). to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose 質(zhì)量記錄的控制Control of quality records 建立《記錄管理程序》, 以便:Record Control Procedure shall be established to A. 建立并保持質(zhì)量記錄, 以提供符合要求和質(zhì)量管理體系有效運(yùn)行的證據(jù)。ensure records can remain legible, readily identifiable and retrievable C. 規(guī)定質(zhì)量記錄的標(biāo)識(shí)、貯存、檢索、保存期限和處置所需的控制. to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records4. 管理職責(zé)Management responsibility 管理承諾Management mitment 總經(jīng)理將通過以下活動(dòng), 對(duì)建立、實(shí)施質(zhì)量管理體系并持續(xù)改進(jìn)有效性的承諾提供證據(jù):General Manager shall provide evidence of its mitment to the development and implementation of the quality management system and continually improving its effectiveness byA. 向公司全體成員傳達(dá)滿足顧客和法律法規(guī)要求的重要性。 establishing the quality policyC. 制定質(zhì)量目標(biāo), 并定期進(jìn)行統(tǒng)計(jì)和檢討。 conducting management reviews, andE. 提供適當(dāng)?shù)馁Y源。General Manager shall ensure that customer requirements are determined and met with the aim of enhancing customer satisfactionB. 建立和實(shí)施《客戶服務(wù)程序》,包括對(duì)顧客訂單進(jìn)行有效評(píng)審及顧客滿意度的調(diào)查.Customer Service Procedure shall be established and implemented, including the customer Order Review and Customer Satisfaction Survey. 質(zhì)量方針Quality policy A. 總經(jīng)理應(yīng)確保質(zhì)量方針:General Manager shall ensure that the quality policy a. 與公司的宗旨想適應(yīng)。includes a mitment to ply with requirements and continually improve the effectiveness of the quality management systemc. 提供制定和評(píng)審質(zhì)量目標(biāo)的框架。is municated and understood within the organization, and e. 在持續(xù)適宜性方面得到評(píng)審.Is reviewed for continuing suitability B. 本公司的質(zhì)量方針, 見“前言”章節(jié).About quality policy of our pany, see the Foreword to this Manual 策劃Planning 質(zhì)量目標(biāo)Quality objectives A. 總經(jīng)理應(yīng)確保在公司的相關(guān)職能和層次上建立質(zhì)量目標(biāo), 質(zhì)量目標(biāo)包括滿足產(chǎn)品要求所需的內(nèi)容。The quality objectives shall be measurable and consistent with the quality policyC. 本公司的質(zhì)量目標(biāo)見附件6: 《質(zhì)量目標(biāo)分解表》About the quality objectives of our pany, see attachment 6, Quality Objectives 質(zhì)量管理體系策劃Quality management system planning 總經(jīng)理應(yīng)確保:General Manager shall ensure that A. 對(duì)質(zhì)量管理體系進(jìn)行策劃, 。 General Manager shall ensure the responsibilities and authorities are defined and municated within our pany B. 各部門的職責(zé)與權(quán)限, 見附件2: 《組織架構(gòu)圖》。 附件5: 《部門職責(zé)一覽表》About departmental responsibilities and authorities, see attachment 2: Organizational Structure。 ensuring that processes needed for the quality management system are established, implemented and maintained B. 向總經(jīng)理報(bào)告質(zhì)量管理體系的業(yè)績和任何改進(jìn)的需求。 ensuring the promotion of awareness of customer requirements throughout our pany, and D. 與質(zhì)量管理體系有關(guān)事宜的外部聯(lián)絡(luò), 如: 認(rèn)證機(jī)構(gòu)、咨詢機(jī)構(gòu), 等. liaising with external parties on matters relating to the quality management system 內(nèi)部溝通Internal munication A. 總經(jīng)理應(yīng)該確保在組織內(nèi)建立適當(dāng)?shù)臏贤ㄟ^程, 并確保對(duì)質(zhì)量管理體系的有效性進(jìn)行溝通。review the quality management system of our pany at least yearly to ensure its continuing suitability, adequacy and effectiveness, and B. 評(píng)審應(yīng)包括評(píng)價(jià)質(zhì)量管理體系改進(jìn)的機(jī)會(huì)和變更的需要, 包括質(zhì)量方針和質(zhì)量目標(biāo)。suitability of the quality policy B. 質(zhì)量目標(biāo)的適宜性。results of both internal and external auditsD. 顧客反饋。process performance and product conformity F. 預(yù)防和糾正措施的狀況。followup actions from previous management reviews H. 經(jīng)策劃的可能影響質(zhì)量管理體系的變更。Improvement of the effectiveness of the quality management system and its processesB. 與顧客有關(guān)的產(chǎn)品的改進(jìn)。to implement and maintain the quality management system and continually improve its effectiveness, and B. 通過滿足顧客要求, 增強(qiáng)顧客滿意.to enhance customer satisfaction by meeting customer requirements 人力資源Human resources 總則General 基于適當(dāng)?shù)慕逃?、培?xùn)、技能和經(jīng)驗(yàn), 從事影響產(chǎn)品質(zhì)量工作的人員應(yīng)是能夠勝任的. Personnel performing work affecting product quality shall be petent on the basis of appropriate education, training, skills and experience 能力、意識(shí)和培訓(xùn)Competence, awareness and training 建立、實(shí)施和改進(jìn)《培訓(xùn)程序》, 以:Training Procedure shall be established, implemented and improved to A. 確定從事影響產(chǎn)品質(zhì)量工作的人員所必要的能力。 provide training or take other actions to satisfy these needs C. 評(píng)價(jià)所采取措施的有效性。ensure that the personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and E. 保持教育、培訓(xùn)、技能和經(jīng)驗(yàn)的適當(dāng)記錄. maintain appropriate records of education, training, skills and experience 基礎(chǔ)設(shè)施Infrastructure A. 公司應(yīng)確定、提供并維護(hù)為達(dá)到產(chǎn)品要求的符合性所需的基礎(chǔ)設(shè)施, 如:Our pany shall d