管理评审控制程序 (2).doc

1 目的Objective最高管理者按规定的时间间隔对质量体系现状进行评审，对所选定的质量体系的适宜性、有效性和充分性做出综合评价，保证满足标准的要求和实现质量方针及质量目标。The top management shall review the present status of the quality system at a specified time interval and make comprehensive assessment of its suitability, effectiveness and sufficiency, ensuring to meet the standards, quality policies and quality objectives.2 适用范围Applicable Scope适用于最高管理者对现行的QS-9000:1998/ISO9001:1994质量体系的评审。This is applicable to the review of QS-9000:1998 / ISO9001:1994 Quality System by the top management.3 职责Responsibility3.1 公司总经理负责主持管理评审会议，审批管理评审报告，并对管理评审的全过程进行监督。 The General Manager is responsible to preside over the management review meeting, examine and approve the management review reports, and supervise the whole process of management review.3.2 管理者代表负责向总经理汇报质量体系运行情况，提出改进建议，组织编写管理评审报告。负责组织对管理评审中的持续改进、纠正预防措施的实施跟踪和验证 The management representative is responsible to report the status of quality system to the General Manager, submit improvement recommendations and formulate management review reports. It shall also responsible to follow and verify the continuous improvement and corrective & preventative actions as defined in management review. 3.3 各职能部门负责提供与本部门工作有关的评审资料，负责评审报告中所涉及的与本部门相关联的决定的落实。 Each functional department is responsible to provide relevant information for review and implement the applicable decisions as in the review reports.3.4 质量部负责编制管理评审计划，收集并提供管理评审所需的资料，负责对评审的纠正预防措施和持续改进计划进行跟踪和验证，对管理评审资料整理归档。The Quality Department is responsible to formulate management review plans, collect and provide necessary information for management review, follow and verify the corrective & preventative actions and continuous improvement plans, and process and keep management review documents.4 工作程序Work Procedures4.1 管理评审的依据Basis of Management Reviewa. 管理评审的依据是受益者（所有者、顾客、分供方、员工、社会）的期望，特别是顾客期望和社会要求，还应考虑质量体系随新技术、质量概念、市场战略、社会要求和环境等的变化进行更新。The management review is based on the expectations of the beneficiaries (owners, clients, suppliers, staffs and society), especially on clients expectations and social demands. In addition, the quality system should be renewed with the change and development of new technologies, quality concepts, market strategy, social demands and environments.b. QS9000:1998/ISO9001:1994质量体系所有要素的要求。 All requirements as defined in the elements of QS9000:1998/ISO9001:1994 Quality System.4.2 评审频次的规定Review Frequencies管理评审每年进行一次，每次评审在每年的十二月，但在下列情况下可适时地进行不定期的评审：The management review will be launched in December on yearly basis. However under the following conditions, the management review shall be carried out whenever necessary:a. 质量体系建立后的运转初期。At the initial operation stage after the quality system is established.b. 市场需求、内部组织机构有重大变化或连续出现重大事故。At the occurrence of significant changes in market demands and internal organizational structures, or significant accidents continuously.c. 顾客的重大投诉。At the occurrence of serious customer complaints. d. 当最高管理者发生变更时。At the change of top management. 4.3 管理评审的组织和实施Organization and Implementation of Management Review4.3.1 管理者代表应根据本程序的要求制定具体的年度管理评审计划并布置收集必需的评审资料，管理评审计划应经最高管理者审批后在评审前一周下发给评审组成员。 The management representative shall formulate the detail annual management review plans and collect necessary information in accordance with the requirements of this procedure. The management review plan, subject to the approval of top managers, shall be released to the audit members one week before the audit starts.4.3.2 参加管理评审成员由最高管理者决定，一般由下列人员组成：公司领导层、管理者代表和各职能部门负责人。 The members in participation of the management review shall be decided by the top managers, and they usually consist of: corporate management members, management representative and department managers.4.3.3 评审组成员需收集的评审资料主要包括以下方面： The review team members shall collect necessary information, which mainly includes:a. 上一次管理评审确定的需要采取纠正措施和预防措施、改进方面以及质量体系运行状况总结等有效性材料。The corrective and preventative actions, improvements, conclusion of quality system operation status and other valid materials as determined in last management review.b. 统计分析资料和记录，可以包括： The statistical and analysis data and records, covering:* 不合格的统计资料Statistical data on nonconformance* 纠正和预防措施的统计资料Statistical data on corrective and preventative actions* 对产品质量水平的统计分析和采用纠正措施资料Statistics and analysis of product quality level and the information for corrective actions.* 对影响生产效率的基本因素的分析以及采用纠正措施情况Analysis of fundamental factors affecting the productivity and the adoption of corrective actions.* 服务过程的分析和采用纠正措施情况Analysis of service processes and the adoption of corrective actions.* 顾客投诉状况和顾客满意度的调查结果Survey results of customer complaints and satisfaction.* 持续改进情况Continuous improvement* 质量目标达成情况Realization of quality objectives * 运用统计技术分析所得的分析结果Analysis results obtained in application of statistical techniques.c. 内部和外部质量审核结果及其实施纠正措施的有效性验证材料。Internal and external quality audit results & associated effectiveness verification materials on corrective measures implementation.d. 有关采用新技术、质量目标的变化、员工方面的变化等信息（应注意收集质量体系长期存在的和系统性问题的有关信息）。The information concerning the adoption of new technologies, change of quality objectives and movement of staffs (Attention should be paid to the collection of information in respect to the long-run and systematic problems in quality system).4.3.4 管理评审一般采取会议的形式进行，由最高管理者主持评审会议。会议可按以下议程进行 （管理评审会议不一定涉及下述的所有内容，公司管理者可根据实际情况，针对质量体系中存在的重大问题或公司重大决策对质量体系提出的新要求进行专题评审）： The management review is generally carried out in the form of meeting, and shall be presided by top managers. The meeting is held according to the following agenda (The management review might not be involved in all the aspects as described below. If required by actual conditions, the corporate managers are allowed to launch an audit of a special topic concerning the significant problems in quality system, or the latest requirements of corporate significant decisions for quality system.a. 对上一次管理评审决定和改进的有效性进行评价；Assessing the effectiveness of the decisions in last management review and the related improvement.b. 对目前质量体系所有要素运行状况进行评价；Assessing the status of all the components in present quality system.c. 对会议所提供的统计资料、分析结果和记录进行评审；Reviewing the statistical reports, analysis results and records provided in the meeting.d. 对内部质量审核结果及纠正措施有效性进行评审；Reviewing the internal quality audit results and the effectiveness of corrective actions.e. 对质量目标、市场战略、社会和环境要求、法规要求等变化情况进行评审；Reviewing the changes of quality objectives, market strategy, social & environment requirements and applicable legislations.f. 对公司其它有关决策如采用新技术、开发新产品、质量开发计划及持续改进的情况进行评审；Reviewing other corporate decisions, e.g. adoption of new technologies, new products development, quality development plan and continuous improvements.g. 对质量体系持续有效性和适宜性以及所有质量目标的完成情况作出总体评价；General assessment of the continuous effectiveness and suitability of quality system, as well as the fulfillment of quality objectives.h. 对管理评审后的质量改进作出决策。Making quality improvement decisions after management review.4.4 管理评审报告Management Review Report4.4.1 管理评审的结果应形成管理评审报告。 A management review report shall be formulated based on the management review results.4.4.2 管理者代表负责组织编制管理评审报告，经最高管理者审批后下达各相关部门。 The management representative is responsible for the formulation of management review reports, which shall be released to relevant departments subject to the examination and approval of top managers.4.4.3 管理评审报告内容包括：The management review report includes:a. 评审日期和评审组成员；Date and team members of reviewb. 评审目的和依据；Objectives and basis of review.c. 评审范围和评审内容；Scope and contents of reviewd. 质量改进意见（包括纠正、纠正措施、预防措施、持续改进等）。Quality improvement suggestions (including correction, corrective measures, preventative measures, continuous improvement, etc).4.5 管理评审后的改进Improvement after Management Review4.5.1 管理者代表应根据管理评审中确定的质量体系有待改进的现状，组织有关职能部门按纠正和预防措施控制程序和持续改进控制程序制定切实可行的措施，并实施跟踪监督。 The management representative, in accordance with management review decisions on improving the quality system, shall organize relevant functional departments to work out practical measures as required in “ Corrective & Preventative Action Control Procedures” and “ Continuous Improvement Control Procedures”, while making follow-up supervision.4.5.2 管理者代表负责管理评审报告中有关决策引起的质量方针、目标及质量体系文件的更改，并按文件和资料控制程序进行更改。 The management representative is responsible for the revision of quality policies, quality objectives and quality system documentation due to the decisions in management review report