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希尼尔翻译 公司ISO9001质量管理体 系

  


质量管理体 系

1  目的

    确定建立、实施、保持质量管理体 系的总要求及文件管理的总要求。

2  范围

    适用于我公司质量管理体 系及文件的管理。

3  职责

3.1  总经理

1)负责领导质量管理体 系的建立、实施和保持;

2)批准质量 手册和质量方针、质量目标。

3.2  管理者代表

1)确保质量管理体 系所需的过程的建立、实施和保持;

2)向总经理报告质量管理体 系的业绩和任何改进的需求;

3)确保我公 司满足顾客要求意识的形成和提高;

4)就质量管理体 系的有关事宜对外联络。

3.3  办公室

    1)负责质量管理体 系的正常运行;

    2)负责质量管理体 系文件的管理。

4  程序概述

4.1  质量管理体 系的总要求

我公司结合 公司的实际管理要求和ISO90012008的要求建立了质量管理体 系,形成适当的文件,加以实施和保持,并对其有效性、适宜性和充分性进行评价,予以持续改进。为此我公司应满足以下要求:

    1)确定质量管理体 系所需的过程,编制相应的文件。这些过程包括管理活动、资源管理、产品和服务实现及监视、测量和改进有关的大过程,也可以是质量活动的子过程。

    2)  确定过程的 顺序及相互的接口关系,确保输入、输出和所需资源、信息,并制定控制的方法和准则,以支持过程的运行和对过程进行监视。

3)通过确定 、监控、测量分析等对过程进行管理,并利用包括统计方法在内的各种方式获得必要的信息,达到持续改进的目的。

4)目前我公 司部分销售产品的运输过程外包。按本手册7.4条款实施控 制,签署运输协议,明确控制要求。对外包过程控制的类型和程度可受外包过程对公司提供满足要求的产品的能力的潜在影响、外包过程控制的分担程度等,确保对外包过程的控制,并不免除其满足顾客和法律法规要求的责任。

4.2   质量管理体 系文件的总要求

4.2.1  我公司根据质量管理体 系要求形成体系文件,并实施和持续改进,确保体系的有效运行。

4.2.2  我公司的质量管理体 系文件结构

1)质量手册(包括质量方针和质量目标及程序文件)。质量管理体 系覆盖的范围及删减说明;形成文件的质量管理体 系程序;质量管理体 系过程之间的相互作用等。         

2)管理文件。各岗位运行质量管理体 系的常用实施细则, 如各种管理 制度、质量记录、外来文件等。                  

4.2.3  质量管理体 系文件应与我公司的实际管理情况相适应,具有可操作性,并应定期评审其有效性、适宜性、充分性。执行《文件控制程 序》。

4.2.4  质量管理体 系文件根据我公司的规模和活动的类型、过程及其相互作用的复杂程度和人员的能力确定数量和详略程度。

4.2.5  文件的承载 体为纸张,也可以是磁盘或图片等,均应对其进行有效控制。

4.2.6为提供符合要求及质量管理体 系有效运行的证据而建立的记录,应得到控制。编制《记录控制程 序》以规定记录的标识、贮存、保护、检索、保留和处置所需的控制。

记录应保持 清晰、易于识别和检索。

4.3  为确保以上 要求,特制定以下程序文件:

    4.1  文件控制程 序                            

    4.2  记录控制程 序
Quality management system
1. Purpose
    Determine the general requirements for establishing, implementing, and maintaining a quality management system and the general requirements for document management.
2. area
    Applicable to the management of our company's quality management system and documents.
3 duties
3.1 General Manager
1) Responsible for the establishment, implementation and maintenance of the leadership quality management system;
2) Approved quality manuals and quality guidelines and quality objectives.
3.2 Management representative
1) ensure the establishment, implementation and maintenance of the processes required for the quality management system;
2) Report to the general manager the performance of the quality management system and any improvement needs;
3) Ensure that our company meets the formation and improvement of customer awareness;
4) External liaison on matters related to the quality management system.
3.3 Office
    1) Responsible for the normal operation of the quality management system;
    2) Responsible for the management of quality management system documents.
4 Program Overview
4.1 General requirements for quality management systems
Our company has established a quality management system based on the company's actual management requirements and ISO9001:2008 requirements, formed appropriate documents, implemented and maintained, and evaluated its effectiveness, suitability and adequacy, and continued to improve. To this end, our company should meet the following requirements:
    1) Determine the processes required for the quality management system and prepare corresponding documents. These processes include management activities, resource management, product and service implementation and monitoring, measurement and improvement of large processes, and sub-processes of quality activities.
    2) Determine the sequence of processes and their inter-interface relationships, ensure input, output and required resources, information, and develop control methods and guidelines to support the operation of the process and monitor the process.
3) Manage the process through identification, monitoring, measurement and analysis, and use the various methods including statistical methods to obtain the necessary information to achieve continuous improvement.
4) At present, the transportation process of some of our products is outsourced. Implement control in accordance with Clause 7.4 of this manual, sign the transportation agreement, and clarify the control requirements. The type and extent of outsourcing process control can be affected by the potential impact of the outsourcing process on the company's ability to provide products that meet the requirements, the degree of sharing of outsourced process control, etc., to ensure control of the outsourcing process, and does not exempt it from meeting customer and legal requirements. Responsibility.
4.2 General requirements for quality management system documentation
4.2.1 Our company forms system documents according to the requirements of the quality management system, and implements and continuously improves to ensure the effective operation of the system.
4.2.2 My company's quality management system document structure
1) Quality Manual (including quality policy and quality objectives and procedures). The scope of the quality management system coverage and the description of the deletion; the quality management system procedures that form the document; the interaction between the quality management system processes.
2) Manage files. Common implementation rules for the quality management system of each post, such as various management systems, quality records, and foreign documents.
4.2.3 The quality management system documents should be compatible with the actual management of our company, and have operability, and should be reviewed regularly for their effectiveness, suitability and adequacy. Execute the File Control Program.
4.2.4 The quality management system documentation determines the quantity and level of detail based on the size of the company and the type of activity, the complexity of the process and its interactions, and the capabilities of the personnel.
4.2.5 The carrier of the file is paper, or it can be a disk or a picture, etc., and it should be effectively controlled.
4.2.6 Records established to provide evidence of compliance with the requirements and effective operation of the quality management system shall be controlled. The Record Control Procedure is prepared to define the controls required for the identification, storage, protection, retrieval, retention and disposal of records.
Records should be kept clear, easy to identify and retrieve.
4.3 To ensure the above requirements, the following procedure documents are specially formulated:
    4.1 File Control Program
    4.2 Record Control Program
青岛希尼尔 翻译有限公司

2019年2月14日

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