实验室认可实验室认可准备和实施概述

实验室认可实验室认可准备和实施概述发布时间: 2012-01-05 21:56 点击：

实验室认可实验室认可准备和实施概述
Laboratory accreditation laboratory accreditation preparation and implementation overview
一、最高管理者决策
One, the top management decision
从提高实验室管理水平、充分发挥固有的检测或校准技术能力，开发检测或校准市场、更好地实现总体目标的需要出发，最高管理者审时度势，决定按照《认可准则》要求，建立、实施和保持管理体系，申请CNAS认可。
From raise the laboratory management level, give full play to the inherent test or calibration technology ability, development of test or calibration market, to better achieve the overall objective needs, top management to size up the situation, decide to follow the" accreditation criteria" requirements, establish, implement and maintain a management system, apply CNAS recognition.
二、实验室认可准备
Two, prepare for Laboratory Accreditation
1、意向申请
In 1, the intention to apply
实验室可以通过到访、电话、传真和其他电子通讯方式与CNAS秘书处联系，表达申请实验室认可的意向，从CNAS秘书处获得现行有效版本的与实验室认可有关的公开文件。
Laboratory can visit, telephone, fax and other means of electronic communication with the CNAS Secretariat for laboratory accreditation, expression of intention, from the CNAS Secretariat to obtain the current valid version of the public documents relating to laboratory accreditation.
2、正式申请前的准备
In 2, a formal application for preparation
1）组织落实
1) organize and implement
实验室派出去、请进来，宣贯《认可准则》，培训管理和技术骨干和内审员，提高对实验室认可意义、作用的认识。
Laboratory sent, please come in," Publicizing" accreditation guidelines, training management and technical backbone and internal auditors, to improve the understanding of the role of significance, laboratory accreditation.
最高管理者成立实验室认可准备领导小组，自任组长。
Top management establishment of laboratory accreditation for leadership of the group, since the group leader.
最高管理者组建管理体系文件编制组、技术能力准备组，并授权。
Top management to set up the management system documentation group, technical ability to group, and authorization.
2）实验室认可准备领导小组的职责
2) laboratory accreditation for leadership group
（1）最高管理者
( 1) top management
*   决定组织结构，设置职能部门、岗位；
* decision organization structure, functions, post setting;
*     组织策划管理体系组成和管理体系文件架构；
* organize management system and management system document structure;
*     制订总体目标、质量方针和质量目标。
* develop overall objective, the quality policy and quality objectives.
（2）管理体系文件编制组
( 2) management system document compilation group
*     与CNAS秘书处联系，获取有关申请实验室认可的公开文件和信息；
* and CNAS Secretariat, obtain the relevant application laboratory accreditation of public documents and information;
*    进一步学习、理解《认可准则》，调查实验室的现状，清理现有规章制度和文件，整理出行之有效的办法、制度和规定
* further learning, understanding" accreditation criteria", a survey of laboratory situation, clean-up of existing regulations and documents, sort out the effective measures, rules and regulations
* 按照《认可准则》要求，结合实验室的实际情况和行之有效的办法、制度和规定，策划管理体系组成要求和管理体系文件架构；
* according to the" accreditation criteria" requirements, combined with the actual situation of laboratory and effective way, rules and regulations, planning management system requirements and management system document structure;
*    根据实验室实际情况，选择适用的《认可准则》在相应特殊领域的“应用说明”，以及适用的其他认可准则、认可规则；
* according to actual situation, to choose the applicable" accreditation criteria in the field of" special" application", as well as the application of other rules for the accreditation, accreditation criteria;
*     编制《质量手册》与《认可准则》要求、条款对照表草案，制订总体目标、质量方针和质量目标，草案，所需程序文件目录草案，最高管理者批准；
* the preparation of" quality manual" and" accreditation criteria" requirements, in terms of table the draft, formulate the overall goal, the quality policy and quality objectives, desired draft, draft program files directory, top management for approval;
*     编制《质量手册》，包括制订总体目标、质量方针和质量目标；
* the preparation of" quality manual", including the formulation of overall objective, the quality policy and quality objectives;
*       《质量手册》是规定管理体系管理要求的纲领性文件；
*" quality manual" is regulated management system management requirements of the creed sex file;
*       《质量手册》应规定管理体系的组成要求，明确剪裁的不适用的《认可准则》的要求和条款及其理由或原因；
*" quality manual" should stipulate the management system requirements, clear cut not applicable" accreditation criteria" requirements and the provision and its the reason or cause;
*       《质量手册》既要满足并符合《认可准则》和相应特殊领域的“应用说明”，又要符合本实验室的实际情况；
*" quality manual" to meet and comply with the" accreditation criteria" and the corresponding special field" application", but also accord with the actual situation of the laboratory;
*     编制程序文件（应回答5W1H，具有可操作性）；
* the preparation of program files ( to answer 5W1H, have maneuverability );
*     反复修改、完善《质量手册》、程序文件；
* modify, perfect" quality manual, procedure documents";
*     最高管理者批准发布；
* top management approval;
*     组织管理体系运行。
* organization management system.
3）技术能力准备组
3) the ability to prepare group technology
*     进一步学习、理解《认可准则》，调查实验室的现状，整理现有检测项目及其检测方法、校准的仪器类型及其校准方法、指导书、技术记录表格；
* further learning, understanding" accreditation criteria", laboratory investigation status, finishing the existing detection program and detection method, the calibration of the instrument type and its calibration method, instruction, technical record form;
* 编制检测技术能力清单，包括（但不限于）检测项目，检测方法，检测方法要求配备设备的技术要求或技术指标，现有设备的技术指标，溯源有效期内设备的技术指标，检测方法、设备、被检测物品处置要求的环境条件，现有的环境条件，检测方法要求的实施细则或附加细则，设备要求的指导书，检测原始记录表格，《检测报告》格式等；
* the preparation of detection capability list, including ( but not limited to ) detection, detection method, detection method for equipment technical requirements and technical indicators, the existing equipment of the technical indicators, traceability within the validity period of equipment of the technical indicators, detection method, equipment, testing items being disposed requirements environmental conditions, the existing environmental conditions method for detecting requirements, implementation details or additional details, equipment requirements of the guide book, the original test record form"," test report format;
*     或编制校准技术能力清单，包括（但不限于）校准仪器类型，校准方法或校准规范，校准方法要求配备测量标准的技术要求或技术指标，现有测量标准的技术指标，溯源有效期内测量标准的技术指标，校准方法、测量标准、被校准仪器处置要求的环境条件，现有的环境条件，校准方法要求的实施细则或附加细则，测量设备要求的指导书、校准原始记录表格，《校准证书》格式等；
* or preparation of calibration technology capabilities list, including ( but not limited to ) the calibration instrument type, method of calibration or calibration standard, calibration method for measuring requirements with the technical requirements of the standard or technical indicators, the existing measurement standards, technical indicators, within the period of validity of measurement traceability standard technical indicators, calibration method, measurement standards, calibration apparatus disposed of requirements of environmental conditions, the existing environmental conditions, the calibration method for implementing rules or additional rules, requirements of measuring equipment guide book, original record form" calibration, calibration certificate" format;
*     组织制订上述技术文件；
* organize the technical file;
*     查询CNAS网站，了解CNAS承认的能力验证、测量审核和实验室间比对提供者和CNAS能力验证计划，制订参加能力验证计划的方案，技术管理者批准后组织实施。
* query CNAS site, understand CNAS recognition capability validation, measurement audit and interlaboratory comparison providers and CNAS proficiency testing program, formulate in ability testing plan, technical management for approval and implementation.
*     参与技术要求所需程序文件的编制和修改。
* participate in technical requirements desired procedure document preparation and modification.
4）管理体系运行
4) management system
内部审核时机：管理体系文件批准发布实施不少于4～6个月。
Internal audit time: management system documents approval issued not less than 4 to 6 months.
制定内部审核不符合项整改计划、实施整改，编写整改报告并提供见证材料证实不符合项关闭。
Internal audit nonconformities rectification plan, the implementation of rectification rectification report, prepared and provided testimony material that can be closed.
管理评审时机：完成内部审核不符合项整改活动并跟踪验证整改有效后（约内部审核后1个月）。
Management review timing: complete internal audit nonconformities rectification activity and track verification effective rectification ( after about 1 months after the internal audit ).
填写《实验室认可申请书》，准备《实验室认可申请书》要求的附表和申请材料。
Fill in" application for Laboratory Accreditation", for" application for Laboratory Accreditation" requirements of the schedule and the application materials.
5）正式申请
5) the formal application
通过邮件或到CNAS秘书处提交《实验室认可申请书》及相应的申请材料。
Through the mail or to the CNAS Secretariat" application for Laboratory Accreditation" and the corresponding application materials.
三、现场评审准备
Three, on-site review preparation
1、CNAS现场评审准备
In 1, CNAS site assessment for
CNAS实验室处组织申请材料初审，需要时反馈给实验室修改至基本符合申请认可要求后立项，向实验室发出正式受理申请通知。
CNAS laboratory at the organization of the application materials review, need feedback to modify to basic requirements for laboratory accreditation requirements after project approving, formally accepting the application notice issued to the laboratory.
CNAS实验室处项目负责人指定评审组长，征求实验室意见并获得书面确认。
CNAS labs project responsible person appointed assessment team leader, and obtained the written confirmation opinions for laboratory.
CNAS实验室处项目负责人组建评审组，就评审员征求实验室意见并获得书面确认。
CNAS laboratory department person in charge of the project to establish evaluation group, as reviewers for laboratory observations and obtain a written confirmation.
评审组长审查申请认可材料，提出文审修改意见、建议和现场评审安排建议，反馈给项目负责人。
Assessment team leader to review the application of approved material, puts forward the proposals and amendments, the proposed arrangement for on-site assessment, feedback to the project manager.
项目负责人编制现场评审通知，实验室处领导批准。
The man responsible for the project plan site notice, laboratory department leads approval.
实验室处发出评审通知。
Laboratory Department issued a notice.
2、实验室现场评审准备
In 2, the laboratory on-site review preparation
按照CNAS初审和文审意见和建议修改管理体系文件。
According to the CNAS trial and the trial of comments and suggestions to modify the management system documentation.
整理管理体系运行以来的记录，分类归档。
Order management system since the recording, classifying and filing.
质量主管与CNAS项目负责人和评审组长、技术评审员联系现场评审事项。
Quality supervisor and CNAS project and assessment team leader, technical assessors linked site assessment item.
准备现场试验所需检测或校准物品。
To prepare the site required to test the test or calibration items.
四、现场评审
Four, on-site review
配合评审组实施现场评审，指定联系人，提供评审组所需资料、材料，配备所需资源（如打印机或文字输入人员）。
With the review group on-site review, the designated contact, provide review group required information, materials, equipped with required resources ( such as a printer or text input personnel ).
完成评审组下达的现场试验项目，及时提交《检测报告》或《校准证书》。
Complete the review group issued a field test project, the timely submission of" test report" or" calibration certificate".
最高管理者、技术管理者、质量主管、授权签字人接受评审组评审。
Top management, technology management, quality manager, authorized signatories accept assessment panel.