ISO/IEC 17025:2017《检测和校准实验室能力的通用要求》的管理体系要求-深圳市九域企业管理顾问有限公司
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ISO/IEC 17025:2017《检测和校准实验室能力的通用要求》的管理体系要求

Date2023-03-16 10:37:51  Views2946次

中国合格评定国家认可委员会(英文缩写:CNAS)等同采用ISO/IEC 17025:2017《检测和校准实验室能力的通用要求》 作为对检测和校准实验室能力进行认可的基本认可准则。为支持特定领域的认可活动, CNAS还根据不同领域的专业特点,制定一系列的特定领域应用说明,对本准则的要求进行必要的补充说明和解释,但并不增加或减少本准则的要求。本准则内容及条款号与国际标准 ISO/IEC 17025:2017内容及条款号完全一致。CNAS鼓励申请认可的机构购买和使用正版国际和国家标准。

8 管理体系要求Management system requirements

8.1 方式Options
8.1.1 总则General
实验室应建立、实施和保持形成文件的管理体系,该管理体系应能够支持和证明实验室持续满足本标准的要求,并且保证实验室结果的质量。除满足第4章至第7章的要求外,实验室应按方式A或方式B实施管理体系。
The laboratory shall establish, document, implement and maintain a management system that is capable of supporting and demonstrating the consistent achievement of the requirements of this document and assuring the quality of the laboratory results. In addition to meeting the requirements of Clauses 4 to 7, the laboratory shall implement a management system in accordance with Option A or Option B.
注:更多信息参见附录B。
NOTE  See Annex B for more information.
G001应用说明:如果实验室是某个机构的一部分,该机构的管理体系已覆盖了实验室的活动,实验室应将该组织管理体系中有关实验室的规定予以提炼和汇总,形成针对实验室活动的文件,并明确相关的支持性文件;如果针对实验室建立单独的管理体系,管理体系还应覆盖为支撑体系运作的所有相关部门,管理体系中有关实验室和相关支持部门工作职责的文件应由对实验室和相关部门承担管理职责的该组织的负责人批准。
8.1.2 方式Option A
实验室管理体系至少应包括下列内容:
As a minimum, the management system of the laboratory shall address the following:
——管理体系文件(见8.2);
— management system documentation (see 8.2);
——管理体系文件的控制(见8.3);
— control of management system documents (see 8.3);
——记录控制(见8.4);
— control of records (see 8.4);
——应对风险和机遇的措施(见8.5);
— actions to address risks and opportunities (see 8.5);
——改进(见8.6);
— improvement (see 8.6);
——纠正措施(见8.7);
— corrective action (see 8.7);
——内部审核(见8.8);
— internal audits (see 8.8);
——管理评审(见8.9)。
— management reviews (see 8.9).
8.1.3 方式Option B
实验室按照GB/T 19001的要求建立并保持管理体系,能够支持和证明持续符合第4章至第7章的要求,也至少满足了8.2至8.9中规定的管理体系要求的目的。
A laboratory that has established and maintains a management system, in accordance with the requirements of ISO 9001, and that is capable of supporting and demonstrating the consistent fulfilment of the requirements of Clauses 4 to 7, also fulfils at least the intent of the management system requirements specified in 8.2 to 8.9.
G001应用说明:如果实验室采用方式B建立和运行管理体系,实验室也应提供证据证明实验室活动的管理和运作满足标准中第8.2条款至第8.9条款中规定的管理体系要求。
8.2 管理体系文件Management system documentation(方式Option A)
8.2.1 实验室管理层应建立、编制和保持符合本标准目的的方针和目标,并确保该方针和目标在实验室组织的各级人员得到理解和执行。
Laboratory management shall establish, document, and maintain policies and objectives for the fulfilment of the purposes of this document and shall ensure that the policies and objectives are acknowledged and implemented at all levels of the laboratory organization.
注:实验室的目标应具体、可量化、可考核,并与其方针保持一致。
GL030认可指南:实验室在制定质量方针和目标时,应考虑所在母体组织的业务内容、质量方针和目标,应有利于控制和提高检测结果准确性,保障所在组织的产品质量。
8.2.2 方针和目标应能体现实验室的能力、公正性和一致运作。
The policies and objectives shall address the competence, impartiality and consistent operation of the laboratory.
8.2.3 实验室管理层应提供建立和实施管理体系以及持续改进其有效性承诺的证据。
Laboratory management shall provide evidence of commitment to the development and implementation of the management system and to continually improving its effectiveness.
8.2.4 管理体系应包含、引用或链接与满足本标准的要求相关的所有文件、过程、系统和记录等。
All documentation, processes, systems, records, related to the fulfilment of the requirements of this document shall be included in, referenced from, or linked to the management system.
注:管理体系文件可包括质量手册、程序文件、作业指导书(含记录格式、表格)、记录。
GL030认可指南:实验室的管理体系应覆盖母体组织中的协助部门。注:如实验室服务与供应品的采购、新进人员的招聘与培训及废弃物处理等工作,可能由母体中的相关部门协助完成。
8.2.5 参与实验室活动的所有人员应可获得适用其职责的管理体系文件和相关信息。
All personnel involved in laboratory activities shall have access to the parts of the management system documentation and related information that are applicable to their responsibilities.
8.3 管理体系文件的控制Control of management system documents(方式Option A)
8.3.1 实验室应控制与满足本标准的要求有关的内部和外部文件。
The laboratory shall control the documents (internal and external) that relate to the fulfilment of this document.
注:本标准中,“文件”可以是政策声明、程序、规范、制造商的说明书、校准表格、图表、教科书、张贴品、通知、备忘录、图纸、计划等。这些文件可承载于各种载体,例如硬拷贝或数字形式。
NOTE  In this context, “document” can be policy statements, procedures, specifications, manufacturer’s instructions, calibration tables, charts, text books, posters, notices, memoranda, drawings, plans, etc. These can be on various media, such as hard copy or digital.
GL030认可指南:
实验室质量管理体系文件在引用母体组织的相关文件时,应进行有效衔接和控制。注:实验室的母体组织在运行ISO 9001、ISO 14001等管理体系时,如果已经包含了实验室的相关工作规范,实验室在建立自身管理体系时可将母体组织的相关规范名称或章节直接引用至实验室管理规范中。
实验室接收到外来文件时,需对其适用性、有效性和分发范围等进行识别,并根据识别结果确定是否纳入质量管理体系,进行有效控制。
8.3.2 实验室应确保:
The laboratory shall ensure that:
a)文件发布前由授权人员审查其充分性并批准;
a) documents are approved for adequacy prior to issue by authorized personnel;
b)定期审查文件,并在必要时更新;
b) documents are periodically reviewed, and updated as necessary;
c)识别文件更改和当前修订状态;
c) changes and the current revision status of documents are identified;
d)在使用地点应可获得适用文件的相关版本,并在必要时控制其发放;
d) relevant versions of applicable documents are available at points of use and, where necessary, their distribution is controlled;
e)对文件进行唯一性标识;
e) documents are uniquely identified;
f)防止误用作废文件,并对出于某种目的而保留的作废文件做出适当标识。
f) the unintended use of obsolete documents is prevented, and suitable identification is applied to them if they are retained for any purpose.
g)对需要保密的文件应按有关保密规定确定适当密级,并进行管理。
8.4 记录控制Control of records(方式Option A)
8.4.1 实验室应建立和保存清晰的记录以证明满足本标准的要求。
The laboratory shall establish and retain legible records to demonstrate fulfilment of the requirements in this document.
GL030认可指南:质量记录包括内部审核报告和管理评审报告以及纠正措施和预防措施的记录等。技术记录包括检验相关工作记录,包括检验原始记录、环境监测记录、仪器设备使用及维护记录、原始图谱等。
8.4.2 实验室应对记录的标识、存储、保护、备份、归档、检索、保存期和处置实施所需的控制。实验室记录保存期限应符合合同义务。记录的调阅应符合保密承诺,且记录应易于获得。
The laboratory shall implement the controls needed for the identification, storage, protection, back-up, archive, retrieval, retention time, and disposal of its records. The laboratory shall retain records for a period consistent with its contractual obligations. Access to these records shall be consistent with the confidentiality commitments and records shall be readily available.
注:对技术记录的其他要求见7.5。
NOTE  Additional requirements regarding technical records are given in 7.5.
G001应用说明:除特殊情况外,所有技术记录,包括检测或校准的原始记录,应至少保存6年。如果法律法规、CNAS专业领域认可要求文件或客户规定了更长的保存期要求,则实验室应满足这些要求。人员或设备记录应随同人员工作期间或设备使用时限全程保留,在人员调离或设备停止使用后,人员或设备技术记录应再保存6年。技术记录,无论是电子记录还是纸面记录,应包括从样品的接收到出具检测报告或校准证书过程中观察到的信息和原始数据,并全程确保样品与报告/证书的对应性。注:除非相关法规另有规定外,当实验室承担的检测或校准结果用于产品认证、行政许可等用途时,相关技术记录和报告副本的保存期应当考虑相关产品认证、行政许可证书规定的有效期。
8.5 应对风险和机遇的措施Actions to address risks and opportunities(方式Option A)
8.5.1 实验室应考虑与实验室活动相关的风险和机遇,以:
The laboratory shall consider the risks and opportunities associated with the laboratory activities in order to:
a)确保管理体系能够实现其预期结果;
a) give assurance that the management system achieves its intended results;
b)增强实现实验室目的和目标的机遇;
b) enhance opportunities to achieve the purpose and objectives of the laboratory;
c)预防或减少实验室活动中的不利影响和可能的失败;
c) prevent, or reduce, undesired impacts and potential failures in the laboratory activities;
d)实现改进。
d) achieve improvement.
8.5.2 实验室应策划:
The laboratory shall plan:
a)应对这些风险和机遇的措施;
a) actions to address these risks and opportunities;
b)如何:
b) how to:
——在管理体系中整合并实施这些措施;
— integrate and implement these actions into its management system;
——评价这些措施的有效性。
— evaluate the effectiveness of these actions.
注:虽然本标准规定实验室应策划应对风险的措施,但并未要求运用正式的风险管理方法或形成文件的风险管理过程。实验室可决定是否采用超出本标准要求的更广泛的风险管理方法,如:通过应用其他指南或标准。
NOTE  Although this document specifies that the laboratory plans actions to address risks, there is no requirement for formal methods for risk management or a documented risk management process. Laboratories can decide whether or not to develop a more extensive risk management methodology than is required by this document, e.g. through the application of other guidance or standards.
8.5.3 应对风险和机遇的措施应与其对实验室结果有效性的潜在影响相适应。
Actions taken to address risks and opportunities shall be proportional to the potential impact on the validity of laboratory results.
注1:应对风险的方式包括识别和规避威胁,为寻求机遇承担风险,消除风险源,改变风险的可能性或后果,分担风险,或通过信息充分的决策而保留风险。
NOTE 1  Options to address risks can include identifying and avoiding threats, taking risk in order to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed decision.
注2:机遇可能促使实验室扩展活动范围,赢得新客户,使用新技术和其他方式应对客户需求。
NOTE 2  Opportunities can lead to expanding the scope of the laboratory activities, addressing new customers, using new technology and other possibilities to address customer needs.
GL030认可指南:实验室应根据检测结果的趋势为生产环节进行风险提示。
8.6 改进Improvement(方式Option A)
8.6.1 实验室应识别和选择改进机遇,并采取必要措施。
The laboratory shall identify and select opportunities for improvement and implement any necessary actions.
注:实验室可通过评审操作程序、实施方针、总体目标、审核结果、纠正措施、管理评审、人员建议、风险评估、数据分析和能力验证结果识别改进机遇。
NOTE  Opportunities for improvement can be identified through the review of the operational procedures, the use of the policies, overall objectives, audit results, corrective actions, management review, suggestions from personnel, risk assessment, analysis of data, and proficiency testing results.
8.6.2 实验室应向客户征求反馈,无论是正面的还是负面的。应分析和利用这些反馈,以改进管理体系、实验室活动和客户服务。实验室应有为军工产品提供现场服务的承诺和规定。
The laboratory shall seek feedback, both positive and negative, from its customers. The feedback shall be analysed and used to improve the management system, laboratory activities and customer service.
注:反馈的类型示例包括:客户满意度调查、与客户的沟通记录和共同评价报告。
NOTE  Examples of the types of feedback include customer satisfaction surveys, communication records and review of reports with customers.
GL030认可指南:实验室可结合母体组织的工作模式,通过沟通会、邮件、电话、短信息、意见本等多种形式征求客户反馈意见并及时处理。
8.7 纠正措施Corrective actions(方式Option A)
8.7.1 当发生不符合时,实验室应:
When a nonconformity occurs, the laboratory shall:
a)对不符合作出应对,并且在适用时:
a) react to the nonconformity and, as applicable:
——采取措施以控制和纠正不符合;
— take action to control and correct it;
——处置后果;
— address the consequences;
b)通过下列活动评价是否需要采取措施,以消除产生不符合的原因,避免其再次发生或者在其他场合发生:
b) evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere, by:
——评审和分析不符合;
— reviewing and analysing the nonconformity;
——确定不符合的原因;
— determining the causes of the nonconformity;
——确定是否存在或可能发生类似的不符合;
— determining if similar nonconformities exist, or could potentially occur;
c)实施所需的措施;
c) implement any action needed;
d)评审所采取的纠正措施的有效性;
d) review the effectiveness of any corrective action taken;
e)必要时,更新在策划期间确定的风险和机遇;
e) update risks and opportunities determined during planning, if necessary;
f)必要时,变更管理体系。
f) make changes to the management system, if necessary.
G001应用说明:对于发现的不符合,实验室不应仅仅纠正发生的问题,还应进行全面、细致的分析,确定不符合是否为独立事件,是否还会再次发生,查找产生问题的根本原因,按本条款要求启动纠正措施。注:对于不符合,仅进行纠正、无需采取纠正措施的情况很少发生。比如在认可评审中,经常发现实验室未按CNAS规定的要求参加能力验证,仅是提供事后参加能力验证的证据,这种措施是不充分的,实验室应当全面分析未参加能力验证的根本原因,如资金不足、能力验证计划不全面、缺乏对计划实施情况的有效监督等,从而采取有效的纠正措施。
8.7.2 纠正措施应与不符合产生的影响相适应。
Corrective actions shall be appropriate to the effects of the nonconformities encountered.
8.7.3 实验室应保存记录,作为下列事项的证据:
The laboratory shall retain records as evidence of:
a)不符合的性质、产生原因和后续所采取的措施;
a) the nature of the nonconformities, cause(s) and any subsequent actions taken;
b)纠正措施的结果。
b) the results of any corrective action.
8.8 内部审核Internal audits(方式Option A)
8.8.1 实验室应按照策划的时间间隔进行内部审核,以提供有关管理体系的下列信息:
The laboratory shall conduct internal audits at planned intervals to provide information on whether the management system:
a)是否符合:
a) conforms to:
——实验室自身的管理体系要求,包括实验室活动;
— the laboratory’s own requirements for its management system, including the laboratory activities;
——本标准的要求;
— the requirements of this document;
b)是否得到有效的实施和保持。
b) is effectively implemented and maintained.
8.8.2 实验室应:
The laboratory shall:
a)考虑实验室活动的重要性、影响实验室的变化和以前审核的结果,策划、制定、实施和保持审核方案,审核方案包括频次、方法、职责、策划要求和报告;
a) plan, establish, implement and maintain an audit programme including the frequency, methods, responsibilities, planning requirements and reporting, which shall take into consideration the importance of the laboratory activities concerned, changes affecting the laboratory, and the results of previous audits;
b)规定每次审核的审核准则和范围;
b) define the audit criteria and scope for each audit;
G001应用说明:实验室内部审核依据应包括CNAS发布的CNAS-CL01在相关领域的应用说明。注:建议内部审核每12个月进行一次。内部审核的周期和覆盖范围应当基于风险分析。CNAS-GL011《实验室和检验机构内部审核指南》为内部审核的实施提供了指南。
c)确保将审核结果报告给相关管理层;
c) ensure that the results of the audits are reported to relevant management;
d)及时采取适当的纠正和纠正措施;
d) implement appropriate correction and corrective actions without undue delay;
e)保存记录,作为实施审核方案和审核结果的证据。
e) retain records as evidence of the implementation of the audit programme and the audit results.
注:内部审核相关指南参见GB/T 19011。
NOTE ISO 19011 provides guidance for internal audits.
8.9 管理评审Management reviews(方式Option A)
8.9.1 实验室管理层应按照策划的时间间隔对实验室的管理体系进行评审,以确保其持续的适宜性、充分性和有效性,包括执行本标准的相关方针和目标。
The laboratory management shall review its management system at planned intervals, in order to ensure its continuing suitability, adequacy and effectiveness, including the stated policies and objectives related to the fulfilment of this document.
G001应用说明:对规模较大的实验室,管理评审可以分级、分部门、分次进行。实验室应根据具体情况进行前期策划,确保管理评审输入和输出的完整性。注1:建议管理评审每12个月进行一次。CNAS-GL012《实验室和检验机构管理评审指南》为管理评审的实施提供了指南。注2:对于集团式管理的实验室,通常每个地点均为单独的法人机构,对从属于同一法人的实验室应按本条款实施完整的管理评审。
8.9.2 实验室应记录管理评审的输入,并包括以下相关信息:
The inputs to management review shall be recorded and shall include information related to the following:
a)与实验室相关的内外部因素的变化;
a) changes in internal and external issues that are relevant to the laboratory;
b)目标实现;
b) fulfilment of objectives;
c)政策和程序的适宜性;
c) suitability of policies and procedures;
d)以往管理评审所采取措施的情况;
d) status of actions from previous management reviews;
e)近期内部审核的结果;
e) outcome of recent internal audits;
f)纠正措施;
f) corrective actions;
g)由外部机构进行的评审;
g) assessments by external bodies;
h)工作量和工作类型的变化或实验室活动范围的变化;
h) changes in the volume and type of the work or in the range of laboratory activities;
i)客户和人员的反馈;
i) customer and personnel feedback;
j)投诉;
j) complaints;
k)实施改进的有效性;
k) effectiveness of any implemented improvements;
l)资源的充分性;
l) adequacy of resources;
m)风险识别的结果;
m) results of risk identification;
n)保证结果有效性的输出;
n) outcomes of the assurance of the validity of results; and
o)其他相关因素,如监控活动和培训。
o) other relevant factors, such as monitoring activities and training.
8.9.3 管理评审的输出至少应记录与下列事项相关的决定和措施:
The outputs from the management review shall record all decisions and actions related to at least:
a)管理体系及其过程的有效性;
a) the effectiveness of the management system and its processes;
b)与满足本标准要求相关的实验室活动的改进;
b) improvement of the laboratory activities related to the fulfilment of the requirements of this document;
c)提供所需的资源;
c) provision of required resources;
d) 所需的变更。
d) any need for change.
附录Annex A:计量溯源性Metrological traceability
(资料性附录informative)
计量溯源性Metrological traceability
A.1 总则General
计量溯源性是确保测量结果在国内和国际上具有可比性的重要概念,本附录给出了有关计量溯源性的更详细的信息。
This annex provides additional information on metrological traceability, which is an important concept to ensure comparability of measurement results both nationally and internationally.
A.2 建立计量溯源性Establishing metrological traceability
A.2.1 建立计量溯源性需考虑并确保以下内容:
Metrological traceability is established by considering, and then ensuring, the following:
a)规定被测量(被测量的量);
a) the specification of the measurand (quantity to be measured);
b)一个形成文件的不间断的校准链,可以溯源到声明的适当参考对象(适当参考对象包括国家标准或国际标准以及自然基准);
b) a documented unbroken chain of calibrations going back to stated and appropriate references (appropriate references include national or international standards, and intrinsic standards);
c)按照约定的方法评定溯源链中每次校准的测量不确定度;
c) that measurement uncertainty for each step in the traceability chain is evaluated according to agreed methods;
d)溯源链中每次校准均按照适当的方法进行,并有测量结果及相关的、已记录的测量不确定度;
d) that each step of the chain is performed in accordance with appropriate methods, with the measurement results and with associated, recorded measurement uncertainties;
e)在溯源链中实施一次或多次校准的实验室应提供其技术能力的证据。
e) that the laboratories performing one or more steps in the chain supply evidence for their technical competence.
A.2.2 当使用被校准的设备将计量溯源性传递至实验室的测量结果时,需考虑该设备的系统测量误差(有时称为偏倚)。有几种方法来考虑测量计量溯源性传递中的系统测量误差。
The systematic measurement error (sometimes called “bias”) of the calibrated equipment is taken into account to disseminate metrological traceability to measurement results in the laboratory. There are several mechanisms available to take into account the systematic measurement errors in the dissemination of measurement metrological traceability.
A.2.3 具备能力的实验室报告测量标准的信息中,如果只有与规范的符合性声明(省略了测量结果和相关不确定度),该测量标准有时也可用于传递计量溯源性,其规范限是不确定度的来源,但此方法取决于:
Measurement standards that have reported information from a competent laboratory that includes only a statement of conformity to a specification (omitting the measurement results and associated uncertainties) are sometimes used to disseminate metrological traceability. This approach, in which the specification limits are imported as the source of uncertainty, is dependent upon:
——使用适当的判定规则确定符合性;
— the use of an appropriate decision rule to establish conformity;
——在后续的不确定度评估中,以技术上适当的方式来处理规范限。
— the specification limits subsequently being treated in a technically appropriate way in the uncertainty budget.
此方法的技术基础在于与规范符合性声明确定了测量值的范围,并预计真值以规定的置信度处于该范围内,该范围考虑了真值的偏倚以及测量不确定度。
The technical basis for this approach is that the declared conformance to a specification defines a range of measurement values, within which the true value is expected to lie, at a specified level of confidence, which considers both any bias from the true value, as well as the measurement uncertainty.
示例:使用国际法制计量组织(OIML)R111各种等级砝码校准天平。
EXAMPLE  The use of OIML R 111 class weights to calibrate a balance.
A.3 证明计量溯源性Demonstrating metrological traceability
A.3.1 实验室负责按本准则建立计量溯源性。符合本标准的实验室提供的校准结果具有计量溯源性。符合 ISO 17034 的标准物质生产者提供的有证标准物质的标准值具有计量溯源性。有不同的方式来证明与本标准的符合性,即第三方承认(如认可机构)、客户进行的外部评审或自我评审。国际上承认的途径包括但不限于:
Laboratories are responsible for establishing metrological traceability in accordance with this document. Calibration results from laboratories conforming to this document provide metrological traceability. Certified values of certified reference materials from reference material producers conforming to ISO 17034 provide metrological traceability. There are various ways to demonstrate conformity with this document, third party recognition (such as an accreditation body), external assessment by customers or self-assessment. Internationally accepted paths include, but are not limited to the following.
a)已通过适当同行评审的国家计量院及其指定机构提供的校准和测量能力。该同行评审是在国际计量委员会相互承认协议(CIPM MRA)下实施的。 CIPM MRA所覆盖的服务可以在国际计量局的关键比对数据库(BIPM KCDB)附录C中查询,其给出了每项服务的范围和测量不确定度。
a) Calibration and measurement capabilities provided by national metrology institutes and designated institutes that have been subject to suitable peer-review processes. Such peer-review is conducted under the CIPM MRA (International Committee for Weights and Measures Mutual Recognition Arrangement). Services covered by the CIPM MRA can be viewed in Appendix C of the BIPM KCDB (International Bureau of Weights and Measures Key Comparison Database) which details the range and measurement uncertainty for each listed service.
b)签署国际实验室认可合作组织(ILAC)协议或ILAC承认的区域协议的认可机构认可的校准和测量能力能够证明具有计量溯源性。获认可的实验室的能力范围可从相关认可机构公开获得。
b) Calibration and measurement capabilities that have been accredited by an accreditation body subject to the ILAC (International Laboratory Accreditation Cooperation) Arrangement or to Regional Arrangements recognized by ILAC have demonstrated metrological traceability. Scopes of accredited laboratories are publicly available from their respective accreditation bodies.
A.3.2 当需要证明计量溯源链在国际上被承认的情况时,BIPM、OIML(国际法制计量组织International Organization of Legal Metrology)、ILAC和ISO关于计量溯源性的联合声明提供了专门指南。
The Joint BIPM, OIML (International Organization of Legal Metrology), ILAC and ISO Declaration on Metrological Traceability provides specific guidance when there is a need to demonstrate international acceptability of the metrological traceability chain.
附录Annex B:管理体系方式Management system options
(资料性附录informative)
管理体系方式Management system options
B.1 随着管理体系的广泛应用,日益需要实验室运行的管理体系既符GB/T 19001,又符合本标准。因此,本标准提供了实施管理体系相关要求的两种方式。
Growth in the use of management systems generally has increased the need to ensure that laboratories can operate a management system that is seen as conforming to ISO 9001, as well as to this document. As a result, this document provides two options for the requirements related to the implementation of a management system.
B.2 方式A(见8.1.2)给出了实施实验室管理体系的最低要求,其已纳入GB/T 19001中与实验室活动范围相关的管理体系所有要求。因此,符合本准则第4条款至第7条款,并实施第8条款方式A的实验室,其运作也基本符合GB/T 19001的原则。
Option A (see 8.1.2) lists the minimum requirements for implementation of a management system in a laboratory. Care has been taken to incorporate all those requirements of ISO 9001 that are relevant to the scope of laboratory activities that are covered by the management system. Laboratories that comply with Clauses 4 to 7 and implement Option A of Clause 8 will therefore also operate generally in accordance with the principles of ISO 9001.
B.3 方式B(见8.1.3)允许实验室按照GB/T 19001的要求建立和保持管理体系,并能支持和证明持续符合第4条款至第7条款的要求。因此实验室实施第8条款的方式B,也是按照GB/T 19001运作的。实验室管理体系符合GB/T 19001的要求,并不证明实验室在技术上具备出具有效的数据和结果的能力。实验室还应符合第4条款至第7条款。
Option B (see 8.1.3) allows laboratories to establish and maintain a management system in accordance with the requirements of ISO 9001, in a manner that supports and demonstrates the consistent fulfilment of Clauses 4 to 7. Laboratories that implement Option B of Clause 8 will therefore also operate in accordance with ISO 9001. Conformity of the management system within which the laboratory operates to the requirements of ISO 9001 does not, in itself, demonstrate the competence of the laboratory to produce technically valid data and results. This is accomplished through compliance with Clauses 4 to 7.
B.4 两种方式的目的都是为了在管理体系的运行,以及符合第4条款至第7条款的要求方面达到同样的结果。
Both options are intended to achieve the same result in the performance of the management system and compliance with Clauses 4 to 7.
注:如同GB/T 19001和其他管理体系标准,文件、数据和记录是成文信息的组成部分。8.3条款规定文件控制。8.4条款和7.5条款规定了记录控制。7.11条款规定了有关实验室活动的数据控制。
NOTE  Documents, data and records are components of documented information as used in ISO 9001 and other management system standards. Control of documents is covered in 8.3. The control of records is covered in 8.4 and 7.5. The control of data related to the laboratory activities is covered in 7.11.
B.5 图B.1给出了一种可能展示第7条款所描述的实验室运作过程的示意图。
Figure B.1 illustrates an example of a possible schematic representation of the operational processes of a laboratory, as described in Clause 7.
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