ISO/IEC 17025:2017《检测和校准实验室能力的通用要求》的过程要求-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》的过程要求

Date2023-03-16 10:34:36  Views1820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。


7 过程要求Process requirements

7.1 要求、标书和合同的评审Review of requests, tenders and contracts
7.1.1 实验室应有要求、标书和合同评审程序。该程序应确保:
The laboratory shall have a procedure for the review of requests, tenders and contracts. The procedure shall ensure that:
GL030认可指南:实验室应结合自身特点建立可行和有效的要求、标书和合同评审的程序。
a)要求被予以充分规定,形成文件,并易于理解;
a)the requirements are adequately defined, documented and understood;
注1:要求可包括(但不限于):
——客户明示的要求;
——隐含的要求;
——必须执行的要求(如法律法规规定的要求)。
注2:必要时,实验室承担军工产品检测任务能力的评审应按军工产品检测的有关规定进行。
b)实验室有能力和资源满足这些要求;
b) the laboratory has the capability and resources to meet the requirements;
c)当使用外部供应商时,应满足6.6的要求,实验室应告知客户由外部供应商实施的实验室活动,并获得客户同意;
c) where external providers are used, the requirements of 6.6 are applied and the laboratory advises the customer of the specific laboratory activities to be performed by the external provider and gains the customer’s approval;
A011应用说明:实验室委托外部制样时,应告知客户制样活动由外部机构提供,并获得客户同意。
A002应用说明:需要时,实验室应与客户在合同中明确约定与后续检测相关的抽样(含取样、采样)的方案,包括抽样位置、时间、方法、样本量等信息。
注1:在下列情况下,可能使用外部提供的实验室活动:
NOTE 1  It is recognized that externally provided laboratory activities can occur when:
——实验室有实施活动的资源和能力,但由于不可预见的原因不能承担部分或全部活动;
— the laboratory has the resources and competence to perform the activities, however, for unforeseen reasons is unable to undertake these in part or full;
——实验室没有实施活动的资源和能力。
— the laboratory does not have the resources or competence to perform the activities.
注4:使用外部提供的实验室活动时,应优先选择获得DILAC认可的实验室。
d)选择适当的方法或程序,并能满足客户的要求。
d) the appropriate methods or procedures are selected and are capable of meeting the customers’ requirements.
注2:对于内部或例行客户,要求、标书和合同评审可简化进行。
NOTE 2  For internal or routine customers, reviews of requests, tenders and contracts can be performed in a simplified way.
GL030认可指南:根据实验室实际情况可将母体组织(包括代加工厂)或原料供应商的要求分为的单次检测要求或重复性检测要求。无论何种形式的要求都应明确检测项目、检测依据。对于重复性检测要求至少每年评审一次。
7.1.2 当客户要求的方法不合适或是过期的,实验室应通知客户。
The laboratory shall inform the customer when the method requested by the customer is considered to be inappropriate or out of date.
7.1.3 当客户要求针对检测或校准作出与规范或标准符合性的声明时(如通过/未通过,在允许限内/超出允许限),应明确规定规范或标准以及判定规则。应将选择的判定规则通知客户并得到同意,除非规范或标准本身已包含判定规则。
When the customer requests a statement of conformity to a specification or standard for the test or calibration (e.g. pass/fail, in-tolerance/out-of-tolerance) the specification or standard, and the decision rule shall be clearly defined. Unless inherent in the requested specification or standard, the decision rule selected shall be communicated to, and agreed with, the customer.
注:符合性声明的详细指南见ISO/IEC指南98-4。
NOTE  For further guidance on statements of conformity, see ISO/IEC Guide 98-4.
7.1.4 要求或标书与合同之间的任何差异均应在实施实验室活动前解决。每项合同都应被实验室和客户双方接受。客户要求的偏离不应影响实验室的诚信或结果的有效性。
Any differences between the request or tender and the contract shall be resolved before laboratory activities commence. Each contract shall be acceptable both to the laboratory and the customer. Deviations requested by the customer shall not impact the integrity of the laboratory or the validity of the results.
7.1.5 与合同的任何偏离都应通知客户。
The customer shall be informed of any deviation from the contract.
7.1.6 如果工作开始后修改合同,应重新进行合同评审,并将修改的内容通知所有受影响的人员。
If a contract is amended after work has commenced, the contract review shall be repeated and any amendments shall be communicated to all affected personnel.
7.1.7 在澄清客户要求和允许客户监控其相关工作表现方面,实验室应与客户或其代表合作。
The laboratory shall cooperate with customers or their representatives in clarifying the customer’s request and in monitoring the laboratory’s performance in relation to the work performed.
注:这种合作可包括:
NOTE  Such cooperation can include:
a)允许客户合理进入实验室相关区域,以见证与该客户相关的实验室活动。
a) providing reasonable access to relevant areas of the laboratory to witness customer-specific laboratory activities;
b)客户出于验证目的所需物品的准备、包装和发送。
b) preparation, packaging, and dispatch of items needed by the customer for verification purposes.
G001应用说明:必要时,实验室应给客户提供充分说明,以便客户在申请检测或校准项目时能更加适合自身的需求与用途。
GL030认可指南:当实验室的客户均为内部客户时,可邀请客户不定期到实验室观察检测活动、宣传检测活动的相关知识。
7.1.8 实验室应保存评审记录,包括任何重大变化的评审记录。针对客户要求或实验室活动结果与客户所进行的讨论,也应作为记录予以保存。
Records of reviews, including any significant changes, shall be retained. Records shall also be retained of pertinent discussions with a customer relating to the customer’s requirements or the results of the laboratory activities.
7.2 方法的选择、验证和确认Selection, verification and validation of methods
7.2.1 方法的选择和验证Selection and verification of methods
7.2.1.1 实验室应使用适当的方法和程序开展所有实验室活动,适当时,包括测量不确定度的评定以及使用统计技术进行数据分析。
The laboratory shall use appropriate methods and procedures for all laboratory activities and, where appropriate, for evaluation of the measurement uncertainty as well as statistical techniques for analysis of data.
注:本标准所用“方法”可视为是ISO/IEC指南99定义的“测量程序”的同义词。
NOTE “Method” as used in this document can be considered synonymous with the term “measurement procedure” as defined in ISO/IEC Guide 99.
A011应用说明:实验室开展力学性能检测时,应防止不正确的试样夹持或放置对检测结果的影响。使用不同标准进行力学性能检测时,应注意标准之间的差异部分,包括试样尺寸和精度、对设备的要求、试验过程的要求、计算结果的修约等。用同一台火花放电原子发射光谱仪对不同基体材料进行化学分析时,应有程序保证在基体切换时不会造成元素干扰。
A002应用说明:实验室应关注检测方法中提供的限制说明、浓度范围和样品基体,选择的检测方法应确保在限值附近给出可靠的结果。实验室应建立和执行与检测方法要求相匹配的校准曲线,并定期使用中间浓度水平的校准标样检查校准曲线,建立检查结果可否接受的判定标准。
G001应用说明:实验室应对使用的检测或校准方法实施有效的控制与管理,明确每种新方法投入使用的时间,并及时跟进检测或校准技术的发展,定期评审方法能否满足检测或校准需求。
GL030认可指南:
实验室使用方法进行检测活动,应确保:
(1) 遵循样品制备步骤;
(2) 遵循标准物质/试剂存储和使用要求;
(3) 遵循仪器设备的运行和操作要求;
(4) 按检测方法规定程序检测空白样品和质量控制样品;
(5) 遵循检测方法中定性/定量的方法和要求。
7.2.1.2 所有的方法、程序和支持文件,例如与实验室活动相关的指导书、标准、手册和参考数据,应保持现行有效并易于人员获取(见8.3)。
All methods, procedures and supporting documentation, such as instructions, standards, manuals and reference data relevant to the laboratory activities, shall be kept up to date and shall be made readily available to personnel (see 8.3).
A011应用说明:采用与标准图谱比较的方法进行金相评估检验时,应至少配有一套原版图谱或标准图谱图集。为方便操作而进行的复制,应确保与原版图谱或标准图谱的一致性(大小、色彩、灰度、分辨率等)。
7.2.1.3 实验室应确保使用最新有效版本的方法,除非不合适或不可能做到。必要时,应补充方法使用的细则以确保应用的一致性。
The laboratory shall ensure that it uses the latest valid version of a method unless it is not appropriate or possible to do so. When necessary, the application of the method shall be supplemented with additional details to ensure consistent application.
注:如果国际、区域或国家标准,或其他公认的规范文本包含了实施实验室活动充分且简明的信息,并便于实验室操作人员使用时,则不需要再进行补充或改写为内部程序。可能有必要制定实施细则,或对方法中的可选择步骤提供补充文件。
NOTE  International, regional or national standards or other recognized specifications that contain sufficient and concise information on how to perform laboratory activities do not need to be supplemented or rewritten as internal procedures if these standards are written in a way that they can be used by the operating personnel in a laboratory. It can be necessary to provide additional documentation for optional steps in the method or additional details.
A011应用说明:实验室对抽样和取样活动在必要时应制订作业指导书,取样作业指导书应规定取样部位、取样方向、取样量和取样方法。对力学性能检测、金相检验及微观结构检测、仪器法化学成分分析的试样制备应制定作业指导书,明确加工及其他相关的技术要求,如关键参数的具体指标(尺寸、形位公差、表面粗糙度等)、避免加工硬化和过热等要求。必要时,力学性能检测的制样作业指导书应有相应的图纸,并对加工的试样图纸进行管理和控制。微观结构分析如果采用通则方法,应针对检测对象制定具体的作业指导书。
G001应用说明:对于标准方法,应定期跟踪标准的制修订情况,及时采用最新版本标准。
GL030认可指南:实验室应建立在用检测标准的清单,并规定方法查新的频率、查新方式和查新结果的处置要求。 如检测标准存在可选择执行要求或易产生歧义理解时,实验室应编制作业指导书,以保证在实验室内部检测操作的一致性。
7.2.1.4 当客户未指定所用的方法时,实验室应选择适当的方法并通知客户。推荐使用以国际标准、区域标准或国家标准发布的方法,或由知名技术组织或有关科技文献或期刊中公布的方法,或设备制造商规定的方法。实验室制定或修改的方法也可使用。
When the customer does not specify the method to be used, the laboratory shall select an appropriate method and inform the customer of the method chosen. Methods published either in international, regional or national standards, or by reputable technical organizations, or in relevant scientific texts or journals, or as specified by the manufacturer of the equipment, are recommended. Laboratory-developed or modified methods can also be used.
注:实验室开展军工产品的检测和校准工作时,应优先选择国家军用标准。
GL030认可指南:实验室应优先使用以国际、区域、国家或行业标准发布的方法,也可选择母体组织制定的方法。除使用国家强制执行的标准外,鼓励实验室根据应用需要开发适用性更强、技术更先进、效率更高的非标准检测方法。
7.2.1.5 实验室在引入方法前,应验证能够正确地运用该方法,以确保实现所需的方法性能。应保存验证记录。如果发布机构修订了方法,应依据方法变化的内容重新进行验证。
The laboratory shall verify that it can properly perform methods before introducing them by ensuring that it can achieve the required performance. Records of the verification shall be retained. If the method is revised by the issuing body, verification shall be repeated to the extent necessary.
A002应用说明:实验室应对首次采用的标准方法进行技术能力的验证,如适用的浓度范围和样品基体、正确度和精密度等,尤其对于痕量分析和超痕量分析,还应关注检出限、定量限等。当标准方法发生变更涉及到技术能力发生变化,如检测方法原理、仪器设备、环境设施、操作方法、方法适用范围等,需要通过技术验证重新证明正确运用新标准的能力。
G001应用说明:在引入检测或校准方法之前,实验室应对其能否正确运用这些标准方法的能力进行验证,验证不仅需要识别相应的人员、设施和环境、设备等,还应通过试验证明结果的准确性和可靠性,如精密度、线性范围、检出限和定量限等方法特性指标,必要时应进行实验室间比对。
7.2.1.6 当需要开发方法时,应予以策划,并指定具备能力的人员,为其配备足够的资源。在方法开发的过程中,应进行定期评审,以确定持续满足客户需求。开发计划的任何变更应得到批准和授权。必要时,方法制定过程的相应阶段应进行评审,以证实要求得到满足。
When method development is required, this shall be a planned activity and shall be assigned to competent personnel equipped with adequate resources. As method development proceeds, periodic review shall be carried out to confirm that the needs of the customer are still being fulfilled. Any modifications to the development plan shall be approved and authorized.
7.2.1.7 对所有实验室活动方法的偏离,应事先将该偏离形成文件,经技术判断,获得授权并被客户接受。
Deviations from methods for all laboratory activities shall occur only if the deviation has been documented, technically justified, authorized, and accepted by the customer.
注:客户接受偏离可以事先在合同中约定。
NOTE Customer acceptance of deviations can be agreed in advance in the contract.
GL030认可指南:当使用标准方法不能满足要求需要偏离检测标准时,实验室应将偏离形成作业指导书,并按非标准方法的控制要求执行。
7.2.2 方法确认Validation of methods
7.2.2.1 实验室应对非标准方法(含军工产品非通用的专用测试设备校准规范)、实验室开发的方法、超出预定范围使用的标准方法、或其他修改的标准方法进行确认。确认应尽可能全面,以满足预期用途或应用领域的需要。
The laboratory shall validate non-standard methods, laboratory-developed methods and standard methods used outside their intended scope or otherwise modified. The validation shall be as extensive as is necessary to meet the needs of the given application or field of application.
A011应用说明:对仪器法成分分析,如果使用时超出了标准方法的预定范围、或扩充和修改了标准方法,应进行方法确认,并制定作业指导书。
A002应用说明:任何对标准方法的修改, 包括超出适用的浓度范围或基体范围、采用分析性能更佳的替代技术等等都应进行确认。
GL030认可指南:非标准方法应进行确认,以满足预期用途或应用领域的需要。
注1:确认可包括检测或校准物品的抽样、处置和运输程序。
NOTE 1 Validation can include procedures for sampling, handling and transportation of test or calibration items.
注2:可用以下一种或多种技术进行方法确认:
NOTE 2  The techniques used for method validation can be one of, or a combination of, the following:
a)使用参考标准或标准物质进行校准或评估偏倚和精密度;
a)calibration or evaluation of bias and precision using reference standards or reference materials;
注3:实验室的参考标准(实验室最高标准)应溯源到国防最高测量标准或国家测量标准或国际测量标准 。
注4:可能时,标准物质(参考物质)应溯源到国防最高测量标准或国家测量标准或国际测量标准,包括溯源到国家有证军用标准物质DILAC 认可准则 DILAC/AC01:2018(参考物质)或国家有证标准物质(参考物质)或国际有证标准物质(参考物质)。
b)对影响结果的因素进行系统性评审;
b) systematic assessment of the factors influencing the result;
c)通过改变受控参数(如培养箱温度、加样体积等)来检验方法的稳健度;
c) testing method robustness through variation of controlled parameters, such as incubator temperature, volume dispensed;
d)与其他已确认的方法进行结果比对;
d) comparison of results achieved with other validated methods;
e)实验室间比对;
e) interlaboratory comparisons;
f) 根据对方法原理的理解以及抽样或检测方法的实践经验,评定结果的测量不确定度。
f) evaluation of measurement uncertainty of the results based on an understanding of the theoretical principles of the method and practical experience of the performance of the sampling or test method.
GL030认可指南:定量检测的非标方法确认时还应考虑测量结果不确定度的影响。
7.2.2.2 当修改已确认过的方法时,应确定这些修改的影响。当发现影响原有的确认时,应重新进行方法确认。
When changes are made to a validated method, the influence of such changes shall be determined and where they are found to affect the original validation, a new method validation shall be performed.
7.2.2.3 当按预期用途评估被确认方法的性能特性时,应确保与客户需求相关,并符合规定的要求。
The performance characteristics of validated methods, as assessed for the intended use, shall be relevant to the customers’ needs and consistent with specified requirements.
注:方法性能特性可包括但不限于:测量范围、准确度、结果的测量不确定度、检出限、定量限、方法的选择性、线性、重复性或复现性、抵御外部影响的稳健度或抵御来自样品或测试物基体干扰的交互灵敏度以及偏倚。
NOTE  Performance characteristics can include, but are not limited to, measurement range, accuracy, measurement uncertainty of the results, limit of detection, limit of quantification, selectivity of the method, linearity, repeatability or reproducibility, robustness against external influences or cross-sensitivity against interference from the matrix of the sample or test object, and bias.
7.2.2.4 实验室应保存以下方法确认记录:
The laboratory shall retain the following records of validation:
a)使用的确认程序;
a) the validation procedure used;
b)要求的详细说明;
b) specification of the requirements;
c) 方法性能特性的确定;
c) determination of the performance characteristics of the method;
d) 获得的结果;
d) results obtained;
e)方法有效性声明,并详述与预期用途的适宜性。
e) a statement on the validity of the method, detailing its fitness for the intended use.
7.3 抽样Sampling
7.3.1 当实验室为后续检测或校准对物质、材料或产品实施抽样时,应有抽样计划和方法。抽样方法应明确需要控制的因素,以确保后续检测或校准结果的有效性。在抽样地点应能得到抽样计划和方法。只要合理,抽样计划应基于适当的统计方法。
The laboratory shall have a sampling plan and method when it carries out sampling of substances, materials or products for subsequent testing or calibration. The sampling method shall address the factors to be controlled to ensure the validity of subsequent testing or calibration results. The sampling plan and method shall be available at the site where sampling is undertaken. Sampling plans shall, whenever reasonable, be based on appropriate statistical methods.
G001应用说明:
a) 如果实验室仅进行抽样,而不从事后续的检测或校准活动,CNAS将不认可该抽样项目。
b) 实验室如需从客户提供的样品中取出部分样品进行后续的检测或校准活动时,应有书面的取样程序或记录,并确保样品的均匀性和代表性。注:抽样除包含从一个批次抽取样品的活动外,还包含检测领域常用的概念“采样”和“取样”。
7.3.2 抽样方法应描述:
The sampling method shall describe:
a)样品或地点的选择;
a) the selection of samples or sites;
b)抽样计划;
b) the sampling plan;
c)从物质、材料或产品中取得样品的制备和处理,以作为后续检测或校准的物品。
c) the preparation and treatment of sample(s) from a substance, material or product to yield the required item for subsequent testing or calibration.
注:实验室接收样品后,进一步处置要求见7.4的规定。
NOTE When received into the laboratory, further handling can be required as specified in 7.4.
7.3.3 实验室应将抽样数据作为检测或校准工作记录的一部分予以保存。相关时,这些记录应包括以下信息:
The laboratory shall retain records of sampling data that forms part of the testing or calibration that is undertaken. These records shall include, where relevant:
a)所用的抽样方法;
a) reference to the sampling method used;
b)抽样日期和时间;
b) date and time of sampling;
c)识别和描述样品的数据(如编号、数量和名称);
c) data to identify and describe the sample (e.g. number, amount, name);
d)抽样人的识别;
d) identification of the personnel performing sampling;
e)所用设备的识别;
e) identification of the equipment used;
f)环境或运输条件;
f) environmental or transport conditions;
g)适当时,标识抽样位置的图示或其他等效方式;
g) diagrams or other equivalent means to identify the sampling location when appropriate;
h)与抽样方法和抽样计划的偏离或增减。
i)deviations, additions to or exclusions from the sampling method and sampling plan.
A011应用说明:对大宗金属材料的抽样操作,应记录抽样情况,如货场堆垛情况、样品批量数、抽样数,抽样样品号、材料取样部位等,需要时可用图表、照片等方式标记以证明样品的代表性。
7.4 检测或校准物品的处置Handling of test or calibration items
7.4.1 实验室应有运输、接收、处置、保护、存储、保留、处理或归还检测或校准物品的程序,包括为保护检测或校准物品的完整性以及实验室与客户利益所需的所有规定。在物品的处置、运输、保存/等候和制备过程中,应注意避免物品变质、污染、丢失或损坏。应遵守随物品提供的操作说明。
The laboratory shall have a procedure for the transportation, receipt, handling, protection, storage, retention, and disposal or return of test or calibration items, including all provisions necessary to protect the integrity of the test or calibration item, and to protect the interests of the laboratory and the customer. Precautions shall be taken to avoid deterioration, contamination, loss or damage to the item during handling, transporting, storing/waiting, and preparation for testing or calibration. Handling instructions provided with the item shall be followed.
检测和校准的物品涉及军工产品保密要求时,物品处置的全过程应遵守国防科技工业有关的保密规定。
A011应用说明:实验室建立的样品处置程序应分别规定金属材料大样、加工后小样和检测后样品的处置要求,包括保管条件和保留时间。对金相样品应适当保存,避免损伤。对有表面层及制样有特殊要求的金属材料要确保在抽样、取样、制样及储存过程中,表面层及其内部性能不被损坏。
G001应用说明:通常情况下,样品标识不应粘贴在容易与盛装样品容器分离的部件上,如容器盖,因其可能会导致样品的混淆。
GL030认可指南:
无论在实验室内或母体组织指定的实验室外的其他部门进行留样时,都应符合本条款要求。
母体组织可依据工作需求指定实验外的其他部门协助留样,实验室应建立留样要求,并确保相关部门满足这些要求。
7.4.2 实验室应有清晰标识检测或校准物品的系统。物品在实验室负责的期间内应保留该标识。标识系统应确保物品在实物上、记录或其他文件中不被混淆。适当时,标识系统应包含一个物品或一组物品的细分和物品的传递。
The laboratory shall have a system for the unambiguous identification of test or calibration items. The identification shall be retained while the item is under the responsibility of the laboratory. The system shall ensure that items will not be confused physically or when referred to in records or other documents. The system shall, if appropriate, accommodate a sub-division of an item or groups of items and the transfer of items.
A011应用说明:实验室的检测样品标识应存在于样品抽样、取样、制样、分组、检测和留样保存等各个环节。接收样品时应记录客户赋予样品的标识,并建立客户赋予标识与实验室赋予标识的对应关系。委托外部加工样品的,必要时实验室应进行试样标识的转移或监督转移。
7.4.3 接收检测或校准物品时,应记录与规定条件的偏离。当对物品是否适于检测或校准有疑问,或当物品不符合所提供的描述时,实验室应在开始工作之前询问客户,以得到进一步的说明,并记录询问的结果。当客户知道物品偏离了规定条件仍要求进行检测或校准时,实验室应在报告中作出免责声明,并指出偏离可能影响的结果。
Upon receipt of the test or calibration item, deviations from specified conditions shall be recorded. When there is doubt about the suitability of an item for test or calibration, or when an item does not conform to the description provided, the laboratory shall consult the customer for further instructions before proceeding and shall record the results of this consultation. When the customer requires the item to be tested or calibrated acknowledging a deviation from specified conditions, the laboratory shall include a disclaimer in the report indicating which results may be affected by the deviation.
A011应用说明:实验室在接收样品时,应进行符合性检查(或按批抽查),应根据方法的要求对试样的关键参数指标进行检查并提供相应的检查记录,如冲击试样缺口、疲劳试样表面粗糙度等。需要时,应检查试样的取样部位和方向。
7.4.4 如物品需要在规定环境条件下储存或状态调节时,应保持、监控和记录这些环境条件。
When items need to be stored or conditioned under specified environmental conditions, these conditions shall be maintained, monitored and recorded.
GL030认可指南:当实验室母体组织其他部门协助留样时,该部门应具备保持样品完整性和不改变其性状的条件。
7.5 技术记录Technical records
7.5.1 实验室应确保每一项实验室活动的技术记录包含结果、报告和足够的信息,以便在可能时识别影响测量结果及其测量不确定度的因素,并确保能在尽可能接近原条件的情况下重复该实验室活动。技术记录应包括每项实验室活动以及审查数据结果的日期和责任人。原始的观察结果、数据和计算应在观察或获得时予以记录,并应按特定任务予以识别。
The laboratory shall ensure that technical records for each laboratory activity contain the results, report and sufficient information to facilitate, if possible, identification of factors affecting the measurement result and its associated measurement uncertainty and enable the repetition of the laboratory activity under conditions as close as possible to the original. The technical records shall include the date and the identity of personnel responsible for each laboratory activity and for checking data and results. Original observations, data and calculations shall be recorded at the time they are made and shall be identifiable with the specific task.
军工产品的检测和校准记录的保存时间,应按军工产品、国防科技工业的有关要求在文件中作出规定。
A011应用说明:检测记录应有充分的信息。需要时,应包含与试验过程有关的试样和试验方法(条件)的详细信息,如抽样情况、试样的取样部位和方向(可采用文字、图片的形式说明)、试样尺寸和形状、试样状态信息、测量表面层厚度/深度时测量点的位置、浸蚀剂成分或代号、浸蚀的温度和时间等。
A002应用说明:当实验室弃用检测数据时,应记录原因(符合相关技术要求时除外)。
G001应用说明:
a) 实验室应确保能方便获得所有的原始记录和数据,记录的详细程度应确保在尽可能接近条件的情况下能够重复实验室活动。只要适用,记录内容应包括但不限于以下信息:
• 样品描述;
• 样品唯一性标识;
• 所用的检测、校准和抽样方法;
• 环境条件,特别是实验室以外的地点实施的实验室活动;
• 所用设备和标准物质的信息,包括使用客户的设备;
• 检测或校准过程中的原始观察记录以及根据观察结果所进行的计算;
• 实施实验室活动的人员;
• 实施实验室活动的地点(如果未在实验室固定地点实施);
• 检测报告或校准证书的副本;
• 其他重要信息。
注:检测报告或校准证书的副本是指实验室发给客户的报告或证书版本的副本,可以是纸质版本或不可更改的电子版本,其中应包含报告或证书的签发人、认可标识(如使用)等信息。
b) 实验室应在记录表格中或成册的记录本上保存检测或校准的原始数据和信息,也可直接录入信息管理系统中,也可以是设备或信息系统自动采集的数据。对自动采集或直接录入信息管理系统中的数据的任何更改,应满足7.5.2的要求。注1:原始记录为试验人员在试验过程中记录的原始观察数据和信息,而不是试验后所誊抄的数据。当需要另行整理或誊抄时,应保留对应的原始记录。注2:实验室不能随意用一页白纸来保存原始记录。
GL030认可指南:对于技术记录中的固定的、每日重复检测的大批量样品项目,可将相同信息固化到原始记录中。
7.5.2 实验室应确保技术记录的修改可以追溯到前一个版本或原始观察结果。应保存原始的以及修改后的数据和文档,包括修改的日期、标识修改的内容和负责修改的人员。电子形式存储的记录应做只读处理。
The laboratory shall ensure that amendments to technical records can be tracked to previous versions or to original observations. Both the original and amended data and files shall be retained, including the date of alteration, an indication of the altered aspects and the personnel responsible for the alterations.
7.6 测量不确定度的评定Evaluation of measurement uncertainty
7.6.1 实验室应识别测量不确定度的贡献。评定测量不确定度时,应采用适当的分析方法考虑所有显著贡献,包括来自抽样的贡献。
Laboratories shall identify the contributions to measurement uncertainty. When evaluating measurement uncertainty, all contributions which are of significance, including those arising from sampling, shall be taken into account using appropriate methods of analysis.
注:测量不确定度的评定可参照国家军用标准GJB 3756进行。
A002应用说明:实验室应有文件规定,明确评定测量不确定度的要求。当与客户商定判定规则,需要时应评估获得测量不确定度的合理性,并制定报告规则。
7.6.2 开展校准的实验室,包括校准自有设备的实验室,应评定所有校准的测量不确定度。
A laboratory performing calibrations, including of its own equipment, shall evaluate the measurement uncertainty for all calibrations.
7.6.3 开展检测的实验室应评定测量不确定度。当由于检测方法的原因难以严格评定测量不确定度时,实验室应基于对理论原理的理解或使用该方法的实践经验进行评估。
A laboratory performing testing shall evaluate measurement uncertainty. Where the test method precludes rigorous evaluation of measurement uncertainty, an estimation shall be made based on an understanding of the theoretical principles or practical experience of the performance of the method.
注1:某些情况下,公认的检测方法对测量不确定度主要来源规定了限值,并规定了计算结果的表示方式,实验室只要遵守检测方法和报告要求,即满足7.6.3的要求。
NOTE 1  In those cases where a well-recognized test method specifies limits to the values of the major sources of measurement uncertainty and specifies the form of presentation of the calculated results, the laboratory is considered to have satisfied 7.6.3 by following the test method and reporting instructions.
注2:对某一特定方法,如果已确定并验证了结果的测量不确定度,实验室只要证明已识别的关键影响因素受控,则不需要对每个结果评定测量不确定度。
NOTE 2  For a particular method where the measurement uncertainty of the results has been established and verified, there is no need to evaluate measurement uncertainty for each result if the laboratory can demonstrate that the identified critical influencing factors are under control.
注3:更多信息参见ISO/IEC指南98-3、ISO 21748和ISO 5725系列标准。
NOTE 3  For further information, see ISO/IEC Guide 98-3, ISO 21748 and the ISO 5725 series.
7.7 确保结果有效性Ensuring the validity of results
7.7.1 实验室应有监控结果有效性的程序。记录结果数据的方式应便于发现其发展趋势,如可行,应采用统计技术审查结果。实验室应对监控进行策划和审查,适当时,监控应包括但不限于以下方式:
The laboratory shall have a procedure for monitoring the validity of results. The resulting data shall be recorded in such a way that trends are detectable and, where practicable, statistical techniques shall be applied to review the results. This monitoring shall be planned and reviewed and shall include, where appropriate, but not be limited to:
a)使用标准物质或质量控制物质;
a) use of reference materials or quality control materials;
b)使用其他已校准能够提供可溯源结果的仪器;
b) use of alternative instrumentation that has been calibrated to provide traceable results;
c)测量和检测设备的功能核查;
c) functional check(s) of measuring and testing equipment;
d)适用时,使用核查或工作标准,并制作控制图;
d) use of check or working standards with control charts, where applicable;
e)测量设备的期间核查;
e) intermediate checks on measuring equipment;
f)使用相同或不同方法重复检测或校准;
f) replicate tests or calibrations using the same or different methods;
g)留存样品的重复检测或重复校准;
g) retesting or recalibration of retained items;
h)物品不同特性结果之间的相关性;
h) correlation of results for different characteristics of an item;
i)报告结果的审查;
i) review of reported results;
j)实验室内比对;
j) intralaboratory comparisons;
k)盲样测试。
l)testing of blind sample(s).
A011应用说明:
实验室对金相检验、微观结构分析等人为因素影响较大的检测活动,应加强质量监控,可通过实施人员比对或者实验室间比对以保证相关检测人员能力。
对于仪器法化学成分分析,应按标准方法的要求建立校准曲线,并使用与检测样品含量匹配的标样对建立的校准曲线进行验证。应定期使用中间点的标样检查校准曲线,建立定期检查结果可否接受的判定标准,且该判定标准应与测量不确定度相当。
G001应用说明:
a) 实验室对结果的监控应覆盖到认可范围内的所有检测或校准(包括内部校准)项目,确保检测或校准结果的准确性和稳定性。当检测或校准方法中规定了质量监控制要求时,实验室应符合该要求。适用时,实验室应在检测方法中或其他文件中规定对应检测或校准方法的质量监控方案。实验室制定内部质量监控方案时应考虑以下因素:
•检测或校准业务量;
•检测或校准结果的用途;
•检测或校准方法本身的稳定性与复杂性;
•对技术人员经验的依赖程度;
•参加外部比对(包含能力验证)的频次与结果;
•人员的能力和经验、人员数量及变动情况;
•新采用的方法或变更的方法等。
注:实验室可以采取多种适用的质量监控手段,如:
•定期使用标准物质、 核查标准或工作标准来监控结果的准确性;
•通过使用质量控制物质制作质控图持续监控精密度;
•通过获得足够的标准物质,评估在不同浓度下检测结果的准确性;
•定期留样再测或重复测量以及实验室内比对,监控同一操作人员的精密度或不同操作人员间的精密度;
•采用不同的检测方法或设备测试同一样品,监控方法之间的一致性;
•通过分析一个物品不同特性结果的相关性,以识别错误;
•进行盲样测试,监控实验室日常检测的准确度或精密度水平。
b) 适用时,实验室应使用质量控制图来监控检测或校准结果的准确性和精密度。
c) 一些特殊的检测活动,检测结果无法复现,难以按照7.7.1a)进行质量控制,实验室应关注人员的能力、培训、监督以及与同行的技术交流。
7.7.2 可行和适当时,实验室应通过与其他实验室的结果比对监控能力水平。监控应予以策划和审查,包括但不限于以下一种或两种措施:
The laboratory shall monitor its performance by comparison with results of other laboratories, where available and appropriate. This monitoring shall be planned and reviewed and shall include, but not be limited to, either or both of the following:
a)参加能力验证;
a) participation in proficiency testing;
注:GB/T 27043包含能力验证和能力验证提供者的详细信息。满足GB/T 27043要求的能力验证提供者被认为是有能力的。
NOTE  ISO/IEC 17043 contains additional information on proficiency tests and proficiency testing providers. Proficiency testing providers that meet the requirements of ISO/IEC 17043 are considered to be competent.
b)参加除能力验证之外的实验室间比对。
c)participation in interlaboratory comparisons other than proficiency testing.
A011应用说明:实验室按CNAS-RL02选择参加能力验证计划时,如果认可的检测项目在同一子领域内有多项可获得的能力验证活动,应避免连续只参加同一项目的能力验证,参加的人员、设备也应考虑适当更换。
G001应用说明:外部质量监控方案不仅包括CNAS-RL02《能力验证规则》中要求参加的能力验证计划,适当时,还应包含实验室间比对计划。实验室制定外部质量监控计划除应考虑7.7.1a)中描述的因素外,还应考虑以下因素:
•内部质量监控结果;
•实验室间比对(包含能力验证)的可获得性,对没有能力验证的领域,实验室应有其他措施来确保结果的准确性和可靠性;
• CNAS、客户和管理机构对实验室间比对(包含能力验证)的要求。
注:CNAS-RL02《能力验证规则》要求参加的能力验证领域和频次只是CNAS对能力验证的最低要求。实验室应关注对于没有能力验证的领域,可以采取有何措施确保结果的准确性和可靠性。
RL02验证规则:
金属与合金类材料与制品检测领域的能力验证频次:化学分析和机械性能每年至少1次,物理性能每2年至少1次。
7.7.3 实验室应分析监控活动的数据用于控制实验室活动,适用时实施改进。如果发现监控活动数据分析结果超出预定的准则时,应采取适当措施防止报告不正确的结果。
Data from monitoring activities shall be analysed, used to control and, if applicable, improve the laboratory’s activities. If the results of the analysis of data from monitoring activities are found to be outside pre-defined criteria, appropriate action shall be taken to prevent incorrect results from being reported.
A011应用说明:适用时,实验室应建立控制图,观察和分析控制图显示的趋势,必要时采取处理措施。
7.8 报告结果Reporting of results
7.8.1 总则General
7.8.1.1 结果在发出前应经过审查和批准。
The results shall be reviewed and authorized prior to release.
G001应用说明:
a) 除检测方法、法律法规另有要求外,实验室应在同一份报告上出具特定样品不同检测项目的结果,如果检测项目覆盖了不同的专业技术领域,也可分专业领域出具检测报告。
注:即使客户有要求,实验室也不得随意拆分检测报告,如将“满足规定限值”的结果与“不满足规定限值”的结果分别出具报告,或只报告“满足规定限量”的检测结果。
c)一般情况下,实验室应按GB/T 8170《数值修约规则与极限数值的表示和判定》进行数值修约。
GL030认可指南:结果的电子传送,当实验室利用网络或信息化系统传送检测结果时,应满足7.11的要求,同时应符合报告审核和发送报告的流程。
7.8.1.2 实验室应准确、清晰、明确和客观地出具结果,并且应包括客户同意的、解释结果所必需的以及所用方法要求的全部信息。实验室通常以报告的形式提供结果(例如检测报告、校准证书或抽样报告)。所有发出的报告应作为技术记录予以保存。
The results shall be provided accurately, clearly, unambiguously and objectively, usually in a report (e.g. a test report or a calibration certificate or report of sampling) and shall include all the information agreed with the customer and necessary for the interpretation of the results and all information required by the method used. All issued reports shall be retained as technical records.
注1:检测报告和校准证书有时称为检测证书和校准报告。
NOTE 1  For the purposes of this document, test reports and calibration certificates are sometimes referred to as test certificates and calibration reports, respectively.
注2:只要满足本标准的要求,报告可以硬拷贝或电子方式发布。
NOTE 2  Reports can be issued as hard copies or by electronic means, provided that the requirements of this document are met.
注3:如有特殊需要,证书或报告可不包括客户有保密要求的信息。
A011应用说明:应按标准中规定的修约要求报告检测结果。如果标准中有规定,在报告检测结果时还应报告试验条件。
A002应用说明:检测结果的报告应符合如下要求:
a)当检出结果低于方法检出限或定量限,应在检测报告中提供方法检出限或定量限的数值。
b)如果报告的结果是用数字表示的数值,应按照所用检测方法的规定进行表述。当方法没有相关规定时,应依照有效数值修约的规定表述。
c)当需要解释检测结果时,或客户有要求时,或检测方法要求时,实验室应报告质量控制结果。当质量控制结果不完全满足检测方法要求且无法重新测试时,应在报告中以适当方式进行标注和说明。
d)必要时,报告中应注明与后续检测相关的抽样(含取样、采样)信息。
GL030认可指南:实验室在为内部客户出具报告时,可以简化,但报告中简化的信息应能方便地从实验室中获得并可追溯。
EL-13认可说明:样品信息准确,并且必须是实测样品。
7.8.1.3 如客户同意,可用简化方式报告结果。如果未向客户报告7.8.2至7.8.7条款中所列的信息,客户应能方便地获得。
When agreed with the customer, the results may be reported in a simplified way. Any information listed in 7.8.2 to 7.8.7 that is not reported to the customer shall be readily available.
7.8.2 (检测、校准或抽样)报告的通用要求Common requirements for reports (test, calibration or sampling)
7.8.2.1 除非实验室有有效的理由,每份报告应至少包括下列信息,以最大限度地减少误解或误用的可能性:
Each report shall include at least the following information, unless the laboratory has valid reasons for not doing so, thereby minimizing any possibility of misunderstanding or misuse:
a)标题(例如“检测报告”、“校准证书”或“抽样报告”);
a) a title (e.g. “Test Report”, “Calibration Certificate” or “Report of Sampling”);
b)实验室的名称和地址;
b) the name and address of the laboratory;
c)实施实验室活动的地点,包括客户设施、实验室固定设施以外的场所、相关的临时或移动设施;
c) the location of performance of the laboratory activities, including when performed at a customer facility or at sites away from the laboratory’s permanent facilities, or in associated temporary or mobile facilities;
EL-13认可说明:如果测试地点不在实验室的固定场所,如在客户地点或样品所在地, 报告中应给出详细的地址信息,仅给出“客户地点”等模糊信息是不充分的。
d)将报告中所有部分标记为完整报告的一部分的唯一性标识,以及表明报告结束的清晰标识;
d) unique identification that all its components are recognized as a portion of a complete report and a clear identification of the end;
e)客户的名称和联络信息;
e) the name and contact information of the customer;
f)所用方法的识别;
f) identification of the method used;
g)物品的描述、明确的标识,以及必要时,物品的状态;
g) a description, unambiguous identification, and, when necessary, the condition of the item;
A011应用说明:必要时,检测报告应提供来样实物照片,并标记出取样部位。
h)检测或校准物品的接收日期,以及对结果的有效性和应用至关重要的抽样日期;
h) the date of receipt of the test or calibration item(s), and the date of sampling, where this is critical to the validity and application of the results;
i) 实施实验室活动的日期;
i) the date(s) of performance of the laboratory activity;
j) 报告的发布日期;
j) the date of issue of the report;
k) 如与结果的有效性或应用相关时,实验室或其他机构所用的抽样计划和抽样方法;
k) reference to the sampling plan and sampling method used by the laboratory or other bodies where these are relevant to the validity or application of the results;
l) 结果仅与被检测、被校准或被抽样物品有关的声明;
l) a statement to the effect that the results relate only to the items tested, calibrated or sampled;
m) 结果,适当时,带有测量单位;
m) the results with, where appropriate, the units of measurement;
A011应用说明:需要时,金相检测报告应提供试样中有代表性的金相照片。
n) 对方法的补充、偏离或删减;
n) additions to, deviations, or exclusions from the method;
o) 报告批准人的识别;
o) identification of the person(s) authorizing the report;
p) 当结果来自于外部供应商时所做的清晰标识。
p) clear identification when results are from external providers.
EL-13认可说明:实验室出具的报告中如有摘用其他机构报告信息的内容,则应在报告中给出清晰的标注,标注的方式应确保报告的使用人不会产生误解。当使用认可标识时,按“外部提供的信息”(视同“分包”)要求控制。
注:报告中声明除全文复制外,未经实验室批准不得部分复制报告,可以确保报告不被部分摘用。
NOTE Including a statement specifying that the report shall not be reproduced except in full without approval of the laboratory can laboratory can provide assurance that parts of a report are not taken out of context.
EL-13认可说明:如果实际测试过程是由客户的技术人员操作,实验室只是目击了试验的过程并记录下测试数据和信息,报告应以清晰的方式在正文中注明是目击试验,并且不得使用认可标识或声明认可。
7.8.2.2 除客户提供的信息除外,实验室应对报告中的所有信息负责。客户提供的数据应予明确标识。此外,当客户提供的信息可能影响结果的有效性时,报告中应有免责声明。当实验室不负责抽样(如样品由客户提供),应在报告中声明结果适用于收到的样品。
The laboratory shall be responsible for all the information provided in the report, except when information is provided by the customer. Data provided by a customer shall be clearly identified. In addition, a disclaimer shall be put on the report when the information is supplied by the customer and can affect the validity of results. Where the laboratory has not been responsible for the sampling stage (e.g. the sample has been provided by the customer), it shall state in the report that the results apply to the sample as received.
EL-13认可说明:对于客户送样,除非抽样信息影响到测试结果,报告中不应包含抽样信息。如果报告中包含样品抽样信息(如地点),实验室应以显著方式在报告正文中说明此为客户提供信息,实验室对此真实性不承担责任。
7.8.3 检测报告的特定要求Specific requirements for test reports
7.8.3.1 除7.8.2所列要求之外,当解释检测结果需要时,检测报告还应包含以下信息:
In addition to the requirements listed in 7.8.2, test reports shall, where necessary for the interpretation of the test results, include the following:
a)特定的检测条件信息,如环境条件;
a) information on specific test conditions, such as environmental conditions;
b)相关时,与要求或规范的符合性声明(见7.8.6);
b) where relevant, a statement of conformity with requirements or specifications (see 7.8.6);
c)适用时,在下列情况下,带有与被测量相同单位的测量不确定度或被测量相对形式的测量不确定度(如百分比):
c) where applicable, the measurement uncertainty presented in the same unit as that of the measurand or in a term relative to the measurand (e.g. percent) when:
——测量不确定度与检测结果的有效性或应用相关时;
— it is relevant to the validity or application of the test results;
——客户有要求时;
— a customer’s instruction so requires, or
——测量不确定度影响与规范限的符合性时。
— the measurement uncertainty affects conformity to a specification limit;
d)适当时,意见和解释(见7.8.7);
d) where appropriate, opinions and interpretations (see 7.8.7);
e)特定方法、法定管理机构或客户要求的其他信息。
e) additional information which may be required by specific methods, authorities, customers or groups of customers.
7.8.3.2 如果实验室负责抽样活动,当解释检测结果需要时,检测报告还应满足7.8.5的要求。
Where the laboratory is responsible for the sampling activity, test reports shall meet the requirements listed in 7.8.5 where necessary for the interpretation of test results.
7.8.4 校准证书的特定要求Specific requirements for calibration certificates
7.8.4.1 除7.8.2的要求外,校准证书应包含以下信息:
In addition to the requirements listed in 7.8.2, calibration certificates shall include the following:
a)与被测量相同单位的测量不确定度或被测量相对形式的测量不确定度(如百分比);
a) the measurement uncertainty of the measurement result presented in the same unit as that of the measurand or in a term relative to the measurand (e.g. percent);
注:根据ISO/IEC指南99,测量结果通常表示为一个被测量值,包括测量单位和测量不确定度。
NOTE  According to ISO/IEC Guide 99, a measurement result is generally expressed as a single measured quantity value including unit of measurement and a measurement uncertainty.
b)校准过程中对测量结果有影响的条件(如环境条件);
b) the conditions (e.g. environmental) under which the calibrations were made that have an influence on the measurement results;
c)测量结果如何实现计量溯源性的声明(参见附录A);
c) a statement identifying how the measurements are metrologically traceable (see Annex A);
d)如可获得,设备被调整或修理前后的结果;
d) the results before and after any adjustment or repair, if available;
e)相关时,与要求或规范的符合性声明(见7.8.6);
e) where relevant, a statement of conformity with requirements or specifications (see 7.8.6);
f)适当时,意见和解释(见7.8.7)。
f) where appropriate, opinions and interpretations (see 7.8.7).
7.8.4.2 如果实验室负责抽样活动,当解释校准结果需要时,校准证书还应满足7.8.5的要求。
Where the laboratory is responsible for the sampling activity, calibration certificates shall meet the requirements listed in 7.8.5 where necessary for the interpretation of test results.
7.8.4.3 校准证书或校准标签不应包含校准周期的建议,除非已与客户达成协议。
A calibration certificate or calibration label shall not contain any recommendation on the calibration interval, except where this has been agreed with the customer.
7.8.5 报告抽样Reporting sampling——特定要求specific requirements
如果实验室负责抽样活动,除7.8.2中的要求外,当解释结果需要时,报告还应包含以下信息:
Where the laboratory is responsible for the sampling activity, in addition to the requirements listed in 7.8.2, reports shall include the following, where necessary for the interpretation of results:
a)抽样日期;
a) the date of sampling;
b)抽取的物品或物质的唯一性标识(适当时,包括制造商的名称、标示的型号或类型以及序列号);
b) unique identification of the item or material sampled (including the name of the manufacturer, the model or type of designation and serial numbers, as appropriate);
c)抽样位置,包括图示、草图或照片;
c) the location of sampling, including any diagrams, sketches or photographs;
d)抽样计划和抽样方法;
d) a reference to the sampling plan and sampling method;
e)抽样过程中影响结果解释的环境条件的详细信息;
e) details of any environmental conditions during sampling that affect the interpretation of the test results;
f)评定后续检测或校准测量不确定度所需的信息。
f) information required to evaluate measurement uncertainty for subsequent testing or calibration.
7.8.6 报告符合性声明Reporting statements of conformity
7.8.6.1 当做出与规范或标准的符合性声明时,实验室应考虑与所用判定规则相关的风险水平(如错误接受、错误拒绝以及统计假设),将所使用的判定规则形成文件,并应用判定规则。
When a statement of conformity to a specification or standard is provided, the laboratory shall document the decision rule employed, taking into account the level of risk (such as false accept and false reject and statistical assumptions) associated with the decision rule employed, and apply the decision rule.
注:如果客户、法规或规范性文件规定了判定规则,无需进一步考虑风险水平。
NOTE  Where the decision rule is prescribed by the customer, regulations or normative documents, a further consideration of the level of risk is not necessary.
7.8.6.2 实验室在报告符合性声明时应清晰标识:
The laboratory shall report on the statement of conformity, such that the statement clearly identifies:
a)符合性声明适用的结果;
a) to which results the statement of conformity applies;
b)满足或不满足的规范、标准或其中的条款;
b) which specifications, standards or parts thereof are met or not met;
c)应用的判定规则(除非规范或标准中已包含)。
c) the decision rule applied (unless it is inherent in the requested specification or standard).
注:详细信息见ISO/IEC指南98-4。
NOTE  For further information, see ISO/IEC Guide 98-4.
7.8.7 报告意见和解释Reporting opinions and interpretations
7.8.7.1 当表述意见和解释时,实验室应确保只有授权人员才能发布相关意见和解释。实验室应将意见和解释的依据形成文件。
When opinions and interpretations are expressed, the laboratory shall ensure that only personnel authorized for the expression of opinions and interpretations releases the respective statement. The laboratory shall document the basis upon which the opinions and interpretations have been made.
注:注意区分意见和解释与GB/T 27020中的检验声明、GB/T 27065中的产品认证声明以及7.8.6中符合性声明的差异。
NOTE  It is important to distinguish opinions and interpretations from statements of inspections and product certifications as intended in ISO/IEC 17020 and ISO/IEC 17065, and from statements of conformity as referred to in 7.8.6.
G001应用说明:
实验室可以选择是否做出意见和解释,并在管理体系中予以明确,并对其进行有效控制,包括合同评审。
注 1:根据检测或校准结果,与规范或客户的规定限量做出的符合性判断,不属于本准则所规定的“意见和解释”。“意见和解释”的示例:
• 对被测结果或其分布范围的原因分析,比如在环境中毒素的检测报告中对毒素来源的分析;
• 根据检测结果对被测样品特性的分析;
• 根据检测结果对被测样品设计、生产工艺、材料或结构等的改进建议。
注 2:在校准报告中,一般不需要做出意见和解释。CNAS 暂不开展对校准结果的意见和解释能力的认可。必要时, CNAS 将根据客户需求和相关技术专家的意见,修订此政策。
注 3:对于检测活动,实验室如果申请对某些特定检测项目的“意见和解释”能力的认可,应在申请书中予以明确,并说明针对哪些检测项目做出哪类的意见和解释,并提供以往做出“意见和解释”时所依据的文件、记录及报告。相关人员能力信息应随同申请一同提交。实验室人员如果仅从事过相关的检测活动,而不熟悉检测对象的设计、制造和使用,则不予认可其“意见和解释”能力。
7.8.7.2 报告中的意见和解释应基于被检测或校准物品的结果,并清晰地予以标注。
The opinions and interpretations expressed in reports shall be based on the results obtained from the tested or calibrated item and shall be clearly identified as such.
7.8.7.3 当以对话方式直接与客户沟通意见和解释时,应保存对话记录。
When opinions and interpretations are directly communicated by dialogue with the customer, a record of the dialogue shall be retained.
7.8.8 报告修改Amendments to reports
7.8.8.1 当更改、修订或重新发布已发出的报告时,应在报告中清晰标识修改的信息,适当时标注修改的原因。
When an issued report needs to be changed, amended or re-issued, any change of information shall be clearly identified and, where appropriate, the reason for the change included in the report.
7.8.8.2 修改已发出的报告时,应仅以追加文件或数据传送的形式,并包含以下声明:
“对序列号为……(或其他标识)报告的修改”,或其他等效文字。
Amendments to a report after issue shall be made only in the form of a further document, or data transfer, which includes the statement “Amendment to Report, serial number... [or as otherwise identified]”, or an equivalent form of wording.
这类修改应满足本标准的所有要求。
Such amendments shall meet all the requirements of this document.
7.8.8.3 当有必要发布全新的报告时,应予以唯一性标识,并注明所替代的原报告。
When it is necessary to issue a complete new report, this shall be uniquely identified and shall contain a reference to the original that it replaces.
7.9 投诉Complaints
7.9.1 实验室应有形成文件的过程来接收和评价投诉,并对投诉作出决定。如果检测和校准结果引起的投诉直接涉及军工产品质量时,实验室应立即进行调查,必要时应采取纠正措施,并保存记录。
The laboratory shall have a documented process to receive, evaluate and make decisions on complaints.
G001应用说明:实验室应及时处理收到的投诉。如果实验室收到CNAS转交的投诉,应在2个月内向CNAS反馈投诉处理结果。注:CNAS在收到对实验室的投诉时,通常情况下将转交给实验室进行处理。如果投诉内容是针对实验室能力和诚信时,CNAS将直接处理。处理方式包括安排不定期监督评审等,不定期监督评审可不预先通知实验室。
7.9.2 利益相关方有要求时,应可获得对投诉处理过程的说明。在接到投诉后,实验室应证实投诉是否与其负责的实验室活动相关,如相关,则应处理。实验室应对投诉处理过程中的所有决定负责。
A description of the handling process for complaints shall be available to any interested party on request. Upon receipt of a complaint, the laboratory shall confirm whether the complaint relates to laboratory activities that it is responsible for and, if so, shall deal with it. The laboratory shall be responsible for all decisions at all levels of the handling process for complaints.
7.9.3 投诉处理过程应至少包括以下要素和方法:
The process for handling complaints shall include at least the following elements and methods:
a)对投诉的接收、确认、调查以及决定采取处理措施过程的说明;
a) description of the process for receiving, validating, investigating the complaint, and deciding what actions are to be taken in response to it;
b)跟踪并记录投诉,包括为解决投诉所采取的措施;
b) tracking and recording complaints, including actions undertaken to resolve them;
c)确保采取适当的措施。
c) ensuring that any appropriate action is taken.
7.9.4 接到投诉的实验室应负责收集并验证所有必要的信息,以便确认投诉是否有效。
The laboratory receiving the complaint shall be responsible for gathering and verifying all necessary information to validate the complaint.
7.9.5 只要可能,实验室应告知投诉人已收到投诉,并向投诉人提供处理进程的报告和结果。
Whenever possible, the laboratory shall acknowledge receipt of the complaint, and provide the complainant with progress reports and the outcome.
7.9.6 通知投诉人的处理结果应由与所涉及的实验室活动无关的人员作出,或审查和批准。
The outcomes to be communicated to the complainant shall be made by, or reviewed and approved by, individual(s) not involved in the original laboratory activities in question.
注:可由外部人员实施。
NOTE  This can be performed by external personnel.
7.9.7 只要可能,实验室应正式通知投诉人投诉处理完毕。
Whenever possible, the laboratory shall give formal notice of the end of the complaint handling to the complainant.
7.10 不符合工作Nonconforming work
7.10.1 当实验室活动或结果不符合自身的程序或与客户协商一致的要求时(例如设备或环境条件超出规定限值、监控结果不能满足规定的准则),实验室应有程序予以实施。该程序应确保:
The laboratory shall have a procedure that shall be implemented when any aspect of its laboratory activities or results of this work do not conform to its own procedures or the agreed requirements of the customer (e.g. equipment or environmental conditions are out of specified limits, results of monitoring fail to meet specified criteria). The procedure shall ensure that:
a)确定不符合工作管理的职责和权力;
a) the responsibilities and authorities for the management of nonconforming work are defined;
b)基于实验室建立的风险水平采取措施(包括必要时暂停或重复工作以及扣发报告);
b) actions (including halting or repeating of work and withholding of reports, as necessary) are based upon the risk levels established by the laboratory;
c)评价不符合工作的严重性,包括分析对先前结果的影响;
c) an evaluation is made of the significance of the nonconforming work, including an impact analysis on previous results;
d)对不符合工作的可接受性作出决定;
d) a decision is taken on the acceptability of the nonconforming work;
e)必要时,通知客户并召回;
e) where necessary, the customer is notified and work is recalled;
f)规定批准恢复工作的职责。
f) the responsibility for authorizing the resumption of work is defined.
G001应用说明:
实验室常见的不符合工作包括(但不限于)实验室环境条件不满足要求、试验样品的处置时间不满足要求、试样未在规定的时间内检测、质量监控结果超过规定的限制、能力验证或实验室间比对结果不满意等。实验室所有人员均应熟悉不符合工作控制程序,尤其是直接从事检测、校准和抽样活动的人员。实验室在内部审核中应特别关注不符合工作控制程序的执行情况。
7.10.2 实验室应保存不符合工作和执行7.10.1中b)至f)规定的措施的记录。
The laboratory shall retain records of nonconforming work and actions as specified in 7.10.1, bullets b) to f).
7.10.3 当评价表明不符合工作可能再次发生时,或对实验室的运行与其管理体系的符合性产生怀疑时,实验室应采取纠正措施。
Where the evaluation indicates that the nonconforming work could recur, or that there is doubt about the conformity of the laboratory’s operations with its own management system, the laboratory shall implement corrective action.
G001应用说明:实验室应对发生的不符合工作的原因进行分析,对于不是偶发的、个案的问题,不应仅仅纠正发生的问题,还应按本条款要求启动纠正措施。
7.11 数据控制和信息管理Control of data and information management
7.11.1 实验室应获得开展实验室活动所需的数据和信息。
The laboratory shall have access to the data and information needed to perform laboratory activities.
GL030认可指南:实验室大型仪器如液相色谱仪、气相色谱仪等原始谱图,如果不保存纸版记录,应按照电子记录进行管理,明确保存路径并可进行追溯。
7.11.2 用于收集、处理、记录、报告、存储或检索数据的实验室信息管理系统,在投入使用前应进行功能确认,包括实验室信息管理系统中接口的正常运行。对管理系统的任何变更,包括修改实验室软件配置或现成的商业化软件,在实施前应被批准、形成文件并确认。
The laboratory information management system(s) used for the collection, processing, recording, reporting, storage or retrieval of data shall be validated for functionality, including the proper functioning of interfaces within the laboratory information management system(s) by the laboratory before introduction. Whenever there are any changes, including laboratory software configuration or modifications to commercial off-the-shelf software, they shall be authorized, documented and validated before implementation.
注1:本标准中“实验室信息管理系统”包括计算机化和非计算机化系统中的数据和信息管理。相比非计算机化的系统,有些要求更适用于计算机化的系统。
NOTE 1  In this document “laboratory information management system(s)” includes the management of data and information contained in both computerized and non-computerized systems. Some of the requirements can be more applicable to computerized systems than to non-computerized systems.
注2:常用的现成商业化软件在其设计应用范围内的使用可被视为已经过充分的确认。
NOTE 2  Commercial off-the-shelf software in general use within its designed application range can be considered to be sufficiently validated.
注3:处理与军工产品有关的检测和/或校准数据时,应实施保密措施(如,与因特网物理断开)。
G001应用说明:实验室使用信息管理系统(LIMS)时,应确保该系统满足所有相关要求,包括审核路径、数据安全和完整性等。实验室应对 LIMS 与相关认可要求的符合性和适宜性进行完整的确认,并保留确认记录;对 LIMS 的改进和维护应确保可以获得先前产生的记录。
7.11.3 实验室信息管理系统应:
The laboratory information management system(s) shall:
a)防止未经授权的访问;
a) be protected from unauthorized access;
b)被安全保护以防止篡改和丢失;
b) be safeguarded against tampering and loss;
c)在符合系统供应商或实验室规定的环境中运行,或对于非计算机化的系统,提供保护人工记录和转录准确性的条件;
c) be operated in an environment that complies with supplier or laboratory specifications or, in the case of non-computerized systems, provides conditions which safeguard the accuracy of manual recording and transcription;
d)以确保数据和信息完整性的方式进行维护;
d) be maintained in a manner that ensures the integrity of the data and information;
e)包括记录系统失效、适当的紧急措施及纠正措施的记录。
e) include recording system failures and the appropriate immediate and corrective actions.
7.11.4 当实验室信息管理系统在异地或由外部供应商进行管理和维护时,实验室应确保系统的供应商或运营商符合本标准的所有适用要求。
When a laboratory information management system is managed and maintained off-site or through an external provider, the laboratory shall ensure that the provider or operator of the system complies with all applicable requirements of this document.
7.11.5 实验室应确保员工易于获取与实验室信息管理系统相关的说明书、手册和参考数据。
The laboratory shall ensure that instructions, manuals and reference data relevant to the laboratory information management system(s) are made readily available to personnel.
7.11.6 应对计算和数据传送进行适当和系统地检查。
Calculations and data transfers shall be checked in an appropriate and systematic manner.

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