5.4.2 方法的選擇 Selection of methods
實驗室應採用滿足客戶需要並適用於所進行的檢測和(或)校準的方法,包括在抽樣的方法.應優先使用以國際、區域或國家標準發佈的方法.實驗室應確保使用標準的最新有效版本,除非該版本不適宜或不可能使用.必要時,應採用附加細則對標準加以補充,以確保應用的一致性.
The laboratory shall use test and/or calibration methods, including methods for sampling, which meet the needs of the customer and which are appropriate for the tests and/or calibrations it undertakes. Methods published in international, regional or national standards s hall preferably be used. The laboratory shall ensure that it uses the latest valid edition of a standard unless it is not appropriate or possible to do so. When necessary, the standard shall be supplemented with additional details to ensure consistent application.
當客戶未指定所用方法時,實驗室應選擇以國際、區域或國家標準發佈的,或由知名的技術組織或有關科學書籍和期刊公佈的,或由設備製造商指定的方法.實驗室制定的或採用的方法如能滿足實驗室的預期用途並以過驗證,也可使用.所選用的方法應通知客戶.在開始檢測或校準之前,實驗室應確認能夠正確地運用標準的方法.如果標準的方法發生的變化,應重新進行確認.
When the customer does not specify the method to be used, the laboratory shall select appropriate methods that have been 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. Laboratory-developed methods or methods adopted by the laboratory may also be used if they are appropriate for the intended use and if they are validated. The customer shall be informed as to the method chosen. The laboratory shall confirm that it can properly operate standard methods before introducing the tests or calibrations. If the standard method changes, the confirmation shall be repeated.
當認爲客戶提出的方法不合適或已過期時,實驗室應通知客戶.
The laboratory shall inform the customer when the method proposed by the customer is considered to be inappropriate or out of date.
5.4.3 實驗室制定的方法 Laboratory-developed methods
實驗室爲其慶用而制定檢測和校準方法的過程應是有計劃的活動,並應指定具有足夠資源的有資格的人員進行.
The introduction of test and calibration methods developed by the laboratory for its own use shall be a planned activity and shall be assigned to qualified personnel equipped with adequate resources.
計劃應隨方法制定的進度加以更新,並確保所有有關人員之間的有效溝通.
Plans shall be updated as development proceeds and effective communication amongst all personnel involved shall be ensured.
5.4.4 非標準方法 Non-standard methods
當必須使用標準方法中未包含的方法時,應徵得客戶的同意,包括對客戶要求的明確說明以及檢測和(或)校準的目的.所制定的方法在使用前應以適當的確認.
When it is necessary to use methods not covered by standard methods, these shall be subject to agreement with the customer and shall include a clear specification of the customer's requirements and the purpose of the test and/or calibration. The method developed shall have been validated appropriately before use

注:對新的檢測和(或)校準的方法,在進行檢測和(或)校準之前需製成程序.程序中至少需包含下列信息:
NOTE For new test and/or calibration methods, procedures should be developed prior to the tests and/or calibrations being performed and should contain at least the following information:
a) 適當的識別;
appropriate identification;
b) 範圍;
scope;
c) 被檢測或校準物品類型的描述;
description of the type of item to be tested or calibrated;
d) 被測定的參數或量和範圍;
parameters or quantities and ranges to be determined;
e) 裝置和設備,包括技術性能要求;
apparatus and equipment, including technical performance requirements;
f) 所需的參考標準和參考物質;
reference standards and reference materials required;
g) 要求的環境條件和所需的穩定周期;
environmental conditions required and any stabilization period needed;
h) 程序的描述,包括:
description of the procedure, including
— 物品的附加識別標誌、處置、運輸、存儲和準備;
affixing of identification marks, handling, transporting, storing and preparation of items,
— 工作開始前所進行的校核;
checks to be made before the work is started,
— 檢查設備工作是否正常,需要時,在每次使用之前對設備進行校準和調整;
checks that the equipment is working properly and, where required, calibration and adjustment of the equipment before each use,
— 觀察和結果的記錄方法;
the method of recording the observations and results,
— 需遵循的安全措施;
any safety measures to be observed;
i) 接受(或拒絕)的準則和(或)要求;
criteria and/or requirements for approval/rejection;
j) 需記錄的數據以及分析和表達的方法;
data to be recorded and method of analysis and presentation;
k) 不確定度或評定不確定度的程序.
the uncertainty or the procedure for estimating uncertainty.
5.4.5 方法的確認 Validation of methods
5.4.5.1 確認是通過核查並提供客觀證據,以證實某一特定預期用途的特殊要求得到滿足.
Validation is the confirmation by examination and the provision of objective evidence that the particular requirements for a specific intended use are fulfilled.

5.4.5.2 實驗室應對非標準方法、實驗室設計(制定)的方法、超出其預定範圍使用的標準方法、擴充和修改過的標準方法進行確認,以證實該方法適用於預期的用途.確認應盡可能全面,以滿足預定用途或應用的需要.實驗室應記錄所獲得的結果、使用的確認程序以及該方法是否適合預期用途的聲明.
The laboratory shall validate non-standard methods, laboratory-designed/developed methods, standard methods used outside their intended scope, and amplifications and modifications of standard methods to confirm that the methods are fit for the intended use. The validation shall be as extensive as is necessary to meet the needs of the given application or field of application. The laboratory shall record the results obtained, the procedure used for the validation, and a statement as to whether the method is fit for the intended use.
注1: 可包括對抽樣、處置和運輸程序的確認;
NOTE 1 Validation may include procedures for sampling, handling and transportation.
注2:用於確定某方法性能的技術性能的技術宜是下列情況之一,或是其組合:
NOTE 2 The techniques used for the determination of the performance of a method should be one of, or a combination of, the following:
— 使用參考標準或參考物質進行校準;
calibration using reference standards or reference materials;
— 與其他方法所得的結果進行比較;
comparison of results achieved with other methods;
— 實驗室間比對;
interlaboratory comparisons;
— 對影響結果的因素作系統性評審;
systematic assessment of the factors influencing the result;
— 根據對方法的理論原理和實踐經驗的科學理解,對所得結果不確定度進行的評定.
assessment of the uncertainty of the results based on scientific understanding of the theoretical principles of the method and practical experience.
注3:當對已確認的非標準方法作某些改動時,需將這些改動的影響制訂成文件,適當時需重新進行確認.
NOTE 3 When some changes are made in the validated non-standard methods, the influence of such changes s hould be documented and, if appropriate, a new validation should be carried out.
5.4.5.3 按預期用途進行評價所確認的方法得到的值的範圍和準確度,應適應客戶的需求.這些值諸如:結果的不確定度、檢出限、方法的選擇性、線性、重復性和(或)複現性限、抵禦外來影響的穩健度和(或)抵禦來自樣品(或檢測物)母體干擾的交互靈敏度.
The range and accuracy of the values obtainable from validated methods (e.g. the uncertainty of the results, detection limit, selectivity of the method, linearity, limit of repeatability and/or reproducibility, robustness against external influences and/or cross-sensitivity against interference from the matrix of the sample/test object), as assessed for the intended use, shall be relevant to the customers' needs.
注1: 確認包括對要求的詳細說明、方法我量的測定、利用該方法能滿足要求的核實以及有關確認的有效性的聲明.
NOTE 1 Validation includes specification of the requirements, determination of the characteristics of the methods, a check that the requirements can be fulfilled by using the method, and a statement on the validity.
注2:在方法制定過程中,需進行定期的評審,以證實客戶的需求仍能得到滿足.對修訂編制計劃所需的要求中的 任何變更,均需得到批准和授權.
NOTE 2 As method-development proceeds, regular review should be carried out to verify that the needs of the customer are still being fulfilled. Any change in requirements requiring modifications to the development plan should be approved and authorized.

注3:確認通常是成本、風險和技術可行性之間的一種平衡.許多情況下,由於缺乏信息,數值(如:準確度、檢出限、選擇性、線性、重復性、複現性、穩健度和交互靈敏度)的範圍和不確定度只能以簡化的方式給出.
NOTE 3 Validation is always a balance between costs, risks and technical possibilities. There are many cases in which the range and uncertainty of the values (e.g. accuracy, detection limit, selectivity, linearity, repeatability, reproducibility, robustness and cross-sensitivity) can only be given in a simplified way due to lack of information.
5.4.6 測量不確定度的評定 Estimation of uncertainty of measurement
5.4.6.1 校準實驗室或進行自校準的檢測實驗室,對所有的校準和各種校準類型都應具有並應用評定測量不確定度的程序.
A calibration laboratory, or a testing laboratory performing its own calibrations, shall have and shall apply a procedure to estimate the uncertainty of measurement for all calibrations and types of calibrations.
5.4.6.2 檢測實驗室應具有並應用評定測量不確定度的程序.某些情況下,檢測方法的性質會妨礙對測量不確定度進行嚴密的計量學和統計學上的有效計算.這種情況下,實驗室至少應努力找現出不確定度的所有分量且作出合理評定,並確保結果的表達方式不會對不確定度造成錯覺.合理的評定應依據對方法性能的理解和測量範圍,並利用諸如過去的經驗和確認的數據.
Testing laboratories shall have and shall apply procedures for estimating uncertainty of measurement. In certain cases the nature of the test method may preclude rigorous, metrologically and statistically valid, calculation of uncertainty of measurement. In these cases the laboratory shall at least attempt to identify all the components of uncertainty and make a reasonable estimation, and shall ensure that the form of reporting of the result does not give a wrong impression of the uncertainty. Reasonable estimation shall be based on knowledge of the performance of the method and on the measurement scope and shall make use of, for example, previous experience and validation data.
注1: 測量不確定度評定所需的嚴密程度取決於某些因素,諸如:
NOTE 1 The degree of rigor needed in an estimation of uncertainty of measurement depends on factors such as:
— 檢測方法的要求;
the requirements of the test method;
— 客戶的要求;
the requirements of the customer;
— 據以作出滿足某規範決定的窄限.
the existence of narrow limits on which decisions on conformity to a specification are based.
注2:某些情況下,公認的檢測方法規定了測量不確定度主要來源的值極限,並規定了計算結果的表示方式,這時,實驗室只要遵守該檢測方法和報告的說明(見 5.10),即被認爲符合本款的要求.
NOTE 2 In those cases where a well-recognized test method specifies limits to the values of the major sources of uncertainty of measurement and specifies the form of presentation of calculated results, the laboratory is considered to have satisfied this clause by following the test method and reporting instructions (see 5.10).
5.4.6.3 在評定測量不確定度時,對給定條件下的所有重要不確定度分量,均應採用適當的分析方法加以考慮.
When estimating the uncertainty of measurement, all uncertainty components which are of importance in the given situation shall be taken into account using appropriate methods of analysis.
注1:構成不確定度的不源包括(但不限於)所用的參考標準和參考物質、方法和設備、環境條件、被檢測或校準物品的性能和狀態以及操作人員.
NOTE 1 Sources contributing to the uncertainty include, but are not necessarily limited to, the reference standards and reference materials used, methods and equipment used, environmental conditions, properties and condition of the item being tested or calibrated, and the operator.
注2: 在評定測量不確度時,通常不考慮被檢測和(或)校準物品預計的長期性能.
NOTE 2 The predicted long-term behaviour of the tested and/or calibrated item is not normally taken into account when estimating the measurement uncertainty.
注3:進一步信息參見 ISO 5725 和“guide to the expression of uncertainty in measurement”(參考文獻)
NOTE 3 For further information, see ISO 5725 and the Guide to the Expression of Uncertainty in Measurement (see Bibliography).

5.4.7 數據控制 Control of data
5.4.7.1 應對計算和數據傳送進行系統和適當的檢查.
Calculations and data transfers shall be subject to appropriate checks in a systematic manner.
5.4.7.2 當利用計算機或自動設備對檢測或校準數據進行採集、處理、記錄、報告、存儲或檢索時,實驗室應確保:
When computers or automated equipment are used for the acquisition, processing, recording, reporting, storage or retrieval of test or calibration data, the laboratory shall ensure that:
a) 由使有者開發的計算機軟件應被制訂成足夠詳細的文件,並對其適用性進行適當驗證;
computer software developed by the user is documented in sufficient detail and is suitably validated as being adequate for use;
b) 建立並實施數據保護的程序.這引起程序應包括(但不限於): 數據輸入或採集、數據存儲、數據傳輸和數據處理的完整性的保密性;
procedures are established and implemented for protecting the data; such procedures shall include, but not be limited to, integrity and confidentiality of data entry or collection, data storage, data transmission and data processing;
c) 維護計算機和自動設備以確保其功能正常,並提供保護檢測和校準數據完整性所必需的環境和運行條件.
computers and automated equipment are maintained to ensure proper functioning and are provided with the environmental and operating conditions necessary to maintain the integrity of test and calibration data.
注: 通用的商業現成軟件(如文字處理、數據庫和統計程序),在其設計的應用範圍內可認爲是充分有效的.但實驗室對軟件的配置(或調整)需按 5.4.7.2.a 進行確認.
NOTE Commercial off-the-shelf software (e.g. wordprocessing, database and statistical programmes) in general use within their designed application range may be considered to be sufficiently validated. However, laboratory software configuration/modifications should be validated as in 5.4.7.2 a).

5.7 抽樣 Sampling
5.7.1 實驗室爲後續檢測或校準而對物質、材料或産品進行抽樣時,應有用於抽樣的抽樣計藍程序.抽樣計劃和程序在抽樣的地點應能夠得到.只要合理,抽樣計劃應根據適當的統計方法制定.抽樣過程應注意需要控制的因素,以確保檢測和校準結果的有效性.
The laboratory shall have a sampling plan and procedures for sampling when it carries out sampling of substances, materials or products for subsequent testing or calibration. The sampling plan as well as the sampling procedure shall be available at the location where sampling is undertaken. Sampling plans shall, whenever reasonable, be based on appropriate statistical methods. The sampling process shall address the factors to be controlled to ensure the validity of the test and calibration results.
注1:抽樣是取出物質、材料或産品的一部分作爲其整體的代表性樣品進行檢測或校準的一種規定程序.抽樣也可能是由檢測或校準該物質、材料或産品的相關規範要求的.某些情況下(如清規法醫分析),樣品可能不具備代表性,而是由其可獲性所決定.
NOTE 1 Sampling is a defined procedure whereby a part of a substance, material or product is taken to provide for testing or calibration of a representative sample of the whole. Sampling may also be required by the appropriate specification for which the substance, material or product is to be tested or calibrated. In certain cases (e.g. forensic analysis), the sample may not be representative but is determined by availability.
注2:抽樣程序宜對取自某個物質、材料或産品的一個或多個樣品的選擇、抽樣計劃、提取和製備進行描述,以提供所需的信息.
NOTE 2 Sampling procedures should describe the selection, sampling plan, withdrawal and p reparation of a sample or samples from a substance, material or product to yield the required information.
5.7.2 當客戶對文件規定的抽樣程序有偏離、添加或刪節的要求時,應詳細記錄這引起要求和相關的抽樣資料,並記入包含檢測和(或)校準結果的所有文件中,同時告知相關人員.
Where the customer requires deviations, additions or exclusions from the documented sampling procedure, these shall be recorded in detail with the appropriate sampling data and shall be included in all documents containing test and/or calibration results, and shall be communicated to the appropriate personnel .
5.7.3 當抽樣作爲檢測或校準工作的一部分時,實驗室應有程序記錄與抽樣有關的資料和操作.這些記錄應包括所用的同樣程序、抽樣人的識別、環境條件(如果相關)、必要時有抽樣地點的圖示或其他等效方法,如果合適,還應包括抽樣程序所依據的統計方法.
The laboratory shall have procedures for recording relevant data and operations relating to sampling that forms part of the testing or calibration that is undertaken. These records shall include the sampling procedure used, the identification of the sampler, environmental conditions (if relevant) and diagrams or other equivalent means to identify the sampling location as necessary and, if appropriate, the statistics the sampling procedures are based upon.

5.8 檢測和校準物品的處置 Handling of test and calibration items
5.8.1 實驗室應有用於檢測和(或)校準物品的運輸、接收、處置、保護、存儲、保留和(或)清理的程序,包括爲保護檢測和(或)校準物品的完整性以及實驗室與客戶利益所需的全部條款.
The laboratory shall have procedures for the transportation, receipt, handling, protection, storage, retention and/or disposal of test and/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.
5.8.2 實驗室應具有檢測和(或)校準物品的標識系統.物品在實驗室的整個期間應保留該標識.標識系統的統計和使用應確保物品不會在實物上或在涉及的記錄和其他文件中混淆.如果合適,標識系統應包停職物品群組的細分和物品在實驗室內外部的傳遞.
The laboratory shall have a system for identifying test and/or calibration items. The identification shall be retained throughout the life of the item in the laboratory. The system shall be designed and operated so as to ensure that items cannot be confused physically or when referred to in records or other documents. The system shall, if appropriate, accommodate a sub-division of groups of items and the transfer of items within and from the laboratory.
5.8.3 在接收檢測或校準物品時,應記錄異常情況或對檢測或校準方法中所述正常(或規定)條件的偏離.當對物品是否適合於檢測或校準存在有疑問時,或當物品不符合所提供的描述,或對所要求的檢測或校準規定得不夠詳盡時,實驗室應在開始工作之前問詢客戶,以得到進一步的說明,並記錄下討論的內容.
Upon receipt of the test or calibration item, abnormalities or departures from normal or specified conditions, as described in the test or calibration method, shall be recorded. When there is doubt as to the suitability of an item for test or calibration, or when an item does not conform to the description provided, or the test or calibration required is not specified in sufficient detail, the laboratory shall consult the customer for further instructions before proceeding and shall record the discussion.
5.8.4 實驗室應有程序和適當的設施避免檢測或校準物品在存儲、處置和準備過程中發生退化、丟失或損壞.應遵守物品提供的處理說明.當物品需要被存放或規定的環境條件下養護時,應維持、監控和記錄這些條件.當一個檢測或校準物品或其一部分需要安全保護時,實驗室應對存放和安全作出安排,以保護該物品或其有關部分的狀態和完整性.
The laboratory shall have procedures and appropriate facilities for avoiding deterioration, loss or damage to the test or calibration item during storage, handling and preparation. Handling instructions provided with the item shall be followed. When items have to be stored or conditioned under specified environmental conditions, these conditions shall be maintained, monitored and recorded. Where a test or calibration item or a portion of an item is to be held secure, the laboratory shall have arrangements for storage and security that protect the condition and integrity of the secured items or portions concerned.
注1: 在檢測之後要重新投入使用的檢測物品,需特別注意確保物品在處置、檢測或存儲(或待檢)過程中不被破壞或損傷.
NOTE 1 Where test items are to be returned into service after testing, special care is required to ensure that they are not damaged or injured during the handling, testing or storing/waiting processes.
注2: 需向負責抽樣和運樣品的人員提供有關樣品存儲和運輸的信息,包括影響檢測或校準結果的抽樣要求的信息.
NOTE 2 A sampling procedure and information on storage and transport of samples, including information on sampling factors influencing the test or calibration result, should be provided to those responsible for taking and transporting the samples.
注3: 維護檢測或校準樣品安全的原由可能出自記錄、安全或價值的原因,或是爲了日後進行補充的檢測和(或)校準.
NOTE 3 Reasons for keeping a test or calibration item secure can be for reasons of record, safety or value, or to enable complementary tests and/or calibrations to be performed later.

5.9 檢測和校準結果質量的保證 Assuring the quality of test and calibration results
5.9.1 實驗室應有質量控制程序以監控檢測和校準的有效性.所得數據的記錄方式便於可發現其發展趨勢,如可行,應採用統計技術對結果進行審查.這種監控應有計劃並加以評審,可包括(但不限於)下列內容:
The laboratory shall have quality control procedures for monitoring the validity of tests and calibrations undertaken. The resulting data shall be recorded in such a way that trends are detectable and, where practicable, statistical techniques shall be applied to the reviewing of the results. This monitoring shall be planned and reviewed and m ay include, but not be limited to, the following:
a) 定期使用有證參考物質和(或)次級參考物質進行內部質量控制;
regular use of certified reference materials and/or internal quality control using secondary reference materials;
b) 參加實驗室間的比對或能力驗證計劃;
participation in interlaboratory comparison or proficiency-testing programmes;
c) 利用相同或不同方法進行重復檢測或校準;
replicate tests or calibrations using the same or different methods;
d) 對存留物品進行再檢測或再校準;
retesting or recalibration of retained items;
e) 分析一個物品不同特性結果的相關性.
correlation of results for different characteristics of an item.
注:選用的方法需與所進行工作的類型和工作量相適應.
NOTE The selected methods should be appropriate for the type and volume of the work undertaken.
5.9.2 應分析質量控制的數據,在發現質量控制數據超出預定的判據時,應采取有計劃的措施來糾正出現的問題,並防止報告錯誤的結果.
Quality control data shall be analysed and, where they are found to be outside pre-defined criteria, planned action shall be taken to correct the problem and to prevent incorrect results from being reported.
5.10 結果報告 Reporting the results
5.10.1 總則 General
實驗室應準確、清晰、明確和客觀地報告每一項檢測、校準,或一系列的檢測或校準的結果,並符合檢測或校準方法中規定的要求.
The results of each test, calibration, or series of tests or calibrations carried out by the laboratory shall be reported accurately, clearly, unambiguously and objectively, and in accordance with any specific instructions in the test or calibration methods.
結果通常應以檢測報告或校準證書的形式出具,並且應包括客戶要求的、說明檢測或校準結果所必需的和所用方法要求的全部信息.這些信息通常是 5.10.2 和 5.10.3 和 5.10.4 中要求的內容.
The results shall be reported, usually in a test report or a calibration certificate (see Note 1), and shall include all the information requested by the customer and necessary for the interpretation of the test or calibration results and all information required by the method used. This information is normally that required by 5.10.2, and 5.10.3 or 5.10.4.

在爲內部客戶進行檢測和校準或與客戶有書面協議的情況下,可用簡化的方式報告結果.對於 5.10.2 至5.10.4 中所列卻未向客戶報告的信息,應能方便地從進行檢測和(或)校準的實驗室中獲得.
In the case of tests or calibrations performed for internal customers, or in the case of a written agreement with the customer, the results may be reported in a simplified way. Any information listed in 5.10.2 to 5.10.4 which is not reported to the customer shall be readily available in the laboratory which carried out the tests and/or calibrations.

注1: 檢測報告和校準證書有時分別稱爲檢測證書和校準報告.
NOTE 1 Test reports and calibration certificates are sometimes called test certificates and calibration reports, respectively.
注2: 只要滿足本標準的要求,檢測報告或校準證書可用硬拷貝或電子數據傳輸的方式發佈.
NOTE 2 The test reports or calibration certificates may be issued as hard copy or by electronic data transfer provided that the requirements of this International Standard are met.
5.10.2 檢測報告和校準證書 Test reports and calibration certificates
除非實驗室有充分的理由,否則每份檢測報告或校準證書應至少包括下列信息:
Each test report or calibration certificate shall include at least the following information, unless the laboratory has valid reasons for not doing so:
a) 標題(例如“檢測報告”或“校準證書”);
a title (e.g. “Test Report” or “Calibration Certificate”);
b) 實驗室的名稱和地址,進行檢測和(或)校準的地點(如果與實驗室的地址不同);
the name and address of the laboratory, and the location where the tests and/or calibrations were c arried out, if different from the address of the laboratory;
c) 檢測報告或校準證書的唯一性標識(如系列號)和每一頁上的標識,確保能夠識別該頁是屬於檢測報告或校準證書的一部分,以及表明檢測報告或校準證書結束的清晰標識;
unique identification of the test report or calibration certificate (such as the serial number), and on each page an identification in order to ensure that the page is recognized as a part of the test report or calibration certificate, and a clear identification of the end of the test report or calibration certificate;
d) 客戶的名稱和地址;
the name and address of the customer;
e) 所用方法的標識;
identification of the method used;
f) 檢測或校準物品的描述、狀態和明確的標識;
a description of, the condition of, and unambiguous identification of the item(s) tested or calibrated;
g) 對結果的有效性和應用至關重要的檢測或校準物品的接收日期和進行檢測或校準的日期;
the date of receipt of the test or calibration item(s) where this is critical to the validity and application of the results, and the date(s) of performance of the test or calibration;
h) 如與結果的有結果的效性和應用相關時,實驗室或其他機構所用的抽樣計劃和程序的說明;
reference to the sampling plan and procedures used by the laboratory or other bodies where these are relevant to the validity or application of the results;
i) 檢測和校準的結果,適用時,帶有測量單位;
the test or calibration results with, where appropriate, the units of measurement;
j) 檢測報告或校準證書批准人的姓名、職務、簽字或等同的標識;
the name(s), function(s) and signature(s) or equivalent identification of person(s) authorizing the test report or calibration certificate;
k) 相關之處,結果僅與被檢測或被校準物品有關的聲明.
where relevant, a statement to the effect that the results relate only to the items tested or calibrated.
注1:檢測報告和校準證書的硬拷貝也需有頁碼和總頁數.
NOTE 1 Hard copies of test reports and calibration certificates should also include the page number and total number of pages.
注2:建議實驗室作出未經實驗室書面批准,不得複製(全文複製除外)檢測報告或校準證書的聲明.
NOTE 2 It is recommended that laboratories include a statement specifying that the test report or calibration c ertificate shall not be reproduced except in full, without written approval of the laboratory.

5.10.3 檢測報告 Test reports
5.10.3.1 當需對檢測結果作出解釋時,除 5.10.2 中所列的要求之外,檢測報告中還應包括下列內容:
In addition to the requirements listed in 5.10.2, test reports shall, where necessary for the interpretation of the test results, include the following:
a) 對檢測方法的偏離、增添或刪節,以及特殊檢測條件的信息,如環境條件;
deviations from, additions to, or exclusions from the test method, and information on specific test conditions, such as environmental conditions;
b) 需要時,符合(或不符合)要求和(或)規範的聲明;
where relevant, a statement of compliance/non-compliance with requirements and/or specifications;
c) 適用時,評定測量不確定度的聲明.當不確定度與檢測結果的有效性或應用有關,或客戶的指令中有要求,或當不確定度影響到對限度的符合性,檢測報告中還需要包括不確定度的信息;
where applicable, a statement on the estimated uncertainty of measurement; information on uncertainty is needed in test reports when it is relevant to the validity or application of the test results, when a customer's instruction so requires, or when the uncertainty affects compliance to a specification limit;
d) 適用時,提出意見和解釋(見5.10.5);
where appropriate and needed, opinions and interpretations (see 5.10.5);
e) 特定方法、客戶或客戶群體要求的附加信息.
additional information which may be required by specific methods, customers or groups of customers.
5.10.3.2 當需對檢測結果作解釋時,對含抽樣結果在內的檢測報告,除此之外了 5.10.2 和 5.10.3.1 所列的要求之外,還應包括下列內容:
In addition to the requirements listed in 5.10.2 and 5.10.3.1, test reports containing the results of sampling shall include the following, where necessary for the interpretation of test results:
a) 抽樣日期;
the date of sampling;
b) 抽取的物質、材料或産品的清晰標識(適當時,包括製造者的名稱、標示的型號或類型和相應的系列號);
unambiguous identification of the substance, material or product sampled (including the name of the manufacturer, the model or type of designation and serial numbers as appropriate);
c) 抽樣地點,包括任何簡圖、草圖或照片;
the location of sampling, including any diagrams, sketches or photographs;
d) 所用抽樣計劃和程序的說明;
a reference to the sampling plan and procedures used;
e) 抽樣過程中可能影響檢測結果解釋的環境條件的詳細信息;
details of any environmental conditions during sampling that may affect the interpretation of the test results;
f) 與抽樣方法或程序有關的標準或規範,以及對這些規範的偏離、增添或刪節.
any standard or other specification for the sampling method or procedure, and deviations, additions to or exclusions from the specification concerned.
5.10.4 校準證書 Calibration certificates
5.10.4.1 如需對校準結果進行解釋時,除 5.10.2 中所列的要求之外,校準證書還應包含下列內容:
In addition to the requirements listed in 5.10.2, calibration certificates shall include the following, where necessary for the interpretation of calibration results:
a) 校準活動中對測量結果有影響的條件(例如環境條件);
the conditions (e.g. environmental) under which the calibrations were made that have an influence on the measurement results;
b) 測量不確定度和(或)符合確定的計量規範或條款的聲明;
the uncertainty of measurement and/or a statement of compliance with an identified metrological specification or clauses thereof;
c) 測量可溯源證據(見5.6.2.1.1注2).
evidence that the measurements are traceable (see Note 2 in 5.6.2.1.1).
5.10.4.2 校準證書應僅與量和功能性檢測的結果有關,如欲作出符合某規範的聲明,就指明符合或不符合該規範的那些條款.
The calibration certificate shall relate only to quantities and the results of functional tests. If a statement of compliance with a specification is made, this shall identify which clauses of the specification are met or not met.
當符合某規範的聲明中略去了測量結果和相關的不確定度時,實驗室應記錄並保存這些結果,以備日後查閱.
When a statement of compliance with a specification is made omitting the measurement results and associated uncertainties, the laboratory shall record those results and maintain them for possible future reference.
作出符合性聲明時,應考慮測量不確定度.
When statements of compliance are made, the uncertainty of measurement shall be taken into account.
5.10.4.3 當用於校準的儀器已被調整或修理時,如果可獲得,應報告調整或修理前後的校準結果.
When an instrument for calibration has been adjusted or repaired, the calibration results before and after adjustment or repair, if available, shall be reported.

5.10.4.4 校準證書(或校準標簽)不應包含對校準的時間間隔的建議,除非已與客戶在成協議.該要求可能被法規取代.
A calibration certificate (or calibration label) shall not contain any recommendation on the calibration interval except where this has been agreed with the customer. This requirement may be superseded by legal regulations.
5.10.5 意見和解釋 Opinions and interpretations
當證書中包含意見和解釋時,實驗室應把意見和解釋的依據制訂成文件.與在檢測報告中一樣,意見和解釋應被清晰標注.
When opinions and interpretations are included, the laboratory shall document the basis upon which the opinions and interpretations have been made. Opinions and interpretations s hall be clearly marked as such in a test report.
注1:意見和解釋不應與ISO/IEC 17020和ISO/IEC指南65中所指的檢查和産品認證相混淆.
NOTE 1 Opinions and interpretations should not b e confused with inspections and product certifications as intended in ISO/IEC 17020 and ISO/IEC Guide 65.
注2:檢測報告中包含的意見和解釋可以包括(但不限於)下列內容:
NOTE 2 Opinions and interpretations included in a test report may comprise, but not be limited to, the following:
— 關於結果符合(或不符合)要求聲明的意見;
an opinion on the statement of compliance / noncompliance of the results with requirements;
— 合同要求的履行;
fulfilment of contractual requirements;
— 如何使用結果的建議;
recommendations on how to use the results;
— 用於改進的指導.
guidance to be used for improvements.
注3:許多情況下,通過與客戶直接對話來傳達意見和解釋或許更爲恰當,但這些對話需有文字記錄.
NOTE 3 In many cases it might be appropriate to communicate the opinions and interpretations by direct dialogue with the customer. Such dialogue should be written down.
5.10.6 從分包方獲得的檢測和校準結果 Testing and calibration results obtained from subcontractors
當檢測報告包含了由分包方所出具的檢測結果時,這些結果應予清晰標明.分包方應以書面或電子方式報告結果.
When the test report contains results of tests performed by subcontractors, these results shall be clearly identified. The subcontractor shall report the results in writing or electronically.
當校準工作被分包時,執行該工作的實驗室應向分包給其工作的實驗室出具校準證書.
When a calibration has been subcontracted, the laboratory performing the work shall issue the calibration certificate to the contracting laboratory.
5.10.7 結果的電子傳送 Electronic transmission of results
當用電話、電傳、傳真或其他電子或電磁方式傳送檢測或校準結果時,應滿足本標準的要求(見 5.4.7).
In the case of transmission of test or calibration results by telephone, telex, facsimile or other electronic or electromagnetic means, the requirements of this International Standard shall be m et (see also 5.4.7).

5.10.8 報告和證書的格式 Format of reports and certificates
報告和證書的格式應設計爲適用於所進行的各種檢測或校準類型,並儘量減小産生誤解或誤用的可能性.
The format shall be designed to accommodate each type of test or calibration carried out and to minimize the possibility of misunderstanding or misuse.
注1: 需注意檢測報告或校準證書的編排尤其是檢測或校準數據的表達方式,並易於讀者理解.
NOTE 1 Attention should be given to the lay-out of the test report or calibration certificate, especially with regard to the presentation of the test or calibration data and ease of assimilation by the reader.
注2:表頭需盡可能地標準化.
NOTE 2 The headings should be standardized as far as possible.
5.10.9 檢測報告和校準證書的修改 Amendments to test reports and calibration certificates
對已布的檢測報告或校準證書的實質性修改,應僅以追加文件或資料調換的形式,並包括如下聲明:
Material amendments to a test report or calibration certificate after issue shall be made only in the form of a further document, or data transfer, which includes the statement:
“對檢測報告(或校準證書)的補充,系列號 ……(或其他標識)”,或其他等同的文字形式.
“Supplement to Test Report [or Calibration Certificate], serial number... [or as otherwise identified]”, or an equivalent form of wording.
這種修改應滿足本標準的所有要求.
Such amendments shall meet all the requirements of this International Standard.
當有必要發佈全新的檢測報告或校準證書時,應注以唯一性標識,並注明所替代的原件.
When it is necessary to issue a complete new test report or calibration certificate, this shall be uniquely identified and shall contain a reference to the original that it replaces.