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GBT 27025-2019 General requirements for testing and calibration laboratory capabilities
GB/T 27025-2019 General requirements for testing and calibration laboratory capabilities (full text analysis), this standard specifies general requirements for laboratory capabilities, impartiality and consistent operation. This standard applies to all organizations engaged in laboratory activities, regardless of the number of personnel.
Edited at 2024-11-28 14:09:46
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Questo è il capitolo 5 del libro dell'insegnante Zhao Zhou "Questo è abbastanza da leggere", che parla principalmente di questi aspetti: ① L'importanza dell'abilità di apprendimento ② Come aggiungere contesto alle informazioni ③ Come distinguere la conoscenza e le informazioni Non mi affretta a mettere in discussione e sfidare ⑤Come usare note appiccicose per aggiornare la capacità di apprendimento ⑥ Perché inseguire i "merci secche" uno pseudo-apprendimento?
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GBT 27025-2019 General requirements for testing and calibration laboratory capabilities
- È sufficiente leggere in questo modo Capitolo 5 Creazione di tre dimensioni della capacità di apprendimento
Questo è il capitolo 5 del libro dell'insegnante Zhao Zhou "Questo è abbastanza da leggere", che parla principalmente di questi aspetti: ① L'importanza dell'abilità di apprendimento ② Come aggiungere contesto alle informazioni ③ Come distinguere la conoscenza e le informazioni Non mi affretta a mettere in discussione e sfidare ⑤Come usare note appiccicose per aggiornare la capacità di apprendimento ⑥ Perché inseguire i "merci secche" uno pseudo-apprendimento?
- Collezione dell'utente di DeepSeek
Per aiutare tutti a usare DeepSeek in modo più efficiente, è stata compilata una raccolta di Map Mind Mind Guide DeepSeek! Questa mappa mentale riassume il contenuto principale: collegamenti correlati a Yitu, analisi del profilo DS, confronto tra rotte tecnologiche DeepSeek e Chatgpt, Guida di distribuzione del modello DeepSeek e Qwen, come fare più soldi con DeepSeek, come giocare a DeepSeek, DeepSeek Scientific Research Application Aspetta, permettendoti di cogliere rapidamente l'essenza dell'interazione AI. Che si tratti di creazione di contenuti, pianificazione del piano, generazione di codice o miglioramento dell'apprendimento, DeepSeek può aiutarti a ottenere il doppio del risultato con metà dello sforzo!
- DeepSeek 30 Istruzioni di alimentazione
Questa è una mappa mentale sulle 30 istruzioni a livello di alimentazione di DeepSeek.
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GB/T 27025-2019 General requirements for competence of testing and calibration laboratories
1 range
This standard specifies general requirements for laboratory competence, impartiality and consistent operation.
This standard applies to all organizations engaged in laboratory activities, regardless of the number of personnel.
This standard is used by the laboratory's customers, statutory regulatory agencies, organizations and programs using peer review, accreditation bodies, and others to demonstrate or recognize laboratory competency.
2 Normative reference documents
The following documents are essential for the application of this document. For dated references, only the dated version applies to this document. For undated referenced documents, the latest version (including all amendments) applies to this document.
ISO/IEC Guide 99 International Vocabulary of Metrology Basic and general concepts and related terms (VIM) (International
vocabulary of metrology—Basic and general concepts and associated terms (VIM))"
ISO/IEC17000 Conformity assessment Vocabulary and general principles (Conformity assessment—Vocabulary and general principles)
3 Terms and definitions
The terms and definitions defined in ISO/IEC Guide 99 and ISO/IEC 17000 and the following apply to this document.
The address of the terminology database maintained by ISO and IEC for standardization is as follows:
——ISO online browsing platform: http://www.iso.org/obp;
——IEC electronic open platform: http://www.electropedia.org/.
3.1 impartiality
The existence of objectivity.
Note 1: Objectivity means that conflicts of interest do not exist or have been resolved and will not adversely affect the subsequent activities of the laboratory (3.6).
Note 2: Other terms that may be used to express elements of impartiality are: no conflict of interest, no prejudice, no bias, neutrality, fairness, open-mindedness, impartiality, freedom from influence by others, balance.
Note 3: Adapted from GB/T 27021.1-2017, definition 3.2. Modification—Replace “certification body” with “laboratory” in Note 1, and delete “independent” in Note 2.
3.2 Complaints
Any person or organization expressing dissatisfaction with its activities or results to the laboratory (3.6) and expecting a response.
Note: Adapted from GB/T 27000-2006, definition 6.5. Modification - "Except for appeals" has been deleted, and "the laboratory with respect to its activities or results" has been replaced with "conformity assessment body or accreditation body with respect to its activities".
3.3 interlaboratory comparison
The organization, implementation and evaluation of measurements or testing of the same or similar items by two or more laboratories according to pre-specified conditions.
[GB/T 27043-2012, definition 3.4]
1) ISO/IEC Guide 99 is also known as JCGM 200.
3.4 intralaboratory comparison intralaboratory comparison
The organization, implementation and evaluation of measurements or tests on the same or similar items within the same laboratory (3.6) according to pre-specified conditions.
3.5 proficiency testing proficiency testing
Utilize interlaboratory comparisons to evaluate participant abilities against pre-established criteria.
Note: Rewritten GB/T 27043-2012, definition 3.7, modified - deleted the note.
3.6 laboratory laboratory
An organization engaged in one or more of the following activities:
——Detection;
--calibration;
— Sampling associated with subsequent testing or calibration.
Note: In this standard, "laboratory activities" refers to the above three activities.
3.7 decision rule decision rule
Rules describing how measurement uncertainty is taken into account when claiming conformity with specified requirements.
3.8 verification verification
Provide objective evidence that a given project meets specified requirements.
Example 1: Confirmation that the homogeneity of a given reference material is consistent with its claim for the relevant quantities and measurement procedures when measuring sample masses as small as 10 mg.
Example 2: Confirmation that the performance characteristics or statutory requirements of the measurement system have been met.
Example 3: Confirmation that the target measurement uncertainty is met.
Note 1: When applicable, measurement uncertainty should be considered.
Note 2: An item can be, for example, a process, measurement procedure, substance, compound or measurement system.
Note 3: Meets specified requirements, such as manufacturer's specifications.
Note 4: Verification defined in the International Legal Metrology Terminology (VIML), and verification generally referred to in conformity assessment, refers to the inspection and marking of the measurement system and/or the issuance of a verification certificate.
Note 5: Verification should not be confused with calibration. Not every verification is a confirmation (3.9).
Note 6: In chemistry, when verifying the identity or activity of an entity, it is necessary to describe the structure or properties of the entity or activity.
[ISO/IEC Guide 99:2007, Definition 2.44]
3.9 Confirmation
Verification that specified requirements meet the intended use (3.8).
Example: A measurement procedure commonly used to measure the mass concentration of nitrogen in water can also be used to measure the mass concentration of nitrogen in human serum after validation.
[ISO/IEC Guide 99:2007, Definition 2.45]
4 General requirements
4.1 Impartiality
4.1.1 The laboratory should implement laboratory activities fairly and ensure impartiality in terms of organizational structure and management.
4.1.2 Laboratory management should make a commitment to impartiality.
4.1.3 The laboratory shall be responsible for the impartiality of laboratory activities and shall not allow commercial, financial or other pressures to compromise impartiality.
4.1.4 The laboratory should continuously identify risks that affect impartiality. These risks should include risks arising from laboratory activities, relationships within the laboratory, or relationships with laboratory personnel. However, these relationships do not necessarily create risks to the integrity of the laboratory.
NOTE: Relationships that jeopardize the integrity of a laboratory may be based on ownership, control, management, personnel, shared resources, finance, contracts, marketing (including branding), payment of sales commissions, or commissions for referring clients.
4.1.5 If a risk to impartiality is identified, the laboratory should be able to demonstrate how this risk has been eliminated or minimized.
4.2 Confidentiality
4.2.1 The laboratory shall assume management responsibility for all information obtained or generated during laboratory activities by making legally binding commitments. The laboratory should provide advance notice to customers of the information it intends to disclose. Except for information disclosed by the customer, or when the laboratory has an agreement with the customer (for example, for the purpose of responding to a complaint), all other information is considered proprietary information and shall be kept confidential.
4.2.2 When the laboratory discloses confidential information as required by law or authorized by contract, the laboratory shall notify the relevant customer or individual of the information provided, unless prohibited by law.
4.2.3 The laboratory should keep confidential information about customers obtained from sources other than customers (such as complainants, regulatory agencies) between the customer and the laboratory. Unless the information provider agrees, the laboratory shall keep the information provider (source) confidential and shall not disclose it to the customer.
4.2.4 Personnel, including committee members, contracted personnel, personnel from outside agencies, or individuals representing the laboratory, shall keep confidential all information obtained or generated in the conduct of laboratory activities, except as required by law.
5 structural requirements
5.1 The laboratory shall be a legal entity, or a clearly defined part of a legal entity, which shall bear legal responsibility for laboratory activities.
NOTE: For the purposes of this standard, government laboratories are considered legal entities based on their government status.
5.2 The laboratory should determine the management who is fully responsible for the laboratory.
5.3 The laboratory should determine the scope of laboratory activities that comply with this standard and formulate documents. The laboratory shall declare only the scope of laboratory activities that comply with this standard and shall not include laboratory activities that are continuously obtained from outside sources.
5.4 The laboratory shall carry out laboratory activities in a manner that meets the requirements of this Standard, the laboratory's clients, statutory regulatory bodies and organizations providing recognition, including in fixed facilities, locations other than fixed facilities, temporary or mobile facilities, and clients' facilities. Implemented laboratory activities.
5.5 The laboratory shall:
a) Determine the organizational and management structure of the laboratory, its position within the parent organization, and the relationship between management, technical operations and support services;
b) define the responsibilities, authorities and interrelationships of all management, operating or verification personnel who have an impact on the results of laboratory activities;
c) Document procedures to a level of detail that ensures the consistency of laboratory activities and the validity of results.
5.6 The laboratory should have personnel who perform the following responsibilities (whether or not they are assigned other responsibilities) and should be given the necessary authority and resources:
a) Implement, maintain and improve the management system;
b) Identify deviations from the management system or laboratory activity procedures;
c) take steps to prevent or minimize such deviations;
d) Report the operating status of the management system and improvement needs to the laboratory management;
e) Ensure the effectiveness of laboratory activities.
5.7 Laboratory management should ensure that:
a) Communicate on the effectiveness of the management system and the importance of meeting customer and other requirements;
b) Maintain the integrity of the management system when planning and implementing changes to the management system.
6 Resource requirements
6.1 General
The laboratory should have access to the personnel, facilities, equipment, systems and support services necessary to manage and implement laboratory activities.
6.2 Personnel
6.2.1 All personnel who may affect laboratory activities, whether internal or external, should behave fairly, be competent and work in accordance with the requirements of the laboratory management system.
6.2.2 The laboratory shall document the competency requirements for each function that affects the results of laboratory activities, including requirements for education, qualifications, training, technical knowledge, skills and experience.
6.2.3 The laboratory should ensure that personnel have the ability to carry out the laboratory activities for which they are responsible, as well as the ability to assess the impact of deviations.
6.2.4 Laboratory management should communicate its responsibilities and authorities to laboratory personnel.
6.2.5 The laboratory should have procedures for the following activities and keep relevant records:
a) Determine competency requirements;
b) Personnel selection;
c)Personnel training;
d) Personnel supervision;
e) Personnel authorization;
f) Monitoring of personnel capabilities.
6.2.6 The laboratory should authorize personnel to engage in specific laboratory activities, including but not limited to the following activities:
a) Develop, modify, verify and validate methods;
b) Analysis results, including compliance statements or opinions and explanations;
c) Report, review and approve results.
6.3 Facilities and environmental conditions
6.3.1 Facilities and environmental conditions should be suitable for laboratory activities and should not adversely affect the validity of results.
Note: Factors that may adversely affect the validity of results may include, but are not limited to: microbial contamination, dust, electromagnetic interference, radiation, humidity, power supply, temperature, sound and vibration.
6.3.2 The laboratory shall document the requirements for facilities and environmental conditions necessary for laboratory activities.
6.3.3 When relevant specifications, methods or procedures require environmental conditions, or when environmental conditions affect the validity of results, the laboratory shall monitor, control and record the environmental conditions.
6.3.4 The laboratory should implement, monitor and regularly review measures to control facilities. These measures should include but are not limited to:
a) Access to and use of areas affecting laboratory activities;
b) Prevent contamination, interference or adverse effects on laboratory activities;
c) Effectively isolate incompatible laboratory activity areas.
6.3.5 When the laboratory implements laboratory activities in places or facilities outside permanent control, it should ensure that the requirements for facilities and environmental conditions in this standard are met.
6.4 Equipment
6.4.1 The laboratory should obtain the equipment required to properly carry out laboratory activities and affect the results, including but not limited to: measuring instruments, software, measurement standards, reference materials, reference data, reagents, consumables or auxiliary devices.
Note 1: Standard materials and certified reference materials have many names, including standard samples, reference standards, calibration standards, standard reference materials and quality control materials.
ISO 17034 gives further information on reference material producers. Producers of reference materials that meet the requirements of ISO 17034 are considered competent.
Reference material producers that meet the requirements of ISO 17034 provide a product information sheet/certificate containing at least the specified properties of uniformity and stability, among other properties. For certified reference materials, the information includes standard values for specified properties, associated measurement uncertainty and metrological traceability.
Note 2: ISO Guide 33 gives guidance on the selection and use of reference materials. ISO Guide 80 gives guidance on the in-house preparation of quality control substances.
6.4.2 When the laboratory uses equipment other than permanent control, it should ensure that the requirements of this standard for the equipment are met.
6.4.3 The laboratory shall have procedures for handling, transporting, storing, using and scheduled maintenance of equipment to ensure its proper function and to prevent contamination or performance degradation.
6.4.4 Before equipment is put into service or put back into service, the laboratory shall verify that it complies with specified requirements.
6.4.5 The equipment used for measurement should be able to achieve the required measurement accuracy and/or measurement uncertainty to provide valid results.
6.4.6 Measuring equipment shall be calibrated under the following circumstances:
— When measurement accuracy or measurement uncertainty affects the validity of the reported results; and/or
— To establish metrological traceability of reported results, calibration of equipment is required.
NOTE: Equipment types that affect the validity of reported results may include:
- Equipment used to directly measure the measured object, such as using a balance to measure mass;
- Equipment used to correct measured values, such as temperature measurement;
—A device used to calculate and obtain measurement results from multiple quantities.
6.4.7 The laboratory should develop a calibration plan and review and make necessary adjustments to maintain confidence in the calibration status.
6.4.8 All equipment that requires calibration or has a specified validity period should be identified with labels, codes or other means to allow equipment users to easily identify the calibration status or validity period.
6.4.9 If the equipment is overloaded or mishandled, gives questionable results, has been shown to be defective or exceeds specified requirements, it should be discontinued. These devices should be segregated to prevent misuse or labeled/marked to clearly indicate that the device is out of service until it has been verified to be functioning properly. The laboratory should examine the effects of equipment defects or deviations from specified requirements and should initiate nonconforming work management procedures (see 7.10).
6.4.10 When periodic verification is required to maintain confidence in equipment performance, the verification should be carried out according to procedures.
6.4.11 If calibration and reference material data contain reference values or correction factors, the laboratory shall ensure that the reference values and correction factors are appropriately updated and applied to meet specified requirements.
6.4.12 The laboratory should have practical measures to prevent equipment from being accidentally adjusted and causing invalid results.
6.4.13 The laboratory should keep records of equipment that affects laboratory activities. When applicable, records should include the following:
a) Identification of the device, including software and firmware versions;
b) Manufacturer’s name, model number, serial number or other unique identifier;
c) Verification evidence that the equipment meets specified requirements;
d) Current location;
e) Calibration date, calibration results, equipment adjustments, acceptance criteria, scheduled date of next calibration or calibration cycle;
f) Documents, results, acceptance criteria, relevant dates and validity periods of reference materials;
g) Maintenance plans and performed maintenance related to equipment performance;
h) Details of damage, malfunction, modification or repair of equipment.
6.5 Metrological traceability
6.5.1 The laboratory shall establish and maintain metrological traceability of measurement results through a documented, uninterrupted chain of calibrations, linking measurement results to appropriate reference objects. Each calibration introduces measurement uncertainty.
Note 1: In ISO/IEC Guide 99, metrological traceability is defined as “the characteristic of linking measurement results to a reference object through an uninterrupted calibration chain specified in the document. Each calibration in the calibration chain introduces measurement uncertainty. Spend".
Note 2: See Appendix A for more information on metrological traceability.
6.5.2 The laboratory shall ensure that measurement results are traceable to the International System of Units (SI) through the following methods:
a) Calibration provided by a competent laboratory; or
Note 1: Laboratories that meet the requirements of this standard are considered competent.
b) Standard values of certified reference materials provided by a competent reference material producer and declared to be metrologically traceable to SI; or
Note 2: Producers of reference materials that meet the requirements of ISO 17034 are considered competent.
c) Direct reproduction of SI units, guaranteed by direct or indirect comparison with national or international standards.
Note 3: The SI manual gives details of actual reproduction of some important unit definitions.
6.5.3 When metrological traceability to SI units is technically impossible, the laboratory should demonstrate that metrological traceability to an appropriate reference object is possible, such as:
a) Standard values of certified reference materials provided by competent reference material producers;
b) The results of reference measurement procedures, prescribed methods or protocol standards that are clearly described, meet the intended purpose and are guaranteed by appropriate comparisons.
6.6 Externally provided products and services
6.6.1 The laboratory shall ensure the suitability of externally provided products and services that affect laboratory activities, including:
a) For the laboratory’s own activities;
b) Provide part or all of it directly to customers;
c) Used to support laboratory operations.
Note: Products may include measurement standards and equipment, auxiliary equipment, consumable materials and reference materials. Services may include calibration services, sampling services, testing services, facility and equipment maintenance services, proficiency testing services, and review and audit services.
6.6.2 The laboratory should have procedures for the following activities and keep relevant records:
a) Determine, review and approve the laboratory’s requirements for externally provided products and services;
b) Establish criteria for evaluating, selecting, monitoring performance and re-evaluating external suppliers;
c) Before using externally provided products and services, or before providing them directly to customers, ensure that they meet the requirements specified by the laboratory or, where applicable, the relevant requirements of this standard;
d) Take actions based on the results of evaluation, monitoring performance and re-evaluation of external suppliers.
6.6.3 The laboratory should communicate with external suppliers to clarify the following requirements:
a) Products and services to be provided;
b) Acceptance criteria;
c) Competencies, including required qualifications of personnel;
d) Activities intended to be performed by the laboratory or its customers at the external supplier's premises.
7 Process requirements
7.1 Review of requirements, bids and contracts
7.1.1 The laboratory should have procedures for review of requirements, bids and contracts. The procedure should ensure:
a) Requirements are fully specified, documented and understandable;
b) the laboratory has the capabilities and resources to meet these requirements;
c) When using external suppliers, the requirements of 6.6 should be met, and the laboratory should inform customers of laboratory activities performed by external suppliers and obtain customer consent;
NOTE 1: Externally provided laboratory activities may be used under the following circumstances:
——The laboratory has the resources and capabilities to carry out the activities, but is unable to undertake some or all of the activities due to unforeseen reasons;
——The laboratory does not have the resources and capabilities to implement the activity.
d) Select appropriate methods or procedures that meet customer requirements.
Note 2: For internal or routine customers, review of requirements, bids and contracts may be simplified.
7.1.2 When the method requested by the customer is unsuitable or out of date, the laboratory shall notify the customer.
7.1.3 When the customer requires a statement of compliance with a specification or standard for testing or calibration (such as pass/fail, within the allowable limit/exceed the allowable limit), the specification or standard and the judgment rules should be clearly defined. The client should be notified of the decision rules chosen and agreed to, unless the specification or standard itself already contains decision rules.
Note: Detailed guidance on declarations of conformity is provided in ISO/IEC Guide 98-4.
7.1.4 Any differences between the requirements or bid and contract shall be resolved before laboratory activities are carried out. Each contract shall be acceptable to both the laboratory and the client. Deviations from customer requirements should not affect the integrity of the laboratory or the validity of the results.
7.1.5 Any deviation from the Contract shall be notified to the Client.
7.1.6 If the contract is modified after work has started, the contract should be reviewed again and all affected personnel should be notified of the modifications.
7.1.7 The laboratory shall cooperate with the customer or his or her representatives in clarifying customer requirements and allowing the customer to monitor related work performance.
Note: This cooperation may include:
a) Allow customers reasonable access to relevant areas of the laboratory to witness laboratory activities related to the customer;
b) Preparation, packaging and dispatch of items required by the customer for verification purposes.
7.1.8 The laboratory shall maintain review records, including review records of any significant changes. Discussions with customers regarding customer requirements or results of laboratory activities should also be retained as records.
7.2 Method selection, verification and validation
7.2.1 Method selection and validation
7.2.1.1 The laboratory shall use appropriate methods and procedures to conduct all laboratory activities, including, where appropriate, the assessment of measurement uncertainty and the use of statistical techniques for data analysis.
Note: The "method" used in this standard can be regarded as a synonym for the "measurement procedure" defined in ISO/IEC Guide 99.
7.2.1.2 All methods, procedures and supporting documents, such as instructions, standards, manuals and reference data relevant to laboratory activities, shall remain current and readily accessible to personnel (see 8.3).
7.2.1.3 The laboratory shall ensure that the latest valid version of the method is used unless it is inappropriate or impossible to do so. When necessary, details on the use of methods should be supplemented to ensure consistent application.
NOTE: If international, regional or national standards, or other recognized normative texts contain sufficient and concise information for the performance of laboratory activities and can be easily used by laboratory operators, they do not need to be supplemented or adapted into internal procedures. It may be necessary to develop implementation details or provide supplementary documentation for optional steps in the methodology.
7.2.1.4 When the client does not specify the method to be used, the laboratory shall select the appropriate method and notify the client. It is recommended to use methods published in international standards, regional standards or national standards, or methods published by well-known technical organizations or relevant scientific literature or journals, or methods specified by equipment manufacturers. Laboratory developed or modified methods may also be used.
7.2.1.5 Before introducing a method, the laboratory should verify that the method can be used correctly to ensure that the required method performance is achieved. Verification records should be maintained. If the issuing agency modifies the method, the validation should be re-validated based on the method changes.
7.2.1.6 When method development is required, it should be planned and competent personnel should be designated and provided with adequate resources. During method development, periodic reviews should be conducted to ensure that customer needs are continued to be met. Any changes to the development plan should be approved and authorized.
7.2.1.7 Deviations from all laboratory activity methods should be documented in advance, authorized and accepted by the customer after technical judgment.
Note: The customer's acceptance of deviations can be agreed in advance in the contract.
7.2.2 Method validation
7.2.2.1 The laboratory shall validate non-standard methods, laboratory-developed methods, standard methods used beyond the intended scope, or other modified standard methods. Qualification should be as comprehensive as possible to meet the needs of the intended use or application area.
Note 1: Validation may include sampling, handling and transportation procedures for test or calibration items.
Note 2: Method validation can be performed using one or more of the following techniques:
a) Use reference standards or reference materials for calibration or assessment of bias and precision;
b) Conduct a systematic review of factors affecting the results;
c) Test the robustness of the method by changing controlled parameters (such as incubator temperature, sample volume, etc.);
d) Compare the results with other confirmed methods;
e) Inter-laboratory comparison;
f) Evaluate the measurement uncertainty of the results based on the understanding of the method principles and practical experience with the sampling or testing methods.
7.2.2.2 When modifications are made to a validated method, the effects of these modifications should be determined. When it is found that the original validation is affected, the method should be re-validated.
7.2.2.3 When evaluating the performance characteristics of a validated method against its intended use, it should be ensured that it is relevant to customer needs and meets specified requirements.
Note: Method performance characteristics may include, but are not limited to: measurement range, accuracy, measurement uncertainty of results, detection limit, quantitation limit, method selectivity, linearity, repeatability or reproducibility, robustness against external influences Cross-sensitivity and bias against interference from the sample or test article matrix.
7.2.2.4 The laboratory should keep the following method validation records:
a) Validation procedures used;
b) Detailed description of the requirements;
c) Determination of method performance characteristics;
d) the results obtained;
e) A statement of method validity, detailing suitability for the intended use.
7.3 Sampling
7.3.1 When the laboratory samples substances, materials or products for subsequent testing or calibration, it should have a sampling plan and method. The sampling method should identify factors that need to be controlled to ensure the validity of subsequent testing or calibration results. Sampling plans and methods should be available at the sampling site. Whenever justified, sampling plans should be based on appropriate statistical methods.
7.3.2 The sampling method shall describe:
a) Selection of samples or locations;
b) Sampling plan;
c) The preparation and processing of samples obtained from substances, materials or products for subsequent testing or calibration.
Note: After the laboratory receives the sample, please refer to 7.4 for further disposal requirements.
7.3.3 The laboratory should save sampling data as part of the testing or calibration work records. Where relevant, these records should include the following information:
a) Sampling method used;
b) Sampling date and time;
c) Data identifying and describing the sample (such as number, quantity and name);
d) Identification of sampling persons;
e) identification of equipment used;
f) Environmental or transportation conditions;
g) Where appropriate, diagrams or other equivalent means of identifying sampling locations;
h) Deviations, additions or deletions from the sampling method and sampling plan.
7.4 Disposal of test or calibration items
7.4.1 The laboratory shall have procedures for transporting, receiving, handling, protecting, storing, retaining, handling or returning test or calibration items, including all provisions necessary to protect the integrity of the test or calibration items and the interests of the laboratory and its customers . During handling, transportation, storage/waiting and preparation of items, care should be taken to avoid item deterioration, contamination, loss or damage. The operating instructions provided with the item should be followed.
7.4.2 The laboratory should have a system for clearly identifying test or calibration items. The item shall retain this marking while it is under the laboratory's responsibility. The identification system should ensure that items cannot be confused physically, in records or other documents. Where appropriate, the identification system should include the subdivision of an item or group of items and the delivery of items.
7.4.3 When receiving test or calibration items, deviations from specified conditions should be recorded. When there is doubt as to the suitability of an item for testing or calibration, or when the item does not conform to the description provided, the laboratory should query the customer before commencing work to obtain further clarification and record the results of the inquiry. When a customer knows that an item deviates from specified conditions and still requests testing or calibration, the laboratory should make a disclaimer in the report and indicate how the deviation may affect the results.
7.4.4 If items need to be stored or conditioned under specified environmental conditions, these environmental conditions should be maintained, monitored and recorded.
7.5 Technical Records
7.5.1 The laboratory shall ensure that the technical records of each laboratory activity contain results, reports and sufficient information to identify, where possible, the factors affecting the measurement results and their measurement uncertainties, and to ensure that the results can be obtained as close as possible to the original results. Repeat this laboratory activity under the conditions. Technical records should include each laboratory activity along with the date and person responsible for reviewing the data results. Original observations, data, and calculations should be recorded as they are observed or obtained and should be identified by the specific task.
7.5.2 The laboratory shall ensure that modifications to technical records can be traced back to previous versions or original observations. Original and modified data and documents should be saved, including the date of modification, identifying the content of the modification and the person responsible for the modification.
7.6 Assessment of measurement uncertainty
7.6.1 The laboratory shall identify contributions to measurement uncertainty. When assessing measurement uncertainty, all significant contributions, including those from sampling, should be taken into account using appropriate analytical methods.
7.6.2 Laboratories that perform calibrations, including those that calibrate their own equipment, should evaluate the measurement uncertainty for all calibrations.
7.6.3 The laboratory performing the testing should evaluate the measurement uncertainty. When it is difficult to strictly evaluate measurement uncertainty due to the detection method, the laboratory should make an evaluation based on an understanding of theoretical principles or practical experience using the method.
Note 1: In some cases, recognized testing methods specify limits on the main sources of measurement uncertainty and specify the expression of calculation results. As long as the laboratory complies with the testing methods and reporting requirements, it will meet the requirements of 7.6.3 Require.
Note 2: For a specific method, if the measurement uncertainty of the results has been determined and verified, the laboratory does not need to assess the measurement uncertainty for each result as long as it demonstrates that the identified key influencing factors are under control.
Note 3: For more information, see ISO/IEC Guide 98-3, ISO 21748 and ISO 5725 series of standards.
7.7 Ensure the validity of results
7.7.1 The laboratory should have procedures for monitoring the validity of results. The resulting data should be recorded in a manner that facilitates the detection of trends and, where feasible, statistical techniques should be used to review the results. The laboratory should plan and review monitoring. When appropriate, monitoring should include but not be limited to the following methods:
a) Use reference materials or quality control materials;
b) Use other instruments that have been calibrated to provide traceable results;
c) Functional verification of measuring and testing equipment;
d) When applicable, use verification or work standards and prepare control charts;
e) Periodic verification of measuring equipment;
f) Repeat testing or calibration using the same or different methods;
g) Repeated testing or repeated calibration of retained samples;
h) The correlation between the results of different characteristics of the item;
i) Review of reported results;
j) In-laboratory comparison;
k) Blind sample test.
7.7.2 Where feasible and appropriate, laboratories should monitor competency levels by comparison of results with other laboratories. Monitoring should be planned and reviewed and include, but not limited to, one or both of the following measures:
a) Participate in proficiency testing;
Note: GB/T 27043 contains details of proficiency testing and proficiency testing providers. Proficiency testing providers that meet the requirements of GB/T 27043 are considered competent.
b) Participate in inter-laboratory comparisons other than proficiency testing.
7.7.3 The laboratory shall analyze data from monitoring activities to control laboratory activities and implement improvements where applicable. If the results of a monitoring activity data analysis are found to fall outside predetermined guidelines, appropriate steps should be taken to prevent incorrect results from being reported.
7.8 Reporting results
7.8.1 General
7.8.1.1 Results should be reviewed and approved before being issued.
7.8.1.2 The laboratory shall issue results accurately, clearly, unambiguously and objectively, and shall include all information agreed to by the client, necessary to interpret the results and required by the method used. Laboratories usually provide results in the form of reports (such as test reports, calibration certificates, or sampling reports). All reports issued shall be retained as technical records.
Note 1: Test reports and calibration certificates are sometimes called test certificates and calibration reports.
Note 2: Reports may be issued in hard copy or electronically as long as the requirements of this standard are met.
7.8.1.3 Results may be reported in a simplified format if agreed to by the client. If the information listed in 7.8.2 to 7.8.7 is not reported to the client, it should be readily available to the client.
7.8.2 General requirements for reporting (testing, calibration or sampling)
7.8.2.1 Unless the laboratory has a valid justification, each report shall include at least the following information to minimize the possibility of misunderstanding or misuse:
a) Title (such as "Test Report", "Calibration Certificate" or "Sampling Report");
b) Name and address of the laboratory;
c) The location where laboratory activities are performed, including customer facilities, locations other than fixed laboratory facilities, and related temporary or mobile facilities;
d) A unique identifier that marks all parts of the report as part of the complete report, and a clear identification indicating the end of the report;
e) Customer’s name and contact information;
f) Identification of the method used;
g) Description, clear identification of the item, and, if necessary, the status of the item;
h) the date of receipt of the test or calibration items and the date of sampling that is critical to the validity and application of the results;
i) Date of implementation of laboratory activities;
j) Date of publication of the report;
k) the sampling plan and sampling methods used by the laboratory or other organization, as relevant to the validity or application of the results;
l) A statement that the results relate only to the items being tested, calibrated or sampled;
m) Results, where appropriate, with units of measurement;
n) Supplements, deviations or deletions from the methods;
o) Identification of the report approver;
p) Clear identification of results when obtained from external suppliers.
Note: stating in the report that in addition to full-text reproduction, partial reproduction of the report is not allowed without laboratory approval can ensure that the report is not partially excerpted.
7.8.2.2 The laboratory is responsible for all information in the report except for information provided by the client. Data provided by customers should be clearly identified.
Additionally, there should be a disclaimer in the report when the information provided by the client may affect the validity of the results. When the laboratory is not responsible for sampling (such as samples provided by the customer), it should state in the report that the results are applicable to the samples received.
7.8.3 Specific requirements for test reports
7.8.3.1 In addition to the requirements listed in 7.8.2, when required to interpret the test results, the test report shall also contain the following information:
a) Specific testing condition information, such as environmental conditions;
b) where relevant, a statement of conformity to requirements or specifications (see 7.8.6);
c) When applicable, with measurement uncertainty in the same unit as the measurand or in a form relative to the measurand (e.g. percentage):
——When the measurement uncertainty is related to the validity or application of the test results;
——When customers require it;
——When measurement uncertainty affects compliance with specification limits.
d) where appropriate, opinions and explanations (see 7.8.7);
e) Other information required by specific methods, statutory regulatory authorities or customers.
7.8.3.2 If the laboratory is responsible for sampling activities, the test report shall also meet the requirements of 7.8.5 when needed to interpret the test results.
7.8.4 Specific requirements for calibration certificates
7.8.4.1 In addition to the requirements of 7.8.2, the calibration certificate shall contain the following information:
a) Measurement uncertainty in the same unit as the measurand or measurement uncertainty in a form relative to the measurand (such as percentage);
Note: According to ISO/IEC Guide 99, measurement results are usually expressed as a measurand, including the unit of measurement and measurement uncertainty.
b) Conditions that affect the measurement results during the calibration process (such as environmental conditions);
c) Statement on how to achieve metrological traceability of measurement results (see Appendix A);
d) If available, the results before and after the equipment has been adjusted or repaired;
e) where relevant, a statement of conformity to requirements or specifications (see 7.8.6);
f) opinions and explanations, as appropriate (see 7.8.7).
7.8.4.2 If the laboratory is responsible for sampling activities, the calibration certificate shall also meet the requirements of 7.8.5 when required for interpretation of calibration results.
7.8.4.3 The calibration certificate or calibration label shall not contain recommendations for calibration intervals unless agreed with the customer.
7.8.5 Report sampling – specific requirements
If the laboratory is responsible for the sampling activity, in addition to the requirements in 7.8.2, the report shall also contain the following information when necessary to interpret the results:
a) Sampling date;
b) Unique identification of the extracted items or substances (including, where appropriate, the manufacturer's name, marked model or type and serial number);
c) Sampling locations, including illustrations, sketches or photographs;
d) Sampling plan and sampling method;
e) details of environmental conditions during sampling that affect the interpretation of results;
f) Information required to assess the uncertainty of subsequent testing or calibration measurements.
7.8.6 Reporting Declaration of Conformity
7.8.6.1 When making a declaration of conformity to a specification or standard, the laboratory shall consider the level of risk associated with the decision rules used (such as false acceptance, false rejection, and statistical assumptions), document the decision rules used, and Apply decision rules.
Note: If the client, regulations or normative documents specify the determination rules, no further consideration of the risk level is required.
7.8.6.2 When reporting a declaration of conformity, the laboratory shall clearly indicate:
a) The results to which the declaration of conformity applies;
b) Specifications, standards or terms thereof that are met or not met;
c) Decision rules to be applied (unless already included in the specification or standard).
Note: See ISO/IEC Guide 98-4 for details.
7.8.7 Report opinions and explanations
7.8.7.1 When expressing opinions and interpretations, the laboratory shall ensure that only authorized personnel can issue relevant opinions and interpretations. The laboratory shall document the basis for opinions and interpretations.
Note: Pay attention to distinguish the differences between opinions and explanations and the inspection statement in GB/T 27020, the product certification statement in GB/T 27065 and the conformity statement in 7.8.6.
7.8.7.2 Opinions and interpretations in the report should be based on the results of the items being tested or calibrated and clearly labeled.
7.8.7.3 When communicating opinions and explanations directly with customers through dialogue, records of the dialogue should be kept.
7.8.8 Report modification
7.8.8.1 When an issued report is changed, revised or reissued, the modified information should be clearly identified in the report and the reason for the revision should be noted where appropriate.
7.8.8.2 Modifications to a sent report should only be in the form of additional files or data transfers and contain the following statement:
"Modifications to the report with serial number... (or other identification)", or other equivalent text.
Such modifications shall comply with all requirements of this standard.
7.8.8.3 When it is necessary to issue a brand new report, it should be uniquely identified and the original report to be replaced should be noted.
7.9 Complaints
7.9.1 The laboratory shall have a documented process for receiving, evaluating and making decisions on complaints.
7.9.2 A description of the complaint handling process should be available to stakeholders upon request. Upon receipt of a complaint, the laboratory shall verify whether the complaint is related to laboratory activities for which it is responsible and, if so, handle it. The laboratory is responsible for all decisions made during the complaint handling process.
7.9.3 The complaint handling process should at least include the following elements and methods:
a) Description of the process of receiving, confirming, investigating complaints and deciding to take handling measures;
b) track and record complaints, including the steps taken to resolve them;
c) Ensure appropriate measures are taken.
7.9.4 The laboratory receiving the complaint shall be responsible for collecting and verifying all necessary information to confirm whether the complaint is valid.
7.9.5 Whenever possible, the laboratory should inform the complainant that the complaint has been received and provide the complainant with a report and results of the handling process.
7.9.6 Notification of the outcome to the complainant shall be made, or reviewed and approved, by personnel not associated with the laboratory activities involved.
Note: Can be implemented by outsiders.
7.9.7 Whenever possible, the laboratory should formally notify the complainant that the complaint has been processed.
7.10 Not suitable for the job
7.10.1 When laboratory activities or results do not comply with its own procedures or requirements agreed with customers (for example, equipment or environmental conditions exceed specified limits, monitoring results cannot meet specified criteria), the laboratory should implement procedures. The procedure should ensure:
a) Determine non-compliance with work management responsibilities and authorities;
b) Take actions based on the risk level established by the laboratory (including suspending or repeating work and withholding reports when necessary);
c) Evaluate the seriousness of the nonconforming work, including analyzing the impact on previous results;
d) make decisions on the acceptability of nonconforming work;
e) If necessary, notify customers and recall;
f) Specify responsibilities for approving restoration work.
7.10.2 The laboratory shall keep records of non-conforming work and implementation of measures specified in b) to f) in 7.10.1.
7.10.3 When the evaluation indicates that non-conforming work may reoccur, or there is doubt about the compliance of the laboratory's operations with its management system, the laboratory shall take corrective measures.
7.11 Data control and information management
7.11.1 The laboratory should obtain the data and information required to carry out laboratory activities.
7.11.2 Laboratory information management systems used to collect, process, record, report, store or retrieve data should be functionally confirmed before being put into use, including the normal operation of the interfaces in the laboratory information management system. Any changes to the management system, including modifications to laboratory software configurations or off-the-shelf commercial software, should be approved, documented, and validated before implementation.
Note 1: "Laboratory information management system" in this standard includes data and information management in computerized and non-computerized systems. Some requirements apply more to computerized systems than to non-computerized systems.
Note 2: The use of commonly used off-the-shelf commercial software within the scope of its design application can be considered to have been fully confirmed.
7.11.3 The laboratory information management system should:
a) prevent unauthorized access;
b) be securely protected against tampering and loss;
c) Operate in an environment that complies with system vendor or laboratory specifications, or for non-computerized systems, provides conditions to protect the accuracy of manual recording and transcription;
d) maintained in a manner that ensures the integrity of data and information;
e) Include records of system failures, appropriate emergency measures and corrective actions.
7.11.4 When the laboratory information management system is managed and maintained off-site or by an external supplier, the laboratory shall ensure that the supplier or operator of the system complies with all applicable requirements of this standard.
7.11.5 The laboratory shall ensure that instructions, manuals and reference data related to the laboratory information management system are easily accessible to employees.
7.11.6 Calculations and data transfers should be properly and systematically checked.
8 Management system requirements
8.1 Method
8.1.1 General
The laboratory should establish, implement and maintain a documented management system that can support and demonstrate that the laboratory continues to meet the requirements of this standard and ensure the quality of laboratory results. In addition to meeting the requirements of Chapters 4 to 7, the laboratory shall implement the management system according to Method A or Method B.
Note: See Appendix B for more information.
8.1.2 Method A
The laboratory management system should at least include the following contents:
——Management system documents (see 8.2);
- Control of management system documents (see 8.3);
—Record control (see 8.4);
—Measures to address risks and opportunities (see 8.5);
—Improvements (see 8.6);
— corrective measures (see 8.7);
— Internal audit (see 8.8);
— Management review (see 8.9).
8.1.3 Method B
The laboratory establishes and maintains a management system in accordance with the requirements of GB/T 19001, which can support and prove continued compliance with the requirements of Chapters 4 to 7, and at least meet the purposes of the management system requirements specified in 8.2 to 8.9.
8.2 Management system documents (Method A)
8.2.1 Laboratory management should establish, prepare and maintain policies and objectives that are consistent with the purpose of this standard, and ensure that the policies and objectives are understood and implemented by personnel at all levels of the laboratory organization.
8.2.2 Policies and objectives should reflect the laboratory's competence, impartiality and consistent operations.
8.2.3 Laboratory management should provide evidence of commitment to establishing and implementing the management system and continuously improving its effectiveness.
8.2.4 The management system should contain, reference or link all documents, processes, systems and records related to meeting the requirements of this standard.
8.2.5 All personnel involved in laboratory activities shall have access to management system documentation and related information applicable to their responsibilities.
8.3 Control of management system documents (Method A)
8.3.1 The laboratory shall control internal and external documents relevant to meeting the requirements of this standard.
Note: In this standard, "documents" can be policy statements, procedures, specifications, manufacturer's instructions, calibration forms, charts, textbooks, posters, notices, memoranda, drawings, plans, etc. These documents may be carried on a variety of media, such as hard copy or digital form.
8.3.2 The laboratory shall ensure:
a) Documents are reviewed for adequacy and approved by authorized personnel before release;
b) Review documentation regularly and update when necessary;
c) Identify document changes and current revision status;
d) Make relevant versions of applicable documents available at the point of use and, where necessary, control their issuance;
e) Uniquely identify files;
f) Prevent the misuse of obsolete documents and appropriately mark obsolete documents retained for a purpose.
8.4 Recording control (mode A)
8.4.1 The laboratory shall establish and maintain clear records to demonstrate compliance with the requirements of this standard.
8.4.2 The laboratory shall implement necessary controls for the identification, storage, protection, backup, archiving, retrieval, retention and disposal of records. Laboratory record retention periods should be consistent with contractual obligations. Access to records should be consistent with a commitment to confidentiality and records should be readily accessible.
Note: See 7.5 for other requirements for technical records.
8.5 Measures to address risks and opportunities (Option A)
8.5.1 The laboratory shall consider the risks and opportunities associated with laboratory activities to:
a) ensure that the management system achieves its intended results;
b) enhance opportunities to achieve laboratory goals and objectives;
c) Prevent or reduce adverse effects and possible failures in laboratory activities;
d) achieve improvements.
8.5.2 The laboratory should plan:
a) Measures to address these risks and opportunities;
b) How to:
— Integrate and implement these measures in the management system;
- Evaluate the effectiveness of these measures.
Note: Although this standard specifies that laboratories should plan measures to address risks, it does not require the use of formal risk management methods or documented risk management processes. Laboratories may decide whether to adopt a broader risk management approach beyond the requirements of this standard, e.g. by applying other guidelines or standards.
8.5.3 Actions to address risks and opportunities should be proportionate to their potential impact on the validity of laboratory results.
Note 1: Ways to respond to risk include identifying and avoiding threats, taking risks to pursue opportunities, eliminating sources of risk, changing the likelihood or consequences of risks, sharing risks, or retaining risks through well-informed decisions.
Note 2: Opportunities may lead laboratories to expand the scope of their activities, win new customers, use new technologies and otherwise meet customer needs.
8.6 Improvement (Method A)
8.6.1 The laboratory should identify and select improvement opportunities and take necessary measures.
Note: The laboratory can identify improvement opportunities by reviewing operating procedures, implementation policies, overall objectives, audit results, corrective actions, management reviews, personnel recommendations, risk assessments, data analysis and proficiency testing results.
8.6.2 The laboratory should solicit feedback from customers, whether positive or negative. This feedback should be analyzed and used to improve management systems, laboratory activities, and customer service.
Note: Examples of types of feedback include: customer satisfaction surveys, records of communications with customers, and joint review reports.
8.7 Corrective measures (Option A)
8.7.1 When nonconformity occurs, the laboratory shall:
a) Respond to non-conformities and, where applicable:
— Take measures to control and correct nonconformities;
——Disposal consequences;
b) Use the following activities to evaluate whether measures need to be taken to eliminate the causes of nonconformity and avoid their recurrence or occurrence on other occasions:
——Review and analysis are inconsistent;
- Determine the reasons for non-compliance;
— determine whether similar nonconformities exist or are likely to occur;
c) implement the required measures;
d) Review the effectiveness of corrective actions taken;
e) update, if necessary, the risks and opportunities identified during planning;
f) Change the management system when necessary.
8.7.2 Corrective actions should be proportionate to the impact of nonconformity.
8.7.3 The laboratory shall maintain records as evidence of:
a) The nature of the nonconformity, its causes and subsequent measures taken;
b) Results of corrective actions.
8.8 Internal Audit (Method A)
8.8.1 The laboratory shall conduct internal audits at planned intervals to provide the following information about the management system:
a) Does it comply with:
——The laboratory's own management system requirements, including laboratory activities;
——Requirements of this standard;
b) Whether it has been effectively implemented and maintained.
8.8.2 The laboratory shall:
a) Plan, develop, implement and maintain an audit plan, considering the importance of laboratory activities, changes affecting the laboratory and the results of previous audits. The audit plan includes frequency, methods, responsibilities, planning requirements and reporting;
b) Specify the audit criteria and scope of each audit;
c) ensure that audit results are reported to relevant management;
d) Take appropriate corrective and corrective actions in a timely manner;
e) Maintain records as evidence of implementation of the audit plan and audit results.
Note: For relevant guidelines on internal audit, please refer to GB/T 19011.
8.9 Management Review (Method A)
8.9.1 Laboratory management should review the laboratory management system at planned intervals to ensure its continued suitability, adequacy and effectiveness, including the implementation of relevant policies and objectives of this standard.
8.9.2 The laboratory shall record the input from the management review and include the following relevant information:
a) Changes in internal and external factors related to the laboratory;
b) Goal achievement;
c) the appropriateness of policies and procedures;
d) Information on measures taken in previous management reviews;
e) Results of recent internal audits;
f) corrective measures;
g) Reviews conducted by external agencies;
h) Changes in workload and type of work or changes in the scope of laboratory activities;
i) Customer and personnel feedback;
j) Complaints;
k) effectiveness of implemented improvements;
1) Adequacy of resources;
m) Results of risk identification;
n) Output to ensure the validity of the results;
o) Other relevant factors such as monitoring activities and training.
8.9.3 The output of the management review should at least record decisions and actions related to the following matters:
a) The effectiveness of the management system and its processes;
b) improvements in laboratory activities relevant to meeting the requirements of this standard;
c) Provide required resources;
d) Required changes.
Appendix A (Informative Appendix) Measurement Traceability
A.1 General
Metrological traceability is an important concept to ensure that measurement results are comparable domestically and internationally. This appendix gives more detailed information about metrological traceability.
A.2 Establish metrological traceability
A.2.1 The following contents need to be considered and ensured when establishing metrological traceability:
a) Specify the measurand (the quantity to be measured);
b) a documented, uninterrupted chain of calibrations traceable to a declared appropriate reference (appropriate references include national or international standards and natural datums);
c) Assess the measurement uncertainty of each calibration in the traceability chain according to the agreed method;
d) Each calibration in the traceability chain is performed according to appropriate methods, and has measurement results and related, recorded measurement uncertainties;
e) Laboratories that perform one or more calibrations in the traceability chain should provide evidence of their technical competence.
A.2.2 When calibrated equipment is used to convey metrological traceability to laboratory measurement results, the systematic measurement error (sometimes called bias) of the equipment needs to be taken into account. There are several ways to consider systematic measurement errors in the transfer of metrological traceability.
A.2.3 If a competent laboratory reports only a statement of conformity to a specification (omitting measurement results and associated uncertainties) in the information on a measurement standard, the measurement standard can sometimes be used to convey metrological traceability, and its specification limits is a source of uncertainty, but this method depends on:
— Use appropriate decision rules to determine compliance;
— Treat specification limits in a technically appropriate manner in subsequent uncertainty assessments.
The technical basis of this method is that the statement of compliance with the specification establishes a range of measured values and the true value is expected to lie within this range with a specified confidence level, taking into account the bias of the true value as well as the measurement uncertainty.
Example: Calibrate the balance using various grades of International Organization for Legal Metrology (OIML) R111 weights.
A.3 Demonstrate metrological traceability
A.3.1 The laboratory is responsible for establishing metrological traceability in accordance with this standard. Calibration results provided by laboratories that comply with this standard are metrologically traceable.
The standard values of certified reference materials provided by reference material producers that comply with ISO 17034 have metrological traceability. There are different ways to demonstrate conformity to this standard, namely third-party recognition (such as an accreditation body), external assessment by the customer or self-assessment. Internationally recognized pathways include but are not limited to:
a) Calibration and measurement capabilities provided by national metrology institutes and their designated bodies that have undergone appropriate peer review. This peer review is conducted under the International Committee for Weights and Measures Mutual Recognition Agreement (CIPM MRA). The services covered by the CIPM MRA can be queried in Appendix C of the International Bureau of Weights and Measures’ Key Comparison Database (BIPM KCDB), which gives the range and measurement uncertainty for each service.
b) Calibration and measurement capabilities accredited by accreditation bodies that have signed the International Laboratory Accreditation Cooperation (ILAC) agreement or a regional agreement recognized by ILAC can demonstrate metrological traceability. The scope of competence of an accredited laboratory is publicly available from the relevant accreditation body.
A.3.2 When it is necessary to prove that a metrological traceability chain is recognized internationally, the joint statement on metrological traceability by BIPM, OIML (International Organization for Legal Metrology), ILAC and ISO provides specific guidance.