This standard specifies the general requirements for the laboratory's ability to perform tests and (or) calibrations (including sampling capabilities). These tests and calibrations include tests and calibrations performed using standard methods, non-standard methods, and methods developed by the laboratory. This standard applies to all organizations engaged in testing and (or) calibration, including first-party, second-party, and third-party laboratories, as well as laboratories that use testing and (or) calibration as part of inspection and product certification. GB/T 27025-2008 General requirements for the ability of testing and calibration laboratories GB/T27025-2008 Standard download decompression password: www.bzxz.net
This standard specifies the general requirements for the laboratory's ability to perform tests and (or) calibrations (including sampling capabilities). These tests and calibrations include tests and calibrations performed using standard methods, non-standard methods, and methods developed by the laboratory. This standard applies to all organizations engaged in testing and (or) calibration, including first-party, second-party, and third-party laboratories, as well as laboratories that use testing and (or) calibration as part of inspection and product certification.
This standard is equivalent to ISO/IEC17025:2005 "General requirements for the competence of testing and calibration laboratories" and its technical corrigendum (Technical corrigendum1, published on August 15, 2006).
This standard replaces GB/T15481-2000 "General requirements for the competence of testing and calibration laboratories" (idtISO/IEC17025:1999) from the date of implementation. The main difference between this standard and GB/T15481 is reflected in the reference to GB/T19001. GB/T15481-2000 refers to GB/T19001-1994, and GB/T19001 has been converted to version 2000. Therefore, this standard is revised to refer to GB/T19001-2000, and the relevant requirements in GB/T19001-2000 are added to maintain coordination with GB/T19001-2000. In addition, 4.10 Improvement Factors are added to emphasize the role of continuous improvement. In order to meet the requirements of my country's national standard system for conformity assessment, the number of this standard is changed to GB/T 27025, but it still inherits GB/T15481-2000. GB/T15481-2000 is equivalent to ISO/IEC17025:1999 (i.e. the first edition), and this standard is equivalent to ISO/IEC17025:2005 (the second edition).
Appendix A and Appendix B of this standard are informative appendices.
This standard is proposed and managed by the National Technical Committee for Certification and Accreditation Standardization (SAC/TC261).
This standard is drafted by the China National Accreditation Service for Conformity Assessment.
Participating drafting units of this standard: National Certification and Accreditation Administration, China National Institute of Metrology, Guangzhou Electric Science Research Institute, Beijing Entry-Exit Inspection and Quarantine Bureau of the People's Republic of China, Shandong Entry-Exit Inspection and Quarantine Bureau of the People's Republic of China, Liaoning Entry-Exit Inspection and Quarantine Bureau of the People's Republic of China. ||tt
||Main drafters of this standard: Liu Anping, Qi Xiao, Qiao Dong, Song Guilan, Zhai Peijun, Shi Changyan, Yu Yadong, Mao Zuxing, Wu Guoping, Cao Shi, Zhang Mingxia, Liu Xuehui, Cao Zhijun, Liu Laifu.
The previous versions of the standards replaced by this standard are:
---GB/T15481-2000.
GB/T27000 Conformity Assessment Vocabulary and General Principles (GB/T27000-2006, ISO/IEC17000:2004, IDT) VIM, International General Terms of Metrology, issued by the International Bureau of Weights and Measures (BIPM), the International Electrotechnical Commission (IEC), the International
Federation of Clinical Chemistry and Laboratory Medicine (IFCC), the International Organization for Standardization (ISO), the International Union of Pure and Applied Chemistry (IUPAC), the International Union of Theoretical and Applied Physics (IUPAP) and the International Organization of Legal Metrology (OIML).
Note: More standards, guidelines, etc. related to this standard are given in the references.
Preface III
Introduction IV
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Management requirements 1
4.1 Organization 1
4.2 Management system 2
4.3 Document control 3
4.4 Review of requirements, tenders and contracts 3
4.5 Subcontracting of testing and calibration 4
4.6 Procurement of services and supplies 4
4.7 Serving customers 4
4.8 Complaints 5
4.9 Control of nonconforming testing and/or calibration work 5
4.10 Improvement 5
4.11 Corrective action 5
4.12 Preventive measures6
4.13 Control of records6
4.14 Internal audit6
4.15 Management review6
5 Technical requirements7
5.1 General7
5.2 Personnel7
5.3 Facilities and environmental conditions8
5.4 Test and calibration methods and method validation8
5.5 Equipment10
5.6 Measurement traceability11
5.7 Sampling12
5.8 Disposal of test and calibration items13
5.9 Assurance of the quality of test and calibration results13
5.10 Result report13
Appendix A (Informative Appendix) Comparison with the provisions of GB/T19001-2000 16
Appendix B (Informative Appendix) Guidelines for the formulation of application details for specific fields 19
References 20

ICS 03.120.20
National Standard of the People's Republic of China
GB/T 27025--2008/IS0/IEC 17025:2005 replaces GB/T15481-2000
General reguirements for the competence oftesting and calibration laboratories(IS0/IEC 17025:2005, IDT)
2008-05-08 Issuedwww.bzxz.net
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China
Standardization Administration of the People's Republic of China
2008-08-01 Implementation
Normative references
Terms and definitions
Management requirements
Management system
Document control
Review of requirements, tenders and contracts,
Subcontracting of testing and calibration
Purchase of services and supplies
Services to customers
Control of non-conformance to testing and (or) calibration work 4.10||tt| |Improvement,
Corrective action
Preventive measures·
Control of records·
Internal audit
Management review·
Technical requirements
Facilities and environmental conditions
Test and calibration methods and confirmation of methods
Measurement traceability
Sampling…
Disposal of test and calibration items…
5.9 Assurance of the quality of test and calibration results·5.10 Result report
Appendix A (informative appendix) Comparison with the clauses of GB/T19001-2000 Appendix B (informative appendix) Guidelines for formulating detailed application plans for specific fields References
GB/T 27025—2008/ISO/IEC 17025:20050
GB/T 27025—2008/IS0/IEC 17025:2005 This standard is equivalent to ISO/1EC17025:2005 "General requirements for the competence of testing and calibration laboratories" and its technical corrigendum (Technical corrigendum1, published on August 15, 2006). This standard replaces GB/T15481—2000 "General requirements for the competence of testing and calibration laboratories" (idtISO/IEC17025:1999) from the date of implementation. The main difference between this standard and GB/T15481 is reflected in the reference to GB/T19001. GB/T15481-2000 refers to GB/T19001-1994, and GB/T19001 has been converted to version 2000. Therefore, this standard is revised to refer to GB/T19001-2000, and the relevant requirements in GB/T19001-2000 are added to maintain coordination with GB/T19001-2000. In addition, the "4.10 Improvement" key is added to emphasize the role of continuous improvement. In order to meet the requirements of my country's national standard system for conformity assessment, the number of this standard is changed to GF/T27025, but it is still inherited from GB/T15481-2000. GB/T15481-2000 is equivalent to ISO/IEC17025:1999 (i.e. the first edition), and this standard is equivalent to ISO/IEC17025:2005 (the second edition). Appendix A and Appendix B of this standard are informative appendices. This standard was proposed and coordinated by the National Technical Committee for Standardization of Certification and Accreditation (SAC/TC261). This standard was drafted by the China National Accreditation Service for Conformity Assessment. Participating drafting units of this standard: National Certification and Accreditation Administration, China National Institute of Metrology, Guangzhou Electric Science Research Institute, Beijing Entry-Exit Inspection and Quarantine Bureau of the People's Republic of China, Shandong Entry-Exit Inspection and Quarantine Bureau of the People's Republic of China, Liaoning Entry-Exit Inspection and Quarantine Bureau of the People's Republic of China.
Main drafters of this standard: Liu Anping, Qi Xiao, Qiao Dong, Song Guilan, Zhai Peijun, Shi Changyan, Yu Yadong, Mao Zuxing, Wu Guoping, Cao Shi, Zhang Ming, Liu Xuehui, Zun Zhijun, Liu Laifu. The previous versions replaced by this standard are: -GB/T 15481—2000.
GB/T27025--2008/IS0/IEC17025:2005 Introduction
This standard contains all the requirements for testing and calibration laboratories that wish to demonstrate that they have implemented a management system, have technical competence and can produce technically valid results.
Chapter 4 of this standard specifies the requirements for effective management of laboratories, and Chapter 5 specifies the technical competence requirements for the testing and (or) calibration performed by the laboratories.
With the widespread application of management systems, the need for laboratories that are part of larger organizations or provide other services to operate in accordance with management systems that comply with both GB/T19001 and this standard is also growing. This standard takes care to incorporate all the requirements in GB/T19001 related to the scope of testing and calibration services covered by the laboratory management system. Therefore, testing and calibration laboratories that follow this standard also operate in accordance with GB/T19001. The fact that the laboratory quality management system complies with the requirements of GB/T19001 does not prove that the laboratory has the ability to produce technically valid data and results; the fact that the laboratory quality management system complies with this standard does not mean that its operation complies with all the requirements of GB/T19001. ISO/IEC17025, which is equivalent to this standard, is the basic standard adopted by international testing and calibration laboratory accreditation bodies. If a laboratory follows this standard and obtains accreditation from my country's accreditation bodies, its testing and calibration results can be more widely recognized through the mutual recognition agreements signed between my country's accreditation bodies and corresponding bodies in other countries. The application of this standard has positive significance in facilitating the cooperation between laboratories and other institutions, the exchange of information and experience, and the coordination of standards and procedures.
GB/T 27025—2008/1S0/LEC 17025:2005 General requirements for the competence of testing and calibration laboratories 1.1 This standard specifies the general requirements for the competence (including sampling capability) of laboratories for testing and (or) calibration. These tests and calibrations include tests and calibrations performed using standard methods, non-standard methods, and laboratory developed methods. 1.2 This standard applies to all organizations engaged in testing and (or) calibration, including first-party, second-party and third-party laboratories, as well as laboratories that perform testing and (or) calibration as part of inspection and product certification. This standard applies to all laboratories, regardless of the number of personnel or the scope of their testing and (or) calibration activities. When a laboratory does not engage in one or more of the activities covered by this standard, such as sampling and the design (development) of new methods, it may not apply the requirements of the relevant clauses of this standard.
1.3 The notes in this standard are explanations, examples and guidance to the text. They neither contain requirements nor constitute the main part of this standard. 1.4 This standard is used for laboratories to establish a management system for quality, administrative and technical operations. Laboratory users, regulatory agencies and accreditation bodies can also use this standard to confirm or recognize the laboratory's capabilities. This standard is not intended to be used as the basis for laboratory accreditation. Note 1: The term "management system" in this standard refers to the quality, administrative and technical systems that control the operation of the laboratory. Note 2: Certification of a management system is sometimes also called certification. 1.5 This standard does not include regulatory and safety requirements that the laboratory should comply with in its operations. 1.6 If the testing and calibration laboratory complies with the requirements of this standard, the quality management system it operates for testing and calibration activities will also meet the principles of GB/T19001. Appendix A provides a comparison of the terms of this standard with GB/T19001. This standard includes technical capability requirements that are not included in GB/T19001. Note 1: To ensure consistency in application,It may be necessary to explain or interpret some of the requirements of this standard. Appendix B provides guidance on the development of application details for specific areas, especially for accreditation bodies (see GB/T27011). Note 2: If a laboratory wishes to obtain accreditation for some or all of its testing and calibration activities, it should choose an accreditation body that operates in accordance with GR/T27011. 2 Normative references
The clauses in the following documents become clauses of this standard through reference in this standard. For all referenced documents with a date, all subsequent amendments (excluding errata) or revisions are not applicable to this standard. However, the parties to an agreement based on this standard are encouraged to study whether the latest versions of these documents can be used. For all undated referenced documents, the latest versions are applicable to this standard. GB/127000 Conformity Assessment Vocabulary and General Principles (GB/T27000--2006, ISO/1EC17000:2004, IDT) VIM, International General Terms of Metrology, issued by the International Bureau of Weights and Measures (BIPM), the International Electrotechnical Commission (IEC), the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), the International Organization for Standardization (ISO), the International Union of Pure and Applied Chemistry (IUPAC), the International Union of Theoretical and Applied Physics (IUPAP) and the International Organization for Legal Measurement (OIML) Note: More standards, guidelines, etc. related to this standard are given in the references. 3 Terms and definitions
This standard uses the relevant terms and definitions given in GB/T27000 and VIM. Note: GB/T19000 stipulates the general definitions related to quality, while GB/T27000 specifically stipulates the definitions related to certification and laboratory accreditation. If there are differences in the definitions given in GB/T19000, GB/T27000 and VIM, the definitions in GB/T27000 and VIM shall prevail. 4 Management requirements
4.1 Organization
4.1.1 The laboratory or its organization shall be an entity that can assume legal responsibility. 4.1.2 The laboratory is responsible for ensuring that the testing and calibration activities it conducts comply with the requirements of this standard and meet the needs of customers, regulatory agencies or organizations that provide recognition to it.
GB/T27025-2008/ISO/1EC17025:2005.
4.1.3 The laboratory's management system shall cover the laboratory's work in fixed facilities, at locations away from its fixed facilities, or in related temporary or mobile facilities.
4.1.4 If the laboratory is part of an organization that also engages in activities other than testing and/or calibration, the responsibilities of key personnel in the organization who are involved in, or have an impact on, testing and/or calibration activities should be defined to identify potential conflicts of interest. Note: If the laboratory is part of a larger organization, the organization should be set up so that departments with conflicts of interest, such as production, operations or finance, do not have an adverse impact on the laboratory's ability to meet the requirements of this International Standard. Note 2: If the laboratory wishes to be recognized as a third-party laboratory, the laboratory should be able to demonstrate its impartiality and that the laboratory and its employees are not subject to any improper commercial, financial or other pressures that may affect their technical judgment. A third-party testing or calibration laboratory should not engage in any activities that may impair its independence of judgment and reduce the confidence in its testing or calibration. 4.1.5 The laboratory shall: a) have management and technical personnel who, regardless of their other qualifications, have the necessary authority and resources to perform their duties, including implementing, maintaining and improving the management system, identifying deviations from the management system or testing and/or calibration procedures, and taking measures to prevent or reduce these deviations (see 5.2); have measures to ensure that its management and employees are not subject to any improper commercial, financial and other pressures and influences from internal or external sources that may have a negative impact on the quality of work!
c) Have policies and procedures to protect the client's confidential information and proprietary rights, including procedures for the protection of electronic storage and transmission of results; d) Have policies and procedures to avoid engaging in any activities that would reduce its credibility in terms of its ability, impartiality, judgment or integrity of operation;
Determine the laboratory's organizational and management structure, its position in the parent organization, and the relationship between quality management, technical operations and support services e)
Specify the responsibilities, authority and relationships of all management, operational and verification personnel who have an impact on the quality of testing and (or) calibration: g) Adequate supervision of testing and calibration personnel, including trained employees, by personnel who are familiar with the methods, procedures, objectives and results evaluation of each test and (or) calibration;
h) Have a technical manager who has overall responsibility for technical operations and provides the resources necessary to ensure the quality of laboratory operations; Designate an employee as the quality supervisor (regardless of how he is called), regardless of other positions, he should be given the responsibility and authority to ensure at all times that the quality-related management system is implemented and followed. The quality manager should have direct and transparent access to the top management who makes decisions about laboratory policy or resources;
designate deputies for key management personnel (see Note); j
k) Ensure that laboratory personnel understand the relevance and importance of their activities and how they contribute to the achievement of the management system objectives. Note: One person may have multiple functions and it may not be practical to designate deputies for each function. 4.1.6 Top management should ensure that appropriate communication mechanisms are established within the laboratory and that communication is carried out on matters related to the effectiveness of the management system. 4.2 Management System
4.2.1 The laboratory shall establish, implement and maintain a management system that is appropriate to the scope of its activities. The laboratory shall document its policies, systems, plans, procedures and instructions. The degree of documentation should ensure the quality of laboratory test and/or calibration results. System documents should be communicated to, understood, obtained and implemented by relevant personnel. 4.2.2 The quality-related policies of the laboratory management system, including the quality policy statement, should be stated in the quality manual (regardless of how it is called). Overall monthly objectives should be established and reviewed during management reviews. The quality policy statement shall be issued under the authorization of the top management and shall include at least the following: a) the commitment of the laboratory management to good professional behavior and the quality of testing and calibration services provided to customers; b) the statement of the management on the service standards of the laboratory; c) the purpose of the management system related to quality; d) the requirement that all personnel involved in the testing and calibration activities of the laboratory be familiar with the quality documents and implement the policies and procedures in their work; e) the commitment of the laboratory manager to comply with this standard and continuously improve the effectiveness of the management system. Note that the quality policy statement should be concise and may include the requirement that testing and (or) calibration should always be carried out in accordance with the stated methods and customer requirements. When the testing and (or) calibration laboratory is part of a larger organization, some of the quality policy elements may be listed in other documents. 4.2.3 The top management shall provide evidence of the commitment to establish and implement the management system and continuously improve its effectiveness. 4.2.4 Top management shall communicate to the organization the importance of meeting customer and statutory requirements. 4.2.5 The quality manual shall include or specify supporting procedures, including technical procedures, and outline the structure of the documents used in the management system. 4.2.6 The roles and responsibilities of technical management and the quality manager shall be defined in the quality manual, including the responsibility for ensuring compliance with this International Standard. 4.2.7 When planning and implementing changes to the management system, top management shall ensure that the integrity of the management system is maintained. 4.3 Document Control
4.3.1 General
The laboratory shall establish and maintain procedures to control all documents (internal or external) that constitute its management system, such as regulations, standards, other normative documents, test and/or calibration methods, as well as drawings, software, specifications, instructions and manuals. NOTE 1: "Documents" in this standard may be policy statements, procedures, specifications, calibration forms, charts, textbooks, postings, notices, memoranda, software, drawings, plans, etc. These documents may be contained in a variety of media, whether hard copy or electronic media, and may be digital, analog, graphic or written.
Note 2: Control of measurement and calibration data is specified in 5.4.7. Control of records is specified in 4.13. 4. 3. 2 Approval and release of documents
4.3.2.1 All management system documents issued to laboratory personnel shall be reviewed and approved for use by authorized personnel before release. The laboratory shall establish a control list or equivalent document control procedure that identifies the current revision status and distribution of documents in the management system and make it easily accessible to prevent the use of invalid and/or obsolete documents. 4.3.2.2 The document control procedure shall ensure that:
a) the authorized version of the relevant documents is available at all work locations that are important to the effective operation of the laboratory; b) the documents are reviewed regularly and revised as necessary to ensure their continued applicability and meet the requirements of use; invalid or obsolete documents are promptly removed from all places of use or publication, or other methods are used to ensure that they are prevented from misuse; c
d) Obsolete documents retained for legal or knowledge preservation purposes should be appropriately marked. 4.3.2.3 The management system documents developed by the laboratory should be uniquely identified. The identification should include the issue date and (or) revision identification, page number, total number of pages or a mark indicating the end of the document and the issuing agency. 4.3.3 Document changes
4.3.3.1 Unless otherwise specified, changes to documents should be reviewed and approved by the original person. The designated person should obtain relevant background information on which to base the review and approval. 4.3.3.2 If feasible, the changed or new content should be indicated in the document or appropriate attachment. 4.3.3.3 If the laboratory's document control system allows manual amendments to documents before they are re-issued, the procedures and authority for such amendments shall be defined. Amendments shall be clearly marked, initialed and dated. Revised documents shall be formally issued as soon as possible. 4.3.3.4 Procedures shall be established to describe how changes are made to and controlled in documents stored in computer systems. 4.4 Review of requirements, tenders and contracts
4.4.1 The laboratory shall establish and maintain procedures for the review of customer requirements, tenders and contracts. These policies and procedures for the review of contracts for testing and/or calibration shall ensure that:
a) the requirements, including the methods to be used, are adequately specified, documented and understood (see 5.4.2) b) the laboratory has the capability and resources to meet these requirements c) appropriate test and/or calibration methods are selected to meet the customer's requirements (see 5.4.2). Any differences between the customer's requirements or tender and the contract shall be resolved before work commences. Each contract shall be acceptable to both the laboratory and the customer.
Note 1: The review of requirements, bids and contracts should be conducted in a feasible and efficient manner, taking into account financial, legal and time scheduling implications. The review of internal customers, requirements, bids and contracts may be conducted in a simplified manner.
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