This standard specifies the general requirements for the laboratory's ability to perform testing and (or) calibration (including sampling ability). These tests and calibrations include those performed using standard methods, non-standard methods, and laboratory-developed methods. 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 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 included in this standard, such as sampling and the design (development) of new methods, the requirements of the relevant clauses in this standard may not be adopted. This standard is used for laboratories to establish quality, management and technical systems and control their operations. Laboratory customers, statutory management bodies, and accreditation bodies may also use this standard to confirm or recognize the laboratory's capabilities. This standard does not include regulatory and safety requirements that laboratories should comply with in their operations. If the testing and calibration laboratories meet the requirements of this standard, when they are engaged in the design (development) of new methods and (or) the development of work plans combining standard and non-standard testing and calibration methods, the quality system operated by their testing and calibration also meets the requirements of GB/T 19001 (idt ISO 9001): when the laboratory only uses standard methods, it meets the requirements of GB/T 19002 (idt ISO 9002). This standard includes some technical capability requirements not included in GB/T 1900l (idt ISO 900l) and GB/T 19002 (idt ISO 9002). Appendix A provides a comparison of the clauses of ISO/IEC 17025 with ISO 9001 and ISO 9002. GB/T 15481-2000 General requirements for the competence of testing and calibration laboratories GB/T15481-2000 standard download decompression password: www.bzxz.net
This standard specifies the general requirements for the competence of laboratories to conduct testing and (or) calibration (including sampling competence). These tests and calibrations include tests and calibrations performed using standard methods, non-standard methods and laboratory-developed methods. 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 applies to all laboratories, regardless of the number of their personnel or the scope of their testing and (or) calibration activities. When a laboratory does not engage in one or more activities covered by this standard, such as sampling and the design (development) of new methods, it may not adopt the requirements of the relevant clauses in this standard. This standard is used for laboratories to establish quality, management and technical systems and control their operations. Laboratory customers, statutory management agencies and accreditation bodies may also use this standard to confirm or recognize the capabilities of laboratories. This standard does not include the regulatory and safety requirements that the laboratory should comply with in its operation. If the testing and calibration laboratories meet the requirements of this standard, when they are engaged in the design (development) of new methods and (or) the development of work plans combining standard and non-standard testing and calibration methods, the quality system operated by their testing and calibration also meets the requirements of GB/T 19001 (idt ISO 9001): when the laboratory only uses standard methods, it meets the requirements of GB/T 19002 (idt ISO 9002). This standard includes some technical competence requirements not included in GB/T 1900l (idt ISO 900l) and GB/T 19002 (idt ISO 9002). Appendix A provides a comparison of the clauses of ISO/IEC 17025 with ISO 9001 and ISO 9002.

GB/T 15481 ---2000
This standard is equivalent to the first edition of IS0/IEC17025:1999 "General requirements for the competence of testing and calibration laboratories". This standard is a revision of GB/T15481--1995 "General requirements for the competence of calibration and inspection laboratories". Compared with the 1995 version of the standard, this standard has undergone the following major changes: the name has been changed to "General requirements for the competence of testing and calibration laboratories"; the main structure has been changed to "Management requirements" (Chapter 4) and "Technical requirements" (Chapter 5). In terms of content, the requirements of the GB/T19000 family of standards are introduced in terms of management, and the requirements for assessing measurement uncertainty and sampling are strengthened in terms of technology.
Both Appendix A and Appendix B of this standard are informative appendices. This standard replaces GB/T15481-1995 from the date of implementation. This standard is proposed by the China National Accreditation Service for Laboratories. This standard is under the jurisdiction of the China National Accreditation Service for Laboratories. The main drafting organizations of this standard are: China National Accreditation Service for Laboratories, China National Institute of Metrology, National Center for Standard Materials Research
The main drafters of this standard are: Liu Anping, Qiao Dong, Shi Changyan, Yu Yadong, Mao Zuxing, Zhang Bin, Zhai Peijun, Qi Xiao11x
GBT15481:2000
ISO/IEC Foreword
The International Electrotechnical Commission (IEC) and the International Electrotechnical Commission (IEC) are specialized systems formed for global standardization. National organizations that are members of ISO(I) or IFC participate in the formulation of international standards through technical committees composed of organizations engaged in activities in specific technical fields. The technical committees of ISO(I) and IEC collaborate in areas of common interest. Other governmental and non-governmental international organizations also participate in this work through their contacts with ISO(I) and IFC. International standards are drafted in accordance with the provisions of Part 3 of the ISO/IEC Directives. Draft international standards adopted by the technical committees are circulated to the member bodies for voting and are published as international standards only if they are approved by at least 75% of the member bodies voting. Considering that some of the provisions of this standard may involve patent rights, ISO and IEC are not responsible for the identification of any such patent rights. International Standard ISO/IEC 17025 was prepared by the ISO Committee on Conformity Assessment (CASCO). The first edition of ISO/IEC 17025 replaces ISO/IEC Guide 25:1990. Annexes A and B in this standard are only informative appendices. ISO/IEC 17025:1999 was prepared on the basis of extensive experience in the implementation of ISO/IEC Guide 25 and EN 45001 and replaces these two documents. This standard contains all the requirements that should be met by testing and calibration laboratories that wish to demonstrate that they operate a quality system, have technical competence and can produce technically valid results. Accreditation bodies that recognize the capabilities of testing and calibration laboratories should use this standard as the basis for their accreditation. Chapter 4 of this standard specifies the requirements for sound management, and Chapter 5 specifies the technical capability requirements for laboratories engaged in testing and (or) calibration. With the increasing application of quality systems, the need for laboratories that are part of larger organizations or provide other services to ensure that the quality systems they operate comply with ISO9001 or ISO9002 and this standard is also growing. Therefore, this standard takes care to combine all requirements in IS()9001 and ISO9002 related to the scope of testing and calibration services covered by the laboratory quality system. Testing and calibration laboratories that meet this standard also operate in accordance with ISO9001 or ISO9002. Certification based on ISO9001 and ISO9002 does not prove that the laboratory has the ability to produce technically valid data and results. If a laboratory meets this standard and is accredited by an accreditation body, and the accreditation body has reached a mutual recognition agreement with equivalent bodies in other countries that adopt this standard, this will promote mutual recognition of testing and calibration results between countries. The application of this standard will promote cooperation between laboratories and other organizations, and contribute to the exchange of information and experience and the coordination of standards and procedures.
1 Scope
National Standard of the People's Republic of China
General requirements for the competence of testing and calibration laboratoriesGB/T15481--2000
idtISO/EC17025:1999
Replaces GB/T154811995bzxz.net
1.1 This standard specifies the general requirements for the competence of laboratories to perform testing and (or) calibration (including sampling capability). 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 their inspection and product certification work. This standard applies to all laboratories, regardless of the number of their personnel or the scope of their testing and (or) calibration activities. When a laboratory does not engage in one or more activities covered by this standard, such as sampling and the design (development) of new methods, it may not adopt the requirements of the relevant clauses in this standard.
1.3 The notes in the text are explanations, examples and guidance for the main text. They neither contain requirements nor constitute the main body of this standard. 1.4 This standard is used for laboratories to establish quality, management and technical systems and control their operations. Laboratory customers, statutory management bodies and accreditation bodies can also use this standard to confirm or recognize the laboratory's capabilities. 1.5 This standard does not include regulatory and safety requirements that laboratories should comply with in their operations. 1.6 If testing and calibration laboratories meet the requirements of this standard, when they engage in the design (development) of new methods and (or) develop work plans combining standard and non-standard testing and calibration methods, the quality system they operate for testing and calibration also meets the requirements of GB/T19001 (idtIS(9001); when the laboratory only uses standard methods, it meets the requirements of GB/T19002 (idtISO9002). This standard contains some technical competence requirements not included in GB/T 19001 (idt ISO) 9001) and GB/T 19002 (idt ISO9002). Appendix A provides a comparison of the clauses of ISO/IEC 17025 with those of ISO(I) 9001 and ISO9002. NOTE 1 It may be necessary to clarify or explain some of the requirements of this standard in order to ensure the consistency of the application of these requirements. Appendix B gives guidance on the preparation of application details in special areas, particularly for accreditation bodies (see GB/T 15486-1996 idt ISO/IEC Guide 58:1993, 4.1.3). NOTE 2 If a laboratory wishes to have some or all of its testing and calibration activities accredited, it is advisable to select an accreditation body that operates in accordance with GB/T 15486-1996 (idt ISO/IEC Guide 58).
2 Referenced standards
The following standards contain clauses that constitute the clauses of this standard through reference in this standard. When this standard is published, the versions shown are valid. All standards are subject to revision, and parties using this standard should explore the possibility of using the latest versions of the following standards. GB/T19001--1994 Quality Assurance Model for Quality System Design, Development, Production, Installation and Service (idtISO9001:1994)
(GB/T19002-1994 Quality Assurance Model for Quality System Production, Installation and Service (idtISO9002:1994) ISO/IFC Guide 2 General Terms and Definitions for Standardization and Related Activities VIM, International General Metrology Basic Terms, is 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). Approved by the State Administration of Quality and Technical Supervision on December 27, 2000 and implemented on September 1, 2001
GB/T 15481.2000
: JJF10011998 "General metrological terms and definitions" contains all the contents of VIM. 3 Terms and definitions
This standard adopts the following definitions
3.1 Testing laboratory: A laboratory engaged in testing. Testing refers to a technical operation consisting of determining one or more characteristics of a given product, performing processing or providing services in accordance with prescribed procedures. (IS0/1EC Guide 2: 1996) Activity: "test\ is also translated as test, trial or inspection in some occasions: 3.2 Calibration laboratory calibration laboratory is a laboratory engaged in calibration work. Calibration is the operation to determine the relationship between the value indicated by a measuring instrument or measuring system, or the value represented by a physical object, and the corresponding value reproduced by a standard under specified conditions. (JIF10019981
For the purpose of this standard, the terms and definitions given in ISO/IEC Guide 2 and VIM are used. (GH/T6583 (idtIS) 8402) specifies general definitions related to quality, while IS0/IEC Guide 2 specifically specifies definitions related to standardization, certification and laboratory accreditation. If there is a difference between the definitions given in GB/T6583 (idtIS) 8.402) and ISO/IEC Guide 2 and VIM, the definitions in ISO/IEC Guide 2 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's responsibility is to perform testing and calibration in a manner that conforms to the requirements of this standard and meets the needs of customers, statutory authorities or organizations providing accreditation.
4.1.3 The laboratory's management system shall cover the work performed by the laboratory in fixed facilities, at locations away from its fixed facilities, or in relevant temporary or mobile facilities.
4.1.4 If the organization in which the laboratory is located also engages in activities other than testing and/or calibration, in order to identify potential conflicts of interest, the responsibilities of key personnel in the organization who are involved in or have an impact on testing and/or calibration should be defined. Note 1: If the laboratory is part of a larger organization, the organization should ensure that its parts with conflicts of interest, such as production, trade marketing or finance departments, do not have an adverse impact on the laboratory's compliance with the requirements of this standard. Note 2: If the laboratory is part of a larger organization, the organization should ensure that its parts with conflicts of interest, such as production, trade marketing or finance departments, do not have an adverse impact on the laboratory's compliance with the requirements of this standard. Note 2: If the laboratory is part of a larger organization, the organization should ensure that its parts with conflicts of interest, such as production, trade marketing or finance departments, do not have an adverse impact on the laboratory's compliance with the requirements of this standard. A laboratory that wishes to be accredited as a third-party laboratory should be able to demonstrate its impartiality. And the laboratory and its employees should be able to resist any improper commercial, financial and other pressures that may affect their technical judgment. A third-party testing or calibration laboratory should not participate in any activities that undermine its independence of judgment and the integrity of its testing or calibration. 4.1.5 The laboratory should:
) have management and technical personnel who have the necessary authority and resources to perform their duties, identify deviations from the quality system or testing and/or calibration procedures, and take measures to prevent or reduce such deviations (see 5.2); h) have measures to ensure that its management and employees are not subject to any improper commercial, financial and other pressures and influences from inside or outside that have an adverse effect on the quality of their work; () have policies and procedures to protect customer confidentiality and proprietary information, including procedures to protect electronic storage and transmission of results; d) have policies and procedures to avoid involvement in any Any activities that may reduce the credibility of its ability, impartiality, judgment or integrity of operation;
( ) Determine the organizational and management structure of the laboratory, its position in the parent organization, and the relationship between quality management, technical operations and support services;
「) Specify the responsibilities, authorities and relationships of all management, operational and verification personnel that affect the quality of testing and (or) calibration; ) Provide adequate supervision of testing and calibration personnel, including trainees, by personnel who are familiar with the methods, procedures, objectives and results evaluation of each test and (or) calibration:
GB/T15481-2000
h) Have technical management with overall responsibility for technical operations and the resources required to ensure the quality of laboratory operations; i) Designate a person as the quality manager (regardless of how he is called) who, regardless of other existing responsibilities, should be given the responsibility and authority to ensure that the quality system is implemented and followed at all times. The quality manager should have direct access to the highest management who decides laboratory policies and resources;
j) Designate deputies for key management personnel (see Note). Note: Individuals may have multiple functions and it may not be practical to designate a delegate for each responsibility. 4.2 Quality System
4.2.1 The laboratory shall establish, implement and maintain a quality system that is appropriate to the scope of its activities. Its policies, systems, plans, procedures and instructions shall be documented to the extent necessary to ensure the quality of laboratory test and/or calibration results. System documents shall be communicated to relevant personnel and understood, obtained and implemented by them. 4.2.2 The policy and objectives of the laboratory quality system shall be specified in the quality manual (regardless of the name). The overall objectives shall be documented in a policy statement; the quality policy statement shall be authorized by the chief executive and shall include at least the following: a) the laboratory management's commitment to good professional conduct and the quality of testing and calibration services provided to customers; b) the management's statement on the laboratory's service standards; c) the objectives of the quality system;
d) the requirement that all personnel involved in the laboratory's testing and calibration activities be familiar with the relevant quality documents and implement these policies and procedures in their work;
e) the laboratory management's commitment to comply with this standard. NOTE: The quality policy statement should be concise and may include the requirement that tests and/or calibrations shall always be performed in accordance with specified methods and customer requirements. When the testing and/or calibration laboratory is part of a larger organization, some elements of the quality policy may be included in other documents. 4.2.3 The quality manual shall include or indicate supporting procedures, including technical procedures, and outline the structure of the documents used in the quality system. 4.2.4 The quality manual shall define the roles and responsibilities of technical management and the quality manager, including the responsibility for ensuring compliance with this International Standard. 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 quality system, such as regulations, standards, other normative documents, test and/or calibration methods, and drawings, software, specifications, instructions and manuals. NOTE 1: "Documents" in this context may be policy statements, procedures, specifications, calibration forms, charts, textbooks, posters, notices, memoranda, software, drawings, plans, etc. These documents may be contained in a variety of media, whether hard copy or electronic, and may be in digital, analog, photographic or written form.
NOTE 2: Control of test and calibration data is addressed in 5.4.7; control of records is addressed in 4.12. 4.3.2 Approval and release of documents
4.3.2.1 All documents issued to laboratory personnel as part of the quality system shall be reviewed and approved for use by authorized personnel prior to release. A control list or equivalent document control procedure shall be established and readily accessible to identify the current revision status and distribution of documents in the quality system to prevent the use of invalid and/or obsolete documents. 4.3.2.2 The procedures used shall ensure that:
a) authorized versions of relevant documents are available at all work locations that are important to the effective operation of the laboratory; b) documents are reviewed regularly and revised as necessary to ensure continued applicability and meet the requirements of use; c) invalid or obsolete documents are promptly removed from all uses and distribution, or otherwise ensured to prevent misuse; d) obsolete documents retained for legal or knowledge preservation purposes shall be appropriately marked. 4.3.2.3 Quality system documents developed by the laboratory shall be uniquely identified. The identification shall include the issue date and/or revision identification, negative code, 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 shall be reviewed and approved by the original review responsible person. The designated person shall be provided with relevant background information on which the legal changes and approvals are based. GB/T 154812000
4.3.3.2 If practicable, changes 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 modifications to documents before they are reprinted, the procedures and authority for modification should be determined. Modifications should be clearly marked, signed with initials and dated. Revised documents should be formally published as soon as possible. 4.3.3.4 Procedures should be established to describe how to change and control files stored in computer systems. 4.4 Evaluation of requirements, tenders and contracts
4.4.1 The laboratory should establish and maintain procedures for reviewing customer requirements, tenders and contracts. These policies and procedures for reviewing for the signing of testing and (or) calibration contracts should ensure:
a) Requirements, including the methods used, should be appropriately specified, documented, and easy to understand (see 5.4.2); b) the laboratory has the capabilities and resources to meet these requirements; () select appropriate test and/or calibration methods that meet the customer's requirements (see 5.4.2); any differences between the customer's requirements or tenders and the contract shall be resolved before the work begins. Each contract shall be accepted by both the laboratory and the customer.
Note 1: The review of requirements, tenders and contracts shall be conducted in a feasible and effective manner, taking into account the financial, legal and scheduling implications. The review of requirements, tenders and contracts for internal customers may be conducted in a simplified manner. Note 2: The review of the laboratory's capabilities shall confirm that the laboratory has the necessary material, human and information resources and that the laboratory personnel have the necessary skills and expertise for the tests and/or calibrations performed. The review may also include the results of previous inter-laboratory comparisons or proficiency tests and/or the results of trial test or calibration plans using samples or items of known values ​​to determine measurement uncertainty, detection limits, confidence limits, etc. Note 3: A contract can be any written or oral agreement to provide testing and/or calibration services to a customer. 4.4.2 Records of the review, including any significant changes, should be maintained. Records of discussions with the customer regarding the customer's requirements or the results of the work performed during the contract should also be maintained. NOTE: For routine and other simple tasks, the review may be dated and identified (e.g. with initials) by the laboratory personnel responsible for the contract. For repetitive routine work, where customer requirements remain unchanged, a review may only be required at the initial investigation stage or upon approval of the contract for ongoing routine work under a general agreement with the customer. For new, complex or advanced testing and/or calibration tasks, more comprehensive records may be maintained. 4.4.3 The review should include all work that has been subcontracted by the laboratory. 4.4.4 The customer should be notified of any deviations from the contract. 4.4.5 If the contract needs to be modified after work has begun, the same contract review process should be repeated and all affected personnel notified of any modifications.
4.5 Subcontracting of testing and calibration
4.5.1 When the laboratory needs to subcontract work for unexpected reasons (such as workload, the need for additional expertise or temporary lack of capacity) or for ongoing reasons (such as through long-term subcontracting, agency or special agreement), it should subcontract to qualified subcontractors, such as those who can perform the work in accordance with the requirements of this International Standard.
4.5.2 The laboratory should inform the client in writing of the subcontracting arrangements and, where appropriate, obtain the client's permission, preferably in writing. 4.5.3 The laboratory shall be responsible to the client for the work of its subcontractors, except for subcontractors designated by the client or statutory authority. 4.5.4 The laboratory shall maintain a registration of all subcontractors used in testing and/or calibration and maintain records demonstrating that their work complies with this International Standard.
4.6 Procurement of services and supplies
4.6.1 The laboratory shall have policies and procedures for the selection and purchase of services and supplies that affect the quality of testing and/or calibration. There should also be procedures for the purchase, acceptance and storage of reagents and consumables related to testing and calibration. 4.6.2 The laboratory should ensure that the purchased supplies, reagents and consumables that affect the quality of testing and (or) calibration are only put into use after being inspected or confirmed to comply with the standard specifications or requirements specified in the relevant testing and (or) calibration methods. The services and supplies used should comply with the specified requirements. Records of compliance inspection activities taken should be kept. 4.6.3 The procurement documents for items that affect the quality of the laboratory's output should include information describing the purchased services and supplies. The technical content of these procurement documents should be reviewed and approved before they are issued. 154
GB/T15481·-2000
Note: The description may include type, category, grade, precise identification, specifications, drawings, inspection instructions, other technical information including test result approval, customer requirements and the quality system standards under which these works are carried out. 4.6.4 The laboratory shall evaluate the suppliers of important consumables, supplies and services that affect the quality of testing and calibration, and keep records of these evaluations and a list of approved suppliers. 4.7 Customer Service
The laboratory shall cooperate with the customer or its representative to clarify the customer's requirements and allow the customer to visit the laboratory to monitor operations related to its work, provided that other customer confidentiality is ensured. Note 1: Such cooperation may include:
a) Allowing the customer or its representative reasonable access to the relevant areas of the laboratory to directly observe the testing and (or) calibration performed for it; b) Preparation, packaging and delivery of test and (or) calibration items ordered by the customer for verification purposes. Note 2: The customer attaches great importance to maintaining good technical communication with the laboratory and obtaining advice and guidance, as well as opinions and interpretations based on the results. The laboratory should maintain contact with its customers throughout the work, especially those with large business: the laboratory should inform its customers of any delays and major deviations in the testing and/or calibration process.
NOTE 3: The laboratory is encouraged to collect additional feedback from its customers (e.g. through customer surveys), both positive and negative. This feedback can be used to improve the quality system, testing and calibration work and service to customers. 4.8
The laboratory should have policies and procedures for dealing with complaints from customers or other parties. Records of all complaints should be maintained, as well as records of the laboratory's investigation and corrective actions in response to complaints (see 4.10). 4.9 Control of nonconforming testing and/or calibration work 4.9.1 The laboratory should implement established policies and procedures when any aspect of the testing and/or calibration work, or the results of such work, does not conform to the requirements of its procedures or agreed to by its customers. The policy and procedures shall ensure that: a) the responsibilities and authorities for managing nonconforming work are defined. Actions to be taken when nonconforming work is identified (including suspension of work, withholding of test reports and calibration certificates, if necessary) are defined. b) the severity of the nonconforming work is evaluated. c) corrective action is taken immediately and a decision is made on the acceptability of the nonconforming work. d) the customer is notified and the work is cancelled, if necessary. e) the responsibility for approving the resumption of work is defined.
Note: Identification of nonconforming work or problems with the quality system or testing and/or calibration activities may occur at various points in the quality system and technical operations. Examples include customer complaints, quality control, instrument calibration, verification of consumable materials, staff inspection or supervision, verification of test reports and calibration certificates, management review and internal or external audits.
4.9.2 When evaluation indicates that nonconforming work may recur or that there is doubt about the laboratory's operations in accordance with its policies and procedures, the corrective action procedures specified in 4.10 shall be implemented immediately. 4.10 Corrective Action
4.10.1 General
The laboratory shall have policies and procedures and appropriate authority to implement corrective actions when nonconforming work, deviations from the policies and procedures of the quality system or technical operations are identified. NOTE: Problems in the laboratory's quality system or technical operations can be identified through a variety of activities, such as control of nonconforming work, internal or external audits, management reviews, customer feedback or employee observation. 4.10.2 Cause Analysis
The corrective action procedure shall begin with an investigation to determine the root cause of the problem. NOTE: Cause analysis is the most critical and sometimes the most difficult part of the corrective action procedure. The root cause is usually not clear, so a detailed analysis of all potential causes of the problem is required. Potential causes may include: customer requirements, samples, sample specifications, methods and procedures, employee skills and training, consumables, equipment and its calibration.
4.10.3 Selection and implementation of corrective actions
GB/T154812000
When corrective actions are required, the laboratory shall determine the corrective actions to be taken, and select and implement the measures that best eliminate the problem and prevent the problem from recurring.
Corrective actions should be commensurate with the severity of the problem and the size of the risk. The laboratory shall document and implement any changes required by the investigation of corrective actions. 4.10.4 Monitoring of corrective actions
The laboratory shall monitor the results of corrective actions to ensure that the corrective actions taken are effective. 4.10.5 Additional audits
When the identification of nonconformities or deviations leads to doubts about the laboratory's compliance with its policies and procedures, or with this standard, the laboratory shall audit the relevant activity areas as soon as possible in accordance with the provisions of Section 4.13. Note: Additional audits are often conducted after the implementation of corrective actions to determine the effectiveness of the corrective actions. Additional audits are only necessary when it is confirmed that the problem is serious or harmful to the business.
4.11 Preventive measures
4.11.1 The potential causes of nonconformities and the required improvements, whether technical or related to the quality system, should be determined. If preventive measures are required, these action plans should be developed, implemented and monitored to reduce the likelihood of similar nonconformities and take advantage of opportunities for improvement. 4.11.2 The preventive action procedure shall include the initiation and control of actions to ensure their effectiveness. NOTE 1: Preventive action is the process of proactively identifying opportunities for improvement rather than reacting to identified problems or complaints. NOTE 2: In addition to reviewing operating procedures, preventive action involves data analysis including trend and risk analysis and proficiency testing results. 4.12 Control of records
4.12.1 General
4.12.1.1 The laboratory shall establish and maintain procedures for the identification, collection, indexing, access, archiving, storage, maintenance and disposal of quality and technical records. Quality records shall include reports from internal audits and management reviews and records of corrective and preventive actions. 4.12.1.2 All records shall be legible and stored in an accessible manner and in a facility with an appropriate environment to prevent damage, deterioration, loss, etc. The retention period for records shall be specified. NOTE: Records may be stored on any form of media, such as hard copy or electronic media. 4.12.1.3 All records shall be securely protected and confidential. 4.12.1.4 The laboratory shall have procedures to protect and back up records stored in electronic form and to prevent unauthorized access or modification. 4.12.2 Technical records
4.12.2.1 The laboratory shall retain original observation records, derived data, sufficient information to conduct follow-up audits, calibration records, employee records and a copy of each test report or calibration certificate issued for a specified period of time. Whenever possible, the record of each test or calibration shall contain sufficient information to identify the factors affecting the uncertainty and to ensure that the test or calibration can be reproduced under conditions as close to the original as possible. The record shall include the identification of the person responsible for sampling, the person who performed each test and/or calibration and the person who checked the results. NOTE 1: In some areas, it may be impossible or impractical to retain all original observation records. NOTE 2: Technical records are the accumulation of data (see 5.4.7) and information obtained from the performance of tests and/or calibrations that indicate whether the test and/or calibration has achieved the specified quality or specified process parameters. Technical records may include forms, contracts, work orders, work manuals, checklists, work notes, control charts, external and internal test reports and calibration certificates, customer correspondence, documents and feedback. 4.12.2.2 Observations, data and calculations shall be recorded as work is being done and shall be identifiable by specific task classification. 4.12.2.3 When errors are made in records, each error shall be crossed out and not erased to prevent the writing from becoming blurred or obliterated, and the correct value shall be filled in next to it. All changes to records shall be signed or initialed by the person making the change. Equivalent measures shall be taken for electronically stored records to prevent loss or alteration of original data.
4.13 Internal Audit
4.13.1 The laboratory shall periodically conduct internal audits of its activities in accordance with a predetermined schedule and procedure to verify that its operations continue to conform to the requirements of the quality system and this International Standard. The internal audit plan shall cover all elements of the quality system, including testing and/or calibration activities. The quality manager is responsible for planning and organizing internal audits in accordance with the schedule requirements and the needs of management. Audits shall be conducted by trained and qualified personnel who shall be independent of the activities being audited, as resources permit. 156
Note: The internal audit cycle is usually ·· years. GB/T154812000
4.13.2 When problems found during the audit lead to doubts about the effectiveness of operations or the correctness or validity of the laboratory's test and (or) calibration results, the laboratory shall take corrective measures in a timely manner. If the investigation shows that the laboratory's results may have been affected, the customer shall be notified in writing
4.13.3 The scope of the audit activities, the audit findings and the corrective actions taken as a result shall be recorded. 4.13.4 Follow-up audit activities shall verify and record the implementation and effectiveness of corrective actions. 4.14 Management Review
4.14.1 The laboratory's executive management shall review the laboratory's quality system and test and (or) calibration activities regularly according to a predetermined schedule and procedure to ensure their continued applicability and effectiveness, and make necessary changes or improvements. The review should take into account: - the suitability of policies and procedures;
reports from management and supervisory personnel;
- results of recent internal audits;
- corrective and preventive actions;
reviews by external bodies;
results of inter-laboratory comparisons or proficiency testing; changes in workload and type of work;
feedback from customers;
complaints;
- other relevant factors, such as quality control activities, resources and staff training. NOTE 1 The typical cycle for management review is 12 months. NOTE 2 The results of the review need to be input into the laboratory planning system and include the goals, objectives and activity plans for the next year. NOTE 3 The management review includes a review of relevant topics in the regular management meetings. 4.14.2 The findings of the management review and the resulting actions should be recorded. Management should ensure that these actions are implemented within an appropriate and agreed schedule.
5 Technical requirements
5.1 General
5.1.1 There are many factors that determine the accuracy and reliability of laboratory testing and (or) calibration, including: —- Personnel (5.2);
Facilities and environmental conditions (5.3);
Testing and calibration methods and method confirmation (5.4); Equipment (5.5);
Traceability of measurement (5.6);
Sampling (5.7);
Disposal of test and calibration items (5.8). 5.1.2 The influence of the above factors on the total measurement uncertainty varies significantly between (various types of tests) and (various types of) calibration. The laboratory should take these factors into account when developing test and calibration methods and procedures, training and assessing personnel, and selecting and calibrating the equipment used. 5.2 Personnel
5.2.1 The laboratory management should ensure the competence of all personnel who operate specialized equipment, perform tests and (or) calibrations, evaluate the results, and sign test reports and calibration certificates. When using in-training employees, they should be arranged for appropriate supervision. Personnel performing specific work should be qualified as required based on appropriate education, training, experience and (or) demonstrable skills. Note 1: Some technical fields (such as non-destructive testing) may require personnel performing certain work to hold personal qualifications. The laboratory is responsible for meeting the requirements for these specialized personnel to hold certificates. The requirements for personnel qualifications may be statutory, included in the standards of special technical fields, or required by customers. 157
GB/T 15481--2000
Note 2: Personnel responsible for the opinions and interpretations contained in the test report, in addition to having appropriate qualifications, training, experience and sufficient knowledge of the tests performed, shall also have:
Knowledge of the appropriate technology used to manufacture the tested articles, materials, products, etc., knowledge of the methods used or to be used, and knowledge of defects or degradation that may occur during use; knowledge of the general requirements set out in regulations and standards; understanding of the degree of deviation from normal use of the relevant articles, materials and products. 5.2.2 Laboratory management shall establish education, training and skill objectives for laboratory personnel. There shall be policies and procedures for determining training needs and providing personnel training. The training plan shall be appropriate to the current and anticipated tasks of the laboratory. 5.2.3 The laboratory shall use permanent employed or contracted personnel. When using contracted personnel and additional technical personnel and key support personnel, the laboratory shall ensure that these personnel are competent and supervised, and are based on the laboratory's quality System requirements work. 5.2.4 The laboratory shall maintain a current description of the management, technical and key support personnel involved in testing and/or calibration.
Note: Job descriptions can be expressed in a variety of ways, but at least the following must be specified:: Responsibilities for performing testing and/or calibration work Responsibilities for evaluating testing and/or calibration plans and results: ... Responsibilities for submitting opinions and interpretations
... Responsibilities for method improvement, new method development and validation: Required expertise and experience;
Qualifications and training plans;
Management responsibilities.
5.2.5 Management shall authorize specialized personnel to perform special types of sampling, testing and/or calibration, issue test reports and calibration certificates, provide opinions and interpretations, and operate special types of equipment. The laboratory shall maintain records of the relevant authorizations, capabilities, education and professional qualifications, training, skills and experience of all technical personnel (including contracted personnel), including the dates of authorization and/or capability validation. This information shall be readily accessible. 5.3 Facilities and environmental conditions
5.3.1 The laboratory facilities used for testing and/or calibration, including but not limited to energy, lighting and environmental conditions, should facilitate the correct implementation of testing and/or calibration.
The laboratory shall ensure that its environmental conditions do not invalidate the results or adversely affect the required measurement quality. Special attention should be paid when sampling, testing and/or calibration are carried out at locations other than the laboratory's fixed facilities. Technical requirements for facilities and environmental conditions that affect the test and calibration results should be documented.
5.3.2 The laboratory shall monitor, control and record environmental conditions when required by relevant specifications, methods and procedures or when they affect the quality of the results. Attention should be paid to such factors as biological disinfection, dust, electromagnetic interference, radiation, humidity, power supply, temperature, sound level and vibration level, so that they are adapted to the relevant technical activities. When environmental conditions endanger the results of testing and/or calibration, testing and calibration should be stopped. 5.3.3 Adjacent areas of incompatible activities should be effectively isolated. Measures should be taken to prevent cross contamination. 5.3.4 Access to and use of areas that may affect the quality of tests and/or calibrations shall be controlled. The laboratory shall determine the extent of control in light of its specific circumstances.
5.3.5 Measures shall be taken to ensure good housekeeping in the laboratory and, where necessary, specific procedures shall be established. 5.4 Test and calibration methods and validation of methods 5.4.1 General
The laboratory shall use appropriate methods and procedures for all tests and/or calibrations, including sampling, handling, transport, storage and preparation of test and/or calibration items and, where appropriate, the assessment of measurement uncertainty and statistical techniques for the analysis of test and/or calibration data. The laboratory shall have instructions for the use and operation of all relevant equipment and instructions for the handling and preparation of test and/or calibration items, or both, if the absence of such instructions may affect the test and/or calibration results. All instructions, standards, manuals and reference materials relevant to the laboratory's work shall be kept current and readily available to staff (see 4.3). Deviations from test and calibration methods should only be permitted if they have been documented, technically judged, authorized and agreed to by the customer. 158
GB/T154812000
Note: If international, regional or national standards, or other recognized specifications, already contain concise and sufficient information on how to perform tests and (or) calibrations, and if these standards are written in a way that can be used by laboratory operators as public documents, there is no need to supplement or change them into internal procedures. It may be necessary to develop additional details or supplementary documents for optional steps in the methods. 5.4.2 Selection of methods
The laboratory should use methods that meet customer needs and are appropriate for the tests and (or) calibrations being performed, including sampling methods. Methods published as international, regional or national standards should be used preferentially. The laboratory should ensure that the latest valid version of the standard is used, unless that version is This method is not suitable or possible to use. When necessary, the standard should be supplemented with additional details to ensure consistency of application. When the customer does not specify the method to be used, the laboratory should select a method published as an international, regional or national standard, or published by a well-known technical organization or relevant scientific books and journals, or specified by the equipment manufacturer. Methods developed or adopted by the laboratory may also be used if they meet the intended use of the laboratory and have been validated. The selected method should be notified to the customer. Before starting the test or calibration, the laboratory should confirm that the standard method can be applied correctly. If the standard method has changed, it should be reconfirmed. When the method proposed by the customer is considered inappropriate or out of date, the laboratory should notify the customer. 5.4.3 Laboratory-developed methods
The laboratory uses it for its application The process of developing test and calibration methods should be a planned activity and should be carried out by designated qualified personnel with adequate resources.
The plan should be updated as the method development progresses and ensure effective communication between all relevant personnel. 5.4.4 Non-standard methods
When a method not included in the standard method must be used, the customer's consent should be obtained, including a clear statement of the customer's requirements and the purpose of the test and (or) calibration. The developed method should be appropriately validated before use. Note: For new test and (or) calibration methods, procedures must be established before testing and (or) calibration are carried out. The procedure must include at least the following information a) Appropriate identification:
b) Scope:
c) Description of the type of item being tested or calibrated; d) Scope of the test and (or) calibration method. ) Parameters or quantities and ranges to be measured:
e) Apparatus and equipment, including technical performance requirements; f) Required reference standards and standard materials (reference materials); g) Required environmental conditions and required stabilization periods; h) Description of procedures, including:
"… additional identification, handling, transportation, storage and preparation of items; - calibration before work begins;
… checking that equipment is working properly and, if necessary, calibrating and adjusting equipment before each use; methods for recording observations and results,
…· safety measures to be followed;
i) acceptance (or rejection) criteria and (or) requirements; j) data to be recorded and methods of analysis and expression; k) uncertainty or procedures for assessing uncertainty. 5.4.5 Validation of methods
5.4.5.1 Validation is the verification and provision of objective evidence that the specific requirements for a particular intended use are met. 5.4.5.2 The laboratory shall validate non-standard methods, laboratory-designed (developed) methods, standard methods used outside their intended scope, and expanded and modified standard methods to demonstrate that the method is suitable for the intended purpose. Validation should be as comprehensive as possible to meet the needs of the intended purpose or application area. The laboratory shall record the results obtained, the validation procedures used, and a statement on whether the method is suitable for the intended purpose. Note 1: This may include validation of sampling, handling and transportation procedures. Note 2: The techniques used to determine the performance of a method should be one of the following, or a combination of them: \ calibration using reference standards or standard materials (reference materials); comparison with results obtained from other methods; 159or published by a well-known technical organization or relevant scientific books and journals, or specified by the equipment manufacturer. Methods developed or adopted by the laboratory may also be used if they meet the laboratory's intended use and have been validated. The selected method should be notified to the customer. Before starting a test or calibration, the laboratory should confirm that the standard method can be applied correctly. If the standard method has changed, it should be revalidated. The laboratory should inform the customer when the method proposed by the customer is considered inappropriate or out of date. 5.4.3 Laboratory-developed methods
The process of developing test and calibration methods for the laboratory's application should be a planned activity and should be carried out by qualified personnel with adequate resources.
The plan should be updated as the method development progresses and ensure effective communication between all relevant personnel. 5.4.4 Non-standard methods
When a method not included in the standard method must be used, the customer's agreement should be obtained, including a clear statement of the customer's requirements and the purpose of the test and/or calibration. The developed method should be appropriately validated before use. Note: For new test and/or calibration methods, procedures should be established before testing and/or calibration are carried out. The procedure shall contain at least the following information: a) appropriate identification: b) scope: c) description of the type of item to be tested or calibrated; d) parameter or quantity to be measured and its range: e) apparatus and equipment, including technical performance requirements; f) required reference standards and standard materials (reference materials); g) required environmental conditions and required stabilization periods: h) description of the procedure, including: ... additional identification marking, handling, transportation, storage and preparation of items; - checks to be carried out before work begins; ... checking that the equipment is working properly and, if necessary, calibrating and adjusting the equipment before each use; methods for recording observations and results, and safety measures to be followed; i) acceptance (or rejection) criteria and/or requirements; j) data to be recorded and methods of analysis and expression; k) uncertainty or a procedure for assessing uncertainty. 5.4.5 Validation of methods
5.4.5.1 Validation is the verification and provision of objective evidence that the special requirements for a particular intended use are met. 5.4.5.2 The laboratory shall validate non-standard methods, laboratory-designed (developed) methods, standard methods used outside their intended scope, and expanded and modified standard methods to confirm that the method is suitable for the intended use. Validation should be as comprehensive as possible to meet the needs of the intended use or application area. The laboratory shall record the results obtained, the validation procedures used, and a statement on the suitability of the method for the intended use. Note 1: This may include validation of sampling, handling and transport procedures. Note 2: The technique used to determine the performance of a method should be one of the following, or a combination of them: \calibration using reference standards or standard materials (reference materials); comparison with results obtained from other methods; 159or published by a well-known technical organization or relevant scientific books and journals, or specified by the equipment manufacturer. Methods developed or adopted by the laboratory may also be used if they meet the laboratory's intended use and have been validated. The selected method should be notified to the customer. Before starting a test or calibration, the laboratory should confirm that the standard method can be applied correctly. If the standard method has changed, it should be revalidated. The laboratory should inform the customer when the method proposed by the customer is considered inappropriate or out of date. 5.4.3 Laboratory-developed methods
The process of developing test and calibration methods for the laboratory's application should be a planned activity and should be carried out by qualified personnel with adequate resources.
The plan should be updated as the method development progresses and ensure effective communication between all relevant personnel. 5.4.4 Non-standard methods
When a method not included in the standard method must be used, the customer's agreement should be obtained, including a clear statement of the customer's requirements and the purpose of the test and/or calibration. The developed method should be appropriately validated before use. Note: For new test and/or calibration methods, procedures should be established before testing and/or calibration are carried out. The procedure shall contain at least the following information: a) appropriate identification: b) scope: c) description of the type of item to be tested or calibrated; d) parameter or quantity to be measured and its range: e) apparatus and equipment, including technical performance requirements; f) required reference standards and standard materials (reference materials); g) required environmental conditions and required stabilization periods: h) description of the procedure, including: ... additional identification marking, handling, transportation, storage and preparation of items; - checks to be carried out before work begins; ... checking that the equipment is working properly and, if necessary, calibrating and adjusting the equipment before each use; methods for recording observations and results, and safety measures to be followed; i) acceptance (or rejection) criteria and/or requirements; j) data to be recorded and methods of analysis and expression; k) uncertainty or a procedure for assessing uncertainty. 5.4.5 Validation of methods
5.4.5.1 Validation is the verification and provision of objective evidence that the special requirements for a particular intended use are met. 5.4.5.2 The laboratory shall validate non-standard methods, laboratory-designed (developed) methods, standard methods used outside their intended scope, and expanded and modified standard methods to confirm that the method is suitable for the intended use. Validation should be as comprehensive as possible to meet the needs of the intended use or application area. The laboratory shall record the results obtained, the validation procedures used, and a statement on the suitability of the method for the intended use. Note 1: This may include validation of sampling, handling and transport procedures. Note 2: The technique used to determine the performance of a method should be one of the following, or a combination of them: \calibration using reference standards or standard materials (reference materials); comparison with results obtained from other methods; 159
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