Rules for the Examination of the Service of Legal Metrological Verification
Some standard content:
References
Terms and definitions
Organization and management
Quality system
Resource allocation and management
Implementation of verification, calibration and testing
Quality improvement
Assessment procedures
10 Evaluation of assessment results
Assessment specifications for legal metrology verification institutions
JJF1069—2000
Legal metrology verification institutions are metrology technical institutions established or authorized by government metrology administrative departments in accordance with the law, which provide technical guarantees for government metrology administrative departments to implement metrology supervision and provide technical services for the national economy and social life. In order to strengthen the management of legal metrology verification institutions and ensure that they provide fair, accurate and legally effective metrology verification and testing results for the national economy and metrology supervision in accordance with the law, this assessment specification is formulated in accordance with the provisions of the "Metrology Law of the People's Republic of China" and its relevant regulations, as well as the requirements of the International Organization of Legal Metrology (OIML) for legal metrology laboratories. This specification is mainly applicable to the assessment of statutory metrology verification institutions established or authorized by government metrology administrative departments in accordance with the law. Since statutory metrology verification institutions are mainly engaged in metrology verification work, in this specification, metrology verification, metrology calibration and metrology testing work are referred to as "verification, calibration and testing". The assessment content specified in this specification is based on the requirements of my country's metrology laws and regulations for statutory metrology verification institutions, the requirements of the International Legal Metrology Organization for legal metrology laboratories and the general requirements of the International Organization for Standardization (ISO) for the capabilities of inspection and calibration laboratories. In terms of structure, it refers to the structure and principles of the quality system of the ISO9000 family of standards. The assessment procedures and assessment methods of the assessment results specified in this specification are based on the national standard GB/T154861995 "General requirements for operation and accreditation of calibration and testing laboratory accreditation system", and absorb the successful experience of the government metrology administrative departments in recent years in assessing statutory metrology verification institutions. This specification also complies with the accreditation requirements for legal metrology laboratories proposed by the International Committee for Weights and Measures (CIPM) to achieve mutual recognition of metrology standards and calibration/measurement between countries and the International Organization of Legal Metrology to achieve mutual recognition of type approval certificates for measuring instruments.
This specification specifies the requirements that legal metrology verification institutions must meet to obtain authorization from government metrology administrative departments, as well as the requirements for the procedures for the assessment of legal metrology verification institutions and the evaluation of the assessment results. It is applicable to the assessment and supervision and inspection of legal metrology verification institutions by government metrology administrative departments. The requirements of this specification cover the following activities that legal metrology verification institutions carry out in accordance with the law: (1) Establishing metrology standards and social public metrology standards; (2) Carrying out value transfer and performing mandatory verification, non-mandatory verification, arbitration verification and other verification tasks prescribed by law; (3) Carrying out other inspection tasks prescribed by law such as finalization appraisal and prototype testing; (4) Carrying out metrology calibration;
(5) Drafting metrology technical specifications.
1.2 The requirements of this specification are general and applicable to statutory metrology verification institutions established or authorized by the metrology administrative departments of governments at all levels in accordance with the law. When an institution does not engage in metrology calibration or finalization appraisal, prototype testing and other testing work, the requirements can be tailored. This tailoring is limited to the corresponding clauses in Clause 7 "Implementation of Verification, Calibration and Testing". 1.3 This specification applies to the establishment and operation of quality systems by statutory metrology verification institutions, but it does not require statutory metrology verification institutions to change the structure or documents of their quality systems according to the structure of this specification. The composition of the quality system documents of an institution should be suitable for its unique mode of activities.
References
This specification references the following documents:
JJF1001-1998 General Metrology Terms and DefinitionsJJF1059-1999 Evaluation and Expression of Measurement UncertaintyJJF 1033—1992 Specification for the Assessment of Metrological Standards JJF1015—1990 General Specification for the Finalization of Measuring Instruments JJF1016—1990 Guidelines for the Preparation of Specifications for the Finalization and Appraisal of Measuring Instruments ISO/IEC Guide 2:1996 Basic Terms and Definitions for Standardization and Related Activities ISO/IEC17025:1999 General Requirements for the Competence of Testing and Calibration Laboratories GB/T19001—1994 Quality Assurance System
Quality Assurance 3 for Design/Development, Production, Installation and Service
GB/T19022.1—199 5 Quality assurance requirements for measuring equipment Part 1: Metrological confirmation system for measuring equipment ISO 100122: 1997 Quality assurance requirements for measuring equipment GB/T 6583-1994 Quality management and quality assurance terminology
GB/T 19021-1993 Quality system audit guide Part 2: Guide to measurement process control
GB/T 15486-1995 Calibration and testing laboratory accreditation system - General requirements for operation and accreditation GB/T 15483-1999 Proficiency testing using inter-laboratory comparisons When using this specification, Note that the currently valid versions of the above-mentioned references are used. Terms and Definitions
The relevant definitions in JJF1001-1998 "General Metrology Terms and Definitions", GB/T6583 and ISO/IEC Guide 2 apply to this specification. Some of the most relevant definitions are cited below, and some other definitions applicable to this specification are listed. 3.1
Legal Metrology Verification Agency
Metrology verification agencies established by the metrology administrative departments of governments at all levels in accordance with the law, and metrology verification agencies authorized by them. Note: In this specification, legal metrology verification agencies are referred to as "agencies\. 3.2
The procedure for ascertaining and confirming whether the measuring instrument meets the statutory requirements, which includes inspection, marking and (or) issuing a verification certificate.
Verification certificate
A document proving that the measuring instrument has been calibrated and a satisfactory result has been obtained. Notice of verification results
A document stating that a measuring instrument does not comply with the relevant statutory requirements. 3.5
A set of operations to determine the relationship between the value indicated by a measuring instrument or measuring system, or the value represented by a physical measure or reference material, and the corresponding value reproduced by a standard under specified conditions. Note:
The calibration result can give both the indication of the measured value and the correction value of the indication. 2
Calibration can also determine other metrological characteristics, such as the effect of influencing quantities. The calibration results can be recorded in a calibration certificate or calibration report. Calibration method
The technical procedure specified for calibration. 3.7
The technical operation performed in accordance with the specified procedures to determine one or more characteristics or performances of a given product, material, equipment, organism, physical phenomenon, process or service. Note:
The test results are usually recorded in a document called a test report or test certificate. The test referred to in the specification is mainly the finalization and identification of measuring instruments (measuring instruments) or prototype testing. 3.8
Capability comparison test
Use comparison between laboratories to judge the verification, calibration or testing work of the laboratory. Measurement
A set of operations for the purpose of determining the value of a quantity. Note:
The operation can be performed automatically.
Measurement is sometimes also called metrology.
3.10 Metrology
An activity to achieve unified units and accurate and reliable values of measurement. 3.11 Best measurement capability
The highest measurement level usually provided to users, which is expressed by an expanded uncertainty with a coverage factor of -2. Note: Sometimes called calibration measurement capability.
3.12 Finalization and appraisal
To comprehensively test, review and evaluate the full performance of new product prototypes of metrological instruments that have never been produced nationwide (including those that have made major improvements to the original products in terms of structure, performance, materials, technical characteristics, etc.). 3.13
Prototype test
The test, review and confirmation conducted by the government metrology administrative department on the new metrology instruments that have been finalized nationwide and produced for the first time in the unit before they are put into production. Note: The prototype test is the responsibility of the local provincial people's government metrology administrative department, and the test work is carried out by the technical organization authorized by it.
Quality system
The organizational structure, procedures, processes and resources required to implement quality management. Quality manual
A document that explains the quality policy, quality system and quality practices of an organization. Note: The quality manual may list other documents related to the quality work of the organization. Organization and management
Legal status
The legal metrology verification agency established in accordance with the law must be an entity that can bear legal responsibilities independently. It has the documents established by the government metrology administrative department in accordance with the law, and its person in charge should have the legal person qualification certificate and the corresponding appointment letter of the government metrology administrative department.
The legal metrology verification agency authorized to be established must have the documents of consent to authorization by the government metrology administrative department. 4.1.2
The person in charge shall have a certificate of legal person qualification and a letter of appointment from its competent department. If the authorized statutory metrology verification agency is part of an organization, it shall have an independent structure, and its person in charge shall have a letter of authorization from the legal representative. 4.2 Legal responsibilities
The agency must strictly abide by the relevant national metrology laws and regulations, and conscientiously perform the duties assigned by the metrology laws and regulations.
The agency must fully complete the various tasks assigned by the government metrology administrative department to provide technical guarantees for the implementation of the Metrology Law, and consciously accept the supervision and management of the government metrology administrative department. 4.3
Basic conditions
4.3.1 Whether the metrology verification, calibration and testing work is carried out in fixed facilities, in places far away from fixed facilities, or in relevant temporary or mobile facilities, the agency shall be organized and operated in a manner that meets the requirements of this specification. 4.3.2 The organization should a) have appropriate management personnel who have the necessary ability, authority and resources to perform their duties; b) have appropriate measures to ensure that the quality of work of its management and technical personnel is not affected by any internal and external tasks, financial or other pressures; c) have documented policies and procedures to ensure that customer confidential information and proprietary rights are protected; d) have documented policies and procedures to avoid participating in any activities that may impair their ability, impartiality, honesty, independent judgment or affect their professional ethics; e) adopt an organizational chart to clearly define the organization's organizational and management structure, as well as management work, technical work, The relationship between the host organization and the quality system:
f) Clearly define the responsibilities, powers and relationships of all managers, executives or verifiers who have an impact on the quality of verification, calibration and testing;
g) Effective supervision of the work of verification, calibration and testing personnel is implemented by personnel who are familiar with the verification, calibration and testing methods and procedures, understand the purpose of each verification, calibration and testing, and know how to review the results; h) There is a technical person in charge and a quality person in charge, with clear responsibilities and powers, and they are fully responsible for the technical and quality work of the organization;
) Appoint agents for key management personnel, such as agents for the quality person in charge. 5
Quality system
Management responsibilities
The head of the organization shall provide a basis for its commitment to meet the requirements of this specification through the following activities (including but not limited to):
a) Communicate the importance of meeting legal, regulatory, regulatory and customer requirements to the organization; b) Establish quality policies and quality objectives;
c) Establish a quality management system and ensure its effective operation; d) Conduct management review;
e) Ensure the necessary resources are available.
5.2 System documents
5.2.1 General
The head of the organization shall establish a documented quality management system as a basis for ensuring that verification, calibration and testing work meets the specified requirements. The quality management system established shall be appropriate to the verification, calibration and testing activities undertaken by the organization and its scale.
Quality manual
The organization shall prepare a quality manual. The quality manual shall include (but not limited to) a) an overview of the organization; b) quality policy and quality objectives; c) the organization's commitment to customers; d) the quality management system defined; e) a description of the organizational structure; f) the roles and responsibilities of the technical person in charge and the person in charge of quality; g) include or reference the procedure documents used. 5.2.3
Procedure Documents
The organization shall prepare procedure documents. The procedure documents, together with the quality manual, constitute a description of the entire quality management system. The scope of the procedure documents shall cover the requirements of this specification, and the degree of detail shall depend on the complexity of the work, the methods used, and the skills and training of the personnel involved in carrying out the corresponding work. 5.2.4
Quality Records
The organization shall establish and implement procedures for the identification, collection, retrieval, access, storage, maintenance and handling of quality records.
All records should be legible and stored in facilities with appropriate environments to avoid damage or loss and to facilitate retrieval.
The organization should specify the retention period for records and ensure the security and reliability of records. The organization should have procedures to protect and reasonably access data in computers to prevent unauthorized personnel from accessing or modifying data.
5.3 Document Control
The organization should establish procedures for the preparation and revision of documents required for the operation of the quality management system, and should control applicable external documents, such as regulations, verification procedures, calibration specifications, test methods, etc. These procedures should ensure: a) Documents are approved and ensure that they are clear, appropriate, and easy to identify; b) Documents are reviewed regularly and revised when necessary; c) Revisions should be controlled, and unless otherwise specified, document revisions should be reviewed and approved by the original reviewer and approver. d) Documents are kept in an orderly manner, and valid versions of relevant documents are available at the required locations; e) Obsolete documents are promptly withdrawn from all distribution and use locations to prevent misuse; f) Any obsolete documents that need to be retained are properly marked. 5.4 Management Reviewwww.bzxz.net
5.4.1 The head of the organization shall review the organization's quality management system and verification, calibration and testing activities regularly according to the pre-established plan and procedures, and record the results of the review. 5.4.2 The review shall fully collect and pay attention to relevant information such as internal supervision and audit reports, external organization reviews, customer feedback, laboratory comparisons and proficiency verification results, and include other factors such as quality control facilities, resources, and employee training.
6 Resource Allocation and Management
6.1 General
The organization shall provide a list of verification, calibration and testing services it carries out (including such things as the procedures, standards or specifications implemented, project names, measurement uncertainty or allowable error, range or measurement range, etc.). Determine and provide the resources needed to perform its verification, calibration and testing tasks, and to establish and improve the quality management system. 6.2 Personnel
The organization shall be equipped with sufficient management, supervision and verification, calibration and testing personnel according to the needs of the work. 6.2.2
Personnel directly related to metrological verification, calibration and testing services should undergo necessary training and have relevant technical knowledge, legal knowledge and practical operation experience. Verification, calibration and testing personnel must be qualified in accordance with relevant regulations and be approved and certified before taking up their posts.
The organization should make clear requirements for the education and skills of personnel, and have policies and procedures to determine training needs and provide personnel training. 6.2.3
The training plan should meet the current needs and future development of the organization and be implemented. 6.2.4
The organization should establish files on the relevant capabilities, education and training and qualifications, skills and experience of all technical personnel. 6.3
Facilities and environmental conditions
The facilities used for verification, calibration and testing, including (but not limited to) energy, lighting and environmental conditions, should meet the requirements specified in the technical specifications of the projects carried out and should be conducive to the correct operation of verification, calibration and testing work. For verification, calibration and testing work carried out outside fixed laboratory facilities: relevant work procedures should be established to effectively control personnel, equipment environmental conditions, test data, etc. 6.3.2
The organization must monitor, control and record environmental conditions in accordance with the requirements of relevant specifications. When environmental conditions endanger verification,
calibration and testing work and their results, verification, calibration and testing work should be stopped. 6.3.3
Measures should be taken to prevent cross contamination, incompatible activity areas should be effectively isolated, and access and use of areas that affect the quality of verification, calibration and testing work should be controlled. Laboratory management procedures should be formulated and effective measures should be taken to ensure good laboratory work order. Measurement equipment
The organization must be equipped with various equipment that can accurately perform verification, calibration and testing. The name of the established metrological base (standard) and the equipment list should be listed, and the equipment name, model, measurement range (or range), measurement uncertainty (or accuracy), transmission or traceability relationship, etc. should be indicated.
6.4.2 The metrological standards used for verification and calibration must have a valid "Metrological Standard Assessment Certificate", "Social Public Metrological Standard Certificate" and metrological verification certificate or calibration certificate; the measuring instruments (measuring instruments) used for testing should have a valid metrological verification certificate or calibration certificate. 6.4.3 The equipment must be operated by qualified and approved personnel. The latest instructions for the use and maintenance of the equipment (including any relevant manuals provided by the equipment manufacturer) should be available to laboratory personnel at any time. 6.4.4
Each measuring instrument used for verification, calibration or testing, as well as equipment that has a significant impact on the results, should have a unique identification of the equipment, such as the equipment number, etc. 6.4.5
The archives of each equipment that has a significant impact on verification, calibration or testing should be kept. The archives should at least include the following: a) Name of the equipment; b) Name, model and number of the manufacturer, or other unique identification: c) Acceptance date, commissioning date, status at the time of acceptance and acceptance record: d) Current storage location: e) Information or instruction manual provided by the manufacturer: f) Previous verification or calibration certificates and commissioning reports, acceptance criteria and date of next verification or calibration: g) Previous maintenance dates and future maintenance plans (if necessary): h) Records of damage, failure, improvement or repair of equipment 6.4.6
The organization should have procedures for the safe handling, transportation, storage, use and maintenance of measuring equipment to ensure the integrity and normal function of the equipment and prevent damage. 6.4.7 Equipment that is overloaded or misoperated, gives questionable results, is shown to be defective or exceeds specified limits should be removed from the site of use (or isolated from the site of use), clearly identified or marked, and properly stored until it is repaired and passed verification or calibration to indicate normal operation. The organization shall examine the impact of equipment defects or deviations from specified limits on previous verification, calibration and testing, and shall establish "non-conforming work control procedures. All controlled equipment and equipment requiring verification or calibration shall be labeled, numbered or otherwise identified to indicate its verification or calibration status and the date of the next verification or calibration. 6.4.9 When equipment is not under the direct control of the organization for a period of time, the organization shall ensure that the function and verification or calibration status of the equipment can be checked and shown to be satisfactory before the equipment is put back into use. 6.4.10 When computers or automated verification, calibration or testing equipment are used to collect, process, record, report, store or retrieve verification, calibration or test data, the organization shall ensure that In accordance with the requirements of Section 7.3.8 of this rule, when verification methods are needed to maintain the confidence level of the equipment during the verification or calibration cycle, this should be carried out regularly in accordance with the procedures specified by the organization in 6.4.11
.
If a set of correction factors is given by verification or calibration, the organization should have procedures to ensure that its copies (such as data in computer software) are corrected in a timely manner.
Verification, calibration or testing equipment, including hardware and software, should be securely protected to prevent adjustments that invalidate the verification, calibration or testing results.
Implementation of verification, calibration and testing
The organization should determine the processes for the implementation of verification, calibration and testing in order to provide the required verification, calibration and testing services. The sequence and interaction of these processes should be determined, planned and controlled to ensure their effective operation; The implementation process of verification, calibration and testing, stipulates the responsibilities for the operation and supervision of related processes; ensures that the operation of these processes is controlled, and ensures that the results of verification, calibration and testing meet the requirements of metrological laws and regulations, and are consistent with the quality policy and objectives of the organization. 7.2 Customer-related processes
7.2.1 Review of applications, tenders and contracts7.2.1.1 The organization shall establish and implement review procedures for applications, tenders and contracts. Each signed contract, application and tender shall be reviewed in a practical and effective manner to ensure: a) customer requirements are clarified, including how to use them, and documented in an easy-to-understand manner; b) the organization has the qualifications, capabilities and resources to meet customer requirements; c) appropriate verification, calibration and testing methods are selected that meet customer requirements. Review of applications, Any differences in the understanding of the tender and the contract should be resolved before the work is carried out. Every contract must comply with the requirements of laws and regulations and be recognized by both the organization and the customer. 7.2.1.2
Records of the review should be kept, including records of any changes. Records of discussions with the customer on requirements or work results during the contract should also be kept.
The review should also include any tasks subcontracted by the organization. If the contract needs to be modified after the work has begun, the same review process should be repeated and any modifications should be notified to all relevant personnel.
Services to customers
When the organization provides metrological verification, calibration and testing services to customers, it must comply with the regulations of the government metrological administrative department or relevant laws and regulations on the quality of work, completion time and charging fees. 7.2.2.2
The organization should be able to maintain effective contact and cooperation with customers in order to clarify and meet customer requirements and enable customers to supervise the organization's work in terms of the relevant work being carried out. 7.2.3
Handling of Customer Articles
The organization shall have procedures for the transport, receipt, handling, protection and/or disposal of customer articles, including all measures necessary to protect the articles.
The organization shall have a system for identifying articles submitted for inspection. The identification of the articles submitted for inspection shall remain unchanged throughout the operation of the organization. The system shall be applicable to the transfer of branches of the article group within the laboratory and to external parties, as appropriate. 7.2.3.3
When accepting articles submitted for inspection from customers, any abnormalities and deviations from the conditions specified in the relevant verification, calibration or test methods shall be recorded. When the suitability of the article submitted for inspection, calibration or test is uncertain, does not conform to the description provided, or the required specifications are not detailed enough, the organization shall request further clarification from the customer before work is carried out and make a documentary record.
The organization shall have procedures and appropriate facilities to prevent damage or hazards during storage, handling and preparation of customer articles for inspection: the instructions provided by the customer shall accompany the article submitted for inspection. When the items to be inspected must be stored under specified environmental conditions, these conditions should be maintained, measured and recorded. 7.3 Verification, calibration and test methods
7.3.1 General
All verification, calibration and testing performed by the organization within its authorized scope shall use appropriate methods and procedures, including sampling, handling, transportation, storage and preparation of the items to be inspected, and, if necessary, the evaluation of measurement uncertainty and statistical techniques for analyzing verification, calibration or test data. Organization personnel should have instructions for use or necessary operating procedures when using and operating all relevant equipment and handling and preparing items to be inspected. All instructions, standards, procedures, specifications, manuals and reference data related to laboratory work should be kept in current valid versions and be quickly available to staff. Deviations from verification, calibration or test methods are only allowed when they are documented, technically justified, authorized and approved by the customer. 7.3.2 Choice of methods
7.3.2.1 When conducting metrological verification, the organization must use metrological verification procedures. Verification procedures must use national metrological verification procedures. If there are no national metrological verification procedures, departmental or local metrological verification procedures may be used. Metrological verification procedures must be the current valid version.
7.3.2.2 When conducting calibration, the organization shall use national calibration specifications that meet customer needs and are appropriate for the calibration being performed. If there are no national calibration specifications, publicly published international, regional or national standards or technical specifications should be used as much as possible, or refer to the corresponding metrological verification procedures. The organization shall ensure that the standards or technical specifications it uses are the current valid versions.
When the customer does not specify the calibration method to be used, the organization shall select an appropriate published standard method or a method described by the manufacturer. The organization may also use its own methods that are suitable for the intended use and approved. The selected method shall be notified to the customer.
When the organization believes that the method proposed by the customer is not applicable or is outdated, the organization shall notify the customer. When conducting metrological testing, finalization and appraisal of new products of metrological instruments or prototype testing, the finalization and appraisal outline or prototype testing outline formulated by the state shall be used. If there is no finalization and appraisal outline or prototype testing outline formulated by the state, the organization may formulate an appraisal outline or prototype testing outline in accordance with the requirements of the "General Specifications for Finalization of Measuring Instruments" and the "Guidelines for the Preparation of Finalization and Appraisal Specifications for Measuring Instruments". The outline should be scientifically demonstrated and approved by the competent leader of the organization. 7.3.3 Formulation of methods
The work of an organization to formulate metrological verification procedures or calibration specifications commissioned by the government metrology administrative department, or to formulate calibration methods for its own use should be a planned activity and should be carried out by qualified personnel equipped with appropriate resources. When the situation changes during the formulation work, the plan should be updated according to the situation and effective contact should be ensured with all relevant personnel. 7.3.4 Non-standard methods
When methods not covered in the calibration specification must be used, the customer's agreement shall be obtained and a detailed description of the customer's requirements and the purpose of the calibration shall be included.
The established methods shall be validated by appropriate means before use and shall be available to the customer and other authorized recipients for inspection.
7.3.5 Validation of methods
7.3.5.1 Validation means that the organization confirms that the "non-standard method" meets the specific intended use requirements by means of inspection and provision of valid evidence, and assumes corresponding responsibilities. 7.3.5.2
The organization shall validate non-standard methods, methods designed and developed by the organization, and extensions of calibration specifications that exceed the intended scope of use to confirm that the method is suitable for the intended use. The organization shall record the results of the validation validation, the procedures used to validate it, and a statement on whether the method is suitable for the intended use. 7.3.5.3
The range and accuracy of the values obtained by the valid method, such as the uncertainty of the result, the detection limit, the selectivity, linearity, repeatability and (or) reproducibility of the method, the strength to resist external influences and the resistance to interference from the sample (test piece) Mutual sensitivity to interference] When evaluating whether it meets the intended use, it should be consistent with the customer's requirements. 7.3.6
Calibration measurement capability (best measurement capability)
The organization engaged in calibration should have a procedure for calculating its best measurement capability. This calculation should apply to all parameters and ranges of the projects carried out by the organization. 7.3.7
Evaluation of measurement uncertainty
Institutions engaged in verification, calibration and testing should generally have and use procedures for evaluating measurement uncertainty for all types of verification, calibration and testing. 7.3.7.2
When evaluating measurement uncertainty, the methods recommended by the national metrology technical specification JJF1059-1999 "Evaluation and Expression of Measurement Uncertainty" or other regulations should be adopted. , and the methods specified in the specifications. 7.3.8
Control of data
A systematic approach should be adopted to properly check computers and data transfer. When using computers or automated equipment to collect, process, record, report, store, or retrieve verification, calibration, and test data, the organization should ensure that a) computer software developed by the user should be fully documented and properly legalized, otherwise it should be verified whether it is suitable for use.
b) Develop and implement procedures to protect the authenticity of data. The procedure should include (but not be limited to) the authenticity and credibility of data input or collection, data storage, data transfer and data processing. c) Computers and automated equipment should be maintained to ensure their normal function and provide necessary Environmental conditions and operating conditions to maintain the authenticity of verification, calibration and testing data. 7.4 Procurement of services and supplies
7.4.1 The organization shall formulate corresponding policies and procedures for the procurement of services and supplies that affect the quality of verification, calibration and testing work. The procedures shall include the procurement, acceptance, storage and use of consumable materials related to verification, calibration and testing. 7.4.2 The organization shall only use services and suppliers with good reputation and meet the quality required for verification, calibration and testing. The services and suppliers used shall comply with the requirements of this specification. Records of measures taken to check compliance shall be kept. 7.4.3 In the procurement documents, for items that affect the quality of work, the data of the ordered products shall be included, including model, accuracy level, technical indicators, acceptance criteria and methods, etc. The technical content of these procurement documents shall be reviewed and approved before the documents are issued.
The organization shall ensure that the purchased items, reagents and consumable materials that affect the quality have been inspected, verified or calibrated and can only be used after they meet the requirements of the relevant verification procedures, calibration specifications or test methods. 7.4.5
The organization shall evaluate the suppliers of key services that affect the quality of verification, calibration and testing, and keep records of these evaluations and list approved suppliers. 7.5
Subcontracting of calibration and testing work
The organization must carry out metrological verification work within the scope of authorization and shall not subcontract part of the verification work. When the organization intends to subcontract part of a calibration or testing work to another statutory metrological verification organization or other qualified laboratory, the organization shall notify the customer in writing and obtain the customer's consent. 7.5.3
The organization shall ensure and be able to prove that its subcontractors are qualified and capable of carrying out the work and meet the requirements of this specification. The organization is always responsible to its customers for the work done by the subcontractor. The organization shall keep a list of all calibration and testing subcontractors, as well as records of their review and calibration or testing records completed by the subcontractors.
Measurement traceability
All measuring equipment used for verification, calibration and testing, including auxiliary measuring equipment (for example, for environmental conditions measurement), which has a significant impact on the accuracy or effectiveness of verification, calibration and testing, shall have a valid verification or calibration certificate. The organization shall have a procedure for equipment verification or calibration and formulate an implementation plan. 7.6.2 Verification/calibration
The organization shall prepare and implement a periodic verification and calibration plan for the equipment to ensure that the verification, calibration and testing performed by the organization are traceable to the national benchmark.
The traceability of the measurement shall be guaranteed by the verification/calibration service of a statutory metrology verification agency (or an authorized social public metrology standard) that can show its qualifications, measurement capabilities and traceability certificates. Verification/calibration certificates issued by these bodies should indicate a link to a national standard or natural constant through an unbroken chain of calibration. Verification and calibration certificates should include the measurement result and its uncertainty and/or a conclusion as to whether the measurement result complies with the requirements specified in the verification procedure or calibration method. 7.6.3 When traceability to a national standard is not possible and/or inapplicable, other procedures and justifications should be used to ensure the reliability of the measurement results, such as: a) the use of reliable material properties given by certified reference materials; b) agreed standards or methods agreed and clearly defined by the parties concerned; c) participation in appropriately arranged inter-laboratory comparisons or proficiency testing. 7.6.4 Metrological Standards and Reference Materials
7.6.4.1 Metrological Standards
The body should have a block diagram for the transfer of metrological standard values, and a procedure and plan for periodic verification. Metrological standards should be verified by a body that can provide traceability as described in 7.6.2. The metrological standards held by the organization can only be used for verification, calibration and testing, and cannot be used for other purposes unless it can be shown that their performance as metrological standards will not be invalidated. 7.6.4.2 Reference materials
When possible, reference materials should be traceable to the International System of Units, or international or national certified reference materials. Internal reference materials should be checked for their technical and economic practicability. 7.6.4.3 Intermediate verification
When verification is required for the measurement standards, standards and reference materials between two consecutive verifications or calibrations to maintain their accuracy and reliability, it should be implemented in accordance with the prescribed procedures and plans. 7.6.4.4 Transportation and storage
The organization should have procedures for the safe handling, transportation, storage and use of measurement standards, standards and reference materials to prevent contamination or damage and protect their integrity. 7.7 Sampling
7.7.1 When the organization samples substances, matrices, materials or products for verification, calibration or testing, the organization should have sampling procedures and sampling plans.
If the customer requires deviations, additions or exceptions to the documented sampling procedures used by the organization, they must be recorded in detail in the corresponding sampling data and records, including the documents of verification, calibration and test results. The names of the responsible personnel should also be recorded.
The organization should have operating and data recording procedures for sampling related to verification, calibration and testing. These records should include the sampling procedures used, the identification of the samplers, environmental conditions (if relevant), and drawings or other equivalent methods of identifying sampling locations (when necessary). Where appropriate, the statistical techniques based on the sampling procedures should also be recorded. 7.8 Quality control of verification, calibration and testing 7.8.1
Execution of verification, calibration and testing
Verification must be based on verification procedures, and there should be inspection records before and after verification. Calibration should comply with relevant specifications and requirements, and necessary operating procedures can be prepared if necessary. Testing should comply with the identification outline, prototype test outline or relevant technical standards. There should be a way to deal with abnormal phenomena or sudden external interference during the experiment (such as equipment failure, damage, personal safety, etc.).
Supervision of verification, calibration and test results
The organization should have a procedure for supervising the verification, calibration and test results to ensure the quality of the results. This supervision should be planned and reviewed, and may include (but not limited to) the following aspects: a) internal quality control charts using statistical techniques; b) participation in inter-laboratory comparison or proficiency testing programs; c) regular use of certified reference materials and (or) secondary reference materials for internal quality control; d) re-inspection, re-calibration or re-testing using the same or different methods; e) re-verification, calibration or testing of retained inspected, calibrated or tested parts; ) correlation between different characteristics of inspected, calibrated or tested parts. 7.9 Original records and data processing
The organization shall retain original observation data and derived data for the prescribed period, as well as sufficient information required to establish an audit trail, verification, calibration and test records, personnel records and a copy of each verification certificate, calibration certificate or calibration report and test report issued.
Each verification, calibration or test record shall contain sufficient information to facilitate the analysis of factors affecting uncertainty (if possible) and to enable the verification, calibration or test to be reproduced under conditions as close to the original conditions as possible. The record shall include the signatures of the person who performed the sampling, verification, calibration and testing, and the person who verified the results. 7.9.3
Observations, data and calculations shall be clearly recorded, the records shall be permanent and shall identify the measurement.
Tip: This standard content only shows part of the intercepted content of the complete standard. If you need the complete standard, please go to the top to download the complete standard document for free.