Some standard content:
National Metrology Technical Standard of the People's Republic of China JJF tt122003
Rules for Confirmatlon of Metrology Testing System2003-12-26 Issued
Implemented on 2004-04-01
Issued by the General Administration of Quality Supervision, Inspection and Quarantine JJF 1112—2003
Rules for Confirmatiun of
Metrology Testing System
JJF 1112-
—2003
This specification was approved by the General Administration of Quality Supervision, Inspection and Quarantine on December 26, 2003, and will be implemented from April 1, 2004
Responsible unit:
Main drafting unit:
Participating drafting units:
Jinan Legal System and Management Committee Jiangsu Provincial Quality and Technical Supervision Bureau
China Measurement and Testing Society
Metrology Department of the General Administration of Quality Supervision, Inspection and Quarantine Jiangsu Provincial Metrology Association
The relevant units are entrusted with the responsibility of interpreting this specification||t t||The main drafters of this specification:
Huang Yaowen
Shi ShunanbZxz.net
Participating drafters:
He Xihuan
Han Youdao
J.IF1112—2003
(Quality and Technical Supervision Department of Jiangsu Province)
(China Institute of Basic Testing and Measuring)
(General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China)
(Jiangsu Provincial Technical Supervision)
(Jiangsu Provincial Association of Testing and Measuring)
-Scope
-.1 General provisions
1.2 Application
2 In: Use of text
3 Definitions
Part · Requirements
4 Legal requirements for weight units
4.1 General...
4.2 Units of measurement
4.3 Units of measurement
4.4 Measurement standards
4.5 Compulsory verification-
Specific requirements
5 Technical capability requirements
5.1 General...
5.2 Detection capability
Detection level
6 Weight management requirements
6.1 General requirements 6.2 Management responsibilities 6.3 Resource management Implementation of metrological confirmation and measurement process Standard analysis and methods Part I Confirmation methods Confirmation principles 7.2 Principles to be followed by assessors Principles to be followed in the confirmation process 8 Confirmation management Management responsibilities Management procedures Management records Monitoring and review of management 1111—2003
Confirmation Activities
9.1 General
9.2 Initiation of Validation
Document Review
Preparation before On-site Validation
Implementation of On-site Validation
Compilation, Approval and Distribution of Validation Report
Implementation of Follow-up Validation Activities
Post-Validation Supervision
Qualifications of Assessors
Personal Qualifications
Knowledge and Skills
Education, Experience, Training and Certification History
Maintenance and Improvement of Competencies
Evaluation of Assessors
Appendix A
Appendix B
Appendix C
Appendix D
Appendix E
Appendix F
JJF 11122003
General diagram of the process of metrological confirmation of measuring equipment
Format of the report in the confirmation of the testing system
Confirmation specification requirements and relevant documents checklist Verification and calibration items checklist
Testing process control items checklist
Unique item report format
Appendix G: Format of confirmation report of the measuring test system Appendix HJF1112-2003 confirmation requirements GB/T19022-2003 clause comparison (13)
JJF1112-2003
Metrological testing system confirmation specification
An effective The measurement and testing system is part of the entire management system of an organization. It ensures that the measuring equipment and testing processes meet the requirements of customers, organizations and laws and regulations. It is important to enhance customer satisfaction, achieve organizational goals, improve product quality and economic benefits, and manage the risk of incorrect measurement results: the goal of the measurement system is to ensure that there are effective measurement capabilities corresponding to the production and operation of the organization, and to manage the risk of incorrect measurement results caused by the measuring equipment and testing processes that affect the product quality, environmental protection, safe production and economic benefits of the organization. The organization has the responsibility to specify the requirements of the measurement and testing system and the required control level as part of its entire management system.
In this specification, the term "measurement process" applies to measurement, verification and actual measurement activities [such as product design, production, testing and inspection; business management, energy management, safety protection and environmental monitoring activities in the entire organizational management process)
This specification can be cited in the following situations:
. When customers specify the required products; when organizations specify the products they provide; when legislative and law enforcement agencies implement requirements; and when the metrological testing system is confirmed and evaluated. This specification includes two parts: the confirmation requirements and methods of the metrological testing system. Chapters 4 to 6 of this specification are the first part, which puts forward the confirmation requirements of the metrological testing system. The confirmation requirements include three aspects: measurement legal requirements, technical capability requirements and quality management requirements. The confirmation requirements part includes all the requirements of ISO19022-2 (K3/1810012:203 Measurement management system - Requirements for measurement processes and measuring equipment), meets the requirements of the standard, and also meets the requirements of the standard. Appendix 11 provides a comparison between the confirmation requirements of this specification and the provisions of ISO19022-2003: Chapter 4 is "Basic legal requirements", which includes the requirements of the relevant laws and regulations of the People's Republic of China on the organization. Chapter 5 is "Technical capability requirements", which stipulates that the scope of application of the measurement capability of the measurement system should be covered and the level of detection requirements should be consistent with the requirements of the organization's production, operation and management activities. Chapter 6 is "Quality management requirements", which includes all the requirements of Chapter 4 to Chapter 8 of ISO19022-2 (K3/1810012:2003 Measurement management system - Requirements for measurement processes and measuring equipment". This standard specifies the general requirements for the management of metrological responses to measurement processes and measuring equipment, namely the quality management requirements of the measurement management system, which is used to support and prove compliance with metrological requirements. One of the management principles stated in this standard is to emphasize the process approach. In this specification, the measurement management system requirements are part of the confirmation requirements of the measurement and testing system. Therefore, in Section 6 of this specification, "Quality Management Requirements", the "measurement management system" is renamed "metrological testing system", referred to as "system". At the same time, in order to maintain the consistency of the format of this specification, this specification quotes the requirements in the GBT122-2003 standard (3IS010012:2003). Chapter 1 to Chapter 10 of this specification are the second part, which proposes a confirmation method for the measurement and testing system. The confirmation method refers to the national standard (B/T19011-2003/15019011:2 002 Quality and (or) Environmental Management System Audit Guide, and according to the characteristics of the design and testing system, it stipulates the confirmation principles, management responsibilities, confirmation activities and evaluator qualifications.
1 Scope
1.1 General
This specification specifies the confirmation requirements and confirmation methods for metrological testing systems. When an organization regards the metrological testing system as part of the entire management system and needs to prove that it has the ability to meet the metrological requirements of customers, organizations and laws and regulations, this specification can be applied: When the quality and technical supervision department implements confirmation of the metrological testing system, it should follow the confirmation principles, procedures and methods specified in this specification,
1.2 Application
The requirements set forth in this specification are universal, and are intended to be applicable to organizations of various types, providing different products and of a certain size, and to meet the requirements of various activities such as production and operation, quality management, environmental management, energy management and occupational health and safety management. Organizations can choose the scope and degree of management of the metrology and testing system according to the characteristics of their products and management.
The confirmation method specified in this specification is mainly applicable to the research and development of the metrology and testing system by the measurement and technical supervision department. When the organization conducts internal audits on the implementation of the metrology and testing system, it can refer to the contents of this specification: 2 References
In the formulation of this specification, the provisions of the following standards or specifications were referred to. At the time of publication, the valid versions of these documents were also indicated. All standards and specifications will be revised, and all parties using this specification should try to adopt the latest versions of these standards and specifications.
B/T19A)—2000 Basic Vocabulary of Quality Management System H/122—203 Requirements for Measurement Management System, Measurement Processes and Measuring Equipment H/191—2003 Guide for Auditing Quality and Environmental Management System JJF1—1998 General Measurement Terms and Definitions 3 Definitions
This specification applies the terms and definitions given in the above-referenced documents and the following. 3.1 Metrology and Testing System
A set of related or corresponding elements related to metrology laws, technical capabilities and quality management that are necessary to ensure that the metrological requirements of customers, organizations and laws and regulations are met. Note: The metrology and testing system defines the requirements for the total metrology system of an enterprise, so the term "inspection" is used in this specification to clarify the meaning. 3.2 Confirmation of measurement and testing system
A formal recognition by the quality and technical supervision department that the measurement and testing system of an organization meets the metrological requirements of customers, organizations and laws and regulations: 3.3 Group
J.IF 1J12—2003
A group of people and facilities with arranged responsibilities, authorities and relationships, examples: company, group, firm, enterprise, research institute, police agency, agency, association or part or combination of the above organizations
Note: 1 The arrangement is orderly.
2 The organization can be either a certain organization or a certain organization.
3.4 Customer
An organization or individual who receives the product.
Examples: Consumer, commissioner, end user, retailer, recipient and purchaser. Note: the measurement management system is a set of interrelated or interacting factors that are necessary to ensure the continuous control of the measurement process. Note: In this version of the standard, the measurement management system is a set of interrelated or interacting factors that are necessary to ensure the continuous control of the measurement process. Note: In this version of the standard, the measurement management system is required to be a set of interrelated or interacting factors that are necessary to ensure the continuous control of the measurement process. The measurement management system is sometimes called the "system" of measurement and testing. 3.6 Process: A set of operations to determine the value of a measurement. 3.7 Measuring equipment: A general term for measuring instruments, test standards, test materials, auxiliary equipment and data necessary for measurement. 3.8 Metrological characteristics: Distinguishing characteristics that can affect the measurement results. Note: It is usually necessary to remember the characteristics of each measurement. 2 The cleanliness of the measurement can be used as a comparison of the age.
3.9 Metrological confirmation
To ensure that the measurement equipment is in a state that meets the requirements of the intended use, the following operations are required: 1 Metrological confirmation is carried out through: calibration and verification, various important measurements and monitoring, and subsequent calibration. The measurement requirements of the equipment are compared with the required years and length of adjustment. 2 Only when the measurement equipment has been documented to be suitable for the requirements, the metrological confirmation is considered complete. 3 Expired replacement The application requirements include: filter specification, detailed method, good tolerance, etc. 4. The design requirements are often different from the product, and are not specified in the product. 5. The metrological confirmation diagram is recorded.
3.11 Design function
The administrative and technical functions of the organization responsible for defining and implementing the metrological testing system. 3.1 Confirmation criteria
A set of principles, ideas or requirements,
Method: Confirmation criteria are the basis for comparison with general design data. 3 .12 Confirmation evidence
Records, factual statements or other information that are relevant to the confirmation criteria and can be verified. Note: Confirmation evidence can be definite or definite. 3
3.13 Confirmation findings
JJF1112-203
Conclusions on the collected confirmation evidence and the difficulty of the membrane confirmation. Note: Confirmation findings can indicate whether the combination is confirmed or not, and can also indicate the reasons for improvement. 3.14 Confirmation conclusions ||tt ||The assessment team considers the validation results obtained after the traceability criteria and all validation findings. 3.15 Validated party
The organization being validated.
3,16 Assessor
A person who has been trained and passed the test and is capable of implementing the validation of the design and testing system. 3.17 Assessment team
A number of assessors who implement the validation. When necessary, technical experts provide documentation. Note: One of the assessors with the certificate is the head of the assessment team. 3.18 Technical experts
People who provide specific knowledge and skills to the assessment team. Note: Technical knowledge and skills refer to knowledge and skills related to the affected period, focus or activity. 2 In the assessment, the technical system is not the assessment component. 3.19 Confirmation plan
A group (one or more) of activities planned for a specific time period and with specific purposes? Confirmation. Note: The confirmation plan includes the planning, organization and details of the activities required: 3.20 Confirmation plan
A description of a confirmation activity and arrangement. 3.21 Confirmation scope
Content and boundaries of the confirmation. Note: The closed knowledge model diagram also needs to include the actual medical settings, red weaving list, clean activities and the benefits of the time [no adjustment. Part I Confirmation Requirements
4 Metrology Legal Requirements
4.1 General
The measurement and testing system (hereinafter referred to as the "system") of the organization shall comply with the requirements of the Metrology Law of the People's Republic of China and other relevant laws, regulations and rules. The following requirements are proposed in accordance with the current measurement laws and regulations. If they are revised later, they shall be implemented in accordance with the revised requirements.
4.2 Metrology Units
The organization shall use the national statutory measurement units for the following activities:! Issue official documents and statistical tables:
b! Produce and sell products, mark product logos, and prepare product instructions: c) Formulate standards, specifications, procedures, and technical documents: Issue verification, calibration, inspection, and measurement data: 4
J.IF 1112-- 2003
Other activities that should be used in accordance with national regulations: 4.7 Personnel engaged in metrological verification shall hold corresponding valid certificates: 4.4 Measurement standards
The measurement standards of the production and (or) measurement standards of coal and (or) acid shall be approved by the relevant quality and technical departments and then put into use. 4.5 Mandatory inspection
The highest measurement standard of the organization and its use shall be included in the mandatory inspection list of medical and health, safety and environmental monitoring and inspection departments, and the mandatory inspection shall be carried out according to the regulations. 4.6 Special requirements
4.6.1 4.6.2 Organizations engaged in the production of packaged goods shall comply with the relevant provisions of the packaging regulations. 4.3 Organizations engaged in the sales of products shall comply with the relevant product supervision regulations. 5 Technical capability requirements
5.1 The overall product testing capability shall meet the requirements of the relevant laws and regulations. 5.2 Testing capability
The testing capability shall meet the requirements of the relevant laws and regulations. 1. The following requirements are required: 1. Quality management has higher requirements for the inspection and quality of process products; 2. Environmental management has higher requirements for the visual and measurement of the environment; 3. Occupational health and safety management has higher requirements for the policy of measurement; 4. Business management, energy management and production safety have higher requirements for the measurement equipment; 5.3 Inspection level
When taking the lead, the inspection level should meet the following requirements: 5. The inspection technology and testing equipment used should be fully met by the organization's production, operation and management; 6. The inspection system and annual inspection should be managed using computer information technology. 6 Quality Management Requirements
6.1 Effectiveness Requirements
The system shall ensure that the specified design requirements are met, and the measurement equipment and process types determined by the specification are determined. When determining the scope of the system, the system shall be controlled by the designed measurement process, the metrological confirmation of the measurement equipment and the supporting process structure. The measurement process within the system shall be controlled [see Section 6.4.2] All measurement equipment within the system shall be confirmed (see Section 6.4:1) The system shall follow the procedures defined by the organization. :
6.2 Management Responsibilities
6.2.1 Measurement Function
JJF1112—2003
The organization shall define the metrological function and the top management of the organization shall ensure the necessary resources to establish and maintain the metrological capability. The manager of the measurement function shall establish, document, maintain and continually monitor its effectiveness. 6.2.2 Customer Focus
The manager of the measurement function shall ensure that: a) the customer's measurement requirements are determined and translated into product requirements; b) the system meets the customer's metrological requirements; c) the system can demonstrate compliance with the requirements specified in the customer's plan; 6.2.3 Quality Objectives
The manager of the metrological function shall define quality objectives for the system. Performance criteria and procedures for determining the performance of the measurement process should be defined and controlled.
6.2.4 Management review
The management of the organization should systematically review the system at planned intervals to ensure its continuing adequacy, effectiveness and suitability. Management should ensure the necessary resources to review the system: The manager of the metrology function should use the results of the management review to make necessary adjustments to the system, including improving the measurement process (see 6.5) and reviewing the measurement objectives. All review results and actions taken should be recorded. 6.3 Resource management
6.3.1 Human resources
6.3.1.1 Responsibilities of personnel
The manager of the metrology function should define and document the responsibilities of all personnel in the system. 6.3.1.2 Competence and training
The manager of the metrology function should ensure that personnel involved in the system have demonstrable competence to perform the assigned tasks. The management of the metrology department shall ensure that training is provided to meet the identified needs, keep records of training activities, evaluate the effectiveness of training and record them. Employees shall be aware of the responsibilities they undertake and the impact of their activities on the effectiveness of the system and product quality: when using employees in training, adequate and appropriate supervision shall be exercised. 6.3.2 Information resources
6.3.2.1 Procedures
The system's procedures shall be documented to the necessary level of detail and validated to ensure correct implementation and the effectiveness of the results of testing.
The establishment of new procedures or changes to existing procedures shall be authorized and approved and controlled. The procedures should be current and available when required:
6.3.2.2 Software
The software used in the measurement process and result calculation should be documented, identified and controlled to ensure its suitability for continued use. The software and any modifications to it should be tested and/or confirmed before use, approved and archived. Testing should be carried out within the necessary scope to ensure the validity of the measurement results. 6
6.3.2.3 Records
JJF1112—2003
Records of information required for the operation of the system should be maintained. There should be a documented order to ensure the identification, storage, protection, retrieval, retention period and disposal of the records. 6.3.2.4 Identification
The measuring equipment and technical procedures used in the system should be clearly identified: they can be identified individually or in the file: there is an identification of the equipment's confirmation status, and the equipment used for a specific measurement process or those processes should be clearly marked or controlled to prevent unauthorized use. The equipment used in the system should be clearly distinguished from other equipment: 6.3.3 Material resources
6.3.3.1 Measuring equipment
All measuring equipment that meets the specified metrological requirements should be provided and identified in the system: Measuring equipment should be in a valid calibration state before confirmation. The basic measuring equipment should be used in a controlled or known environment to ensure valid measurement results. The measurement equipment used to monitor and record the influence of quantity should be included in the system. The management of the metrological function should establish, maintain and use documented procedures to receive, handle, move, store and issue measuring equipment to prevent misuse, obsolescence, additions and changes in its metrological characteristics. Each measurement device that is included in the system or a micro-system shall have a procedure for handling it.
6.3.3.2 Environment
The environmental conditions required for the effective operation of the measurement processes covered by the system shall be documented. Environmental conditions that affect the measurements shall be monitored and recorded. Corrections made based on environmental conditions shall be recorded and applied to the measurement results.
6.3.4 External Suppliers
The manager of the metrological function shall document requirements for external suppliers of products and services to the system: external suppliers shall be evaluated and selected based on their ability to meet the documented requirements. Rules for selection, monitoring and evaluation shall be defined and documented, and the results of the evaluation shall be recorded. Records of products or services provided by external suppliers shall be maintained. 6.4 Metrological confirmation and implementation of the measurement process
6.4.1 Metrological confirmation
6.4.1.1 General
Metrological confirmation (see Annex 4) shall be designed and implemented to ensure that the metrological characteristics of the measuring equipment meet the metrological requirements of the measured process. Metrological confirmation includes calibration of measuring equipment and verification of measuring equipment: The operator of the measuring equipment shall be provided with information on the metrological confirmation status of the measuring equipment, including any limitations and special requirements. The metrological characteristics of the measuring equipment shall be appropriate for its intended use: 6.4.1.2 Metrological confirmation intervals
The method for determining or changing the metrological confirmation intervals shall be documented in the application program. The metrological confirmation intervals shall be reviewed and adjusted if necessary to ensure that they continue to meet the specified design or requirements: Each time a non-conforming measuring equipment is repaired, adjusted or modified, the design and confirmation intervals shall be reviewed: 6.4.1.3 Equipment maintenance control
On approved measuring equipment, adjustment devices that affect its performance shall be sealed or protected from unauthorized changes. The design and implementation of seals or protective devices should ensure that any changes will be detected. The validation process should include the actions to be taken when seals or protective devices are found to be damaged, broken, removed or lost.4 Identification
The measuring equipment and technical procedures used in the system should be clearly identified: they can be identified individually or in the file: there is an identification of the equipment's confirmation status, and the equipment used for a specific measurement process or for these processes should be clearly marked or controlled to prevent unauthorized use. The equipment used in the system should be clearly distinguished from other equipment: 6.3.3 Material resources
6.3.3.1 Measuring equipment
All measuring equipment that meets the specified metrological requirements should be provided and identified in the system: Measuring equipment should be in a valid calibration state before it is confirmed to be valid. The basic equipment should be used in a controlled or known environment to ensure valid measurement results. The measurement equipment used to monitor and record the influence of quantity should be included in the system. The management of the metrological function should establish, maintain and use documented procedures to receive, handle, transport, store and issue measurement equipment to prevent equipment from being used, misused, added and its metrological characteristics changed. There should be a handling procedure for the measurement equipment that is included in the system or the system.
6.3.3.2 Environment
The environmental conditions required for the effective operation of the measurement processes covered by the system shall be documented. Environmental conditions that affect measurements shall be monitored and recorded. Corrections based on environmental conditions shall be recorded and applied to measurement results.
6.3.4 External Suppliers
The manager of the metrological function shall document requirements for external suppliers of products and services to the system: external suppliers shall be evaluated and selected based on their ability to meet the documented requirements. Rules for selection, monitoring and evaluation shall be defined and documented, and the results of the evaluation recorded. Records of products or services provided by external suppliers shall be maintained. 6.4 Metrological confirmation and implementation of the measurement process
6.4.1 Metrological confirmation
6.4.1.1 General
Metrological confirmation (see Annex 4) shall be designed and implemented to ensure that the metrological characteristics of the measuring equipment meet the metrological requirements of the measured process. Metrological confirmation includes calibration of measuring equipment and verification of measuring equipment: The operator of the measuring equipment shall be provided with information on the metrological confirmation status of the measuring equipment, including any limitations and special requirements. The metrological characteristics of the measuring equipment shall be appropriate for its intended use: 6.4.1.2 Metrological confirmation intervals
The method for determining or changing the metrological confirmation intervals shall be documented in the application program. The metrological confirmation intervals shall be reviewed and adjusted if necessary to ensure that they continue to meet the specified design or requirements: Each time a non-conforming measuring equipment is repaired, adjusted or modified, the design and confirmation intervals shall be reviewed: 6.4.1.3 Equipment maintenance control
On approved measuring equipment, adjustment devices that affect its performance shall be sealed or protected from unauthorized changes. The design and implementation of seals or protective devices should ensure that any changes will be detected. The validation process should include the actions to be taken when seals or protective devices are found to be damaged, broken, removed or lost.4 Identification
The measuring equipment and technical procedures used in the system should be clearly identified: they can be identified individually or in the file: there is an identification of the equipment's confirmation status, and the equipment used for a specific measurement process or for these processes should be clearly marked or controlled to prevent unauthorized use. The equipment used in the system should be clearly distinguished from other equipment: 6.3.3 Material resources
6.3.3.1 Measuring equipment
All measuring equipment that meets the specified metrological requirements should be provided and identified in the system: Measuring equipment should be in a valid calibration state before it is confirmed to be valid. The basic equipment should be used in a controlled or known environment to ensure valid measurement results. The measurement equipment used to monitor and record the influence of quantity should be included in the system. The management of the metrological function should establish, maintain and use documented procedures to receive, handle, transport, store and issue measurement equipment to prevent equipment from being used, misused, added and its metrological characteristics changed. There should be a handling procedure for the measurement equipment that is included in the system or the system.
6.3.3.2 Environment
The environmental conditions required for the effective operation of the measurement processes covered by the system shall be documented. Environmental conditions that affect measurements shall be monitored and recorded. Corrections based on environmental conditions shall be recorded and applied to measurement results.
6.3.4 External Suppliers
The manager of the metrological function shall document requirements for external suppliers of products and services to the system: external suppliers shall be evaluated and selected based on their ability to meet the documented requirements. Rules for selection, monitoring and evaluation shall be defined and documented, and the results of the evaluation recorded. Records of products or services provided by external suppliers shall be maintained. 6.4 Metrological confirmation and implementation of the measurement process
6.4.1 Metrological confirmation
6.4.1.1 General
Metrological confirmation (see Annex 4) shall be designed and implemented to ensure that the metrological characteristics of the measuring equipment meet the metrological requirements of the measured process. Metrological confirmation includes calibration of measuring equipment and verification of measuring equipment: The operator of the measuring equipment shall be provided with information on the metrological confirmation status of the measuring equipment, including any limitations and special requirements. The metrological characteristics of the measuring equipment shall be appropriate for its intended use: 6.4.1.2 Metrological confirmation intervals
The method for determining or changing the metrological confirmation intervals shall be documented in the application program. The metrological confirmation intervals shall be reviewed and adjusted if necessary to ensure that they continue to meet the specified design or requirements: Each time a non-conforming measuring equipment is repaired, adjusted or modified, the design and confirmation intervals shall be reviewed: 6.4.1.3 Equipment maintenance control
On approved measuring equipment, adjustment devices that affect its performance shall be sealed or protected from unauthorized changes. The design and implementation of seals or protective devices should ensure that any changes will be detected. The validation process should include the actions to be taken when seals or protective devices are found to be damaged, broken, removed or lost.
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