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Rules for the Examination of the Service of Legal Metrological Verification

Basic Information

Standard ID: JJF 1069-2003

Standard Name:Rules for the Examination of the Service of Legal Metrological Verification

Chinese Name: 法定计量检定机构考核规范

Standard category:National Metrology Standard (JJ)

state:Abolished

Date of Release2003-03-05

Date of Implementation:2003-06-01

Date of Expiration:2007-04-01

standard classification number

Standard Classification Number:General>>Standardization Management and General Regulations>>A00 Standardization, Quality Management

associated standards

alternative situation:JJF 1069-2000

Publication information

publishing house:China Metrology Press

ISBN:155026-1708

Publication date:2004-06-10

other information

Introduction to standards:

JJF 1069-2003 Standard for the Assessment of Legal Metrology Verification Institutions JJF1069-2003 Standard download decompression password: www.bzxz.net



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National Metrology Technical Specification of the People's Republic of China JJE1069—2003
Rules for the Examination at the Service of Legal Metrological Verification2003-03-05 Issued
Implementation on 2003-09-01
Issued by the General Administration of Quality Supervision, Inspection and Quarantine JIT 1069-2803
Rulcs for the Examination at the Service of Legal Metrological VerificationJJF 10M69—20M3
Replaces JJF 1069—2000
This specification was approved by the General Administration of Quality Supervision, Inspection and Quarantine on March 5, 2003, and came into effect on September 1, 2003.
Responsible unit: National Legal Metrology Management Metrology Technical Committee Main drafting unit: Jiangsu Provincial Quality and Technical Supervision Exhibition Participating drafting unit: Shandong Institute of Metrology Science, Guangdong Institute of Metrology
China Testing Technology Research Institute
The responsible unit for this specification is responsible for interpretation
Main drafters of this specification:
Huang Yaowen
Shi Xiaoyan
Zhao Renchuan
Participating drafter!
Wang Yingjun
He Xihuan
Chen Yuankang
JJE1069-2003
(Jiangsu Quality and Technical Supervision Department)
(China Planning Science Research Institute)
(Guangdong Institute of Metrology)
(Metrology Department of State General Administration of Quality Supervision, Inspection and Quarantine) (Jiangsu Quality and Technical Supervision Bureau)
[China Testing Technology Research Institute)
1.1 General Provisions-
1.2 Application
2 References
Terms and Definitions
4 Organization and Management:
4.1 Legal Status.
Legal liability
4.3 Basic conditions
5 Quality management system
3. Requirements
5.2 General management responsibilities:
5.3 System documents..
5.4 Document control
5.5 Record control..
5.6 Management review..
6 Resource allocation and management
General principles
6.2 Personnel
6.3 Facilities and environmental conditions
6.4 Testing equipment
? Implementation of inspection, calibration and testing, customer-related processes
7.2 Verification, calibration and testing methods
Purchase of services and supplies
Subcontracting of calibration and testing work...
Source of measurement values
Sampling
Disposal of inspection, calibration and testing items
Quality assurance of inspection, calibration and testing
Handling of original records and data
7. Result reporting
8 Quality improvement
Control of non-standard work
JJF1069—2003
(4)
【4】
(6))
Customer satisfaction and 8.4 Corrective measures 8.5 Preventive measures 9 Assessment procedures 1. Review and approval 2. Assessment implementation 3. Assessment report 4. Corrective action tracking 5. Assessment result evaluation 6. Post-certification supervision 7.11 Assessment of expanded items 8.11.1 Expansion of items 9.2 Explanation of expanded items 10.3 Acknowledgement of expanded items 11.4 Acknowledgement of expanded items 12.5 Acknowledgement of supplementary materials 13.6 Appendix B 14.1 Format of written report during assessment 15.6 Assessment item table 16.7 Appendix C: Comparison table of assessment specification requirements and quality management system documents Appendix D: Registration form for assessment certification materials of software/hardware group Assessment report format Appendix F: Corrective action report format G: Confirmed calibration items table Appendix H: Confirmed accuracy/testing status table Appendix I: Confirmed commodity quantity test items table Appendix J: Comparison of clauses between JJF1069-2003 and JJF1069-2000 Appendix K: Comparison of clauses between JJF1069-2003 and GB/T15481-2000 (17) Appendix K: Comparison of clauses between JJF1069-2003 and GB/T15481-2000 (17) L069—2003
Assessment Specifications for Legal Metrology Verification Institutions
A legal metrology verification institution is a metrology technical institution established or authorized by a government metrology administrative department in accordance with the law and qualified by the government metrology administrative department, which provides technical guarantee for the government metrology administrative department to implement metrology supervision and provides technical services for the national economy and social life. In order to strengthen the management of statutory metrology and its verification institutions, ensure that they provide fair, accurate and legally effective metrology inspection, calibration and identification results for national economic and metrological supervision in accordance with the law, this assessment specification is formulated in accordance with the provisions of the "Measures for the Supervision of Statutory Mutual Verification Institutions of the People's Republic of China" and "Measures for the Supervision of Statutory Mutual Verification Institutions" and other relevant regulations, as well as the requirements of the International Organization of Legal Metrology (IOML) for legal metrology laboratories. The assessment content stipulated in this specification is based on the requirements of my country's metrology laws and regulations on statutory metrology verification institutions, the requirements of the International Organization of Legal Metrology for legal metrology laboratories and the national standard GB/T15481--2000iltIS0/IF:CI7025:1999 General requirements for the capabilities of testing and calibration laboratories, and the national standard GBT[2000--2000)IDT[S09000:2000 Quality Management System Fundamentals and Terminology" The assessment process and determination method of assessment results specified in this specification are based on the national standard G/T154Kf-1995 "Accreditation system for calibration and testing laboratories - Operation and accreditation - Requirements", and absorbs the successful experience of the assessment of statutory metrology verification institutions by government departments in recent years. This specification is also derived from the accreditation requirements for legal metrology laboratories put forward by the International Committee on Metrology (CIPM) to achieve mutual recognition of metrology standards and calibration/measurement between countries and the International Legal Interests Organization to achieve mutual recognition of type approval certificates for comparison instruments.
Compared with the 2003 edition, the 2003 edition of this specification mainly adds requirements for commodity testing and the content of expanded item assessment in Chapter 1, and makes appropriate adjustments and textual revisions to individual clauses (see the attached "Comparison of clauses between 1FI0G9-2003 and JJF1069200K").
This specification stipulates the requirements that must be met by statutory metrology verification institutions in order to exercise their administrative powers, as well as the procedures for assessing statutory metrology verification institutions and the methods for evaluating assessment results. This specification is used for the assessment and supervision of legal metrology inspection agencies by government departments, and is also applicable to the assessment and supervision of government metrology administrative departments that are authorized to undertake mandatory inspection tasks. The requirements of this specification are beneficial to the following activities that legal metrology inspection agencies carry out in accordance with the law: carry out measurement transmission, perform mandatory inspection, non-standard inspection, arbitration inspection and other inspection tasks stipulated by law; b) carry out type evaluation, prototype testing, commodity inspection and other inspection tasks stipulated by law: start planning and follow up:
Continue the draft training plan and enter compliance.
1.2 Application
11FJNG92003
The requirements of this specification are general and apply to statutory metrology verification institutions established by the metrology administrative departments of the county level or above in accordance with the law or authorized by law.
When an institution does not engage in metrology calibration or model verification, prototype testing and wide product quality inspection, it can tailor the requirements.
Such tailoring shall only be based on those provisions in Chapter 1 of the specification "Implementation of Verification, Calibration and Testing" that do not affect the institution's ability or responsibility to provide services that meet the requirements of customers and applicable laws and regulations. This specification applies to the establishment and operation of quality management systems for statutory metrology verification institutions, but does not require statutory verification institutions to modify their quality management system structures or documents according to the structure of this specification. The organization's quality management system documents should be suitable for its unique activities. 2 References
This specification refers to the following documents:
11-19 Applicable: Measurement techniques and definitions
103-2 Measurement standards
5200 Type approval and import regulations for measuring instruments
116--2.003 Measurement basic parts type production standard JJF1059:1999 Measurement quality assessment and indication JJF1017)-2000 Standard for measurement of net content of packaged goods ISO 2:1996 Standardization and related adaptation measures - Basic terms and definitions CB/T19000-2000 Quality management system foundation and terminology CB/T190K-2000 Quality management system requirements CB/T154 X】-20X General requirements for the competence of testing and calibration laboratories G319022.1--1995 Quality certification requirements for measuring equipment Part 1: Metrological certification system for measuring equipment
GT19022.22000 Quality assurance requirements for measuring equipment Part 2: Measurement process control measures GB15486-995 Calibration machine test case requirements General requirements for system operation and approval GB/F15483--1990 Proficiency verification test using experimental comparison This standard is intended to use the current valid version of the industry's contribution. 3 Terms and definitions
H General metrological technical evaluation and definition, GB/H-2000 Quality management system: its basis and implementation guide 2 What are the implementation activities of standardization and its definition? The following definitions in this specification are used: The following are some of the most commonly used definitions of this specification: 3.1 Legal verification agency
The verification agency set up by the various measurement departments in accordance with the law and the measurement verification agency authorized by the government, 2
JJT10692003
Note: In this specification, the verification agency for measurement verification refers to the verification agency "measuring instrument" 3.2 [Inspection of measuring instruments
The process of checking and confirming whether the measuring instruments meet the statutory requirements: It includes inspection, marking and (or) issuing a verification certificate.
3.3 Verification certificate
Document proving that the measuring instrument has been calibrated and obtained satisfactory results: 3.4 Verification result notification
Document indicating that the instrument does not meet the statutory requirements. 3.5 Comparison
Under specified conditions , a combination of operations to determine the relationship between the value indicated by a measuring instrument or measuring system, or the value of a physical measuring instrument or reference material, and the corresponding value reproduced by a standard. Note:
[Calibration can be done by measuring the indication of the measured object and the reading of the indication. 2 Calibration can also be done by some people, such as the measurement of the measurement. 3 The calibration can be recorded in a calibration book or calibration book. 3.6 Calibration method
The technical procedure specified for calibration. 3.7 Inspection
The technical operation, processing or service consisting of determining one or more characteristics of a given product according to the specified procedures
1 The technical determination of the source and the door inspection card is called inspection. 2 The inspection referred to in this specification mainly refers to the evaluation or diagnosis of the measuring instrument (measuring instrument), prototype testing and product quality inspection.
3.8 Test method
The technical procedure specified for conducting a test. 3.9 [Test rate, capability certification
The use of comparisons between laboratories to determine the laboratory's test, inspection or inspection capabilities. "The meaning of laboratory capability certification is broad, it includes the following content: 1 Qualitative design - for example, the determination of the average distance between the test products 2 Data drills - the creation of the laboratory's data requirements for progress, in order to forget you a city 3 Single product inspection (or calibration, cough who) - the two people who are familiar with the test are sent to the test item, the foreign connection time this girl is old. 1 Some of the games - just a single thing, the test product is sent to the laboratory 5 Violation plan - according to a certain time and quantity continuously to the laboratory roommate. For example, is to ask 3.1 Inter-laboratory comparison
According to pre-specified conditions: Use two or more laboratories to calibrate phases or similar items under test, the organization, implementation and evaluation of calibration or testing, 3.11 Calibration and testing capabilities
JJF10692003
The highest calibration and testing level normally provided to customers, it uses confidence levels as multiple uncertainty tables Note: There are 3.12 Type evaluation is to confirm whether the type can be modified, whether the device is issued, and whether the type is in progress. Column: Type evaluation is also the type of the final product. 3.13 Government inspection is the administrative department of the government. The inspection, detailed inspection and confirmation of the new product before the production of the device has been determined in the national standard. Product is real you! Ministry of Administration, the test card is not the first step is to carry out 3.1 product
use a base point, product standard product annual value, 4 organization and management
4. [Legal status
4.1.1 The legal metrology verification institution established in accordance with the law must be an entity that can independently bear legal qualifications, with documents approved by the government metrology department, and its responsible person must have a legal person qualification certificate and a letter of appointment from the corresponding government metrology department.
4.1.2 The statutory metrology verification institution authorized to be established must have documents of authorization from the government administrative department, and the person in charge should have a legal person qualification certificate and a letter of appointment from its competent department. If the statutory metrology verification institution authorized to be established is part of a certain organization, it should have an independent structure, and the person in charge should have a letter of authorization from the legal representative. 4.2 Legal responsibilities
4.2.1 The enterprise must comply with all relevant laws and regulations, carry out the duties given by the law, and register the verification, calibration and testing of the equipment in accordance with the requirements of this standard. 4.2.2 The enterprise must be able to provide technical guarantees for the various tasks issued by the government metrology department. Before the completion of the work, the government metrology department shall review the relevant information of the equipment. 4.3 Basic requirements
4.3.: The management system of the organization should cover the verification, calibration and testing work carried out by the organization in the fixed facilities, the unused facilities or the temporary or mobile facilities. 4.3.2 The organization should have corresponding management personnel and technical personnel who have the right to perform environmental protection work. 1) There are documented policies and procedures to avoid activities that may affect the professional ethics of the company and its employees: 1) There are documented policies and procedures to avoid activities that may affect its ability, fairness, honesty and professional ethics:
JIF —23
) Define the organizational and management structure of the organization: The relationship between quality management, technical operations and support services: Define the duties, strengths and relationships of all management, operation, verification and verification personnel who have an impact on verification, calibration and testing;
5 Identify personnel who are familiar with the methods, procedures, and purpose of verification, calibration or testing and who will evaluate the effectiveness of verification, calibration and testing (employees in training): There is a technical manager or technical person in charge who is fully responsible for the operation and quality of the organization's operations:
) Designate a person as the quality manager (not including the name of the person in charge), other responsibilities, and ensure that the quality system is implemented and implemented at all times: Quality manager: The person in charge refers to the person in charge of the establishment and management of the personnel who has the necessary personnel to contact the market and decide on policies and resources.
5 Quality management system
5.1 Information requirements
The organization shall establish, document, implement, maintain and continually improve the effectiveness of a quality management system appropriate to the scope of its activities in accordance with the requirements of this standard. The organization shall a) identify the processes involved in the implementation of the quality management system and verification, calibration and testing and their application in the organization;
5) determine the sequence and interaction of these processes; develop the criteria and methods needed to ensure the effective operation and control of these processes; ) ensure that the necessary resources and information are available to support the operation of these processes and to monitor and analyze these processes;
implement the necessary actions to achieve the planned results of these processes and the maintenance of these processes; and manage these processes in accordance with the requirements of this standard. The organization shall ensure that it exercises control over any subcontracted processes that affect the organization’s ability to conduct inspections and detection. Controls over such subcontracted processes shall be identified in the quality management system. 5.2 General Management Responsibilities The organization’s responsible person shall oversee the following activities to: provide evidence of the organization’s commitment to the implementation of the quality management system and continually improve its effectiveness; convey to the organization the importance of meeting legal, regulatory, and customer requirements; |) Determination of the quality of the output:
Conduct management evaluation:
e) The dual acquisition of Austrian safety resources
5.3 System implementation
5.31 General
The organization shall document the collection, planning, plans, procedures and work instructions to ensure that the organization's verification, calibration and test results are of the required quality. This system document shall be communicated to relevant personnel and understood, adopted and implemented by them.
5.3. 2 Quality Management System Objectives
JIF1069—2003
The objectives and goals of the organization's quality management system should be specified in the quality manual. The overall objectives should be written in a written form: a quality manual statement is authorized by the organization's responsible person and should include at least the following content: a) The organization's management's commitment to good professional behavior and to providing customers with quality verification, calibration and testing services; b) Management's statement of the organization's work standards: the objectives of the management system:
) The organization requires all personnel involved in verification, calibration and testing activities to be familiar with the relevant quality management documents and to implement these policies and procedures in their work; e) The organization's management's commitment to comply with this specification. 5.3.3 Quality Management System Objectives
5.3.3.1. The organization shall prepare and maintain a quality manual. The quality manual shall include or indicate supporting procedures, including technical procedures, and outline the structure of the documents used in the quality management system. 5.3.3.2 The quality manual shall define the roles and responsibilities of technical management (or technical stakeholders) and those responsible for quality management, including ensuring compliance with this specification.
5.3.4 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. The degree of detail shall depend on the complexity of the work, the methods used, and the skills and training of the personnel required to carry out the work. 5.4 Document control
The organization shall control all documents (either internally developed or from external sources) required for the operation of the quality management system, such as laws, regulations, other normative documents, verification procedures, calibration specifications, test methods, inspection rules, standards, as well as drawings, software, specifications, instructions and manuals. Records are a special type of document and should be controlled in accordance with the requirements of 5.5.
A documented sequence of events should be prepared to specify the controls needed to: a) approve documents before they are issued to ensure they are adequate and appropriate; h) review and update documents, as necessary, and re-approve them; and h) ensure that changes to documents are identified as to their current revision status. Revisions should be controlled and, unless otherwise specifically determined, must be reviewed and approved by the original review and approval personnel who can use appropriate background information as the basis for their review and approval; 1. Ensure that the valid version of the applicable document is available at the point of use; 2. Ensure that documents are kept confidential and easily identifiable; 3. Ensure that external documents are identified and their distribution is controlled; 4. Prevent the unintended use of work documents; 5.5 Record control S.5.1 The organization should establish and maintain records to provide evidence of conformity to requirements and the effective operation of the quality management system. It should establish and maintain procedures for identifying, collecting, searching, storing, archiving, validating, maintaining and cleaning up quality records and technical records. Quality records shall include reports from internal and management audits and records of corrective and preventive measures. 5.5.2 All records shall be authentic, clear and concise, and stored and preserved in a manner that prevents damage, deterioration, loss and other hazards. The retention period of records shall be specified. 5.5.3 All records shall be protected and kept confidential. 5.5.4 The organization shall have procedures to protect and copy electronically stored records and prevent unauthorized intrusion or modification.
5.6 Management Review
5.6.1 General
The organization's head shall review the organization's quality management system and its certification, calibration and testing activities regularly in accordance with the predetermined plan and procedures to ensure their continued suitability, adequacy and effectiveness. Records of management reviews shall be maintained.
5.6.2 Review inputs
The inputs to the management review should include information on the following:) Suitability of policies and procedures;
) Reports from management and auditors;
) Results of recent internal audits;
) Corrective and preventive actions;
e) Audits conducted by external organizations;
f) Results of laboratory comparisons or proficiency testing;
g) Changes in the work base and type of work;
b) Customer feedback; bzxz.net
Expectations;
) Other relevant factors, such as changes in control mechanisms, resources and staff training. 5.6.3 Review outputs
The outputs of the management review include any decisions and actions related to the following: a) Improvements in the effectiveness of the management system and its processes; 6) Improvements in verification, calibration and testing related to customer requirements; and resource requirements.
The head of the organization shall ensure that the above decisions and measures are implemented within an appropriate and scheduled period. 6 Resource allocation and management
Center 1 General
The resources that determine the accuracy and reliability of the organization's verification, calibration and testing include personnel, facilities and environmental conditions, measuring equipment, etc. The organization shall provide a list of the verification, calibration and testing items carried out (including such items as item name, quantity or measurement range, measurement uncertainty or allowable error, and proposed procedures, standards, specifications or rules, etc.), determine and provide the resources needed to carry out its verification, calibration and testing tasks, and establish and improve the quality management system. 6.2 Personnel
6.2.1 The organization shall be equipped with sufficient management, supervision, verification, calibration and testing personnel according to the needs of the work. Organization2 Quality Management System Objectives
JIF1069—2003
The objectives and goals of the organization's quality management system should be specified in the quality manual. The overall objectives should be written in a written form: a quality manual statement is authorized by the organization's responsible person and should include at least the following content: a) The organization's management's commitment to good professional behavior and to providing customers with quality verification, calibration and testing services; b) Management's statement of the organization's work standards: the objectives of the management system:
) The organization requires all personnel involved in verification, calibration and testing activities to be familiar with the relevant quality management documents and to implement these policies and procedures in their work; e) The organization's management's commitment to comply with this specification. 5.3.3 Quality Management System Objectives
5.3.3.1. The organization shall prepare and maintain a quality manual. The quality manual shall include or indicate supporting procedures, including technical procedures, and outline the structure of the documents used in the quality management system. 5.3.3.2 The quality manual shall define the roles and responsibilities of technical management (or technical stakeholders) and those responsible for quality management, including ensuring compliance with this specification.
5.3.4 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. The degree of detail shall depend on the complexity of the work, the methods used, and the skills and training of the personnel required to carry out the work. 5.4 Document control
The organization shall control all documents (either internally developed or from external sources) required for the operation of the quality management system, such as laws, regulations, other normative documents, verification procedures, calibration specifications, test methods, inspection rules, standards, as well as drawings, software, specifications, instructions and manuals. Records are a special type of document and should be controlled in accordance with the requirements of 5.5.
A documented sequence of events should be prepared to specify the controls needed to: a) approve documents before they are issued to ensure they are adequate and appropriate; h) review and update documents, as necessary, and re-approve them; and h) ensure that changes to documents are identified as to their current revision status. Revisions should be controlled and, unless otherwise specifically determined, must be reviewed and approved by the original review and approval personnel who can use appropriate background information as the basis for their review and approval; 1. Ensure that the valid version of the applicable document is available at the point of use; 2. Ensure that documents are kept confidential and easily identifiable; 3. Ensure that external documents are identified and their distribution is controlled; 4. Prevent the unintended use of work documents; 5.5 Record control S.5.1 The organization should establish and maintain records to provide evidence of conformity to requirements and the effective operation of the quality management system. It should establish and maintain procedures for identifying, collecting, searching, storing, archiving, validating, maintaining and cleaning up quality records and technical records. Quality records shall include reports from internal and management audits and records of corrective and preventive measures. 5.5.2 All records shall be authentic, clear and concise, and stored and preserved in a manner that prevents damage, deterioration, loss and other hazards. The retention period of records shall be specified. 5.5.3 All records shall be protected and kept confidential. 5.5.4 The organization shall have procedures to protect and copy electronically stored records and prevent unauthorized intrusion or modification.
5.6 Management Review
5.6.1 General
The organization's head shall review the organization's quality management system and its certification, calibration and testing activities regularly in accordance with the predetermined plan and procedures to ensure their continued suitability, adequacy and effectiveness. Records of management reviews shall be maintained.
5.6.2 Review inputs
The inputs to the management review should include information on the following:) Suitability of policies and procedures;
) Reports from management and auditors;
) Results of recent internal audits;
) Corrective and preventive actions;
e) Audits conducted by external organizations;
f) Results of laboratory comparisons or proficiency testing;
g) Changes in the work base and type of work;
b) Customer feedback;
Expectations;
) Other relevant factors, such as changes in control mechanisms, resources and staff training. 5.6.3 Review outputs
The outputs of the management review include any decisions and actions related to the following: a) Improvements in the effectiveness of the management system and its processes; 6) Improvements in verification, calibration and testing related to customer requirements; and resource requirements.
The head of the organization shall ensure that the above decisions and measures are implemented within an appropriate and scheduled period. 6 Resource allocation and management
Center 1 General
The resources that determine the accuracy and reliability of the organization's verification, calibration and testing include personnel, facilities and environmental conditions, measuring equipment, etc. The organization shall provide a list of the verification, calibration and testing items carried out (including such items as item name, quantity or measurement range, measurement uncertainty or allowable error, and proposed procedures, standards, specifications or rules, etc.), determine and provide the resources needed to carry out its verification, calibration and testing tasks, and establish and improve the quality management system. 6.2 Personnel
6.2.1 The organization shall be equipped with sufficient management, supervision, verification, calibration and testing personnel according to the needs of the work. Organization2 Quality Management System Objectives
JIF1069—2003
The objectives and goals of the organization's quality management system should be specified in the quality manual. The overall objectives should be written in a written form: a quality manual statement is authorized by the organization's responsible person and should include at least the following content: a) The organization's management's commitment to good professional behavior and to providing customers with quality verification, calibration and testing services; b) Management's statement of the organization's work standards: the objectives of the management system:
) The organization requires all personnel involved in verification, calibration and testing activities to be familiar with the relevant quality management documents and to implement these policies and procedures in their work; e) The organization's management's commitment to comply with this specification. 5.3.3 Quality Management System Objectives
5.3.3.1. The organization shall prepare and maintain a quality manual. The quality manual shall include or indicate supporting procedures, including technical procedures, and outline the structure of the documents used in the quality management system. 5.3.3.2 The quality manual shall define the roles and responsibilities of technical management (or technical stakeholders) and those responsible for quality management, including ensuring compliance with this specification.
5.3.4 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. The degree of detail shall depend on the complexity of the work, the methods used, and the skills and training of the personnel required to carry out the work. 5.4 Document control
The organization shall control all documents (either internally developed or from external sources) required for the operation of the quality management system, such as laws, regulations, other normative documents, verification procedures, calibration specifications, test methods, inspection rules, standards, as well as drawings, software, specifications, instructions and manuals. Records are a special type of document and should be controlled in accordance with the requirements of 5.5.
A documented sequence of events should be prepared to specify the controls needed to: a) approve documents before they are issued to ensure they are adequate and appropriate; h) review and update documents, as necessary, and re-approve them; and h) ensure that changes to documents are identified as to their current revision status. Revisions should be controlled and, unless otherwise specifically determined, must be reviewed and approved by the original review and approval personnel who can use appropriate background information as the basis for their review and approval; 1. Ensure that the valid version of the applicable document is available at the point of use; 2. Ensure that documents are kept confidential and easily identifiable; 3. Ensure that external documents are identified and their distribution is controlled; 4. Prevent the unintended use of work documents; 5.5 Record control S.5.1 The organization should establish and maintain records to provide evidence of conformity to requirements and the effective operation of the quality management system. It should establish and maintain procedures for identifying, collecting, searching, storing, archiving, validating, maintaining and cleaning up quality records and technical records. Quality records shall include reports from internal and management audits and records of corrective and preventive measures. 5.5.2 All records shall be authentic, clear and concise, and stored and preserved in a manner that prevents damage, deterioration, loss and other hazards. The retention period of records shall be specified. 5.5.3 All records shall be protected and kept confidential. 5.5.4 The organization shall have procedures to protect and copy electronically stored records and prevent unauthorized intrusion or modification.
5.6 Management Review
5.6.1 General
The organization's head shall review the organization's quality management system and its certification, calibration and testing activities regularly in accordance with the predetermined plan and procedures to ensure their continued suitability, adequacy and effectiveness. Records of management reviews shall be maintained.
5.6.2 Review inputs
The inputs to the management review should include information on the following:) Suitability of policies and procedures;
) Reports from management and auditors;
) Results of recent internal audits;
) Corrective and preventive actions;
e) Audits conducted by external organizations;
f) Results of laboratory comparisons or proficiency testing;
g) Changes in the work base and type of work;
b) Customer feedback;
Expectations;
) Other relevant factors, such as changes in control mechanisms, resources and staff training. 5.6.3 Review outputs
The outputs of the management review include any decisions and actions related to the following: a) Improvements in the effectiveness of the management system and its processes; 6) Improvements in verification, calibration and testing related to customer requirements; and resource requirements.
The head of the organization shall ensure that the above decisions and measures are implemented within an appropriate and scheduled period. 6 Resource allocation and management
Center 1 General
The resources that determine the accuracy and reliability of the organization's verification, calibration and testing include personnel, facilities and environmental conditions, measuring equipment, etc. The organization shall provide a list of the verification, calibration and testing items carried out (including such items as item name, quantity or measurement range, measurement uncertainty or allowable error, and proposed procedures, standards, specifications or rules, etc.), determine and provide the resources needed to carry out its verification, calibration and testing tasks, and establish and improve the quality management system. 6.2 Personnel
6.2.1 The organization shall be equipped with sufficient management, supervision, verification, calibration and testing personnel according to the needs of the work. Organization2 Review inputs
The inputs to the management review shall include information on:) Suitability of policies and procedures;
) Reports from management and auditors;
) Results of recent internal audits;
) Corrective and preventive actions;
e) Companion audits conducted by external organizations;
f Results of laboratory comparisons or proficiency testing;
g) Changes in the work base and type of work;
b) Customer feedback;
Expectations;
) Other relevant factors, such as changes in control mechanisms, resources and staff training, etc. 5.6.3 Review outputs
The outputs of the management review shall include any decisions and actions related to: a) Improvements in the effectiveness of the management system and its processes;
6) Improvements in verification, calibration and testing related to customer requirements;
Resource requirements. The head of the organization shall ensure that the above decisions and actions are implemented within an appropriate and scheduled period. 6 Resource allocation and management
Core 1 General
The resources that determine the accuracy and reliability of an organization's verification, calibration and testing include personnel, facilities and environmental components, measuring equipment, etc. The organization shall provide a list of the verification, calibration and testing items carried out (including items such as item name, quantity or measurement range, measurement uncertainty or allowable error, and proposed procedures, standards, specifications or rules, etc.), determine and provide the resources needed to perform its verification, calibration and testing tasks, and establish and improve the quality management system. 6.2 Personnel
6.2.1 The organization shall be equipped with sufficient management, supervision, verification, calibration and testing personnel according to the needs of the work. Organization2 Review inputs
The inputs to the management review shall include information on:) Suitability of policies and procedures;
) Reports from management and auditors;
) Results of recent internal audits;
) Corrective and preventive actions;
e) Companion audits conducted by external organizations;
f Results of laboratory comparisons or proficiency testing;
g) Changes in the work base and type of work;
b) Customer feedback;
Expectations;
) Other relevant factors, such as changes in control mechanisms, resources and staff training, etc. 5.6.3 Review outputs
The outputs of the management review shall include any decisions and actions related to: a) Improvements in the effectiveness of the management system and its processes;
6) Improvements in verification, calibration and testing related to customer requirements;
Resource requirements. The head of the organization shall ensure that the above decisions and actions are implemented within an appropriate and scheduled period. 6 Resource allocation and management
Core 1 General
The resources that determine the accuracy and reliability of an organization's verification, calibration and testing include personnel, facilities and environmental components, measuring equipment, etc. The organization shall provide a list of the verification, calibration and testing items carried out (including items such as item name, quantity or measurement range, measurement uncertainty or allowable error, and proposed procedures, standards, specifications or rules, etc.), determine and provide the resources needed to perform its verification, calibration and testing tasks, and establish and improve the quality management system. 6.2 Personnel
6.2.1 The organization shall be equipped with sufficient management, supervision, verification, calibration and testing personnel according to the needs of the work. Organization
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