General criteria for the operation of various types of bodies performing inspection
Some standard content:
ICS 03. 120. 20
National Standard of the People's Republic of China
GB/T 18346--2001
idtISO/IEC17020.1998
General criteria for the operation of various types of bodies performing inspection2001-04-09 Issued
Implemented on 2001-10-01
Issued by the State Administration of Quality and Technical Supervision
GB/T 18346—20D1
ISO/IEC Foreword
Management requirements
Independence, impartiality and honesty
Confidentiality
Organization and management
Quality system
9 Facilities and equipment
1% Inspection methods and procedures
Disposal of inspection samples or items·
Inspection report and inspection certificate
Reporting and appeal·
16 Cooperation…·|| tt||Appendix A (Standard Appendix) Criteria for the Independence of Type A Inspection Bodies Appendix B (Standard Appendix) Criteria for the Independence of Type B Inspection Bodies Appendix C (Standard Appendix) Criteria for the Independence of Type C Inspection Bodies Appendix D (Suggestive Appendix)
Information to be included or involved in the quality register
GB/T18346—2001
This standard is equivalent to IS0/1EC17020:1998 "General Requirements for the Competence of Various Types of Inspection Bodies". The formulation of this standard aims to promote the improvement of the trust of inspection bodies that comply with the requirements of this standard. In view of the fact that ISO/IEC17020 was originally the EN45004 standard drafted by the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC), it was adopted by the ISO Conformity Assessment Committee according to a "fast track procedure" and approved by ISO member bodies and IEC national committees. This standard does not include the foreword and Appendix ZZ of the European Committee for Standardization (CEN)/European Committee for Electrotechnical Standardization Technical Committee 1 (CENELEC/TC1). According to regulations and market needs, the requirements for the independence of inspection bodies may vary. The inspection bodies referred to in this standard only refer to the three types of inspection bodies in Appendix A, Appendix B and Appendix C.
Appendix A, Appendix B and Appendix C of this standard are standard appendices, and Appendix D is a prompt appendix. This standard is proposed and managed by the China National Accreditation Service for Laboratories. The main drafting units of this standard are the China National Accreditation Service for Laboratories and China Classification Society. The main drafters of this standard are Qiao Dong, Shi Jiajun, Wang Xiaozuo, An Haiyan and Li Yanyong. GB/T18346--2001
ISO/IEC Foreword
ISO (International Organization for Standardization) and IEC (International Electrotechnical Commission) are specialized systems formed for global standardization. National organizations that are members of ISC or IEC participate in the formulation of international standards through technical committees composed of organizations engaged in activities in specific technical fields. ISO and IEC technical committees collaborate in areas of common interest, while other governmental and non-governmental international organizations also participate in this work through liaison with ISO and IEC. International standards are drafted in accordance with the provisions of Part 3 of the ISO/IEC Directives. The draft international standard adopted by the technical committee will be circulated to the member bodies for voting, and it must be approved by at least 75% of the member bodies participating in the vote before it can be published as an international standard. The international standard ISO/IEC17020 was originally drafted by the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC) as the EN45004 standard. It was adopted by the ISO Conformity Assessment Committee (ISO/CASCO) under a fast-track procedure and approved by ISO member bodies and IEC national committees. In order to meet the market demand for an internationally agreed normative document for inspection bodies, the ISO Committee on Conformity Assessment (ISO/CASCO) was authorized to develop international standards and selected EN 45004 to replace ISO/IEC Guide 39:1988 General requirements for accreditation of inspection bodies and ISO/IEC Guide 57:1991 Guide for the presentation of inspection results. Annexes A to D are an integral part of the international standard. Annexes D and ZZ are informative annexes. Annex ZZ provides a list of corresponding international and European standards that do not appear in the international standard. GB/T 18346—2001
This European Standard has been developed with the aim of promoting confidence in inspection bodies that operate in accordance with this standard. This standard has been developed based on the experience of European bodies carrying out inspection activities taking into account the requirements and recommendations of European and international documents such as the ISO/IEC Guide 39 (EN/I5O9000) series of standards and ISO/IEC Guide 39. Inspection bodies carry out assessments on behalf of private clients, their parent organizations and/or official bodies with the aim of providing these bodies with confidence in compliance with regulations, standards or specifications. Inspection parameters may include the quantity, quality, safety, fitness for purpose and continuing safety requirements of the process or system in operation. In order for their services to be accepted by clients and supervisory bodies, it is necessary to unify the requirements to be followed by these inspection bodies into a common set of criteria. Therefore, this standard covers the functions of bodies to inspect materials, products, installations, plants, processes, work procedures or services to determine their conformity with requirements; and subsequently report the results of these activities to the client and, where required, to the supervisory body. Inspection of products, installations or plants may involve all stages of the inspection project, including the design stage. Professional judgement is usually required when providing inspection services, especially when performing conformity assessment.
Requirements for the independence of inspection bodies. Varies according to regulations and market needs, therefore, this standard includes independence criteria in Annexes A, B and C.
This standard has been developed to support the introduction of conformity assessment procedures as provided for in the Council Decision on the implementation of technical harmonization directives. The relevant requirements of the EN/ISO9000 series of standards applicable to the quality system of inspection bodies have been incorporated into this standard. General requirements for the operation of testing laboratories
EN45001
EN 45002
General requirements for the assessment of testing laboratories
General requirements for laboratory accreditation bodies
EN 45003
EN45004
General requirements for the operation of inspection bodies
EN XXXX\) General requirements for the accreditation of various types of inspection bodies EN45011 General requirements for product certification bodies EN 45012
General requirements for quality system certification bodies
General requirements for registration bodies of certification personnel
-EN 45013
General requirements for supplier's declaration of conformity
-EN 45014
--EN 45020
1) is under development.
General terms and definitions for standardization and related activitiesScope
National Standard of the People's Republic of China
General criteria for the competence of various types of inspection bodies
General criteria for the operation of various types of bodies performing inspectionlonGB/T 18346-2001
idtISO/IEC17020:1998
1.1 This standard specifies the general requirements for the competence of various types of impartial inspection bodies and the requirements for the independence of inspection bodies. 1.2 This standard is intended for use by inspection bodies, accreditation organizations for inspection bodies and other organizations that recognize the competence of inspection bodies. 1.3 When this standard is used for special industries or operational inspections, appropriate interpretations may be made. 1.4 This standard does not apply to the requirements for the declaration of conformity of testing laboratories, certification bodies or suppliers. 2 Definitions
This standard adopts the following definitions.
2.1 Inspection
The verification of product design, product, service, process or factory to determine its conformity to specific requirements, or conformity to general requirements based on professional judgment.
Note 1: Process inspection includes personnel, facilities, technology and methods. Note 2t Inspection results can be used to support certification. Note 3; Inspection is defined in ISO/IEC Guide 2 as "conformity evaluation conducted through observation and judgment, combined with testing and inspection when necessary\
2.2 Inspection bodies inspection bodies
A body that performs inspection activities.
Note: This body may be an organization, or part of an organization. The other definitions given in IS/IEC Guide 2 apply. 3 Management requirements
3.1 The inspection body or its parent organization shall have a clear legal status. 3.2 If the parent organization of the inspection body also performs other activities besides inspection, the status of the inspection body within the parent organization shall be clearly identified.
3.3 The inspection body shall have documents describing its functions and the scope of its technical capabilities. The specific scope of the inspection will be determined by the terms of the contract or work order. 3.4 The inspection body shall have appropriate liability insurance. Unless the liability of the inspection body is borne by its parent organization or by the state in accordance with national law.
3.5 The inspection body shall have documents describing the conditions under which it can carry out inspection business. Unless the inspection body is part of an organization and provides inspection services only to that organization.
3.6 The inspection body or its parent organization shall have independent audited accounts. Approved by the State Administration of Quality and Technical Supervision on April 9, 2001 and implemented on October 1, 2001
4 Independence, impartiality and honesty
4.1 General
GB/T18346-2001
The personnel of the inspection body shall not be subject to commercial, financial and other pressures that may affect their impartial judgment, and shall strictly implement procedures to ensure that the inspection results are not affected by personnel or organizations outside the inspection body. 4.2 Independence
The inspection body shall be independent as long as the services provided meet the required conditions. Based on these conditions, the inspection body shall meet the minimum requirements specified in one of the three appendixes A (normative appendix), B (normative appendix) and C (normative appendix) of this standard. 4-21 Category A inspection body Inspection bodies that provide "third party" services shall meet the requirements of the relevant standards. 42.2 Category B inspection bodies Inspection bodies that are an independent and clearly defined part of an organization engaged in the design, production, installation, use or maintenance of products and provide inspection services to organizations that may be involved shall meet the requirements of Appendix B. 42.3 Category C inspection bodies Inspection bodies that manufacture, supply, install, use or maintain competitive products of the inspected products or products and may provide inspection services to organizations outside the parent group shall meet the requirements of the relevant standards. 5 Confidentiality Inspection bodies shall ensure the confidentiality of information obtained during inspection activities, but the ownership of such information shall be protected. 6 Organization and Management
6-1 The inspection organization should have an organizational structure to ensure that it can fulfil its technical functions. 6-2 The inspection body should define and document the responsibilities and relationships within its organization. When the inspection body undertakes certification and/or inspection services, it should clearly define the relationship between the inspection and certification and testing functions. 6.3 The inspection body/organization should appoint a technical supervisor, regardless of the title, who should have the appropriate qualifications and experience in the operation of the inspection body and be fully responsible for the inspection activities in accordance with the overall plan. The technical supervisor should be a permanent member of staff. Note! If the inspection organization is composed of several departments in different areas of activity, each department can have a technical supervisor. 6.4 The inspection body should be effectively supervised by personnel who are responsible for inspection methods and procedures, inspection objectives and evaluation of inspection results. 6.5 The inspection body management shall designate a replacement person to provide inspection services in the absence of the supervisor (or other title). 6.6 The inspection body shall describe any position that affects the quality of the inspection body's services. The description of these positions shall include the requirements for education, training, technical knowledge and experience.
7 Quality system
71 The inspection body management shall define its quality policy, quality standards and quality commitment and shall document them to ensure that they are understood, implemented and maintained by personnel at all levels of the organization.
7.2 The inspection body shall operate an effective quality system that is appropriate to the type, scope and volume of inspection work it performs. 7.3 The quality system shall be documented and a quality manual covering the requirements of this standard and Annex D (informative annex) shall be prepared. 74 The inspection body management shall designate a person who, regardless of other responsibilities, has clear responsibilities and authority for quality assurance within the inspection body and who can communicate directly with top management. 75 The designated person shall be responsible for maintaining the quality system and ensuring that it is effective. 76 The inspection body shall maintain a system of documents that control its activities. Ensure that:) All relevant places and personnel have access to the required documents. Version: 2
GB/F18346—2001
h) All changes or revisions to documents are properly authorized and ensure that they are available in time at the corresponding places; c) Obsolete documents should be withdrawn from the organization except for one copy archived for a specified period; d) When necessary, changes to documents should be notified to other relevant parties. 7.7 The inspection body shall establish and implement a planned and documented internal quality audit system to verify the compliance of its quality system with the requirements of this standard and its effectiveness. Personnel performing audits should be qualified and independent of the audited department. 7.8 The inspection body shall have a procedure document for handling feedback and taking corrective actions to deal with non-conformities found during the operation of the quality system and (or) implementation of inspections.
7.9 The management of the inspection body shall regularly review the quality system to ensure its continued adaptability and effectiveness. The review results should be recorded. 8 Personnel
8.1 The inspection body should have sufficient and relatively stable personnel, and these personnel should have the professional skills required for the inspection work. 8.2 The personnel responsible for the inspection should have the corresponding qualifications, training, experience and be familiar with the requirements of the inspection to be performed, and have the ability to make professional judgments on the compliance with the general requirements and issue corresponding reports based on the inspection results. These personnel should also have relevant knowledge of the manufacturing technology of the inspected products, the process used by the inspected products or the intended use of the products, and the knowledge of defects that may occur during use or service. They should also understand the importance of deviations (deviations) to the normal use of the inspected products or processes. 8.3 The inspection body establishes a documented training system to ensure that its personnel are trained in professional technology and management, and can be continuously updated in accordance with the quality policy.
The training should be based on the capabilities, qualifications and experience of the relevant personnel, and the inspection body should stipulate the necessary training stages for each person. These may include: a) a trainee period b) a period of working under the guidance of a senior inspector c) continuing training throughout the employment period to keep pace with technological developments 8.4 The inspection agency shall keep records of each person's academic or other qualifications, training and experience 8.5 The inspection agency shall provide behavioral guidance for its personnel. 8.6 The remuneration of personnel engaged in inspection activities should not be based solely on the number of inspections carried out, let alone on the results of the inspections 9 Facilities and Equipment 9.1 The inspection agency shall obtain sufficient and suitable facilities and equipment to accommodate all activities related to specific inspection services 9.2 The inspection agency shall have clear provisions for the acquisition and use of specific facilities and equipment. 9.3 The inspection body shall ensure the continued suitability of the facilities and equipment referred to in 1 to meet the requirements for their intended use. 9.4 All equipment purchased as mentioned above shall be properly identified. 9.5 The inspection body shall ensure that all equipment is properly maintained in accordance with the procedures and operating instructions. 9.6 Where appropriate, the inspection body shall ensure that the equipment is calibrated in accordance with the prescribed schedule before and after it is put into use. 9.7 A calibration schedule for equipment shall be established and implemented. To ensure that the measurements made by the inspection body can be traced back to national and/or international measurement standards: when traceability is not possible, the inspection body shall provide sufficient evidence of the relevance and accuracy of the inspection results. 9.8 Measurement reference standards held by the inspection body shall be used only for calibration and not for other purposes. Oxygen reference standards shall be calibrated by a qualified body that can be traced back to national or international measurement standards. 9.9 Where possible, equipment shall be checked in operation between regular calibration cycles. 9.10 Where possible, reference materials shall be traceable to national or international standard reference materials. 9.11 When it comes to the quality of inspection services, the inspection body should have the following procedures: a) Select qualified suppliers:
b) Issue appropriate purchasing documents:
c) Incoming inspection;
d) Ensure appropriate storage facilities.
GB/T18346—2001
9.12 When necessary, conduct regular inspections of the status of stored items to detect deteriorated items. 9.13 If the inspection body uses computers or automated equipment during inspections, it should ensure that: 8) Computer software is tested to confirm its applicability b) Procedures for protecting data integrity are established and implemented; c) Computers and automated equipment are maintained to ensure their proper functioning: d) Procedures for maintaining data security are established and implemented. 9.14 The inspection body shall establish procedures for handling defective equipment. Defective equipment shall be isolated, clearly identified or marked to prevent misuse. And check whether the defect affects previous inspection results. 9.15 Information related to the equipment should be recorded. Usually includes information on identification, calibration and maintenance. 10 Inspection methods and procedures
10.1 The inspection body shall use the inspection methods and procedures specified in the requirements to make judgments on compliance. 10.2 When the lack of documented instructions affects the effectiveness of the inspection process, the inspection body shall develop and use documented instructions for inspection planning, standard sampling and inspection techniques. When necessary, full knowledge of statistical techniques is required to ensure statistically reasonable sampling procedures and correct processing and interpretation of results. 10.3 When the inspection body must use non-standard inspection methods or procedures, these methods and procedures should be reasonable and fully documented. 10.4 All instructions, standards or written procedures, work forms, checklists and reference data related to the inspection body's work should be kept current and easily accessible to employees.
10.5 The inspection body shall have a contract or work order control system to ensure that: a) the work is carried out within its capabilities and that it has sufficient resources to meet the contract requirements; b) the customer's requirements for the inspection body's services are fully clear and the inspection body can correctly understand the special requirements to ensure that clear instructions are given to the personnel responsible for implementation;
c) the work is kept under control through regular review and corrective action; d) the completed work is reviewed to confirm that the requirements are met. 10.6 Observations and (or) data during the inspection process should be recorded in a timely manner to prevent loss of relevant information. 10.7 All calculations and data transmissions should be properly verified. 10.8 The inspection body should have instructions for the safe implementation of the inspection. 11 Disposal of inspection samples or items
11.1 The inspection body shall ensure that the inspection samples or items are uniquely identified to avoid confusion at any time. 11.2 Before the inspection begins, the inspector shall record any obvious abnormalities found or notified. When there is doubt about the suitability of the item to be inspected, or the item does not conform to the description provided, the inspection body should consult the client before proceeding. 11.3 The inspection body should determine whether all necessary preparations have been made for the item, or whether the client requires the inspection body to make corresponding preparations or arrangements.
11.4 The inspection body should have documented procedures and appropriate facilities to avoid deterioration or damage of the inspection items during its responsibility. 12 Records
12.1 The inspection body should maintain a record system that is adapted to its specific environment and meets the specified requirements. 12.2 The records should include sufficient information to enable a proper evaluation of the inspection activities. 12.3 Unless otherwise required by law, all records should be stored securely for a certain period of time and kept confidential by the customer. 4
13 Inspection Report and Inspection Certificate
GB/T18346--2001
13.1 The work completed by the inspection body should be reflected in the inspection report and (or) inspection certificate. 13.2 The inspection report and (or) inspection certificate shall include all inspection results, the conformity judgments made based on these results, and all information required to understand and interpret these results. All this information shall be expressed correctly, accurately and clearly. When the inspection report or inspection certificate contains the results provided by the subcontractor, this shall be clearly indicated. 13.3 Inspection reports and inspection certificates may only be issued or approved by authorized persons. 13.4 After the inspection report or inspection certificate is issued, any corrections or additions shall be recorded and confirmed in accordance with the relevant requirements of this chapter. 14 Subcontracting
14.1 Normally, the inspection body shall independently complete the inspection work required in the contract. 14.2 When the inspection body subcontracts any part of the inspection work, it shall ensure and be able to prove that its subcontracting The subcontractor is capable of undertaking the corresponding services. When necessary, it shall comply with the requirements specified in the relevant standards. The inspection agency shall explain to the customer its intention to subcontract part of the inspection work. The subcontractor shall be accepted by the customer.
14.3 The inspection agency shall record and retain details of the subcontractor's capability and conformity investigation. The inspection agency shall keep records of all subcontracted work.
14.4 When the inspection agency subcontracts certain special businesses, it shall be equipped with qualified and experienced personnel to conduct an independent review of the results of the subcontracting activities. The inspection agency is responsible for whether the inspection results meet the customer's requirements. 15 Complaints and appeals
15.1 The inspection agency shall establish and document procedures for handling complaints from customers or other parties regarding the inspection agency's activities. 15.2 The inspection agency shall formulate Study and document the procedures for resolving complaints raised by statutory agencies. 15.3 Keep records of all complaints, appeals and the actions taken by the inspection body in response. 16 Cooperation
Inspection bodies should exchange experiences and participate in standardization activities when appropriate. GB/T18346—2001
Appendix A
(Appendix to the standard)
Independence criteria for Class A inspection bodies
The inspection bodies referred to in 4.2.1 should meet the following criteria. A1 The inspection body should be independent of the parties involved. The inspection body and the persons responsible for carrying out the inspection should not be the designers, manufacturers, suppliers, installers, owners, users or maintainers of the items they inspect, nor should they be authorized representatives of any of the above parties. A2 The inspection body and its personnel shall not engage in any activity that could violate the independence and integrity of the inspection judgment. In particular, they shall not be directly involved in the design, production, supply, installation, use or maintenance of the inspection project or similar competitive projects. A3 The inspection body services shall be accessible to all interested parties without undue financial costs and other conditions in a non-discriminatory manner. (Standard) Independence criteria for inspection bodies The procedures for the operation of the inspection body shall meet the following criteria in 4.2.2. B1 The responsibilities of inspection personnel and real 0
departments and personnel shall be clearly separated through organizational identification and/or the inspection body's affiliation with the parent organization. B2 The inspection body and its personnel shall not engage in any activity that could violate the independence and integrity of the inspection judgment. B3 Inspection services are only provided by the parent organization of the inspection body. (Standardized Appendix) Criteria for independence of inspection bodies The inspection bodies referred to in 4.2.3 shall meet the following criteria. C1 The inspection body shall take precautions within the organization to ensure complete separation of duties between the various inspection services through organizational and/or documented procedures. D (Informative Appendix) Information to be included or referred to in the quality manual (name, address, telephone number, etc., and legal status). Management's statement of quality policy, objectives, commitment. Statement by the designated person in management as specified in 7.4. Description of the inspection body's activities and scope of competence. Information on the relationship between the inspection body and its parent organization or (where applicable) related organizations. Organization chart.
Related job descriptions.
Policy statement on personnel qualifications and training.
Procedure for document control.
Internal audit procedures.
Procedure for feedback and corrective action.
GB/T 18346—2001
Procedure for quality system management review.
Other procedures and instructions or references to procedures or instructions required in this standard. Function allocation table in the quality manual.5 The inspection body shall have a contract or work order control system to ensure that: a) the work is carried out within its capabilities and that it has sufficient resources to meet the contract requirements; b) the customer's requirements for the inspection body's services should be fully clear, and the inspection body should be able to correctly understand special requirements to ensure that clear instructions are given to those responsible for implementation; c) the work is kept under control through regular review and corrective action; d) the completed work is reviewed to confirm that the requirements are met. 10.6 Observations and (or) data during the inspection process should be recorded in a timely manner to prevent loss of relevant information. 10.7 All calculations and data transmissions should be appropriately verified. 10.8 The inspection body should have instructions for the safe implementation of the inspection. 11 Disposal of inspection samples or items
11.1 The inspection body shall ensure that the inspection samples or items are uniquely identified to avoid confusion at any time. 11.2 Before the inspection begins, the inspector shall record any obvious abnormalities found or notified. When there is doubt about the suitability of the item to be inspected, or the item does not conform to the description provided, the inspection body should consult the client before proceeding. 11.3 The inspection body should determine whether all necessary preparations have been made for the item, or whether the client requires the inspection body to make corresponding preparations or arrangements.
11.4 The inspection body should have documented procedures and appropriate facilities to avoid deterioration or damage of the inspection items during its responsibility. 12 Records
12.1 The inspection body should maintain a record system that is adapted to its specific environment and meets the specified requirements. 12.2 The records should include sufficient information to enable a proper evaluation of the inspection activities. 12.3 Unless otherwise required by law, all records should be stored securely for a certain period of time and kept confidential by the customer. 4
13 Inspection Report and Inspection Certificate
GB/T18346--2001
13.1 The work completed by the inspection body should be reflected in the inspection report and (or) inspection certificate. 13.2 The inspection report and (or) inspection certificate shall include all inspection results, the conformity judgments made based on these results, and all information required to understand and interpret these results. All this information shall be expressed correctly, accurately and clearly. When the inspection report or inspection certificate contains the results provided by the subcontractor, this shall be clearly indicated. 13.3 Inspection reports and inspection certificates may only be issued or approved by authorized persons. 13.4 After the inspection report or inspection certificate is issued, any corrections or additions shall be recorded and confirmed in accordance with the relevant requirements of this chapter. 14 Subcontracting
14.1 Normally, the inspection body shall independently complete the inspection work required in the contract. 14.2 When the inspection body subcontracts any part of the inspection work, it shall ensure and be able to prove that its subcontracting The subcontractor is capable of undertaking the corresponding services. When necessary, it shall comply with the requirements specified in the relevant standards. The inspection agency shall explain to the customer its intention to subcontract part of the inspection work. The subcontractor shall be accepted by the customer.
14.3 The inspection agency shall record and retain details of the subcontractor's capability and conformity investigation. The inspection agency shall keep records of all subcontracted work.
14.4 When the inspection agency subcontracts certain special businesses, it shall be equipped with qualified and experienced personnel to conduct an independent review of the results of the subcontracting activities. The inspection agency is responsible for whether the inspection results meet the customer's requirements. 15 Complaints and appeals
15.1 The inspection agency shall establish and document procedures for handling complaints from customers or other parties regarding the inspection agency's activities. 15.2 The inspection agency shall formulate Study and document the procedures for resolving complaints raised by statutory agencies. 15.3 Keep records of all complaints, appeals and the actions taken by the inspection body in response. 16 Cooperation
Inspection bodies should exchange experiences and participate in standardization activities when appropriate. GB/T18346—2001
Appendix A
(Appendix to the standard)
Independence criteria for Class A inspection bodies
The inspection bodies referred to in 4.2.1 should meet the following criteria. A1 The inspection body should be independent of the parties involved. The inspection body and the persons responsible for carrying out the inspection should not be the designers, manufacturers, suppliers, installers, owners, users or maintainers of the items they inspect, nor should they be authorized representatives of any of the above parties. A2 The inspection body and its personnel shall not engage in any activity that could violate the independence and integrity of the inspection judgment. In particular, they shall not be directly involved in the design, production, supply, installation, use or maintenance of the inspection project or similar competitive projects. A3 The inspection body services shall be accessible to all interested parties without undue financial costs and other conditions in a non-discriminatory manner. (Standard) Independence criteria for inspection bodies The procedures for the operation of the inspection body shall meet the following criteria in 4.2.2. B1 The responsibilities of inspection personnel and real 0
departments and personnel shall be clearly separated through organizational identification and/or the inspection body's affiliation with the parent organization. B2 The inspection body and its personnel shall not engage in any activity that could violate the independence and integrity of the inspection judgment. B3 Inspection services are only provided by the parent organization of the inspection body. (Standardized Appendix) Criteria for independence of inspection bodies The inspection bodies referred to in 4.2.3 shall meet the following criteria. C1 The inspection body shall take precautions within the organization to ensure complete separation of duties between the various inspection services through organizational and/or documented procedures. D (Informative Appendix) Information to be included or referred to in the quality manual (name, address, telephone number, etc., and legal status). Management's statement of quality policy, objectives, commitment. Statement by the designated person in management as specified in 7.4. Description of the inspection body's activities and scope of competence. Information on the relationship between the inspection body and its parent organization or (where applicable) related organizations. Organization chart.
Related job descriptions.
Policy statement on personnel qualifications and training.
Procedure for document control.
Internal audit procedures.
Procedure for feedback and corrective action.
GB/T 18346—2001
Procedure for quality system management review.
Other procedures and instructions or references to procedures or instructions required in this standard. Function allocation table of the quality manual.5 The inspection body shall have a contract or work order control system to ensure that: a) the work is carried out within its capabilities and that it has sufficient resources to meet the contract requirements; b) the customer's requirements for the inspection body's services should be fully clear, and the inspection body should be able to correctly understand special requirements to ensure that clear instructions are given to those responsible for implementation; c) the work is kept under control through regular review and corrective action; d) the completed work is reviewed to confirm that the requirements are met. 10.6 Observations and (or) data during the inspection process should be recorded in a timely manner to prevent loss of relevant information. 10.7 All calculations and data transmissions should be appropriately verified. 10.8 The inspection body should have instructions for the safe implementation of the inspection. 11 Disposal of inspection samples or items
11.1 The inspection body shall ensure that the inspection samples or items are uniquely identified to avoid confusion at any time. 11.2 Before the inspection begins, the inspector shall record any obvious abnormalities found or notified. When there is doubt about the suitability of the item to be inspected, or the item does not conform to the description provided, the inspection body should consult the client before proceeding. 11.3 The inspection body should determine whether all necessary preparations have been made for the item, or whether the client requires the inspection body to make corresponding preparations or arrangements.
11.4 The inspection body should have documented procedures and appropriate facilities to avoid deterioration or damage of the inspection items during its responsibility. 12 Records
12.1 The inspection body should maintain a record system that is adapted to its specific environment and meets the specified requirements. 12.2 The records should include sufficient information to enable a proper evaluation of the inspection activities. 12.3 Unless otherwise required by law, all records should be stored securely for a certain period of time and kept confidential by the customer. 4
13 Inspection Report and Inspection Certificate
GB/T18346--2001
13.1 The work completed by the inspection body should be reflected in the inspection report and (or) inspection certificate. 13.2 The inspection report and (or) inspection certificate shall include all inspection results, the conformity judgments made based on these results, and all information required to understand and interpret these results. All this information shall be expressed correctly, accurately and clearly. When the inspection report or inspection certificate contains the results provided by the subcontractor, this shall be clearly indicated. 13.3 Inspection reports and inspection certificates may only be issued or approved by authorized persons. 13.4 After the inspection report or inspection certificate is issued, any corrections or additions shall be recorded and confirmed in accordance with the relevant requirements of this chapter. 14 Subcontracting
14.1 Normally, the inspection body shall independently complete the inspection work required in the contract. 14.2 When the inspection body subcontracts any part of the inspection work, it shall ensure and be able to prove that its subcontracting The subcontractor is capable of undertaking the corresponding services. When necessary, it shall comply with the requirements specified in the relevant standards. The inspection agency shall explain to the customer its intention to subcontract part of the inspection work. The subcontractor shall be accepted by the customer.
14.3 The inspection agency shall record and retain details of the subcontractor's capability and conformity investigation. The inspection agency shall keep records of all subcontracted work.
14.4 When the inspection agency subcontracts certain special businesses, it shall be equipped with qualified and experienced personnel to conduct an independent review of the results of the subcontracting activities. The inspection agency is responsible for whether the inspection results meet the customer's requirements. 15 Complaints and appeals
15.1 The inspection agency shall establish and document procedures for handling complaints from customers or other parties regarding the inspection agency's activities. 15.2 The inspection agency shall formulate Study and document the procedures for resolving complaints raised by statutory agencies. 15.3 Keep records of all complaints, appeals and the actions taken by the inspection body in response. 16 Cooperation
Inspection bodies should exchange experiences and participate in standardization activities when appropriate. GB/T18346—2001
Appendix A
(Appendix to the standard)
Independence criteria for Class A inspection bodies
The inspection bodies referred to in 4.2.1 should meet the following criteria. A1 The inspection body should be independent of the parties involved. The inspection body and the persons responsible for carrying out the inspection should not be the designers, manufacturers, suppliers, installers, owners, users or maintainers of the items they inspect, nor should they be authorized representatives of any of the above parties. A2 The inspection body and its personnel shall not engage in any activity that could violate the independence and integrity of the inspection judgment. In particular, they shall not be directly involved in the design, production, supply, installation, use or maintenance of the inspection project or similar competitive projects. A3 The inspection body services shall be accessible to all interested parties without undue financial costs and other conditions in a non-discriminatory manner. (Standard) Independence criteria for inspection bodies The procedures for the operation of the inspection body shall meet the following criteria in 4.2.2. B1 The responsibilities of inspection personnel and real 0
departments and personnel shall be clearly separated through organizational identification and/or the inspection body's affiliation with the parent organization. B2 The inspection body and its personnel shall not engage in any activity that could violate the independence and integrity of the inspection judgment. B3 Inspection services are only provided by the parent organization of the inspection body. (Standardized Appendix) Criteria for independence of inspection bodies The inspection bodies referred to in 4.2.3 shall meet the following criteria. C1 The inspection body shall take precautions within the organization to ensure complete separation of duties between the various inspection services through organizational and/or documented procedures. D (Informative Appendix) Information to be included or referred to in the quality manual (name, address, telephone number, etc., and legal status). Management's statement of quality policy, objectives, commitment. Statement by the designated person in management as specified in 7.4. Description of the inspection body's activities and scope of competence. Information on the relationship between the inspection body and its parent organization or (where applicable) related organizations. Organization chart.
Related job descriptions.
Policy statement on personnel qualifications and training.
Procedure for document control.
Internal audit procedures.
Procedure for feedback and corrective action.
GB/T 18346—2001
Procedure for quality system management review.
Other procedures and instructions or references to procedures or instructions required in this standard. Function allocation table in the quality manual.2 When the inspection body subcontracts any part of the inspection work, it shall ensure and be able to demonstrate that the subcontractor is capable of undertaking the corresponding services. Where necessary, the requirements specified in the relevant standards shall be met. The inspection body shall inform the customer of the intention to subcontract part of the inspection work. The subcontractor shall be acceptable to the customer.
14.3 The inspection body shall record and retain details of the subcontractor's capability and conformity investigation. The inspection body shall keep records of all subcontracted work.
14.4 When the inspection body subcontracts certain special business, it shall assign qualified and experienced personnel to conduct independent review of the results of the subcontracted activities. The inspection body is responsible for whether the inspection results meet the customer's requirements. 15 Complaints and appeals
15.1 The inspection body shall establish and document procedures for handling complaints from customers or other parties regarding the inspection body's activities. 15.2 The inspection body shall establish and document procedures for studying and resolving complaints raised by statutory agencies. 15.3 Keep records of all complaints and appeals and the actions taken by the inspection body in response. 16 Cooperation
Inspection bodies should exchange experiences and participate in standardization activities when appropriate. GB/T18346-2001
Appendix A
(Appendix to the standard)
Independence criteria for Class A inspection bodies
Inspection bodies referred to in 4.2.1 should meet the following criteria. A1 Inspection bodies should be independent of all parties involved. Inspection bodies and personnel responsible for implementing inspections should not be designers, manufacturers, suppliers, installers, owners, users or maintainers of the items they inspect, nor should they be authorized representatives of any of the above parties. A2 Inspection bodies and their personnel should not engage in any activities that may violate the independence and integrity of inspection judgment. In particular, they should not directly participate in the design, production, supply, installation, use or maintenance of the inspection items or similar competitive items. A3 All relevant parties should have access to inspection services, without improper financial costs and other conditions HIN
In a non-discriminatory manner.
(Standard)
Independence criteria for inspection bodies
The procedures for the operation of the inspection body shall
The inspection body referred to in 4.2.2 shall meet the following criteria. B1 The responsibilities of inspection personnel and real 0
departments and personnel shall be clearly separated through organizational identification and/or the inspection body's affiliation with the parent organization.
2 The inspection body and its subsidiaries shall not engage in any activities that may violate the independence and integrity of the inspection judgment. They shall not be directly involved in the design, production, supply, installation, operation or maintenance of inspection projects or similar competitive projects. B3 Inspection services are only provided to the parent organization of the inspection body.
(Standard)
Independence criteria for inspection bodies
The inspection body referred to in 4.2.3 shall meet the following criteria. C1 The inspection body shall adopt individual preventive measures within the organization to ensure complete separation of duties and responsibilities for various inspection services through organizational and/or documented procedures.
Cool Record D
(Suggested Appendix)
Information to be included or referred to in the quality manual (name, address, telephone number, etc., and legal status). Management's statement on quality policy, objectives, and commitment. Statement by designated personnel in management as specified in Section 7.4. Description of the inspection body's activities and scope of competence. Information on the relationship between the inspection body and its parent organization or (where applicable) related organizations. Organization chart.
Description of related work.
Statement of policy on personnel qualifications and training.
Procedure for document control.
Internal audit procedures.
Procedure for feedback and corrective action.
GB/T 18346—2001
Procedure for quality system management review.
References to other procedures and instructions or procedures or instructions required in this standard. Functional allocation table of the quality manual.2 When the inspection body subcontracts any part of the inspection work, it shall ensure and be able to demonstrate that the subcontractor is capable of undertaking the corresponding services. Where necessary, the requirements specified in the relevant standards shall be met. The inspection body shall inform the customer of the intention to subcontract part of the inspection work. The subcontractor shall be acceptable to the customer.
14.3 The inspection body shall record and retain details of the subcontractor's capability and conformity investigation. The inspection body shall keep records of all subcontracted work.
14.4 When the inspection body subcontracts certain special business, it shall assign qualified and experienced personnel to conduct independent review of the results of the subcontracted activities. The inspection body is responsible for whether the inspection results meet the customer's requirements. 15 Complaints and appeals
15.1 The inspection body shall establish and document procedures for handling complaints from customers or other parties regarding the inspection body's activities. 15.2 The inspection body shall establish and document procedures for studying and resolving complaints raised by statutory agencies. 15.3 Keep records of all complaints and appeals and the actions taken by the inspection body in response. 16 Cooperation
Inspection bodies should exchange experiences and participate in standardization activities when appropriate. GB/T18346-2001
Appendix A
(Appendix to the standard)
Independence criteria for Class A inspection bodies
Inspection bodies referred to in 4.2.1 should meet the following criteria. A1 Inspection bodies should be independent of all parties involved. Inspection bodies and personnel responsible for implementing inspections should not be designers, manufacturers, suppliers, installers, owners, users or maintainers of the items they inspect, nor should they be authorized representatives of any of the above parties. A2 Inspection bodies and their personnel should not engage in any activities that may violate the independence and integrity of inspection judgment. In particular, they should not directly participate in the design, production, supply, installation, use or maintenance of the inspection items or similar competitive items. A3 All relevant parties should have access to inspection services, without improper financial costs and other conditions HIN
In a non-discriminatory manner.
(Standard)www.bzxz.net
Independence criteria for inspection bodies
The procedures for the operation of the inspection body shall
The inspection body referred to in 4.2.2 shall meet the following criteria. B1 The responsibilities of inspection personnel and real 0
departments and personnel shall be clearly separated through organizational identification and/or the inspection body's affiliation with the parent organization.
2 The inspection body and its subsidiaries shall not engage in any activities that may violate the independence and integrity of the inspection judgment. They shall not be directly involved in the design, production, supply, installation, operation or maintenance of inspection projects or similar competitive projects. B3 Inspection services are only provided to the parent organization of the inspection body.
(Standard)
Independence criteria for inspection bodies
The inspection body referred to in 4.2.3 shall meet the following criteria. C1 The inspection body shall adopt individual preventive measures within the organization to ensure complete separation of duties and responsibilities for various inspection services through organizational and/or documented procedures.
Cool Record D
(Suggested Appendix)
Information to be included or referred to in the quality manual (name, address, telephone number, etc., and legal status). Management's statement on quality policy, objectives, and commitment. Statement by designated personnel in management as specified in Section 7.4. Description of the inspection body's activities and scope of competence. Information on the relationship between the inspection body and its parent organization or (where applicable) related organizations. Organization chart.
Description of related work.
Statement of policy on personnel qualifications and training.
Procedure for document control.
Internal audit procedures.
Procedure for feedback and corrective action.
GB/T 18346—2001
Procedure for quality system management review.
References to other procedures and instructions or procedures or instructions required in this standard. Functional allocation table of the quality manual.
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