Chapter VI Implementation of Quality Management System Requirements of Inspection and Testing Institutions for Special Equipment

Article 21 Inspection and testing institutions shall determine the implementation process of inspection and testing, including the process related to the government and customers, inspection and testing methods, procurement services and supply, inspection and testing subcontracting, sampling and sample processing, inspection and testing safety, records and inspection and testing reports (certificates), so as to provide inspection and testing work that meets the requirements of relevant laws, technical specifications and standards. The sequence and interaction of these processes should be planned, determined and controlled to ensure their effective operation.

The responsibility of supervising the implementation of relevant inspection and test shall be specified to ensure that the operation of these processes is under control, so as to ensure that the inspection and test results meet the requirements of relevant laws, regulations, rules, technical specifications and standards, and are consistent with the quality policy and quality objectives of inspection and test institutions.

Twenty-second inspection and testing institutions related to the government and customers, including work order control or contract review, accept government supervision and provide services to the government and customers.

(1) The inspection and test institution shall have work instruction control or contract review related to inspection and test requirements, and ensure that the following requirements are met:

1. The inspection and testing designated by the government and the statutory application for inspection and testing have been implemented;

Note: Generally, the inspection and statutory inspection designated by the government need not sign a contract with the customer, but only accept the customer's inspection application and issue the work instruction.

2. Have the conditions for inspection and test;

Note: The conditions here refer to the contract conditions, not just the material conditions of the inspection and testing site. These situations usually include the following situations:

(1) Available written inspection and test history and background, such as previous inspection and test reports, equipment operation status and operation records;

(2) Safety requirements for entering the site;

(3) Various preparations for inspection and test, including auxiliary work and requirements for inspection and test;

(4) Reaction to adverse weather conditions.

3. The requirements of the government and customers are fully defined, recorded and understood;

4. Conduct inspection and testing within the approved project scope, and have sufficient resources to meet the requirements of the government and customers;

5. Give clear work instructions to the personnel in charge of inspection and testing;

Note: In the case of accepting oral contracts, inspection and testing institutions need to keep records of all work orders, including requirements (agreements) accepted orally, dates, customer representatives and order publishers.

6. Determine and use appropriate inspection and testing methods that can meet the requirements of the government and customers;

7. Review the inspection and testing work to be subcontracted.

Differences in understanding of work instructions and/or contracts should be resolved before inspection. Each work instruction or contract shall meet the requirements of laws, regulations and technical specifications, and be confirmed by inspection and testing institutions and customers.

If the statutory inspection task cannot be implemented (completed) under special circumstances, it shall be reported to the quality and technical supervision department in advance. If the customer applies for inspection, it shall inform the customer.

In the process of inspection and testing, if it is necessary to modify the work instruction or contract, the same review process shall be repeated and relevant personnel shall be informed of any modification.

Work orders (contracts) and their review records, including records of major changes, shall be kept.

(two) the inspection and testing institutions shall accept the supervision and inspection of the following related work by the government supervision and management departments:

1. Qualification approval, supervision and inspection;

2. Establish scientific and reliable inspection and testing data files, realize data network transmission and * * * sharing among inspection and testing institutions, assist dynamic supervision, report relevant inspection and testing reports and statistical data in time, and complete inspection and testing tasks.

(3) When providing services to the government and customers, inspection and testing institutions shall:

1. Comply with laws, regulations, technical specifications, government and customer regulations on inspection and testing safety, quality, completion time and charging standards. Open inspection procedures, charging standards and service commitments, and accept social supervision;

2. Ensure the completion of the statutory inspection of special equipment within the area or scope of this inspection responsibility. For customers who fail to report for inspection on time, inspection and testing institutions have the obligation to urge them to conduct inspection in accordance with government regulations. And provide technical support for the government to do a good job in safety supervision of special equipment;

3. Establish and maintain effective contact and communication with customers in inspection and test information consultation, work instructions, contract processing and modification, etc., so as to clarify and meet customer requirements and accept customer supervision;

4. Under the premise of ensuring the confidentiality and interests of relevant customers are not infringed, customers are allowed to visit the inspection and testing work site where inspection and testing institutions carry out inspection and testing.

Article 23 The inspection and testing methods formulated by inspection and testing institutions shall meet the needs of inspection and testing.

(a) inspection and testing institutions shall formulate the determination and application procedures of inspection and testing methods, ensure the implementation of inspection and testing services by adopting appropriate inspection and testing methods, ensure the realization of inspection and testing purposes, and meet the requirements of relevant laws, regulations, technical specifications and standards.

All work instruction documents, regulations, technical specifications and reference materials related to inspection and test shall be kept up-to-date and effective, and be convenient for inspection and test personnel to read and execute.

(2) The determination of inspection method shall meet the following requirements:

1. The inspection and test methods shall give priority to the standards and methods specified by laws, regulations and technical specifications, as well as those agreed in the contract or required by customers;

2. When the lack of documented work instructions may affect the inspection and test results or implementation process, the inspection and test institutions shall formulate (including but not limited to) inspection and test rules, inspection and test plans and other work guidance documents to guide the implementation of inspection and test and the judgment of results;

3. The process of making inspection and test work instructions by inspection and test institutions should be a planned activity, and designated personnel with sufficient qualifications and abilities to implement it.

(3) When there are no standards for inspection and test methods, or it is necessary to expand the application scope of standards, non-standard inspection and test methods can be formulated, but they shall meet the following requirements:

1. Get the customer's consent. When non-standard inspection methods are used in the process of statutory inspection, the quality and technical supervision department responsible for equipment registration shall be informed before using this method.

2. Review the non-standard inspection and test methods, the methods used beyond the expected standards, whether the self-developed methods are suitable for the expected use of inspection and test, and whether they are compatible with the requirements of the government or customers.

Note: The evaluation method should be one or a combination of the following situations:

(1) is compared with other methods.

(2) Comparison among inspection and testing institutions;

(3) reinspection or sample reinspection in the next inspection cycle;

(4) accident analysis results;

(5) To systematically review the factors affecting the results.

(4) The application of inspection and test methods shall meet the following requirements:

1. Ensure that the inspection and test methods are familiar to the inspection and test personnel and are correctly applied and implemented;

2. When the inspection and test need to deviate from the original inspection and test methods, such deviation shall be documented, approved by the technical director and recognized by the customer;

3. When the standards and methods put forward by customers are considered inappropriate or out of date, the inspection and testing institutions shall notify customers.

Twenty-fourth procurement of services and materials that have an impact on the quality of inspection and testing, inspection and testing institutions shall formulate procurement procedures and meet the following requirements:

(1) The procedure shall include the requirements for purchasing, acceptance, storage and use of consumable materials related to inspection and test quality;

(two) to ensure the use of consumable materials, supplies and services with good reputation and meeting the quality required for inspection and testing. Evaluate the service providers and suppliers that affect the quality of inspection and testing, and keep the records of these evaluations and the list of recognized service providers and suppliers;

(3) Ensure that the specified procurement requirements are sufficient and appropriate. Before the release of procurement documents, the technical contents shall be examined and approved.

Twenty-fifth under normal circumstances, the inspection and testing institutions shall independently complete the inspection and testing tasks. Special inspection and test items such as nondestructive testing can be subcontracted.

(1) The subcontracted project shall meet the following conditions:

1. Under unforeseen or abnormal circumstances, if key personnel are temporarily unable to take up their posts, key inspection and test equipment cannot be put into use temporarily;

2. Inspection and testing institutions lack specialized technology or equipment in some special fields.

Note: The following situations are not subcontracted:

(1) Provide services related to inspection and testing, such as calibration of inspection and testing equipment;

(2) Inspection and testing institutions temporarily employ personnel with relevant professional skills in inspection and testing, and have signed a formal contract, which has been incorporated into the quality management system of inspection and testing institutions;

(3) Temporary borrowing of inspection and testing equipment other than inspection and testing institutions.

(2) When subcontracting, the inspection and test institution shall:

1. Inform the customer of the subcontracting arrangement in writing before inspection, and obtain the consent of the customer;

2. Assess and confirm that subcontractors have the qualifications and abilities required to undertake subcontracted projects;

3. Be responsible for the work of its subcontractors to customers, except the subcontractors designated by customers;

4. Supervise the work quality of subcontractors;

5. Keep the list of subcontractors, evaluation records and supervision records of subcontractors, etc.

Article 26 Sampling and sample handling in inspection and testing shall meet the following requirements:

(a) the inspection and testing institutions shall have sampling plans or sampling requirements when sampling the inspection objects or parts. In the process of sampling, we should pay attention to the factors that need to be controlled to ensure the validity and representativeness of the test results and the reliability of the test conclusions.

Note: when the inspection and test objects are batch products, statistical methods should be adopted for sampling to ensure their representativeness; When the inspection object is a single product, and some parts of the product are sampled for inspection (local inspection), the sampled parts shall meet the requirements of regulations, standards and inspection purposes.

(2) When the customer deviates from the sampling plan or sampling requirements of the inspection and testing organization but does not violate the relevant laws, regulations and standards, it shall be recorded in detail in the corresponding sampling records, including the documents of inspection and testing results. The information of the person in charge shall be recorded.

(3) There shall be procedures for receiving, disposing, protecting, storing, retaining and/or cleaning the inspection samples, so as to ensure that the samples will not be degraded, lost, damaged or destroyed in the process of receiving, disposing, storing, preparing and inspecting.

(4) Inspection and testing institutions shall have an identification system for inspection and testing samples. When appropriate, the inspection and test institutions shall adopt appropriate methods to identify the inspection and test objects in the whole process of inspection and test. When traceability is required, the inspection and test organization shall control and record the unique identification of inspection and test objects. The identification system shall be designed and used to ensure that the samples will not be confused in types or in records and other documents involved.

Twenty-seventh inspection and testing institutions must ensure the safety of inspection and testing work when carrying out inspection and testing work.

(1) The inspection and testing institution shall establish and maintain procedures to continuously identify the hazards endangering the occupational health and safety of personnel, evaluate their risks and implement necessary risk control.

Note: The requirements of this quality management system have considered the safety requirements of inspection and test, and can also be combined or integrated with other management system requirements of the organization (such as administrative management, environmental management, occupational safety management, financial management, etc.). ). When necessary, these management system requirements can also be independently formed in the organization, and the occupational safety management system can refer to the requirements of GB/T2800 1 Occupational Safety Management System-Specification.

(2) Inspection and testing institutions shall identify potential accidents or emergencies according to the results of hazard identification and risk assessment, and formulate and take corresponding control and safety emergency measures to prevent and reduce possible diseases and injuries. If feasible, these safety emergency measures should be reviewed and tested regularly.

(3) The inspection and testing institutions shall provide sufficient training to the management personnel and inspection and testing personnel to make them aware of and understand the following requirements:

1. Check the actual and potential occupational health and safety consequences in the activity;

2. Roles and responsibilities in implementing relevant occupational health and safety procedures and realizing occupational health and safety management requirements (including safety emergency measures);

3. Potential consequences of deviation from occupational health and safety procedures;

4. Check and detect all actual and potential hazards on the site, as well as the control and emergency measures taken.

(4) All safety records should be kept, such as hazard identification, risk assessment, risk control, safety training and emergency records.

Twenty-eighth inspection and testing institutions shall make records in the inspection and testing work.

(1) Inspection and testing institutions shall formulate and implement procedures for the identification, collection, retrieval, consultation, filing, preservation period and disposal of records, and establish and maintain quality records, technical records and safety records, so as to provide evidence for the conformity of inspection and testing of inspection and testing institutions and the effectiveness of the operation of quality management system.

Quality records shall include reports of internal audit and management review and records of corrective and preventive measures.

(two) all records should be clear and kept in a suitable environment, in order to avoid damage, confidentiality, and easy to retrieve.

(three) the inspection and testing institutions shall stipulate the retention period of records to ensure the safety protection and confidentiality of records.

(4) The technical records of each inspection shall meet the following requirements:

1. contains enough information and ensures that the inspection can be reproduced as close as possible to the original conditions. Records shall include the identification of sampling personnel, inspection and test personnel and result inspectors.

Note: In addition to the personnel identification, the contents of the original inspection records should generally include: the identification number of the original records corresponding to the inspection report; The unique number, technical parameters, status and environmental conditions of the inspected object; Check the unique identification and technical parameters of the testing equipment; Inspection items and contents; Description of the inspection site; Inspection basis, data, results and date, etc.

2. During inspection, observation results, data and calculations shall be recorded, which can be classified and identified according to specific tasks or projects.

3. When there are mistakes in the record, each mistake should be crossed out, and it can't be erased or the handwriting is blurred or disappeared, and the correct content should be filled in next to it. All changes recorded shall be signed and dated by the change person. The same measures should be taken for electronically stored records to avoid the loss or change of the original data.

Note: Technical records are data and information obtained from inspection and testing. Technical records may include: work instructions, agreements or contracts, work logs, inspection and test work flow cards, original inspection and test records, inspection and test reports/certificates, approvals, transmission and feedback, etc.

Article 29 The inspection and testing work completed by inspection and testing institutions shall be reflected in the inspection and testing report (certificate), which shall meet the following requirements:

(a) Including all inspection basis, results and conformity judgment (conclusion) made according to these results, including understanding and explanation of conformity judgment (conclusion) and required information when necessary. All this information should be expressed correctly, accurately and clearly. The formal inspection report (certificate) should have no traces of modification;

(2) When the inspection report (certificate) contains the inspection results provided by subcontractors, it shall be clearly indicated;

(3) The format of the report (certificate) should be suitable for each type of inspection and test, and misunderstandings and errors should be minimized. If required by laws and standards, the inspection report (certificate) shall be directly in the format required by laws and standards; If there are no requirements in laws, regulations and standards, the format of the report (certificate) shall meet the content requirements of this article (1);

(four) the inspection report (certificate) shall be signed by the person in charge of the inspection and testing institution (the top manager) or the authorized technical person in charge. Inspection and testing institutions and their inspection and testing personnel are responsible for the inspection and testing results and appraisal conclusions;

(five) the inspection report (certificate) and the special seal shall be kept by a special person, and the use management regulations shall be established;

(6) When the report (certificate) needs to be corrected after it is issued, the correction that does not affect the inspection conclusion can be delivered to the customer in written form through supplementary instructions. The customer shall be informed in writing of the amendment affecting the inspection conclusion, and the original report and certificate shall be withdrawn, cancelled, filed and recorded, and then the revised report shall be reissued. When the correction result of the inspection conclusion is "unqualified", it shall also inform the quality and technical supervision department responsible for equipment registration in time;

(7) Provisions shall be made on the preservation conditions, preservation time and borrowing of archive reports (certificates) and their original records, so as to prevent the certificates of these inspection results from being damaged, lost, altered and improperly disposed.

Thirtieth inspection and testing institutions shall stipulate the procedures for supervising the inspection and testing process and results to ensure the quality of inspection and testing work. Supervision can choose the following ways:

(a) Regularly supervise and evaluate the working ability and quality of inspection and testing personnel;

(two) regularly review the inspection and testing rules, inspection and testing programs, equipment operation procedures and other work guidance documents;

(three) regularly review the inspection report (certificate) that has been issued;

(four) to participate in the comparison or capability verification plan between inspection and testing institutions;

(five) repeated inspection and testing by the same or different methods;

(6) reinspect the inspection samples or retained samples.