4. 1 mechanism

4. 1. 1 Inspection and testing institutions shall be legal persons or other organizations established according to law and able to bear corresponding legal responsibilities. Inspection and testing institutions or their organizations should have a clear legal status, be responsible for the inspection and testing data and results issued by them, and bear corresponding legal responsibilities. Inspection and testing institutions that do not have independent legal personality shall be authorized by their legal entities.

4. 1.2 inspection and testing institutions should clarify the relationship between their organizational structure and management, technical operation and support services. Inspection and testing institutions shall be equipped with personnel, facilities, equipment, systems and support services required for inspection and testing activities.

4. 1.3 inspection and testing institutions and their personnel shall abide by the provisions of relevant national laws and regulations, follow the principles of objectivity, independence, fairness, impartiality, honesty and credibility, observe professional ethics and assume social responsibilities.

4. 1.4 inspection and testing institutions shall establish and maintain procedures to maintain their impartiality and integrity. Inspection and testing institutions and their personnel should be free from unfair commercial and financial pressures and influences from inside and outside, and ensure that inspection and testing data and results are true, objective, accurate and traceable. Inspection and testing institutions should establish a long-term mechanism to identify fairness risks. If the fairness risk is identified, the inspection and testing institution should be able to prove that the risk has been eliminated or reduced. If the organization where the inspection and testing institution is located is engaged in activities other than inspection and testing, it should identify and take measures to avoid potential conflicts of interest. Inspection and testing institutions shall not use persons who have worked in more than two inspection and testing institutions at the same time.

4. 1.5 inspection and testing institutions shall establish and maintain procedures to protect customers' secrets and ownership, and the procedures shall include the requirements for electronic storage and transmission of protection results information. Inspection and testing institutions and their personnel have the obligation to keep confidential the state secrets, commercial secrets and technical secrets they know in inspection and testing activities, and formulate and implement corresponding security measures.

4.2 personnel

4.2. 1 Inspection and testing institutions shall establish and maintain personnel management procedures to standardize the management of personnel qualification confirmation, appointment, authorization and ability maintenance. Inspection and testing institutions should establish labor, employment or employment relationship with their personnel, and clarify the post responsibilities, post requirements and working relationship of technical personnel and management personnel, so that they can meet the post requirements and have the necessary power and resources to perform the duties of establishing, implementing, maintaining and continuously improving the management system. All personnel in the inspection and test institutions who may affect the inspection and test activities. Both internal and external personnel should act fairly, accept supervision, be competent and perform their duties according to the requirements of the management system.

4.2.2 The inspection and testing institution shall determine the overall responsible manager, who shall fulfill his leading role and commitment to the management system:

A. commitment to fairness; B. Be responsible for the establishment and effective operation of the management system; C. ensure the resources needed for the management system; Ensure that the quality policy and quality objectives are formulated; E. Ensure that the management system requirements are integrated into the whole process of inspection and test; F. Organize the management review of the management system; G. ensure that the management system achieves its expected results; H. Meet the requirements of relevant laws and regulations and customer requirements; First, improve customer satisfaction; Establish management system by process method and analyze risks and opportunities.

4.2.3 The technical director of the inspection and testing institution shall have the relevant professional technical title of intermediate level or above or equivalent ability, and be fully responsible for technical operation; The person in charge of quality shall ensure that the quality management system is implemented and maintained: appoint agents for key management personnel.

4.2.4 The authorized signatory of the inspection and testing institution shall have a professional title above the intermediate level or equivalent ability, and be recognized by the qualification certification department; An unauthorized signatory shall not issue an inspection report or certificate.

4.2.5 Inspection and test institutions shall confirm the ability of personnel operating equipment through sampling, inspection and test, issue inspection and test reports or certificates, and put forward opinions and explanations according to corresponding education, training, skills and experience. Inspection and test personnel, including interns, should be supervised by personnel familiar with the purpose, procedures, methods and results evaluation of inspection and test.

4.2.6 Inspection and testing institutions shall establish and maintain personnel training procedures, determine personnel education and training objectives, determine training needs and implement personnel training, and evaluate the effectiveness of these training activities. The training plan should adapt to the current and expected tasks of inspection and testing institutions.

4.2.7 Inspection and testing institutions shall keep records of personnel's relevant qualifications, competence confirmation, authorization, education, training and supervision, including the determination of competence requirements, personnel selection, personnel training, personnel supervision, personnel authorization and personnel competence monitoring.

4.3 Location

4.3. 1 Inspection and testing institutions shall have fixed, temporary, movable or multiple places, which shall meet the requirements of relevant laws, regulations, standards or technical specifications. The inspection and testing institution shall record the requirements of the site and environment required for inspection and testing activities.

4.3.2 Inspection and test institutions shall ensure that their working environment meets the requirements of inspection and test. When an inspection and testing institution conducts inspection or sampling outside a fixed place, it shall put forward corresponding control requirements to ensure that the environmental conditions meet the requirements of inspection and testing standards or technical specifications.

4.3.3 When inspection and test standards or technical specifications require environmental conditions or environmental conditions affect inspection and test results, environmental conditions shall be monitored, controlled and recorded. When environmental conditions are not conducive to the development of inspection and testing, inspection and testing activities should be stopped.

4.3.4 Inspection and testing institutions shall establish and maintain housekeeping procedures for inspection and testing sites, which shall consider safety and environmental factors. Inspection and testing institutions shall effectively isolate the adjacent areas of incompatible activities, take measures to prevent interference or cross-contamination, control the use and access of parent domains that affect the quality of inspection and testing, and determine the control scope according to specific conditions.

4.4 Equipment and facilities

4.4. 1 Equipment and facilities

Inspection and testing institutions shall be equipped with equipment and facilities that meet the inspection and testing requirements (including sampling, sample preparation, data processing and analysis). The facilities used for inspection and testing should be conducive to the normal development of inspection and testing. Equipment includes equipment, software measurement standards, reference materials, reference data, reagents, consumables, auxiliary equipment or corresponding combined devices that are necessary for inspection and test activities and affect inspection results. When an inspection and testing institution uses equipment other than its own institution, it shall ensure that it meets the requirements of this specification.

When leasing instruments and equipment for inspection and testing, inspection and testing institutions shall ensure that:

A) The management of rented instruments and equipment shall be incorporated into the management system of this inspection and testing institution; B) The inspection and testing institution can use it at its own discretion. That is, the rented instruments and equipment are operated, maintained, verified or calibrated by the personnel of this inspection and testing institution, and the use environment and storage conditions are controlled; C) The lease contract clearly stipulates the right to use, one for common use and the other for standby; D) The same equipment is not allowed to be leased and appraised by different inspection and test institutions at the same time.

4.4.2 Maintenance of equipment and facilities

Inspection and testing institutions shall establish and maintain management procedures for inspection and testing equipment and facilities to ensure that the configuration, maintenance and use of equipment and facilities meet the requirements of inspection and testing.

4.4.3 Equipment management

Inspection and testing institutions shall verify or calibrate the equipment that affects the accuracy and effectiveness of inspection and testing results and sampling results or has requirements for measurement traceability, including auxiliary measuring equipment for measuring environmental conditions. Before the equipment is put into use, it should be inspected, verified or calibrated to confirm whether it meets the requirements of inspection and test. All equipment requiring verification, calibration or expiration date shall be labeled, coded or otherwise identified. In order to facilitate user's verification and calibration, inspection and test equipment, including hardware and software, should be protected to avoid the adjustment of inspection and test results when they leave the machine. The reference standards of inspection and training institutions should meet the traceability requirements. If it cannot be traced back to the national or international measurement standards, the inspection and testing institution shall keep the evidence of the relevance or accuracy of the inspection and testing results. When it is necessary to use mid-term verification to maintain the credibility of equipment verification or calibration status, relevant procedures should be established and maintained. For the calibration information generated by the calibration results or reference values contained in the reference materials, the inspection and testing institutions shall ensure that they are used in their test results and related records, and make backups and updates.

device control

Inspection and testing institutions shall keep records of equipment and its software that have an impact on inspection and testing. If possible, the equipment and its software used for inspection and testing that have an impact on the results shall be uniquely identified. Inspection and test equipment shall be operated by authorized personnel and maintained normally. If the equipment is not under the direct control of the inspection and testing organization, it should be ensured that after the equipment returns, its function, verification and calibration status should be checked before use, and satisfactory results should be obtained.

debugging

When the equipment fails or is abnormal, the inspection and testing organization should take corresponding measures, such as stopping using, isolating or marking the equipment until it is repaired and proved to be working normally through verification, calibration or verification. The influence of these defects or exceeding the specified limits on the previous inspection results should be checked.

reference material

The inspection and testing institutions shall establish and maintain the management table of standard substances. If possible, reference materials should come from Huyuan to S units or certified reference materials. Inspection and testing institutions shall conduct interim verification of standard materials according to procedures.

4.5 Management System

4.5. 1 General rules

Inspection and testing institutions shall establish, implement and maintain a management system suitable for their scope of activities, and document their policies, systems, plans, procedures and instructions. Management system documents shall be communicated to relevant personnel, who shall obtain, understand and execute them. The management system of inspection and testing institutions shall at least include: management system documents, control of management system documents, record control, measures to deal with risks and opportunities, improvement and corrective measures, internal audit and management review.

the policy goal

The inspection and testing institutions shall define the quality policy, set the quality objectives, and conduct the review during the management review.

file control

Inspection and testing institutions shall establish and maintain procedures for controlling internal and external documents of their management system, and clarify the approval, release, identification, modification and abolition of documents to prevent the use of invalid and invalid documents.

Contract review

Inspection and testing institutions shall establish and maintain procedures for reviewing customer requirements, tenders and contracts. Deviations and changes in requirements, tenders and contracts shall be approved and notified by customers. When the inspection and test reports or certificates required by customers contain statements that conform to standards or specifications (such as qualified or unqualified), the inspection and test institutions shall communicate with customers accordingly. If the standards or specifications do not contain decision rules, the inspection and testing institutions shall obtain these rules.

subcontract

When inspection and testing institutions need to subcontract inspection and testing items, they shall subcontract them to inspection and testing institutions that have obtained qualification recognition according to law and have the ability to complete the subcontracted items. Specific subcontracted inspection and test items shall be approved by the entrusting party in advance, and subcontracted items shall be distinguished when issuing inspection and test reports or certificates. Before subcontracting, inspection and testing institutions shall establish and maintain subcontracting procedures, which shall be implemented in the process of inspection and testing business negotiation, contract review and contract signing. Inspection and testing institutions shall not subcontract projects prohibited by laws, regulations, technical standards and other documents.

4.5.6 Procurement

Inspection and testing institutions shall establish and maintain procedures for selecting and purchasing services and supplies that have an impact on the quality of inspection and testing. Define the procurement, acceptance and storage requirements of services, supplies, reagents and consumable materials, and keep supplier evaluation records.

Service client

Inspection and testing institutions shall establish and maintain procedures for serving customers, including maintaining communication with customers, conducting satisfaction surveys on customers, tracking customers' needs, and allowing customers or their representatives to reasonably enter relevant areas for inspection and testing.

complain

Inspection and testing institutions shall establish and maintain procedures for handling complaints. Clarify the responsibilities of receiving, confirming, investigating and handling complaints, track and record complaints, ensure that appropriate measures are taken, and pay attention to the avoidance of personnel.

4.5.9 Non-compliance with work control

Inspection and testing institutions shall establish and maintain procedures for handling nonconforming products. When the activities or results of the inspection and test institutions do not conform to their own procedures or the requirements reached with customers, the inspection and test institutions shall implement the procedures. This procedure should ensure that:

A. define the responsibilities and powers for managing unqualified work; B. Take measures according to the risk level; C. Assess the seriousness of unqualified work, including the impact analysis on past results; D. make a decision on the acceptability of unqualified work; E. When necessary, notify the customer and cancel the work; f？ Provisions for approving the resumption of work responsibilities: record the described unqualified work and measures.

4.5. 10 corrective measures, measures to deal with risks and opportunities and improvement measures

Inspection and testing institutions shall establish and maintain procedures so as to take corrective measures when nonconformities are found. Inspection and testing institutions should continuously improve the suitability, adequacy and effectiveness of the management system by implementing quality policies and objectives, applying audit results, data analysis, corrective measures, management review, personnel suggestions, risk assessment, capability verification and customer feedback. The risks and opportunities related to inspection and test activities should be considered in the inspection and test machines to ensure that the management system can achieve its expected results; Seize the opportunity to achieve the goal; Prevent or reduce the adverse effects and potential failures in inspection and test activities; Realize the perfection of management system. Inspection and testing institutions should plan: measures to deal with these risks and opportunities; How to integrate and implement these measures in the management system; How to evaluate the effectiveness of this measure?

4.5. 1 1 record control

Inspection and test institutions shall establish and maintain records management procedures to ensure that the technical records of each inspection and test activity are full of information, and to ensure that the identification, storage, protection, retrieval, retention and disposal of records meet the requirements.

inside audit

Inspection and testing institutions shall establish and maintain procedures for internal audit of the management system to verify whether its operation meets the requirements of the management system and this specification and whether the management system is effectively implemented and maintained. Internal audit is usually conducted once a year. The quality director plans the internal audit and makes the audit plan. Internal auditors must be trained and qualified. If resources permit, internal auditors should be independent of the audited activities. Inspection and testing institutions shall

A) Plan, formulate, implement and maintain the audit plan according to the importance of relevant processes, changes that have an impact on inspection and test institutions and previous audit results. The audit plan includes frequency, methods, responsibilities, plan requirements and reports; B) Specify the audit criteria and scope of each audit; C) Select auditors and conduct audits; D) Ensure that the audit results are reported to relevant managers; E) Take appropriate corrective and corrective measures in time; F) Save the documented information as evidence for implementing the audit plan and making audit results.

Management review

Inspection and testing institutions shall establish and maintain management review procedures. Management review is usually conducted once every 65,438+02 months, and the management is responsible for it. Managers should ensure that the corresponding changes or improvement measures obtained after management review are implemented to ensure the suitability, adequacy and effectiveness of the management system. Records of management review shall be kept. The management review input shall include the following information:

A) Changes in internal and external factors related to inspection and test institutions; B) Feasibility of objectives; C) Applicability of policies and procedures; D) Information on measures taken in previous management reviews; E) The results of recent internal audit; F) Corrective measures; G) review by external institutions; H) Changes in workload and type of work, or changes in the scope of activities of inspection and test institutions; I) Feedback from customers and employees; Complaints; K) Effectiveness of implementation improvement; I) Rationality of resources; M) Controllability of risk identification; N) Supportability of the result quality; O) Other relevant factors, such as supervision activities and training.

The output of management review shall include the following contents:

A) the effectiveness of the management system and its process; B) Improvement to meet the requirements of this standard; C) Providing the required resources; D) requirements for changes.

4.5. 14 Selection, verification and confirmation of inspection methods

Inspection and test institutions shall establish and maintain control procedures for inspection and test methods. Inspection methods include standard methods and non-standard methods (including self-made methods). Priority should be given to the use of standard methods, and effective versions of standards should be ensured. Before using the standard method, it should be verified. Before using non-standard methods (including self-made methods), it should be confirmed, and inspection and testing institutions should track the changes of methods and re-verify or confirm them. When necessary, inspection and testing institutions shall formulate work instructions. If it is really necessary to deviate from this method, it should be documented, technically judged and approved, and agreed by the customer. When the methods suggested by customers are inappropriate or out of date, customers should be informed, and the use of non-standard methods (including self-made methods) should be approved by customers in advance, and the possible risks of related methods should be informed. When necessary, inspection and testing institutions shall establish and maintain control procedures for developing self-made methods, and the self-made methods shall be confirmed. The inspection and test institution shall record the information as confirmation evidence, the confirmation procedures used, the specified requirements, the determination of method performance, the obtained results and the statement describing the effectiveness of the method to achieve the expected purpose.

Measurement uncertainty

Inspection and testing institutions shall establish and maintain evaluation procedures for measurement uncertainty as required. When the inspection and test items require measurement uncertainty, the inspection and test institutions shall establish and maintain procedures for applying measurement uncertainty. Inspection and testing institutions should establish corresponding mathematical models, and give corresponding evaluation of testing ability and cases of measurement uncertainty. When there are critical values, internal quality control or customer requirements, inspection and testing institutions may need to report measurement uncertainty.

4.5. 16 data information management

Inspection and testing institutions should obtain the data and information needed for inspection and testing activities, and effectively manage their information management systems. Inspection and testing institutions should systematically and properly check the calculation and data transmission. When using computers or automated equipment to collect, process, record, report, store or retrieve inspection and test data, inspection and test institutions shall:

A. Document the self-developed computer software, confirm its applicability before use, and reconfirm it regularly after confirmation, change or upgrade, and keep confirmation records; b？ Establish and maintain protection procedures to protect the integrity, authenticity and confidentiality of data; Maintain computers and automation equipment regularly to ensure their normal operation.

sample

When the inspection and testing institutions need to carry out subsequent inspection and testing on the samples of substances, materials and products, they shall establish and maintain sampling control procedures. The sampling plan shall be formulated according to the appropriate statistical methods, and the sampling shall ensure the validity of the inspection results. When the customer deviates from the sampling procedure, it should be recorded in detail and notified to the relevant personnel. If the deviation of customer requirements affects the inspection results, it should be explained in the report and certificate.

4.5. 18 sample treatment

Inspection and testing institutions shall establish and maintain sample management procedures to protect the integrity of samples and maintain the status of customers. Inspection and testing institutions should have a sample identification system and keep the identification during the whole inspection and testing period. When receiving samples, the normal condition of the samples or the deviation from the inspection and test methods shall be recorded. During transportation, receiving, disposal, protection, storage, retention, cleaning or return, samples shall be controlled and recorded. When samples need to be stored or maintained, environmental conditions should be maintained, monitored and recorded.

Validity of results

Inspection and testing institutions shall establish and ensure the effectiveness of the monitored results. Inspection and testing institutions can regularly use standard materials, regularly use certified or calibrated alternative instruments with traceability, check the functions of equipment, use working standards and control charts, conduct repeated inspection and testing with the same or different methods, save samples for reinspection, analyze the correlation of different results of samples, audit report data, participate in capacity verification or inter-agency comparison, intra-agency comparison, and blind sample inspection and testing. All data of inspection institutions shall be recorded in such a way as to facilitate the discovery of trends. If deviation from the pre-criteria is found, effective measures should be taken to solve the problem to prevent wrong results. Quality control should have appropriate methods and plans and be evaluated.

4.5.20 Results Report

Inspection and testing institutions shall issue inspection and testing results accurately, clearly, clearly and objectively, in line with the provisions of inspection and testing methods, and ensure the effectiveness of inspection and testing results. The results should usually be issued in the form of inspection report or certificate. The inspection report or certificate shall at least include the following information:

A) title; B) Indicate the qualification identification mark and affix the special seal for inspection and test (if applicable); C) The name and address of the inspection and test institution and the place of inspection and test (if different from the address of the inspection and test institution); D) The unique identification (such as serial number) of the inspection report or certificate and the identification on each page to ensure that the page can be recognized as a part of the inspection report or certificate, and a clear identification indicating the end of the inspection report or certificate; E) Name and contact information of the customer; F) Identification of inspection methods used; G) Description, status and identification of inspection samples; H) Date of inspection and test. If it has a significant impact on the validity and application of inspection and test results, the date of receipt of samples or sampling shall be indicated; I) When the validity or application of inspection and test results is affected, provide a description of sampling plans and procedures used by inspection and test institutions or other institutions; J) The name, signature or equivalent identification of the issuer of the inspection report or certificate and the date of issuance; K) Measurement unit of inspection result (if applicable); L) If the inspection and test organization is not responsible for sampling (if the sample is provided by the customer), it shall be stated in the report or certificate that the result is only applicable to the sample provided by the dry customer; M) When the inspection result comes from an external provider, clearly mark it; N) The inspection and test institution shall declare that the report or certificate (except full-text copy) shall not be copied without the approval of the institution.

4.5.2 1 result description

When it is necessary to explain the inspection results, the inspection report or certificate shall also include the following contents:

A) The deviation of inspection and test methods is increased or deleted, and the information of specific inspection and test conditions, such as environmental conditions; B) When applicable, give a statement of compliance (or non-compliance) with the requirements or specifications; C) When the uncertainty is related to the validity or application of the test results, or when the customer requests it, or when the measurement uncertainty affects the standard limit, the inspection report or certificate also needs to include the uncertainty information; D) Put forward opinions and explanations when applicable and necessary; E) The specific inspection methods or additional information required by customers and the data provided by customers shall be clearly identified in the report or certificate. When the information provided by the customer may affect the validity of the inspection results, there should be a disclaimer in the inspection report.

Sampling result

Inspection and testing institutions engaged in sampling inspection and testing shall have complete and sufficient information to support their inspection and testing reports or certificates.

Opinions and explanations

When it is necessary to comment and explain the report or certificate, the inspection and testing institution shall record the basis of the comment and explanation. Comments and explanations should be clearly marked in the inspection report or certificate.

Subcontracting result

When inspection reports or certificates contain inspection results issued by subcontractors, these results shall be clearly marked.

Transmission and format

When the test results are transmitted by telephone, fax or other electronic or electromagnetic means, the requirements of this standard for data control shall be met. The format of inspection report or certificate shall be designed to be suitable for all types of inspection, and the possibility of misunderstanding or misuse shall be minimized.

modify

Any corrections or supplements shall be recorded after the inspection report or certificate is issued. The revised inspection report or certificate shall be marked with the replacement report or certificate and marked with a unique identification.

Recording and preservation

Inspection and testing institutions shall file the original records, reports or certificates of inspection and testing to ensure their traceability, and the retention period of the original records, reports or certificates of inspection and testing shall be no less than 6 years.