As a laboratory technician, where do the testing methods come from, are they compliant, and do they need to be confirmed and verified?

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Selection of testing methods 1. To reduce testing risks, laboratories should prioritize the following officially issued standards as a basis for testing: a) International standards； b) **Standard ； c) Industry standards or **published technical specifications ； d) Local standards ； e) Enterprise designation ； f) Methods published by renowned technical organizations or scientific books and journals ； g) Methods specified by the equipment manufacturer ； h) Custom-developed non-standard methods. Among them, **national standards, industry standards, and local standards** are given priority ； When in a transition period between old and new standards and both can be used, the newer standard should be given priority. 2. To ensure that the standards used are current and valid, the document handler is responsible for searching for and collecting the latest standards and other technical specifications. In accordance with the \"Document Control Procedure,\" they ensure that the standards used by the inspectors are the most up-to-date versions. A \"Standard Verification Form\" is filled out, and it is reviewed by the technical supervisor. 3. When using external corporate standards for testing, care should be taken to prevent any potential intellectual property infringement issues. 4. When there are difficulties in understanding or applying the standards used, the technical supervisor should organize the relevant testing personnel to prepare testing procedure guides to ensure consistency in the implementation of those standards. The test work instruction shall be formulated as a formal written document, go through the written approval procedures by the preparer, reviewer, and approver to maintain its validity, in accordance with the \"Document Control and Maintenance Procedure\". When adjustments or modifications are needed to the inspection work instructions, they should also be carried out in accordance with the \"Document Control and Maintenance Procedure.\" The contents of the work instruction should include: a. The name of the testing method ； b. Scope of application of the testing method ； c. Instrumentation and equipment used for testing, including requirements for technical performance parameters ； d. Required reference materials ； e. Management requirements for the samples under inspection ； f. The parameter or quantity being measured and its range ； g. Facility and environmental conditions required for testing ； h. Description of the testing steps ； i. Safety facilities that must be complied with ； j. Criteria and requirements for testing ； k. Methods for analyzing and presenting the data to be recorded ； l. Requirements for the assessment of uncertainty in test results, if necessary. 5. When the client does not specify a testing method for the commissioned test, the head of the testing team shall first recommend to the client testing methods that fall within the scope of the laboratory’s certification and competence. If those methods cannot meet the client’s requirements, then the testing methods recommended in clause 1 of these procedures shall be used; such recommended methods must obtain the client’s written consent and approval. When the method specified by the customer is inappropriate or has expired, the inspection supervisor should inform the customer clearly. 6. When the testing standards and requirements specified by the client fall within the scope of the laboratory’s capabilities for certification and accreditation, then accepting the client’s request for testing does not require a contractual review of the laboratory’s capabilities against those requirements; however, it is necessary to explicitly include the client’s requirements in the contract in accordance with the \"Procedures for Reviewing Requirements, Proposals, and Contracts\". Development of non-standard methods: For tests required by specific clients, non-standard methods developed independently can be used. Such methods must be validated in accordance with Article 3 of these procedures, and once validated and confirmed, they must be communicated to the client; use of these methods is permitted only after obtaining the client’s approval. In principle, the laboratory does not use non-standard methods; only standard methods are employed. Confirmation of testing methods: 1. For tests carried out in accordance with new versions of standards, regulations, and other technical specifications, the technical supervisor shall, when approving the testing plan, compare the technical requirements, inspection conditions, and procedures of the old and new specifications in order to confirm the capability to conduct such tests. 2. The technical supervisor is responsible for organizing the validation of standard methods that are used beyond their intended scope, as well as of modified and extended versions of such standard methods; they can only be put into use after sufficient and reliable conclusions that meet the requirements have been obtained. 3. The confirmation should include a detailed description of the relevant requirements (the method being confirmed must meet specific requirements for certain intended uses, including meeting the customer’s requirements) ； Determine the characteristics of the testing method ； Verify whether this method can meet the relevant requirements ； Verify statements of validity, etc. 4. The validation of the method should be thorough and comprehensive to meet the requirements of the intended purpose or application area. The method validation personnel shall record the results obtained from the validation, the procedures used for validation, a statement indicating whether the method is suitable for its intended purpose, and where necessary, the validation activities should cover areas such as the preparation of the items and their transportation and storage. 5. The validation of the method shall use one of the following five methods, or a combination of several of them: a) Calibration using reference standards or certified reference materials ； b) Compare with the results obtained from other methods ； c) Comparison with other testing laboratories ； d) Conduct a systematic review of the factors affecting the results ； e) A scientific understanding of the theoretical principles and practical experience behind the method, as well as an assessment of the uncertainty of the obtained results. 6. The validation of the method shall be conducted in accordance with the customer’s requirements and for the intended purpose; the range and accuracy of the measurement values obtained during the validation process shall be compared with the customer’s expected requirements. These measured values should include the following: a. Uncertainty of the measurement result: b. Detection limit ； c. Selectivity of the method ； d. Linear ； e. Repeatability limit ； f. Reproducibility limit ； g. Robustness against external influences ； h. Inter-sensitivity to matrix interference from the sample upon arrival in Hangzhou. Changes and deviations from the standard testing methods: Deviations from the testing methods are permitted only when they have been documented, approved through technical evaluation, authorized, and accepted by the customer; the specific implementation is carried out in accordance with the \"Control Procedure for Permitted Method Deviations\". Collection and storage of testing standards: https://mmbiz.qpic.cn/mmbiz_png/oMlX8Lll9JjwJic5YmoYAaYibLU7jDvXXAf3SwFvW5r9juLNVUd3cXmPJzyuu5KAd0tswt7soMN8hWHju0J5jgibg/640?wx_lazy=1&wx_co=1&wx_fmt=png&wxfrom=5&tp=wxpic1. The head of the testing team is responsible for organizing relevant personnel to collect the testing standards; once collected, these standards are approved by the technical supervisor before being recorded, numbered, and archived for use. 2. The data clerk verifies the standards on a quarterly basis to ensure the validity of the testing. 3. When the new standard introduces significant changes to the allocation of testing resources and technical requirements compared to the old standard, the technical supervisor shall conduct training on the new standard and assess the laboratory’s ability to implement it. Process for confirming testing methods: 1. The head of the testing team formulates a testing plan based on the testing requirements specified by the client, fills out the \"Testing Plan\", and responds to the client. When the testing conditions requested by the customer meet the standard requirements, it is not necessary to provide a specific testing plan; instead, the sales representative can directly respond to the customer as to whether the testing can be carried out ； When the testing conditions requested by the client involve non-standard methods, it is necessary for the head of the testing team to organize senior technical experts in relevant fields to conduct a review and confirmation, and fill out the \"Non-Standard Method Confirmation Review Form\". 2. After clarifying their testing requirements, the clients fill out a specific \"Testing Assignment Form.\" The head of the testing team then hands over both the \"Testing Assignment Form\" and the \"Testing Plan\" to the designated engineer to carry out the testing work. (Simpler, routine testing items do not require a specific testing plan to be provided.)