Laboratory Service Standards

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I) Laboratory accreditation consulting and guidance services 1. CMA accreditation services (RB/T 214). 2. CNAS laboratory accreditation service (ISO 17025). 3. Medical laboratory accreditation (ISO15189). 4. Accreditation of testing laboratory (ISO17020). 5. CNAS Forensic Laboratory (CANS-CL08). 6. CMA Judicial Appraisal Laboratory (RB/T 214). 7. Proficiency testing provider laboratories (ISO 17043). 8. Standard material producer laboratory (CNAS-CL04). 9. Good Laboratory Practice (GLP) laboratory services. 10. Certification services for IATF16949, ISO13485, ISO9001, and ISO14001. II) Difficulties in the laboratory 1. Conduct annual laboratory inspections and mock evaluations to identify issues early and prevent risks ； 2. Unannounced inspections, supervision reviews, pre-review guidance, and identification of gaps for correction ； 2. Guidance on changes such as address changes, method changes, personnel changes, authorized signatory changes, and name changes ； 3. Assist the laboratory in conducting internal audits ； 4. Assist the laboratory in conducting management reviews ； 5. Assist the laboratory with method validation and method confirmation ； 6. Reproduction and revision of system documents. III) Laboratory relocation 1. Ensure that the instruments are in good condition before the relocation. 2. Disassemble and package the instruments on-site in the laboratory. 3. Transport the instrument to the location specified by the customer. 4. Assemble the instrument at the new location and calibrate it. 5. The laboratory conducts an acceptance inspection of the relocated instruments. 6. Issue a calibration certificate for the instruments after relocation (if required). 7. Submit an application for relocation and change regarding CMA and CNAS qualifications (if required). IV) Laboratory Information Management System (LIMS System) The main functions implemented by a LIMS system include: remote sample submission, sampling, contract review, sample receipt, task entry, label printing, task assignment, test scheduling, data upload, message alerts, assignment of user permissions, instrument management, method management, sample management, customer management, file management, standard material management, consumable management, data management, knowledge base, statistical functions, search functions, financial reports, fee management, customer inquiries, equipment reservation, access via mobile devices, automatic generation of original records, quality control, acquisition of instrument data, automatic report generation, report review, electronic signing, and automatic distribution of reports. LIMS can be customized according to the characteristics of the laboratory, supports further development, and is compatible with existing laboratory systems. V) Optimization of laboratory methods and method validation: Development and application of proprietary methods specific to the laboratory (non-standard methods) ； 1. Design a methodological plan based on the laboratory’s conditions and requirements ； 2. Document the developed non-standard methods ； 3. Confirm and verify the development method ； 4. Preparation Method Confirmation and Verification Report ； 5. Apply for CMA or CNAS accreditation for the developed methods (non-standard methods), if required ； VI) Laboratory design, renovation, and construction 1. Laboratory planning and design ； Overall laboratory planning, laboratory design drawings, laboratory instrument configuration, laboratory consumable configuration, laboratory staff allocation ； 2. Laboratory purification: cleanrooms, aseptic rooms, dust-free rooms, operating rooms, fresh air systems ； 3. Laboratory renovation: laboratory partitions, laboratory ceilings, laboratory walls and floors, laboratory plumbing and electricity ； 4. Laboratory furniture: test benches, fume hoods, medicine cabinets, sinks, fire-resistant doors and windows ； 5. Laboratory piping: gas pipes, ventilation ducts, water pipes ； 6. Laboratory waste: devices for treating waste gas and wastewater. VII) Laboratory Training 1. Laboratory system training: ISO17025:2017 (CNAS) training; RB/T 214:2017 (CMA) training; forensic appraisal (CNAS-CL08); medical laboratories (ISO15189); training for research laboratories ； 2. Laboratory support system training: Training on laboratory information management systems (LIMS), 5S management in laboratories, occupational health and safety in laboratories, and laboratory design and construction ； 3. Specialized laboratory training: internal auditor training, management review training, training on measurement uncertainty, quality control training, identification and control of risks and opportunities, laboratory data processing training, compliance assessment training, method validation and verification training, periodic calibration training, experimental data analysis training, training on detection limits and quantitation limits, accuracy and precision training, internal calibration training, sampling and mixing training, training on the interpretation of test results and the preparation of reports, training for top management, technical supervisors, and quality managers, training on metrology and metrological verification, training on laboratory water usage, training on laboratory instrument management, training on the management of laboratory reagents, chemicals, and consumables, and training for the systematic improvement of laboratory technical capabilities ； 4. Testing Technology Training: Training on sample preparation techniques for analysis and testing, training on drug consistency assessment, training on environmental monitoring sampling, training on water quality testing, training on soil and solid waste testing, training on ambient air monitoring, training on food regulations and food safety, training on microbial testing, training on building inspection, training on PCR analysis and testing, training on material properties and analysis, training on mineral testing, training on substance structure and XRD, training on petroleum product testing and fluid monitoring, training on electronics, electrical engineering, and EMC, training on disease control testing and analysis, training on analysis and testing techniques for jewelry, precious stones, and metals, training on toy and textile testing, training on cosmetic analysis and testing, metallographic analysis.

5. Laboratory Instrument Training: Gas chromatography (GC), liquid chromatography (HPLC), gas chromatography-mass spectrometry (GC-MS), liquid chromatography-mass spectrometry (LC-MS), ion chromatography (IC), atomic absorption spectroscopy (AAS), inductively coupled plasma spectroscopy (ICP), inductively coupled plasma spectroscopy-mass spectrometry (ICP-MS), infrared spectroscopy (IR), ultraviolet-visible spectrophotometer (UV), X-ray fluorescence spectroscopy (XRF), X-ray diffraction instrument (XRD), three-coordinate measuring machines, nuclear magnetic resonance analysis, electron microscope analysis ； 6. Training in specialized fields: environmental protection, microbiology, chemistry, electrical engineering, metal materials, construction projects, building material testing, calibration, medical devices, automobiles and motorcycles, non-destructive testing, electromagnetic compatibility, toys, textiles, health quarantine, animal quarantine, plant quarantine, jewelry and precious stones, precious metals, sensory evaluation, software testing, information security, photovoltaic products, laboratory animals, gene amplification. VIII) Reagents, consumables, and reference materials 1. Reference materials: Custom-made reference materials, reference materials for non-ferrous metals, reference materials for steel, reference materials for geology and minerals, reference materials for energy, reference materials for engineering technology and polymers, reference materials for gases, reference materials for inorganic solutions, reference materials for organic solutions, reference materials for instrument calibration, high-purity substances and solutions for volumetric analysis, reference materials for physical and physicochemical properties, reference materials for agriculture and the environment, reference materials for air testing, reference materials for the environment and agriculture, reference materials for pesticides and veterinary drugs, reference materials for food, reference materials for proteins, reference materials for nucleic acid testing, reference materials for clinical and health applications, reference materials for hormones and stimulants, reference materials for building materials, reference materials for nuclear materials and radioactivity, other reference materials ； 2. Laboratory consumables: chromatography columns (gas chromatography columns, liquid chromatography columns, chiral columns), chromatography-related accessories (gas chromatography accessories, liquid chromatography accessories), specialty accessories for instruments, spectroscopy accessories, electron microscope consumables, mass spectrometry accessories, general-purpose accessories (sensors, valves, motor power supplies), glassware, bottles, quartz products, containers, measuring devices, biochemical consumables, plastic products, ceramic products. 3. Personal protective equipment in the laboratory: laboratory gloves, protective masks, gas masks, goggles, spray systems, radiation dosimeters, and hazardous gas concentration alarms. 4. Laboratory reagents: reagents for analytical instruments, organic agents, ELISA kits, proteins/peptides, microbial molecules, culture media, standardizing agents, indicators, color developers, pure elements, rare earths, rare and precious metals and their alloys, as well as standards for petroleum, petrochemicals, and oil monitoring. IX) Instrument calibration and testing subcontracting 1. Issuance of recognized calibration or verification certificates: length measurement, precision mechanical measurement, thermal measurement, mechanical and acoustic measurement, electromagnetic measurement, information and electronic measurement, optical and laser measurement, ionizing radiation measurement, time and frequency measurement, chemical measurement and analysis, measurement of nanomaterials, measurement related to new energy and the environment, medical and biological measurement, and engineering measurement. 2. Issue compliant subcontracting inspection reports: for research-related inspections, food testing, petrochemical product testing, ecological environment testing, microbiological testing, chemical testing, electrical testing, metal material testing, construction project testing, building material testing, medical device testing, non-destructive testing, electromagnetic compatibility testing, toy testing, textile testing, health and quarantine testing, as well as testing of jewelry, precious stones, and precious metals; and gene testing. X) Customized laboratory services (23 items): 1. Revision and updating of CMA and CNAS system documents: The laboratory carries out the revision and updating of these documents to meet the requirements set by CNAS and CMA. 2. Expansion review and surveillance review: The laboratory conducts CNAS and CMA expansion reviews as well as surveillance reviews to ensure its successful passage of these evaluations. 3. Laboratory change applications: Submit CNSA and CMA applications for changes in laboratory personnel, standards, authorized signatories, legal entities, equipment, address, or name, to ensure the successful completion of such changes. 4. Internal audit: The laboratory plans and completes all internal audit tasks, and prepares an internal audit report. 5. Management review: The laboratory plans and carries out the management review, and prepares a management review report. 6. Mock review: The mock review helps the laboratory get familiar with on-site evaluations in advance, understand the precautions required during such evaluations, and identify any gaps that need to be addressed. 7. Method validation and confirmation: Assist the laboratory in completing the entire process of method validation and confirmation, and prepare the corresponding reports. 8. Measurement uncertainty assessment: Helps laboratories conduct the uncertainty assessment for relevant methods and prepare the corresponding uncertainty assessment reports. 9. Quality control: Assist the laboratory in developing quality control plans, implementing quality control measures, analyzing quality control results, and preparing quality control reports. 10. Laboratory safety emergency drills: These are not merely fire drills; they involve comprehensive planning and implementation of emergency responses, along with the preparation of detailed drill reports. 11. Computer software verification: Evaluate and validate the software developed and used in the laboratory to ensure the accuracy, integrity, and reliability of the computer systems. Meet requirements such as GMP and issue verification reports. 12. 3Q verification of instruments and software: Conduct 3Q verification on the laboratory’s instruments and software, and issue verification reports. 13. Instrument periodic verification: Assists the laboratory in carrying out the instrument periodic verification process and preparing the verification report. 14. Periodic verification of reference materials: The laboratory carries out the periodic verification process for reference materials and prepares a report on this verification. 15. Calibration confirmation: The laboratory completes the verification of the calibration (verification) certificate and prepares a calibration confirmation report. 16. Comparison evaluation: The laboratory plans and carries out comparison tests (inter-laboratory comparisons, method comparisons, personnel comparisons, equipment comparisons, etc.), evaluates the comparison data, and prepares comparison reports. 17. Analysis of abnormal data results: Analyze the causes of abnormal data, identify the reasons for such abnormalities, eliminate issues in laboratory tests, and prepare accurate experimental reports. 18. 5S Management: The laboratory implements 5S management to improve the level of site management. 19. Capability verification and measurement audits: The laboratory plans capability verifications (measurement audits) to ensure satisfactory results; any failures in such verifications are addressed through corrective actions, and a report on those corrections is prepared. 20. Rectification of non-conformities: The laboratory completes the rectification of the non-conformities identified on site, prepares a rectification report, and ensures that the rectifications are successful. 21. Quality supervision: The laboratory develops a quality supervision plan, carries out the supervision, and prepares a supervision report. 22. Assessment of authorized signatories: Provide training and guidance to authorized signatories to ensure they pass the assessment. 23. Seal production: The laboratory must provide a certification of accreditation; once this is verified, the accredited laboratory will be authorized to engrave CNAS and CMA seals.