Other health testing institutions and laboratories that voluntarily apply for metrological certification shall apply for metrological certification with reference to this procedure;
Testing institutions and laboratories affiliated to the General Logistics Department of the Ministry of Health may apply for metrological certification with reference to this procedure. Article 4 Application: A testing institution with independent legal person qualification or its subordinate units (hereinafter referred to as the applicant) shall apply for metrological certification to the metrological department of the Institute of Industrial Hygiene of the Ministry of Health, and submit the application for metrological certification (Annex 1), the Metrological Testing Capability Table of Product Quality Inspection Institutions (Annex 2) and other related materials. The person who has completed the examination and filled in the application correctly can accept the application, and the measurement department will send a notice of acceptance to the applicant within 1 month. Article 5 Plan: The metrological department shall, according to the situation of each applicant, make an annual plan for health metrological certification twice a year (in the middle and at the end of the year), and the evaluation team shall put forward a corresponding list of suggestions. After being audited by the Health Standards Management Office and approved by the Department of Science, Technology and Education of the Ministry of Health, it shall be reported to the State Bureau of Technical Supervision for inclusion in the national metrological certification plan. Article 6 Preparations: After receiving the notification of accepting the application, the applicant must complete the following preparations in time:
1. Formulate the quality management manual of the unit;
2. Formulate inspection methods for measuring instruments and test equipment;
3. Write the implementation rules of the test;
4. Verification of instruments and equipment All test instruments and equipment must be verified and labeled as required;
5. The inspector of the personnel appraisal certified unit must hold the inspector certificate; The verification personnel responsible for the verification of measuring instruments shall hold the verification certificate issued by the metrological administrative department or the health administrative department;
6. Adjustment of environmental conditions. Article 7 Preliminary investigation and pre-examination: After accepting the application, the metrological department shall reach an agreement with the applicant on the certification and evaluation plan. In the process of preparation, the applicant may request the metrological department to pre-examine its metrological certification, so as to judge its preparation situation and put forward rectification opinions. Article 8 Formal evaluation: The metrological department shall organize a number of permanent judges and invited judges to form an evaluation team in accordance with regulations to formally evaluate the applicants. Evaluation results are divided into qualified, unqualified and corrected within a time limit. If it is corrected within a specified time limit, it shall be corrected within the specified time limit and passed after confirmation, otherwise it will not be passed. The evaluation team shall write a written evaluation report on metrological certification and submit it to the metrological department. Article 9 Contents of metrological certification:
1. Technical indicators such as metrological verification and test equipment, whose accuracy and range must be suitable for the test items undertaken, and the equipment performance must be stable and reliable, and qualified after verification or calibration;
2. The working environment of metrological verification and test equipment, including temperature, humidity, dustproof, shockproof, anti-corrosion and anti-interference, should meet the needs of test work and the quality inspection requirements of the tested products;
3. Personnel who use metrological verification and testing equipment should have professional knowledge and practical experience suitable for the testing items undertaken, and their operating skills must pass the examination;
4. Testing institutions shall formulate measures to ensure the uniformity and accuracy of numerical values and reliable testing data notarization management system.
The specific contents of measurement certification examination shall be implemented according to Annex 3.
The assessment team can temporarily adjust a small amount of assessment contents according to the nature of the work of the testing organization, but it does not affect whether the assessment is passed.
The review team shall also select standard substances or standard samples, and ask the testing organization to carry out actual measurement; If there is no suitable standard substance or standard sample, the test items should be selected for actual measurement.