First, the laboratory recognizes the requirements for personnel positions

1. Top management By officially appointing documents and receiving laboratory-recognized knowledge training, the basic requirements of the laboratory management system can be clarified, and the main business scope and development direction of the laboratory can be mastered.

2. One person in charge of quality can be part-time by a certain manager of the laboratory. It must have certain management powers and be able to effectively implement the management system; it must have rapid acceptance and learning ability, and can quickly familiarize with the experiment under the guidance of the consultant. Basic requirements for laboratory accreditation; required laboratory testing experience, familiar with the testing capabilities of the laboratory and the technical requirements of most testing projects, can be combined with the consultant's requirements of the management system and the actual laboratory.

3. One person in charge of technology can work full-time or part-time. It is required to be familiar with the technical requirements of all testing fields of the laboratory, including testing personnel's ability training, instrument and equipment technical indicators, and various reagents or materials that need to be consumed during the testing process. Test method standards, test room facilities environmental conditions requirements, instrumentation equipment value traceability (metering verification), relevant technical standards for sample extraction, relevant technical requirements for sample acceptance and storage, and retention requirements.

4. The authorized signatory requires at least two fields in each field within the scope of the application for recognition. If the authorized signatory is familiar with the full scope of the application for certification, then a total of two authorized signers are required. The authorized signatory is part-time. Under normal circumstances, the technical person in charge must be the authorized signatory. The authorized signatory needs to be subject to the on-site assessment of the assessment team. It must be familiar with the technical standards in the signature field and must pass the assessment. Otherwise, it will not be able to issue a report in the future.

 5. Internal auditors All part-time jobs, in order to ensure the independence of internal audit work, generally require at least one of the departments. Requires familiarity with testing, quick thinking, integrity, and rigorous work style. Receive internal auditor training and pass the examination, and obtain the certificate of internal auditor.

 6. Supervisors Generally, the head of the testing room can work part-time. The number depends on the number of testing room departments. The supervisors generally account for 5% - 10% of the testing and/or calibration personnel, and at least one person. Supervisors must be familiar with the technical requirements of the department's testing workflow, testing methods and results data verification.

Management department

1) Director: You can work part-time or full-time, with general coordination ability, no special requirements;

2) File manager: One, requires familiarity with the management of archival materials, diligent, rigorous, and conscientious, with strong computer operation ability, familiar with the application of common office software;

3) Business Transceiver: A full-time one, responsible for the receipt of the inspection task, familiar with the basic requirements for the reception of all samples within the scope of the laboratory's testing capabilities, quick response, clear thinking, and fast acceptance. Must be assessed during the on-site review;

4) Sample manager: one, usually part-time, responsible for sample transfer process management, sample retention management, etc., without special ability requirements, as long as they can work seriously;

5) Computer administrator: one, responsible for the management, maintenance of the computer system, printing and copying of the test report. Familiar with the use and maintenance knowledge of common office software;

Purchaser: One, responsible for the procurement of various reagents, consumables, etc., requires the mastery of the technical requirements of common reagents and consumables, and strong sense of responsibility;

7) Equipment administrator: one, usually part-time, responsible for instrument and equipment file management, equipment maintenance and repair, measurement verification and other work management, requires mastering the use of common office software, basic technical indicators of various instruments and equipment, mastering the knowledge of measurement methods, Familiar with the basic situation of the national value transmission system;

8) Security Officer: One, usually part-time, responsible for laboratory safety work management, familiar with safety work management in water, electricity, fire, etc.;

9) Article member: One, usually part-time, responsible for inventory management of various articles and consumables, without special requirements.

  8, professional departments

The laboratory shall determine the number of professional testing rooms according to the scope of testing capabilities planned by the plan. The technical person in charge shall judge according to experience and there is no strict requirement, which can basically reflect the division of work. 1) Director: Familiar with the basic requirements of the testing project that the professional department is responsible for, and be able to lead the staff in the room to complete the testing task. 2) Testing personnel: Proficiency in the requirements of the testing items that are responsible for them, skilled operation, and obtaining the employment certificate after training. At least two inspectors for each test item, and part-time jobs between different test items.

Second, the laboratory recognizes the requirements of the environmental conditions of the facility

1. The environmental conditions of the facility must meet the requirements of the different testing/calibration items. The requirements for environmental conditions vary greatly. According to the provisions of 5.3.2 of the accreditation criteria, “the relevant specifications, methods and procedures are required, or the results are When quality is affected, the laboratory shall monitor, control and record environmental conditions.” For testing/calibration projects that are sensitive to environmental conditions, the laboratory must meet the relevant requirements and monitor, control and record. For example, in textile testing laboratories, physical indicators (such as strength, elongation, twist, fineness, determination of voltage half-life zone of antistatic material electrostatic capacity) must be in accordance with the standard conditions, and must be configured in the detection area. Automatic temperature recorder (or automatic temperature and humidity monitoring device), and keep a continuous monitoring record during the work. For testing projects that do not have special requirements for environmental conditions, the laboratory does not need to monitor, control and record. For example, in the gold jewelry testing laboratory, some instruments and methods have no special requirements on the environment. 2. Controlling the entry and use of the inspection/calibration area In order to obtain the correct detection/calibration results, the laboratory must implement effective control of the entry and use of the detection/calibration area.

Specific measures and methods are used:

1) Division of laboratory areas by function Different work requires different environmental requirements, so the implementation room area should be divided and marked. The laboratory can be divided into office area, inspection/calibration area, maintenance area, scientific research area and reception area according to functions. According to the test requirements, the detection/calibration area can be divided into a high temperature and humidity stable operation area, a high voltage operation area, an ultra clean operation area, and a sterile operation area.

2) Control of personnel entry Foreign personnel entering the laboratory should be approved. In order to avoid abnormal interference, the internal personnel of the laboratory should also be controlled to limit the entry of unauthorized personnel. To this end, some laboratories use an automatically identifiable access control system. Otherwise, in the room where personnel enter and leave the temperature and humidity fluctuations and affect the detection/calibration results, a warning sign of “Working, Do Not Disturb” should be established. For those who have hygiene requirements, personnel entering the laboratory should be disinfected or other purification measures taken.

3) Control of the experimental area or use For example, the calibration/test area shall not engage in work that is not related to the test/calibration, and shall not accept technical advice from outside personnel. In certain areas of the calibration laboratory (eg balances, gauges, weights), water is not allowed due to a relative humidity requirement of less than 60%; in the magnetic calibration area, no mobile phone is allowed.

 Third, the laboratory accreditation requirements for equipment

1. Equipment Requirements The laboratory shall be equipped with all equipment (including its own, leased, and customer-provided) required for proper testing/calibration. The technical specifications and functions of the equipment used (including sampling, sample preparation, data processing and analysis) should meet the requirements. Use of equipment other than fixed controls (including on-site inspection/calibration) should be performed in accordance with the relevant additional procedures to ensure that the quality of the final inspection/calibration results meets the requirements of this Code.

2. Equipment calibration requirements The critical quantity or value of the equipment (such as measurement range, accuracy level/maximum tolerance, anti-offset, repeatability, drift, resolution, etc.) that has an impact on the detection/calibration results should be calibrated, and Develop a calibration plan. The International Organization of Legal Metrology (OIML) divides metrological verification into two forms, the first verification and the subsequent verification. The former determines whether the equipment fully meets the specified requirements; the latter determines whether the equipment maintains the main measurement characteristics. This article also stipulates that the equipment should be calibrated or verified before it is put into operation (ie, for the first time); it should be checked or calibrated before each use. Equipment should be used during the calibration/validation period.

3. Authorization requirements All equipment, especially important equipment, should be operated by the designated operator. The operator should be trained and hold an operation permit. The operation instructions for the use and maintenance of the equipment (including the technical specifications provided by the manufacturer or related manuals) should be valid at present, so that the relevant personnel can access them and ensure that the equipment is in good working condition.

4. Equipment identification management Each equipment and its software that have an impact on the results shall be uniquely identified as long as possible, such as the equipment management number;

5. Equipment files The laboratory should establish a major equipment file that has a significant impact on the results. Generally, files are created in one file. For a small number of small measuring instruments of the same type, a gauge can be established, and a file is created to store related materials. The equipment technical files generally include the following basic information equipment registration forms, such as equipment, software and manufacturer's name, management number, specification model, factory number, equipment use department, storage location and other unique identification records; product certification; The original of the instruction manual (if there is a translation for the foreign language); other documents for the installation, commissioning and acceptance process; operating procedures, self-calibration procedures, period verification procedures; calibration certificate (or metrological verification certificate, test certificate, self-school report); Used “equipment usage record form” Record of equipment maintenance and repair; other information related to the equipment.

6. Equipment management procedures include requirements for safe disposal, transportation, storage, use and maintenance of equipment. The laboratory is required to prepare equipment maintenance and management procedures and implement them carefully to ensure that the equipment is in good performance and functions properly. Some routine maintenance work not only helps prevent equipment failure, but also reduces the risk of poor instrument performance

7. Management requirements for unqualified equipment This requirement clarifies three issues; one is what is unqualified equipment, the other is how to dispose of unqualified equipment, and the third is the impact on previous inspection/calibration after unqualified discovery. Trace back. It should be pointed out that the defects of equipment are not only the current problems, but also have various subtle influences, which make the equipment change from quantitative to qualitative. The current defects are the accumulation of past problems, the quality control of equipment should be used technology, and the prevention of equipment offset in time to take preventive measures. If there is no daily quality control, it is necessary to trace back, assess the impact of equipment defects on the customer, and even notify the customer.

8. Management requirements for the device calibration status flag The scope and flag content of the calibration status flag are specified. The guidelines do not specify what specific markings are used. For example, three markings can be used to indicate eligibility (green), permissible (yellow), and deactivated (red). Five types of markings can be used to qualify, qualify, limit, and deactivate. And sealed. Some devices that are not directly related to the data, such as regulated power supplies, air conditioners, transformers, etc., function normally, and are not suitable for sticking yellow cards; generally, green cards are attached, and "non-metering" is added to show the difference. Mark directly with "normal function".

9. For equipment that is not in the direct control range, such as equipment lending, on-site inspection/calibration, etc. After the equipment returns, it must be checked for its function and calibration status before it can be used.

10. Requirements for “Periodial Verification” of equipment The verification standard is a relatively stable instrument, product or other object used to represent the object under test. Its measurement range and accuracy level should be close to the object to be tested. Stability is better than the actual object being measured. It should be pointed out that not all devices need to be checked during the period. Only those devices with high drift rates and very frequent use need to be performed. Therefore, for equipment, this requirement is not mandatory and the terms are also "when needed". However, the laboratory should prepare a “procedural verification procedure”, which lists the list and implements it according to the plan and procedures.

11. Protection requirements for equipment This clause is for equipment with adjustments, such as equipment with one or several potentiometers, variable capacitors, or other similar components that affect one or more calibration points of the instrument. Instrument. When a checkpoint is found to be out of tolerance or very close to the tolerance, it is often necessary to adjust these regulators to return to normal. At this point, the laboratory should have measures to prevent the random adjustment of equipment (including hardware and software) and affect the validity of the measurement results.