What are the requirements for field laboratories?

A, laboratory accreditation requirements for personnel positions

1, top manager

Formal appointment documents and laboratory accreditation knowledge training can clarify the basic requirements of laboratory management system and master the main business scope and development direction of the laboratory.

2. Quality Director

1 person, who can be a laboratory manager concurrently, must have certain management power and be able to effectively implement the management system; Must have the ability to accept and learn quickly, and be familiar with the basic requirements of laboratory accreditation quickly under the guidance of consultants; Must have laboratory testing experience, be familiar with the scope of testing ability and technical requirements of most testing items, and be able to cooperate with consultants to combine the requirements of management system with the actual situation of our laboratory.

instructor

65,438+0 people, who can work full-time or part-time, are required to be familiar with the technical requirements of all testing fields in our laboratory, including the ability training of testing personnel, technical indicators of instruments and equipment, various reagents or materials needed in the testing process, testing method standards, requirements for environmental conditions of testing room facilities, traceability of instruments and equipment (metrological verification), relevant technical standards for sample sampling, relevant technical requirements for sample receiving and storage, and requirements for sample retention.

authorized signatory

It is required that there should be at least two authorized signatories in each field within the scope of the testing ability applied for recognition. If the authorized signatory can be familiar with the whole scope of application for registration, only two authorized signatories are needed. Authorized signatories are all part-time employees, and the technical person in charge should generally be an authorized signatory. The authorized signatory needs to go through the on-site evaluation by the evaluation team, and must be familiar with the technical standards in the signature field, otherwise the report cannot be issued in the future.

5. Internal auditors

They are all part-time jobs. In order to ensure the independence of internal audit, each department is generally required to have at least one person. They are required to be familiar with the testing work, be quick-thinking, honest and rigorous in work style. They have been trained, passed the exam and obtained the certificate of internal auditor.

6. Supervisors

Generally, the director of the testing room can work part-time, and the number depends on the number of departments in the testing room. Supervisors generally account for 5%- 10% of the personnel engaged in testing and/or calibration, with at least 1. The supervisor must be familiar with the testing workflow, testing methods and technical requirements for data verification of the results of the department.

administration department

1) director: you can work part-time or full-time, with general coordination ability and no special requirements;

2) Archivist: one, who is required to be familiar with the management of archival materials, be diligent and serious, have strong computer operation ability and be familiar with the application of common office software;

3) Business Transceiver: a full-time person who is responsible for receiving entrusted testing tasks, familiar with the basic requirements for receiving all samples within the testing capacity of our laboratory, with quick response, clear thinking and quick acceptance. It must be evaluated during the on-site review;

4) Sample manager: one, usually part-time, is responsible for the management of sample circulation process and sample retention. There is no special ability requirement, as long as he can work hard;

5) Computer administrator: 1 name, responsible for the management, maintenance, printing and copying of test reports of computer systems, and familiar with the knowledge of the use and maintenance of common office software;

6) Buyer: one, who is responsible for purchasing various reagents, consumables and other items, requires to master the technical requirements of commonly used reagents and consumables, and has a strong sense of responsibility;

7) equipment manager: 1 name, general part-time, responsible for instrument and equipment file management, equipment maintenance, metrological verification, etc. It is required to master the use of common office software, the basic technical indicators of various instruments and equipment, measurement knowledge, and the basic situation of the national value transfer system.

8) Safety officer: one, generally part-time, is responsible for the safety management of the laboratory and is familiar with the safety management of water, electricity and fire;

9) Goods clerk: one, usually part-time, is responsible for the inventory management of various goods and consumables, with no special requirements.

8. Professional departments

The laboratory should determine the number of professional testing rooms according to the planned testing capacity, and the technical director should judge according to experience. There are no strict requirements, which can basically reflect the division of labor.

1) director: familiar with the basic requirements of the testing items in charge of this professional room, and able to lead the staff in this room to complete the testing tasks.

2) Testing personnel: familiar with the requirements of the testing items they are responsible for, skilled in operation, and trained to obtain post certificates. There are at least two inspectors for each testing project, who can work part-time between different testing projects.

Second, laboratory accreditation requirements for environmental conditions of facilities

1, the environmental conditions of the facility must meet the specified requirements.

Different testing/calibration projects have different requirements for environmental conditions. According to Article 5.3.2 of the Accreditation Criteria, "the laboratory shall monitor, control and record the environmental conditions when required by relevant specifications, methods and procedures, or when the quality of the results is affected."

For the detection/calibration items sensitive to environmental conditions, the laboratory must meet the relevant requirements, and monitor, control and record them. For example, in the textile testing laboratory, when testing physical indicators (such as strength, elongation, twist, fineness, electrostatic capacity of anti-woven materials, etc.), environmental conditions must meet the standards. ), and an automatic temperature recorder (or automatic temperature and humidity monitoring device) must be installed in the detection area, and continuous monitoring records should be maintained during work.

The laboratory does not need to monitor, control and record the testing items that have no special requirements for environmental conditions. For example, in the gold and jewelry testing laboratory, some instruments and methods have no special requirements for the environment.

2. Control the access and use of the detection/calibration area.

In order to obtain correct detection/calibration results, the laboratory must effectively control the access and use of detection/calibration areas. Specific measures and methods are as follows:

1) divide the laboratory area by function.

Different jobs have different environmental requirements, so it is necessary to divide and mark the implementation room area. The laboratory can be divided into office area, detection/calibration area, maintenance area, scientific research area and reception area according to its functions. According to the detection requirements, the detection/calibration area can be divided into high temperature and high humidity stable operation area, high pressure operation area, ultra-clean operation area and aseptic operation area.

2) Control of personnel access

Foreign personnel should be approved to enter the laboratory. In order to avoid abnormal interference, we should also control the internal personnel of the laboratory and restrict the entry of unauthorized personnel. Therefore, some laboratories adopt automatic identification access control system. Otherwise, a warning sign of "Do not disturb while working" should be set for people who enter or leave the room that affects the test/calibration results due to temperature and humidity fluctuations. If there are health requirements, the personnel entering the laboratory shall be disinfected or other purification measures shall be taken.

3) Control the experimental area or use. For example, work unrelated to detection/calibration is not allowed in the calibration/testing area, and technical consultation by outsiders is not allowed. In some areas of the calibration laboratory (such as scales, measuring blocks and weights), water is not allowed because the relative humidity is less than 60%; Cell phones are not allowed in the magnetic calibration area.

Three, laboratory accreditation requirements for equipment

1, equipment requirements

The laboratory shall be equipped with all equipment (including self-owned, leased and customer-provided equipment) required for correct testing/calibration. The technical indicators and functions of the equipment used (including sampling, sample preparation, data processing and analysis) shall meet the requirements. When using equipment other than fixed control (including field test/calibration), relevant additional procedures shall be followed to ensure that the quality of final test/calibration results meets the requirements of this specification.

2, equipment calibration requirements

Number or value of key equipment (such as measuring range, accuracy grade/maximum tolerance, deviation resistance, repeatability, drift, resolution, etc.). ) calibration shall be carried out if it affects the test/calibration results, and a calibration plan shall be made. OIML divides metrological verification into two forms: first verification and subsequent verification. The former is to determine whether the equipment fully meets the specified requirements. The latter is to judge whether the equipment maintains the main metering characteristics. This article also stipulates that the equipment should be calibrated or verified before it is put into operation (that is, before it is used for the first time); Check or calibrate before each use. The equipment shall be used within the validity period of calibration/verification.

3. Authorization requirements

All equipment, especially important equipment, should be operated by designated operators, who should be trained and hold operation certificates. Work instructions on the use and maintenance of equipment (including technical specifications or related manuals provided by the manufacturer) shall be effective, convenient for relevant personnel to consult, 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 far as possible, such as the equipment management number;

5, equipment files

The laboratory should establish the main equipment files that have an important impact on the results. Generally speaking, files are created in the form of a set of files. For many small measuring instruments of the same kind, it is possible to establish a measuring tool ledger, establish a file and centrally store relevant information. Equipment technical files generally include the following basic information.

Equipment registration form, such as equipment name, software name, manufacturer name, management number, specifications and models, factory number, records of equipment using department, storage location and other unique identifiers;

Product certificate;

Original instruction (if it is in a foreign language, it should be translated);

Documents such as installation and debugging records in the acceptance process;

Operating procedures, self-calibration procedures and periodic verification procedures;

Calibration certificate (or metrological verification certificate, test certificate and self-calibration report);

Used "Equipment Usage Record Form"

Equipment maintenance and repair records;

Other information related to the equipment.

6, equipment management program

Including the requirements for safe disposal, transportation, storage, use and maintenance of equipment. The laboratory is required to work out equipment maintenance and management procedures, and earnestly implement them to ensure the good performance and normal function of the equipment. Some routine maintenance work not only helps to prevent equipment failure, but also reduces the risk of instrument performance exceeding the standard.

7. Management requirements for unqualified equipment

This requirement clarifies three issues; First, what is unqualified equipment; Second, how to deal with unqualified equipment; Thirdly, after the unqualified equipment is found, it is required to trace back the influence caused by previous testing/calibration. It should be pointed out that equipment defect is not only a current problem, but also has various subtle influences, which make the equipment change from quantitative to qualitative. The present defect is the accumulation of past problems. We should use technology to control the quality of equipment, take preventive measures in time, and find the trend of equipment deviation. Without daily quality control, we should take preventive measures.

8. Management requirements for equipment calibration status marks

Defines the scope and content of the status flag to be calibrated. The guide does not specify what signs to use. For example, three signs can be used to indicate qualified (green), allowed (yellow) and disabled (red), and five signs can also be used, namely qualified, allowed, restricted, disabled and sealed. Some equipment that is not directly related to the output data, such as regulated power supply, air conditioner, transformer, etc. , normal function, with a yellow card. Generally, green cards are labeled as "unmeasurable" to show the difference, and some are directly labeled as "normal function".

9. Requirements for indirect control equipment.

For example, if the equipment is borrowed, on-site inspection/calibration will be carried out. After the equipment is returned, its function and calibration status must be checked before continuing to use, and it can only be used after it is proved to be satisfactory.

10, requirements for "periodic verification" of equipment

Verification standard is a relatively stable instrument, product or other object used to represent the tested object. Its measuring range and precision level should be close to the measured object, and its stability is better than the actual measured object. It should be pointed out that not all equipment needs to be mid-term verified, only equipment with large drift rate and frequent use needs to be mid-term verified. Therefore, this requirement is not mandatory for the equipment, and the terms are also carried out "when necessary". However, the laboratory should

1 1, equipment protection requirements

This clause applies to devices with adjustment functions, such as instruments with one or more potentiometers, variable capacitors or other similar components, which may affect one or more calibration points of the instrument. When a checkpoint is found to be out of tolerance or very close to tolerance during calibration, it is usually necessary to adjust these regulators to return to normal. At this time, the laboratory should take measures to prevent any adjustment of equipment (including hardware and software) from affecting the validity of the measurement results.