Equipment
1. Variety and number of equipment in the laboratory
The equipment in the laboratory should be fully compatible with the list of tests carried out at the laboratory and the workload in the laboratory, and if the preparation or submission of samples for testing in the reference laboratory
2. Purchase of equipment
A) When selecting and purchasing equipment, validated certificates (validated certificates or approved laboratory references) and safety certificates must be taken into account.
B) The criterion for the selection of suppliers (equipment vendors) must be specified and the purchase of equipment from the suppliers that are legally registered and previously evaluated.
3. Installation and location of equipment
The requirements and space required to install the device, including the environmental conditions required at the installation site, the technical conditions and the required accessories according to the manufacturer’s recommendations, must be carefully observed.
4. Ensure the correct operation of the equipment
After purchasing and installing the device and before starting to use, the correct operation of the device should be evaluated by using appropriate controls or methods included in the equipment brochure. Obviously, this action should be carried out periodically in the activities of equipment control and maintenance, as well as after each installation of the machine.
5. Use of equipment
The technical skill needed to work with the devices should be specified. Determination of the person or persons authorized to work with the system-system and the full training of authorized persons, including training on how to operate, control and maintenance, how to prepare documents, and keeping relevant records.
6. Equipment documentation
A) List of equipment in the laboratory
The laboratory should have a list of existing equipment with the registration of each location. In this list, we can give you any identification number or code for ease of tracking. The list should be up-to-date and should be recorded if the equipment is purchased or removed from the service.
B) records of the purchase of equipment
Purchase Request, Sales Invoice, Records of Evaluation and Quality Assurance of the Machine Before Use in the Laboratory and Records related to the training of employees for the Device
C) Technical Instructions for equipment
This instruction is provided for each equipment separately, using the manufacturer’s instructions accompanying the device as well as the authoritative scientific references, and contains all necessary information about the device and how it is used.
D) records relating to the control and maintenance of equipment
All preventive measures performed periodically (daily, weekly, monthly …) to control, maintain and service equipment inside the lab. It must be registered and documented.
E) service or repair records
Whenever an outside-laboratory operation is performed to prevent a malfunction (service of the machine) and also to repair the device after it is damaged, it must be documented and documented and stored in the folder or file of that device.