Equipment Records The following records are maintained for each item or similar piece of equipment used for testing purposes. Figure : Equipment Records Record ID Record Description Record Location Asset ID label is located on each piece of equipment. This Identity of equipment record is also maintained on the asset module. Manufacturer’s name, model This record is maintained on the laboratory asset module. and serial number. Contact information for the This record is maintained in the equipment file. A list of suppliers supplier or manufacturer. and contacts is maintained in Q-Pulse Date of receipt and entering This record is maintained in the equipment file and in the asset into service. module of Q-Pulse. This record is maintained on the laboratory asset module of Current location. Conditions when received e.g. This record is maintained in the equipment file. new, used or reconditioned. This record is maintained in the equipment file or at the point of instructions/ use whichever is appropriate. All instructions are Manufacturer’s manufacturers’ manual recorded as an external document on Q-Pulse, where available this leads to a link to an electronic copy. Validation of equipment Equipment file – Records of Calibration of equipment Equipment file equipment’s initial – acceptability for use when QC On equipment/ floppy/ hardcopy – incorporated into lab. EQA EQA file (hardcopy) or through the scheme website – Asset module of Q-Pulse Maintenance carried out and scheduled preventative PM records, asset module of Q-Pulse maintenance. Equipment performance QC On equipment/ floppy/ hardcopy – records to confirm ongoing EQA EQA file (hardcopy) – acceptance for use. Damage, malfunction, These records are maintained in the equipment file, asset modification and repair module and as non conformities. The procedure [Management of Quality and Technical Records] details the retention times of the above records Reagents & Consumables 5.3.2.1 General Each laboratory department has a documented procedure for the reception, storage, acceptance testing, and inventory management of reagents and consumables. 5.3.2.2 Reagents & consumables- Reception & storage The laboratory stores received reagents and consumables according to manufacturer’s instructions. Reagent and consumables are stored in designated temperature controlled environments where required.
Equipment Records The following records are maintained for each item or similar piece of equipment used for testing purposes. Figure : Equipment Records Record ID Record Description Record Location Identity of equipment Asset ID label is located on each piece of equipment. This record is also maintained on the asset module. Manufacturer’s name, model and serial number. This record is maintained on the laboratory asset module. Contact information for the supplier or manufacturer. This record is maintained in the equipment file. A list of suppliers and contacts is maintained in Q-Pulse Date of receipt and entering into service. This record is maintained in the equipment file and in the asset module of Q-Pulse. Current location. This record is maintained on the laboratory asset module of Conditions when received e.g. new, used or reconditioned. This record is maintained in the equipment file. Manufacturer’s instructions/ manual This record is maintained in the equipment file or at the point of use whichever is appropriate. All manufacturers’ instructions are recorded as an external document on Q-Pulse, where available this leads to a link to an electronic copy. Records of equipment’s initial acceptability for use when incorporated into lab. Validation of equipment – Equipment file Calibration of equipment – Equipment file QC – On equipment/ floppy/ hardcopy EQA – EQA file (hardcopy) or through the scheme website Asset module of Q-Pulse Maintenance carried out and scheduled preventative maintenance. PM records, asset module of Q-Pulse Equipment performance records to confirm ongoing acceptance for use. QC – On equipment/ floppy/ hardcopy EQA – EQA file (hardcopy) Damage, malfunction, modification and repair These records are maintained in the equipment file, asset module and as non conformities. The procedure [Management of Quality and Technical Records] details the retention times of the above records Reagents & Consumables 5.3.2.1 General Each laboratory department has a documented procedure for the reception, storage, acceptance testing, and inventory management of reagents and consumables. 5.3.2.2 Reagents & consumables- Reception & storage The laboratory stores received reagents and consumables according to manufacturer’s instructions. Reagent and consumables are stored in designated temperature controlled environments where required.
Quality%20Manual.docx