Management of Equipment in an ISO/IEC 17025:2017 Accredited Laboratory
Part 2: Equipment Lifecycle Models
4.3 Equipment Installation
The equipment installation phase entails the following activities:
1. Confirming the delivered items conform with those ordered on the purchase order.
2. Confirming all documentation, operator manuals, certificates, software licences and authentication or activation codes are present, documented and achieved.
3. Confirming the selected environment meets the manufactures specifications.
4. Confirming all the individual components and accessories are correctly assembled.
5. Confirming all required software is correctly installed and configured.
6. The instrument is registered in the laboratory equipment database, and laboratory asset numbers are assigned, if applicable.
7. Establishing the systems required to ensure the equipment is constantly operating according to the requirements established in the user, functional and operational specifications.
Before the instrument’s arrival on-site, it is important to consider the instrument’s installation environment, including
1 Ensuring sufficient space to site the instrument,
2 Sufficient room to allow personnel to work around it,
3 All the required utilities are available and able to support the new equipment.
4 Ensuring sufficient power sockets and the electric circuits have sufficient capacity to meet the new equipment’s requirements.
5 Ensuring sufficient network sockets.
The procedure for installing new equipment should explain how these checks should be recorded.
When the equipment arrives on site, the hardware, software, spare parts, consumables, accessories and documentation will need checking to confirm that the correct items have been delivered, delivery is complete and undamaged, and all documentation, including operating and service manuals, licences, and certificates are present. A list of all hardware, including description, manufacturer, part number, serial number, and firmware version, needs to be made to identify and record the equipment.
Before installing the new equipment, make sure it has been electrically tested and conforms to all safety requirements. Once the new equipment and computer software have been installed, the entire equipment needs to be checked for correct installation, including all anti-virus, firewall, and application software. The level of testing will depend on the use and complexity of the equipment. The equipment classifications discussed in the previous paper2 in this series can be used to establish requirements for different categories. The procedure for installing new equipment should provide instruction for determining the extent of testing for a specific instrument. This procedure also needs to provide instructions on how the installation shall be recorded. The level of detail that should be recorded will depend on the use and complexity of the equipment, and the equipment classifications discussed in the previous paper2, in this series, can be used to establish requirements for different categories.
The systems that will ensure the equipment is constantly conforming to specifications also need to be established during the installation of new equipment. This needs to include:
1. Issuing a logbook – A logbook is a means of recording the equipment’s calibrations, maintenance, repair, and change of consumable parts; this can be in any appropriate format, including a physical book, a folder on a computer network or a database
2. Scheduling of calibration and maintenance – This needs to include entering the new equipment into the calibration plan and establishing contracts.
3. Training – If training is required, this needs to be arranged and scheduled
4. Procedures – Any new procedures that need to be created, approved, and distributed
5. Change Control – This is the process of evaluating the potential impact of changes made to equipment and ensuring the necessary controls are implemented to maintain the equipment in a calibrated state.