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The procedure addressing the selection and installation of equipment will also need to provide instructions on how to document instructions for performing an equipment installation and how to record the installation. The following outline is for a combined set of installation instructions and records


1. Purpose: Record the purpose of the document

2. Scope: Define what is covered and what is not covered by the document.

3. Responsibilities: Define who is responsible for doing what

4. Identification of Personnel Involved: Table the following information:

  1. Name
  2. Job Title
  3. Affiliation
  4. Role
  5. Signatures and initials.

5. Documentation of the Site of Installation Record the following information:

Location

  1. Room No. / Bench No.
  2. Required Bench/Floor Area
  3. Available Bench/Floor Area

Electricity supply

  1. Record the required number of power sockets and total current requirement
  2. Record available circuit numbers, number of available sockets, circuit rating, current load, and available current

Network Sockets

  1. Record the required number of network sockets
  2. Record the reference numbers of the available sockets and socket(s) record

6. Reconciliation of Deliveries

  1. Record and check the part number(s) of each item match the part number on the Purchase Order and on supplier’s Delivery Note
  2. Record and check the serial number(s) on each item agree with the serial number on supplier’s Delivery Note
  3. Inspect each item for damage and record condition
  4. Inspect any tilt indicators, confirm they are all present and intact, and do not show the package has been tilted

7. Reconciliation of software, documentation, cables, manuals, spare parts, and consumables. Compile a list of all items together with respective part numbers and document presence and are undamaged.

8. Documentation of the Equipment Record the following information:

  1. Manufacturer
  2. Actual part number
  3. Serial number
  4. Firmware version
  5. Laboratory asset number of the hardware components

9. Documentation of computer hardware

Record the following information relating to the computer and monitor:

  1. manufacturer
  2. model
  3. serial number
  4. laboratory instrument No.
  5. Actual processor type and speed
  6. RAM type and size
  7. Graphics adaptor type
  8. Hard disk size and partitions
  9. LAN Interface model identity
  10. Pointing device
  11. Optical drive type

Determine that the components conform to specification established in the design qualification

10. Installation, configuration, and documentation of software This section is used to record the configuration of the software. This can include:

  1. User accounts
  2. Electronic signatures (format)
  3. Passwords (password expiry and complexity requirements)

11. A list of all installed software Record the following information about each software package installed: -

  1. Description
  2. Software name
  3. Version No.
  4. Location
  5. Licence No.
  6. Activation code

12. Clock Configuration Provide instructions on how to configure the computer clock and record the following information.

  1. Time Zone
  2. Daylight saving (Yes/No)
  3. Time server address

13. Installation Testing Provide instructions on how to test the equipment has been correctly installed. Including testing of:

  1. Key equipment functions
  2. Logon/Logoff
  3. Security features
  4. Audit trail features

14. Equipment Logbook

Confirm an equipment Logbook has been Issued and record logbook number and date of issue.

15. QMS Procedures

Record QMS Procedures numbers and Titles

16. Routine Preventative Maintenance (PM) and Calibration

Record Calibration and Preventative Maintenance (PM) has been scheduled and any contracts have been established.

17. Training

Record all training necessary to use the new equipment

18. Change Control (CC)

Describe change control procedures

Appendices, containing:

  1. Manufacturer’s hardware installation instructions
  2. Manufacturer’s software installation, configuration, and verification instructions
  3. Finance authorisation
  4. Purchase order
  5. Supplier’s delivery note, or waybill
  6. Laboratory instrument number request form(s)
  7. Copies of installation engineer’s training certificates
  8. Copies of calibration certificates
  9. Conformance certificates (e.g. CE marking)
  10. Supporting documentation created during installation


Management of Equipment in an ISO/IEC 17025:2017 Accredited Laboratory

Part 2: Equipment Lifecycle Models


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