Title

Collect all equipment documents and records and store these in the Equipment Archive

Why

An important part of quality management is archiving documents and records. The equipment documents and records provide all the necessary information regarding the preventive maintenance, use and repair of the equipment. These therefore need to be readily accessible in an Equipment Archive.

What

Collect the following documents and records of each piece of equipment and store these in the Equipment Archive:

  • Equipment Identification Page (see below)
  • Equipment Register
  • Maintenance Log Sheets
  • Maintenance forms/calibration forms
  • Completed Usage Log Sheets/log books
  • Manufacturer's instructions
  • Spare Parts Overview (see below)
  • Validation reports (will be developed in phase 4)

How & who

Equipment Officer:

  1. Develop for each piece of equipment included in the Equipment Register an Equipment Identification Page that contains all the characteristics of that piece of equipment. These include:
    • Name of the piece of equipment
    • Serial number
    • Code used in the laboratory
    • Manufacturer
    • Reception date
    • Condition when received
    • Name of staff member responsible for the piece of equipment
    • Preventive maintenance frequency
    • Predicted replacement date (determined based on average lifetime and intensity of use and maintenance)
  2. Make for each piece of equipment for which the laboratory keeps spare parts an overview of these spare parts. This can be a simple table in which all the spare parts kept in the laboratory can be listed for each piece of equipment.
  3. Collect for each piece of equipment the documents and records as listed above under the heading "What".
  4. Insert these documents behind the correct tab in the folder Equipment Archive.

Back to Roadmap Activity Overview
This activity belongs to the QSE Equipment

 

ISO15189:2007: 5.3.4
ISO15189:2012: 5.3.1.7
ISO15190:2003: