Develop personnel files for all staff members


The laboratory needs to be able to show that it has competent staff members that are capable of performing the examinations required.


Personnel files contain evidence of the education of staff members, competency assessment reports, but also health records.

The following should at least be included in the personnel files:

  • Up to date Curriculum Vitae (less than 1 years old)
  • Certificates and diplomas of the complete education of the staff member
  • Record of induction of the staff member to the laboratory
  • A list of techniques the staff member has been induced to
  • Certificates of trainings followed as part of continuous education for the current job tasks
  • Job description specific for the staff member
  • Competency assessment reports
  • Possible reports of accidents that have happened to the staff member during working hours

See ISO 15189:2012 article 5.1.9 (ISO 15189:2007 article 5.1.2) for a list of records required to be included in the personnel files.

How & who


  1. In phase 1 a folder was created titled Personnel Files, used for storing the following personnel information:
    • Training certificate of the biosafety training for the Biosafety Officer
    • Training certificate of the training in change management for the Laboratory Manager
    • Training certificates of the introductory training into quality management for all laboratory staff
    • Diplomas and certificates of past education of all staff members

    In this step the personnel files are completed. Start with making a list of the techniques each staff member has been made familiar with and authorized to perform. Do this with help of the laboratory manager and the staff members themselves.

  2. Insert all the above mentioned records in a logical fashion behind each staff member's tab. Some records may not be present yet (such as the competency assessment reports and possible accident reports). These will be added later in the process of implementing the quality management system.
  3. After completion, store the Personnel Files folder in a locked cabinet that is only accessible to the laboratory manager (as the files contain privacy sensitive data such as the health record the files should be protected from unauthorized access after they have been finalized; only the laboratory manager is allowed to access the personnel files and the staff members are allowed to access their own personnel file).

Laboratory Manager:

  1. Adapt the Authorization Matrix to specify that only you are allowed to access and adapt personnel files.
  2. Assist the secretary in assembling the personnel files, specifically in making the list of tasks to which each staff member has been inducted.

The WHO Laboratory Quality Management System (LQMS) training provides information on personnel files (provided in the right-hand column). ISO 15189:2012 article 5.1.9 (ISO 15189:2007 5.1.2) shows a complete overview of all the records that have to be included in the personnel files.

Back to Roadmap Activity Overview
This activity belongs to the QSE Personnel
ISO15189:2007: 5.1.2
ISO15189:2012: 5.1.9