The laboratory management system: documents, nonconformities, and internal audits

X-Lab LIMS helps keep the quality management system in the same place as the laboratory processes. Documents, staff competence, risks, nonconformities, internal audits, and quality-control records stay connected to the laboratory’s daily work.

The system records the needed details, assigns a responsible person, tracks due dates, and keeps a history of changes. That organizes work with the documents and records of the laboratory management system.

1. Activity area and staff competence

For activity-area elements, the laboratory stores its status and accreditation status, competence, and authorized staff. Portions and the required catalog items can be recorded, and the uncertainty of a result can be calculated.

A staff record stores which work and equipment that person is authorized for. That keeps staff competence in view when laboratory work is organized.

2. Document control

Internal and external documents can be kept in X-Lab LIMS, with the files and the main details.

Staff record their acknowledgment of documents, and a separate journal shows who did that and when. Copies of external documents can be stored, and their currency can be followed.

That organizes the documents and records the laboratory needs for its work.

3. Nonconformities and corrective actions

When a nonconformity is found, the laboratory records its significance, the causes, the correction, and the corrective actions.

Each action has a responsible person and a due date. After the actions are done, the laboratory checks whether they were effective. A nonconformity can also be linked to the relevant clauses of ISO/IEC 17025.

The problem, the actions taken, and the check of their effectiveness stay on one record.

4. Risks and opportunities

For risks and opportunities, the level can be assessed, control measures can be assigned, and the residual risk after those measures can be recorded.

The laboratory can follow the actions and assess their result. Risks can be viewed in a table or on a board by status.

That organizes work with risks and opportunities and keeps the planned actions in view.

5. Planning and carrying out internal audits

Internal audits are planned from the audit programme. The system can store the checks, the evidence, the conclusions, and the reports.

The internal-audit programme is kept in its own journal. Risks and audits can be viewed by status in a table or on a board.

Planning and the audits themselves stay available in that structure.

6. Interlaboratory comparisons and internal quality control

Interlaboratory comparisons can be planned, and what was actually carried out can be recorded.

For internal quality control, a plan and a procedure can be set, control points can be named, and a control chart calculated by the system can be used.

The results of the control procedures give the laboratory the related records and show whether the planned actions were carried out.

7. Environmental conditions and equipment

Temperature, humidity, and pressure can be recorded in the environmental-conditions journal at the places where measurements are made.

A staff record stores which equipment that person is authorized to use. Those limits stay in view when the work is organized.

8. History of changes

The audit trail shows who changed a record and what was changed.

That history helps review changes to the data and see which actions were taken in the system.

The management system next to the laboratory work

Documents, competence, nonconformities, risks, audits, and quality control stay with the laboratory’s daily processes.