Audit in medical laboratory

A laboratory audit is an assessment performed to demonstrate that the laboratory’s operations are
according to regulatory standards and accreditation regulations, such as ISO 15189 and ISO 17025. It
also detects any deviation in their processes that could affect the quality system in medical device and
pharmaceutical company operations.

Importance of medical laboratory audit:

Medical laboratory audits are crucial for ensuring the quality, accuracy, and reliability of diagnostic
testing.

They help identify and rectify errors, ensuring patient safety and satisfaction.

Audits also contribute to regulatory compliance, accreditation, and continuous improvement in

laboratory practices. By reviewing procedures, equipment, and staff competence,

audits enhance overall efficiency and reliability in delivering accurate medical results.

Responsibility
Laboratory Management: They are responsible for establishing and maintaining a quality
management system, ensuring compliance with standards, and providing resources for training and
improvement.

Quality Assurance Team: This team oversees the audit process, conducts internal audits, and
ensures adherence to established quality control procedures.

Laboratory Staff: Individual laboratory personnel are responsible for following standard operating
procedures, maintaining competency, and participating in continuous education and training.

External Auditors: In cases of external audits, independent auditors ensure impartial evaluation of
the laboratory's practices, often for accreditation purposes.

Regulatory Bodies: They set standards and regulations, monitoring compliance to ensure that
laboratories operate within the defined guidelines.
Types of laboratory audits –
1. Internal Audit :

Definition: An internal audit in a medical laboratory is a systematic, independent examination of

laboratory activities and processes conducted by internal staff or a designated quality assurance team.

Purpose: It aims to assess compliance with established procedures, identify areas for improvement,
and ensure the quality, accuracy, and reliability of diagnostic testing. Internal audits help maintain and
enhance the laboratory's overall performance and adherence to standards.

2. External Audit :

Definition: An external audit involves an independent review of a medical laboratory's processes,

procedures, and quality management systems by an external entity or regulatory body.

Purpose: External audits are often conducted for accreditation purposes and to ensure that the
laboratory meets national or international standards. They provide an objective evaluation of the
laboratory's capabilities, contributing to public trust and confidence in the accuracy and reliability of test
results.

3. Horizontal Audit:
Definition: A horizontal audit involves a comprehensive review of a specific process or activity across
different departments or units within an organization.

Purpose: It aims to evaluate consistency, identify best practices, and ensure standardization in
processes across various areas.

4. Vertical Audit:
Definition: A vertical audit focuses on a specific department or functional area within an
organization, examining processes, procedures, and compliance within that specific vertical structure.

Purpose: It helps ensure that a particular department or area meets regulatory standards, follows
established protocols, and operates efficiently.

5. Test Audit:
Definition: A test audit involves a sample examination of a system, process, or set of records to
assess compliance, accuracy, and effectiveness.
Purpose: It provides a snapshot of the overall performance, allowing auditors to test the
effectiveness of controls, identify potential issues, and validate the reliability of data or processes.

Frequency of audit:
Take stock of the processes in your organisation that require immediate auditing. Critical or high-risk
areas should be audited more frequently. This could be done quarterly or twice a year. If the risk is low,
conduct an internal audit just once a year or every other year.

Documentation:
Audit documentation is the documentation of the procedures carried out by auditors, the evidence they
collect, and the conclusions they draw based on their work. It proves the reliability of an auditor’s
opinion in an audit report as it consists of all the essential aspects of the audit.