Internal auditing is one of the fundamental pillars for laboratories seeking to maintain and continuously improve their management system in accordance with the ISO/IEC 17025:2017 standard. This international standard outlines the requirements for the competence of testing and calibration laboratories and assigns a central role to internal audits in quality assurance.
In this article, we explore what an internal audit is, its function under ISO 17025, how it should be planned and carried out, and the benefits it brings from both technical and organizational perspectives.
What Are Internal Audits?
An internal audit is a planned and independent evaluation carried out by the laboratory itself to verify that its management system complies with the ISO/IEC 17025 standard, its own procedures, and commitments made to clients and accreditation bodies.
It is not just a document review. Internal audits also involve direct observation of processes, interviews with staff, review of technical records, and the detection of nonconformities.
Requirements According to ISO/IEC 17025:2017
Section 8.8 of the standard specifies that laboratories must conduct internal audits at planned intervals to determine whether the management system:
- Complies with the laboratory’s own requirements.
- Complies with the requirements of the ISO/IEC 17025 standard.
- Is effectively implemented and maintained.
According to the standard, the laboratory must:
- Plan, establish, implement, and maintain an audit program.
- Define the audit frequency, methods, responsibilities, and criteria.
- Ensure audit results are communicated to management.
- Take appropriate corrective actions without delay.
- Maintain records of the audit program and its results.
📅 The standard does not require a fixed frequency but recommends audits be conducted at least once a year.
How to Plan Effective Internal Audits
- Define the scope and objectives: These may cover the entire system or focus on specific areas such as metrological traceability, method validation, or staff competence.
- Choose impartial auditors: They must be competent and have no conflicts of interest with the audited area.
- Prepare an audit plan: Include dates, activities, responsible parties, and reference documents.
- Conduct the audit: Include interviews, activity observation, review of records, and reports.
- Issue a clear report: Should contain findings, evidence, nonconformities, and recommendations.
- Follow up: Ensure the proposed corrective actions have been implemented.
Benefits of Internal Audits in the Laboratory
- Continuous improvement: Identifies opportunities to strengthen efficiency and quality.
- Error prevention: Detects deviations before they become major failures.
- Preparation for external audits: Helps the lab be ready for accreditation evaluations or inspections.
- Strengthening the quality culture: Encourages staff involvement and commitment.
- Legal and regulatory compliance: Ensures alignment with local and international regulations.
Best Practices Based on ISO/IEC 17025
- Impartiality: Auditors must act objectively and without external pressure.
- Clear documentation: The entire process must be traceable and well-documented.
- Risk-based approach: Evaluate critical areas that may affect result validity.
- Ongoing training: Auditors must be trained in line with ISO 19011 principles.
Key Areas Audits Should Cover
- Impartiality and confidentiality (Clause 4)
- Personnel competence (6.2)
- Facilities and equipment (6.3 and 6.4)
- Method validation (7.2)
- Metrological traceability (6.5)
- Assurance of result validity (7.7)
- Reporting of results (7.8)
- Document and record control (8.3 and 8.4)
How Can SHAPYPRO Help You?
At SHAPYPRO, we have professionals ready to assist you in preparing, conducting, and improving your internal audit system. Whether through training, mock audits, or documentation support, we can help you achieve and maintain your accreditation.
📍 Contact us for personalized assistance.