An internal audit report is a document that summarizes the findings and recommendations of an internal audit conducted in accordance with ISO 17025. The purpose of an internal audit report is to provide evidence of the laboratory's compliance with the standard's requirements, identify areas for improvement, and communicate the results to the management and relevant personnel.
An internal audit report should include the following elements:
The scope and objectives of the audit
The audit criteria and reference documents
The audit methodology and sampling plan
The audit team members and their roles
The audit schedule and duration
The audited processes, activities, and functions
The audit findings, including nonconformities, observations, and good practices
The audit conclusions and recommendations
The audit follow-up actions and responsibilities
An example of an internal audit report for ISO 17025 is shown below:
Internal Audit Report
Audit reference number:
The internal audit covered the following processes and activities of the laboratory: calibration of electrical instruments, testing of water samples, validation of methods, management review, corrective actions, and customer feedback.
The objectives of the audit were to: verify the laboratory's compliance with ISO 17025:2017 and its own policies and procedures; assess the effectiveness and efficiency of the laboratory's operations; identify opportunities for improvement; and provide feedback to the management.
The audit criteria were: ISO 17025:2017 - General requirements for the competence of testing and calibration laboratories; Laboratory Quality Manual; Laboratory Procedures; Work Instructions; Records.
The audit methodology consisted of: document review; interviews with personnel; observation of activities; examination of records; verification of equipment; evaluation of results.
Audit sampling plan:
The audit sampling plan was based on a risk-based approach, taking into account the frequency, complexity, and criticality of the processes and activities. The sample size was determined by using statistical methods and professional judgment. The sample selection was random or representative, depending on the nature of the data.
The audit team consisted of: John Smith (lead auditor), Jane Doe (technical auditor), Mark Lee (observer).
The audit was conducted from April 1 to April 3, 2023. The audit duration was 24 hours.
The audited processes/activities/functions were:
Calibration of electrical instruments (ISO 17025 clause 6.4)
Testing of water samples (ISO 17025 clause 7.2)
Validation of methods (ISO 17025 clause 7.3)
Management review (ISO 17025 clause 8.9)
Corrective actions (ISO 17025 clause 8.10)
Customer feedback (ISO 17025 clause 8.7)
The audit findings were:
One major nonconformity: The laboratory did not validate its method for testing pH in water samples, as required by ISO 17025 clause 7.3.1.
Two minor nonconformities: The laboratory did not calibrate its digital multimeter within the specified interval, as required by ISO 17025 clause 6.4.6; The laboratory did not document its procedure for handling customer complaints, as required by ISO 17025 clause 8.7.2.
Three observations: The laboratory did not have a c481cea774