ISO 17025 Internal Audit in Nepal: A Step-by-Step Guide
Introduction
ISO 17025 is an international laboratory standard for testing and calibration laboratories that ensures competence and reliability. Internal audit is required to apply ISO 17025, as it helps Nepali laboratories to identify non-conformities, streamline processes, and become accredited. This article is a step-by-step guide to performing an ISO 17025 internal audit in Nepal.
Why Internal Audits Are Required in ISO 17025
Internal audits are required for laboratories aiming for ISO 17025 accreditation. Their benefits include:
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Ensuring Compliance: Ensures laboratory compliance with the requirements of ISO 17025.
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Identifying Non-Conformities: Identifies discrepancies and areas for improvement before external audits.
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Improving Laboratory Efficiency: Optimizes processes and resource allocation.
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Minimizing Risks: Prevents errors, inaccuracies, and regulatory non-compliance.
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Continuous Improvement: Encourages the adoption of quality improvement and best practices.
Internal Audit Planning
Planning is to be carried out for the efficient internal audit. Tasks to be performed by the laboratories in Nepal are as follows:
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Define Audit Objectives: Determine what is to be achieved by the audit (e.g., compliance verification, areas for process enhancement).
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Prepare an Audit Checklist: Prepare a checklist founded on ISO 17025 clauses applicable to the laboratory scope.
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Select an Audit Team: Designate internal auditors with relevant experience and familiarity with ISO 17025 requirements.
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Schedule the Plan: Decide on a suitable date, with minimal disruption to laboratory activities.
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Inform the Plan: Inform affected staff of audit date, scope, and expectations.
Internal Audit Conduct
Step 1: Opening Meeting
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Welcome and introduce the audit team and clarify audit purpose and approach.
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Verify that all affected staff are familiar with the process.
Step 2: Document Review
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Evaluate QMS documents, procedures, and records.
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Check equipment maintenance records, calibration certificates, and training records of personnel.
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Compare test procedure and SOP with ISO 17025 requirements.
Step 3: Process Review
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Observe laboratory activities to check compliance with documented procedures.
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Interview personnel to check familiarity with quality and technical requirements.
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Observe environmental conditions, equipment calibration, and sample handling as per procedure.
Step 4: Finding Non-Conformities
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Compare findings with the requirements of ISO 17025.
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Classify non-conformities as minor (easily correctable) or major (high risk of non-compliance).
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Record all discrepancies and supporting evidence.
Step 5: Closing Meeting
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Summarize audit results and discuss non-conformities found.
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Make recommendations for corrective action.
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Answer questions or concerns of laboratory personnel.
Step 6: Preparing the Audit Report
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Record audit scope, objectives, findings, and recommendations.
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Declare non-conformities found and corrective action plans.
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Issue the report to laboratory management and stakeholders.
Step 7: Implementing Corrective Actions
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Assign responsibility for correction to responsible personnel.
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Establish time scales for correction of non-conformity.
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Record and monitor improvement.
Follow-Up and Continuous Improvement
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Conduct follow-up audits to verify effectiveness of corrective actions.
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Maintain a record of all the internal audits in case they might have to refer to them later.
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Maintain processes updated regularly as per audit findings and feedback.
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Update on ISO 17025 revisions and best practices.
Issues in Practicing Internal Audits in Nepal
Though internal audits are useful, Nepalese laboratories can be plagued with the following:
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Limited Resources: Small laboratories lack trained auditors or audit software.
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Lack of Awareness: Employees lack awareness of ISO 17025 requirements.
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Resistance to Change: Employees resist audit reports due to fear of increased workload.
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Inadequate Documentation: Inadequate or outdated documentation can undermine audit success.
Solutions:
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Offer auditor training courses to create in-house competence.
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Train personnel on internal auditing and quality advantage.
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Utilize electronic documentation systems for better record keeping.
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Foster the culture of continuous improvement and accountability.
Conclusion
Internal audits are a component of ISO 17025 accreditation maintenance in Nepal. Laboratories can achieve compliance, enhance efficiency, and high levels of quality with audits. By planning, doing, and checking, laboratories can continuously improve processes and attain accreditation with confidence.
Visit https://qms.com.np/ to learn more about ISO.
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