Steps To Create An Iso 17025 Checklist

By Author: Jenny
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Creating an effective ISO 17025 checklist is a critical step in implementing, auditing, and maintaining compliance with the ISO/IEC 17025 standard. Laboratories aiming for accreditation or improving their current systems benefit immensely from a structured checklist tailored to the standard’s requirements. A well-developed checklist ensures that no critical elements are overlooked during implementation or internal audits, and it facilitates consistency, accuracy, and compliance in laboratory operations.
Step 1: Understand the ISO 17025 Standard
Before developing the checklist, it's essential to thoroughly understand the ISO 17025 standard. The standard is structured into two major components: Management Requirements and Technical Requirements. Each clause outlines specific expectations that a laboratory must fulfil to achieve and maintain accreditation.
Review the official ISO documentation or use training materials to interpret the clauses correctly. This foundational knowledge ensures that your ISO 17025 checklist will be comprehensive and compliant.
Step 2: Define the Scope of the Checklist
Determine ...
... the scope of the checklist based on your laboratory’s services. Whether your laboratory conducts testing, calibration, or both, your checklist must reflect the specific operations, equipment, and methodologies used.
Also, consider if the checklist is being developed for:
•Internal audits
•Initial implementation
•Gap analysis
•External certification preparation
Clarity on the scope ensures relevance and precision in the checklist's content.
Step 3: Break Down the Standard into Key Requirements
The ISO 17025 standard includes several sections, each containing detailed requirements. Break these down into a logical sequence or topics. Typical sections to include in the checklist are:
1.General Requirements (Impartiality and Confidentiality)
2.Structural Requirements
3.Resource Requirements (Personnel, Facilities, Equipment, etc.)
4.Process Requirements (Review of Requests, Method Validation, Sampling, etc.)
5.Management System Requirements
Step 4: Use a Question Format for Clarity
Checklist items should be phrased as questions or affirmative statements that help assess compliance. This format aids in decision-making during implementation or audits.
For example:
•Are the roles and responsibilities of personnel clearly defined?
•Is there documented evidence of equipment calibration and maintenance?
•Does the laboratory have a procedure for handling non-conforming work?
Step 5: Add Evidence Columns
To make the ISO 17025 audit checklist-https://www.certificationchecklist.com/iso-17025-audit-checklist.html practical and audit-ready, include a section for evidence next to each requirement. This can be in the form of:
•Document references
•Procedure names
•Record IDs
•Observation notes
Including a column for compliance status is also useful for internal reviews and progress tracking.
Step 6: Incorporate Risk-Based Thinking
ISO 17025:2017 emphasizes risk-based thinking. Therefore, your checklist should also account for potential risks associated with each requirement. Consider adding a section for identifying risks and opportunities related to each process.
For instance:
•Risk identified: Delay in equipment calibration may impact result accuracy.
•Opportunity: Implementing automated reminders for equipment maintenance.
Including this element aligns the checklist with the strategic intent of the standard.
Step 7: Customize the Checklist Based on Laboratory Practices
No two laboratories are the same. Tailor the checklist to reflect specific operational practices, testing procedures, equipment, and regulatory requirements applicable to your field.
Avoid using generic templates without modification. Consider industry-specific add-ons such as:
•Environmental control monitoring in pharmaceutical labs
•Traceability verification in calibration labs
•Chain-of-custody procedures in forensic labs
Customizing ensures the ISO 17025 audit checklist is both useful and applicable to your unique setup.
Step 8: Review with Cross-Functional Teams
Once the initial draft of the checklist is prepared, conduct a review with key personnel across functions—technical staff, quality managers, and department heads. Their input helps validate the relevance of checklist items and may highlight missing areas.
This collaborative step also increases team ownership and understanding of ISO 17025 requirements.
Step 9: Pilot and Revise
Test the checklist in a pilot run during an internal audit or mock assessment. Observe how well it supports the audit process, how easily evidence can be collected, and whether all key requirements are covered.
Based on this trial, refine the content, adjust wording for clarity, and fill in any gaps. A checklist is a living document and should evolve with feedback and system changes.
Step 10: Maintain and Update Periodically
The ISO 17025 checklist should be reviewed periodically, especially when there are:
•Revisions to the standard
•Changes in laboratory procedures
•New regulatory or customer requirements
An outdated checklist can lead to missed non-conformities or audit failures. Set a formal review cycle to ensure its continued effectiveness.
Conclusion
Creating a robust ISO 17025 checklist is not merely a documentation exercise but a strategic process that ensures compliance, improves laboratory quality, and facilitates continual improvement. By following a systematic approach—understanding the standard, defining scope, breaking down clauses, formatting questions, and involving your team—you can develop a practical tool that strengthens your laboratory’s management system.
A well-structured ISO 17025 checklist serves as a foundational resource for implementation, training, auditing, and sustained compliance, ultimately supporting your journey toward accreditation and operational excellence.