ISO/IEC 17025 2017 Version Checklist PDF
2024-10-24 14:17ISO/IEC 17025 2017 Version Checklist PDF
ISO/IEC 17025 2017 Checklist PDF
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Streamline your ISO/IEC 17025:2017 audit with our detailed checklist, meticulously designed to align with the standard’s specifications. Available for instant download in convenient Word and Excel formats, this checklist is an essential tool for enhancing compliance and simplifying the audit process. It’s perfect for laboratory professionals aiming to maintain precision and efficiency in their quality management systems.
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ISO/IEC 17025 2017 Checklist
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ISO/IEC 17025 2017 Checklist
If you’re planning to prepare a Laboratory Management System in accordance with the ISO/IEC 17025:2017 standard, where should you begin?
We recommend starting with a Gap Analysis to identify the differences between your current management system and the requirements of an ISO/IEC 17025 compliant Laboratory Management System. A Gap Analysis helps assess your organization’s scope, readiness, and resources for developing the Laboratory Management System. This analysis provides essential data to create a detailed project plan for ISO/IEC 17025 implementation.
This gap analysis checklist is a valuable tool for evaluating your Laboratory Management System against the ISO/IEC 17025:2017 requirements.
The ISO/IEC 17025 checklist is an excellent resource for auditors, aiding in the creation of audit questionnaires to verify the effectiveness of the implemented Laboratory Management System. There are numerous internal audit requirements based on the ISO/IEC 17025:2017 standard.
Organizations applying for or renewing their ISO/IEC 17025 certification should complete this checklist. Additionally, if significant changes have been made to the management system’s structure, the ISO/IEC 17025 2017 checklist should be updated.
The sections in the ISO/IEC 17025 2017 checklist follow the order of the official standard. In some instances, they are also referred to as supplementary required documents.
What is an ISO/IEC 17025 2017 Checklist?
An ISO/IEC 17025 checklist is a comprehensive tool designed to assist auditors in evaluating the effectiveness of a laboratory’s management system and its ability to produce valid results against the requirements of the ISO/IEC 17025 standard. This checklist serves as a guideline to ensure all elements of the laboratory’s processes are properly implemented and maintained, covering critical areas such as management requirements, technical requirements, and continuous improvement processes.
By systematically addressing each requirement, the checklist helps identify areas where the laboratory excels or needs improvement, facilitating targeted actions to enhance overall laboratory performance. This structured approach not only supports compliance but also aids in sustaining long-term reliability and accuracy of test and calibration results, making it essential for laboratories committed to quality and competence.
What Does an ISO/IEC 17025 2017 Checklist Include?
An ISO/IEC 17025:2017 Checklist thoroughly evaluates a laboratory’s management system and technical competence against all the specific clauses of the standard, ensuring comprehensive compliance and effective management. The checklist covers:
- Scope: Understanding the boundaries and applicability of the laboratory’s activities.
- Normative References: Ensuring all referenced standards are considered.
- Terms and Definitions: Clarity on all terms used within the standard.
- General Requirements: Assessing impartiality and confidentiality.
- Structural Requirements: Evaluating the organizational structure and management responsibilities.
- Resource Requirements: Verifying the competence of personnel, laboratory environment, and equipment.
- Process Requirements: Examining requirements for methods, validation, sampling, handling of test and calibration items, and reporting of results.
- Management System Requirements: Monitoring, measurement, analysis, and improvement of the management system, ensuring continual improvement.
This checklist serves as a vital tool for laboratories aiming to enhance performance and ensure compliance with the requirements for the competence of testing and calibration laboratories
How to Prepare for an ISO/IEC 17025 Audit?
Preparing for an ISO/IEC 17025 audit involves several key steps to ensure your laboratory’s management system and technical processes comply with the standard:
- Review Documentation: Make sure all your quality policies, procedures, and records are up to date and align with ISO/IEC 17025 requirements.
- Conduct Internal Audits: Perform regular internal audits to identify gaps and non-compliance issues. Address these issues promptly.
- Employee Training: Train your employees on the management system and their specific roles in maintaining ISO/IEC 17025 compliance.
- Management Review: Have top management review the laboratory’s performance, ensuring it meets the strategic objectives and continues to improve.
- Corrective Actions: Implement necessary corrective actions to address any discrepancies found during internal audits or previous external audits.
By meticulously preparing and addressing these aspects, you can help ensure a smooth ISO/IEC 17025 audit process.