ISO 17025 Checklist: Efficient and Regular Monitoring of Laboratory Competencies

Achieve precision in lab competency monitoring! Click here to learn how to create an ISO 17025 checklist efficiently with our expert guide.

Last Updated on January 31, 2024 by Ossian Muscad

ISO 17025 is the international standard that specifies requirements for the competence of testing and calibration laboratories. Laboratories that are accredited to ISO 17025 must demonstrate that they can regularly produce precise and accurate test and calibration results. One way to help meet these requirements is by using a digital iso 17025 checklist. This article will discuss an ISO 17025 checklist, how it can help you meet accreditation requirements, and how to create your own checklists.

 

What are the ISO 17025 Standards?

ISO 17025 standards are a set of globally recognized criteria that focus on the quality and technical expertise of testing and calibration laboratories. To achieve accreditation, labs must demonstrate that their operations follow these standards, ensuring the reliability and accuracy of their test and calibration data. These standards were published by the ISO (International Organization for Standardization) and IEC (International Electrotechnical Commission).

The standards cover several aspects, including the qualification of staff, equipment calibration, quality assurance of test and calibration data, test methodology, and the handling and transportation of test items. By adhering to ISO 17025, laboratories gain international esteem and assure customers of their commitment to best practices and quality results.

To be accredited to ISO 17025, laboratories must demonstrate that they have the personnel, facilities, and equipment to produce precise and accurate test and calibration results. They must also have quality management systems in place to ensure their results’ traceability, repeatability, and reproducibility. 

In addition, laboratories must have a competent staff that is trained in the specific methods they use. They must also participate in proficiency testing to ensure their results are comparable to other laboratories. Laboratories must have written procedures for all aspects of their operations. These procedures must be followed to ensure the quality of their results.

 

What is an ISO 17025 Checklist?

An ISO 17025 checklist is a comprehensive tool that laboratories use to ensure they meet all the requirements of the ISO 17025 standard. It is essentially a detailed list of criteria derived from the standard, covering every aspect of laboratory operations, such as personnel qualifications, equipment calibration, testing methodologies, and quality assurance practices.

By referencing the checklist, laboratory staff can perform internal audits, monitor ongoing compliance, and prepare for external accreditation assessments. These checklists not only aid in maintaining the highest possible quality of lab services but also act as a guide for continuous improvement and adherence to best practices in the scientific community.

 

ISO 17025 and ISO 9001: What’s the Difference?

Although both ISO 17025 and ISO 9001 are rooted in quality management principles, they differ notably in scope and specificity. ISO 17025 is tailored specifically for testing and calibration laboratories, focusing intensely on technical competence and the ability to generate precise and accurate results.

In contrast, ISO 9001 is designed for a broad array of organizations across all industries, emphasizing the consistency of processes and continual improvement. This overarching approach of ISO 9001 means it addresses various aspects of quality management without delving deeply into the unique operational intricacies of laboratories, as ISO 17025 does.

 

How to Prepare for ISO 17025 Certification

Preparing for ISO 17025 certification can be rigorous, but proper guidance and diligent preparation can make it manageable and rewarding. This section will guide you through the essential steps necessary to ready your laboratory for the accreditation process:

  1. Start by thoroughly studying and familiarizing yourself with the ISO 17025:2017 standard, which sets the requirements for testing and calibration laboratories. If you plan to opt for option B for your management system, including the ISO 9001 standards, which focus on quality management, is also essential.
  2. Next, conduct internal audits within your organization to identify any gaps or areas for improvement. These audits will help you uncover any issues and allow you to take corrective actions.
  3. Once you have analyzed the audit results, use the information you have gathered to train your employees. Align your processes with the ISO 17025 standards to ensure compliance and improve overall performance.
  4. It is crucial to maintain well-documented records of all audit results, process changes, and the competencies of your laboratory and employees. This documentation will serve as evidence of your compliance with the ISO 17025 standards.
  5. Finally, reach out to a reputable and distinguished third-party auditor to initiate the process of applying for ISO 17025 certification. Their expertise and guidance will be invaluable in ensuring a smooth certification process for your organization.

 

What Items to Include in an ISO 17025 Checklist

Creating a thorough ISO 17025 checklist is critical to ensure your laboratory adheres to the necessary standards and passes its accreditation. It serves as a roadmap to compliance, shedding light on areas that require attention and systematic review:

  • Personnel Qualifications: List of all laboratory staff, including their educational backgrounds, training records, and skill assessments. This ensures that the laboratory has a competent team capable of performing accurate and reliable tests.
  • Equipment Calibration and Maintenance: Schedule and records equipment calibration, maintenance logs, and performance verification. Regular calibration and maintenance activities help ensure the accuracy and reliability of test results.
  • Test and Calibration Methods: Documented and validated testing procedures, including non-standard methods. Having well-documented and validated methods ensures consistency and reliability in test and calibration processes.
  • Sampling: Procedures for sampling, handling, and transport of test items. Proper sampling procedures minimize the risk of contamination and ensure representative samples for accurate testing.
  • Quality Control Procedures: Details of quality control checks, including control charts and proficiency testing participation. Quality control procedures help monitor and maintain the accuracy and precision of test results.
  • Document Control: A system for document management to ensure the current versions of procedures and policies are in use. Effective document control ensures that laboratory personnel have access to the most up-to-date procedures and policies.
  • Reporting of Results: Templates and protocols for reporting test and calibration results, ensuring accuracy and clarity. Standardized reporting processes enhance the quality and consistency of result reporting.
  • Complaints and Non-conforming Work: Processes to handle complaints and non-conformities, including corrective actions and records. Effective complaint handling and non-conforming work processes help identify and address issues to prevent recurrence.
  • Improvement Processes: Mechanisms for continuous improvement and addressing potential risks and opportunities. Continuous improvement processes foster innovation, efficiency, and effectiveness in laboratory operations.
  • Internal Audits: Schedule and procedures for conducting thorough internal audits. Internal audits provide an independent assessment of the laboratory’s compliance with established standards and procedures.
  • Management Reviews: Timeline and procedures for regular management reviews of the system’s performance. Management reviews ensure the effectiveness and suitability of the laboratory’s quality management system.
  • Supplier Evaluation and Subcontracting: Criteria for evaluating suppliers and subcontractors, ensuring they meet necessary quality standards. Proper evaluation of suppliers and subcontractors helps ensure the quality and reliability of outsourced activities.
  • Environmental Conditions: Monitoring and control of environmental conditions affecting the laboratory operations. Monitoring and controlling environmental conditions help maintain the integrity and reliability of test results.
  • Data and Record Management: Systems for secure data collection, processing, and record retention to ensure data integrity and privacy. Effective data and record management processes protect the confidentiality and integrity of laboratory data.

 

Frequently Asked Questions (FAQs)

Q1: How often should internal audits be conducted to ensure compliance with ISO 17025?

Internal audits should ideally be conducted at least once a year. However, the frequency may increase based on the laboratory’s needs, the number of corrective actions arising from previous audits, or changes in ISO 17025 requirements.

Q2: Is it necessary to have separate checklists for different departments within a single laboratory?

While a central ISO 17025 checklist covers the overall laboratory operations, separate, tailored checklists for different departments may be beneficial. They can address specific procedures and equipment relevant to each department, ensuring a more focused and detailed compliance check.

Q3: How important is proficiency testing for ISO 17025 accreditation?

Proficiency testing is critical as it demonstrates a laboratory’s capability to produce valid results. Participation in these tests is a regular part of quality control procedures and is required for ISO 17025 accreditation.

Q4: Can a laboratory be ISO 9001 certified and still not meet ISO 17025 standards?

Yes, a laboratory can be ISO 9001 certified and still not comply with ISO 17025. ISO 9001 emphasizes quality management systems for various industries, whereas ISO 17025 has specific requirements focusing on the technical competence and result accuracy of laboratories.

Q5: What is the validity period of ISO 17025 certification, and what is the process of renewal?

ISO 17025 certification typically remains valid for three years. The renewal process involves a reassessment audit to ensure continued compliance with the standard. It’s crucial to maintain quality and audit readiness to streamline the renewal process.

Q6: Are there different levels of ISO 17025 accreditation, or is it a single standard?

ISO 17025 is a single standard with no levels of accreditation. It is an all-encompassing standard that defines the general requirements for the competence of testing and calibration laboratories. All accredited laboratories must meet the same requirements.

 

Create an ISO 17025 Checklist with DATAMYTE

DATAMYTE is a quality management platform with low-code capabilities. Our Digital Clipboard, in particular, is a low-code workflow automation software that features a workflow, checklist, and smart form builder. This tool lets you create your own ISO 17025 checklist with ease, defining the criteria and requirements specific to your laboratory.

DATAMYTE also lets you conduct layered process audits, a high-frequency evaluation of critical process steps. This audit focuses on areas with the highest failure risk or non-compliance. Conducting LPA with DATAMYTE lets you effectively identify and correct potential defects before they become major quality issues.

With DATAMYTE, you have an all-in-one solution for managing your ISO 17025 checklist and ensuring compliance. Our platform also enables continuous improvement, data analysis, and reporting capabilities to help your laboratory maintain its accreditation and improve its overall operations. Book a demo now to learn more.

 

Conclusion

Adherence to the ISO 17025 standard is critical for laboratories seeking to demonstrate their technical competency and reliability in testing and calibration. By implementing a robust checklist that encompasses all facets of the standard, laboratories can manage their compliance effectively. Regular internal audits, proficiency testing, and a commitment to continuous improvement are key to maintaining ISO 17025 accreditation.

Moreover, structured data management and detailed record-keeping will support the integrity and reproducibility of test results, fortifying the laboratory’s reputation. Therefore, every laboratory must prioritize and rigorously pursue compliance with ISO 17025 to solidify its standing as a trustworthy and capable establishment in the scientific community.

 

 

Related Articles: