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ISO 17025 is more than just a regulatory requirement, it is a mark of credibility for laboratories. Without it, even highly advanced labs may struggle to gain recognition. But what does the certification process involve? This article explores which laboratories need ISO 17025, its benefits, and provides a step-by-step guide to achieving certification.
ISO 17025 – you’ve probably heard this term more than once. But is it just another bureaucratic hurdle, or does it truly matter for laboratories?
In reality, this standard is the gold seal of credibility. It proves that a lab can consistently deliver accurate results, earning trust from customers, regulators, and accreditation bodies. Without it, even the most advanced lab may struggle to gain recognition.
Accreditation bodies play a crucial role in this process by providing the necessary support and resources for laboratories. They detail the accreditation process, requirements, and the established criteria for maintaining technical competence. Selecting the right accreditation body that aligns with a laboratory's specific needs is essential for quality management and continuous improvement.
But does every lab need ISO 17025 certification? And what does it take to achieve it? In this article, we’ll answer all your ISO-related questions and wrap up with a step-by-step guide to getting this certification. But first, let’s tackle the basics – what types of labs actually need ISO 17025?
ISO/IEC 17025 is an international standard that outlines the general requirements for the competence, impartiality, and consistent operation of testing and calibration laboratories. This standard is designed to instill confidence in the operation of these laboratories, ensuring they produce accurate and reliable test and calibration results. Essentially, ISO 17025 provides a framework for laboratories to demonstrate their technical competence and adhere to international best practices. By following this standard, laboratories can ensure that their operations are consistent, their results are reliable, and their processes are transparent and impartial.
For testing and calibration laboratories, ISO 17025 is indispensable. It provides a structured framework that ensures the quality and reliability of their test and calibration results. This standard is widely recognized and respected by regulatory authorities, accreditation bodies, and customers. Often, it is a prerequisite for laboratories aiming to demonstrate their technical competence and achieve accreditation. Implementing ISO 17025 can significantly enhance a laboratory’s credibility and reputation, boost customer confidence, and provide a competitive edge in the marketplace. By adhering to this standard, laboratories can ensure their operations meet the highest levels of quality and reliability, which is crucial for gaining trust and recognition in the industry.
ISO 17025 isn’t just for high-profile research facilities. It applies to any lab that performs testing, calibration, or measurement services. While the certification isn’t always mandatory, many companies pursue it to strengthen their credibility and reduce compliance risks.
Here are the main industries that pursue ISO 17025 certification:
Here’s why so many labs pursue it, even when it’s not legally required:
✅ Builds credibility. ISO 17025 certification proves that a lab meets globally recognized quality and competence standards. Clients, regulatory bodies, and even international partners see it as a guarantee that lab results are accurate, reliable, and produced under strict quality controls. Without it, a lab might struggle to win large contracts or expand into new markets.
✅ Reduces additional audits. ISO 17025 certification serves as a globally recognized proof of a lab’s competence, demonstrating that it follows standardized procedures and produces reliable results. Many clients and regulatory agencies accept this certification as sufficient evidence of compliance, reducing the need for separate audits for each customer or authority. This minimizes disruptions, saves time, and accelerates project approvals.
✅ Saves costs. Errors in testing and calibration are expensive. Incorrect results can lead to product recalls, compliance failures, or costly rework. ISO 17025 helps labs establish strict quality controls, reducing the likelihood of mistakes and ensuring that tests are done right the first time.
✅ Improves risk management. ISO 17025 enforces structured procedures for everything, from equipment maintenance to staff training, reducing the chances of flawed results, regulatory violations, or liability issues. It helps labs operate with confidence, knowing they’re meeting international best practices.
✅ Enhances quality control. ISO 17025 ensures that every test and calibration follows the same high standards. With clear procedures in place, results are more accurate and mistakes are less frequent. Over time, this commitment to quality builds trust and sets a lab apart as an industry leader.
Now that we’ve seen its benefits, let’s break down the key requirements for achieving ISO 17025 certification.
Achieving laboratory accreditation to ISO 17025 offers numerous benefits for testing and calibration laboratories. One of the most significant advantages is enhanced credibility and global recognition. Accreditation signifies that a laboratory has undergone an independent assessment and has been found competent and impartial. This provides a high level of assurance that the laboratory’s test and calibration results are accurate and reliable, which can significantly boost customer confidence and trust. Additionally, accreditation can offer a competitive advantage in the market, as it demonstrates a commitment to quality and excellence.
Accreditation to ISO 17025 also facilitates international trade and cooperation by providing a common framework for evaluating the competence of laboratories across different countries and regions. This global recognition can open up new markets and opportunities for laboratories.
Other benefits of ISO 17025 accreditation include:
Overall, laboratory accreditation to ISO 17025 can help testing and calibration laboratories improve their operations, enhance their credibility and reputation, and gain a competitive edge in the market.
ISO 17025 compliance is built on five core requirements:
The management system requirements outlined in ISO 17025 emphasize the importance of a structured management system within a laboratory. This includes documentation control, risk management, continual improvement, corrective actions, internal audits, and management reviews, all crucial for ensuring compliance and quality in laboratory practices.
Let’s see what each of these requirements imposes.
Results should never be influenced by outside pressure, and sensitive client data must be protected. Laboratory activities, as outlined in the ISO/IEC 17025 standard, must be documented to ensure compliance and effective management. This means setting up policies that prevent conflicts of interest and ensuring only authorized personnel have access to test results. For example, in a food and beverage lab, strict protocols must be in place to prevent cross-contamination between test samples and to protect sensitive information related to client products.
Next comes structure – a lab needs clear leadership and a solid legal foundation. Who’s responsible for quality assurance? Who oversees compliance? Defining roles and responsibilities prevents confusion and ensures accountability. In a food lab, for instance, it's crucial to document who is responsible for reviewing testing procedures to ensure they meet regulatory standards and consistently produce reliable results.
Skilled technicians and calibrated instruments are the backbone of reliable testing. Labs must provide ongoing staff training and ensure their equipment meets strict accuracy standards. Proficiency testing is crucial in training personnel on proper sample handling and evaluation processes, and it is integral to achieving compliance with ISO 17025. For a beverage lab, this might involve regularly calibrating pH meters and temperature-controlled storage equipment to maintain accurate measurements in product testing.
Labs must follow standardized methods for testing, documentation, and record-keeping to ensure consistency. ISO 17025 outlines protocols for laboratories to ensure competency and reliability through rigorous testing and calibration processes. Every contract, test sample, and report should follow the same structured approach. In a food lab, as an example, ensuring that every batch of raw ingredients is tested for contaminants using the same method prevents inconsistencies in the final product quality.
Finally, there’s continuous improvement – a lab can’t just get certified and call it a day. Regular internal audits, document control, and process reviews are essential to staying compliant and optimizing operations. A beverage lab, for instance, should regularly review its testing methods to ensure they meet evolving health and safety regulations and maintain high standards of product safety.
Ensuring that testing and calibration results are recognized and trusted by suppliers and regulatory authorities is critical. Accreditation under the ISO/IEC 17025 standard outlines the requirements for the competence of laboratories conducting such tests.
To sum up these requirements, here’s ISO 17025 at a glance:
These five principles lay the foundation for a well-functioning, internationally recognized lab. Now let’s discover the path to certification.
Achieving ISO 17025 certification doesn’t happen overnight. It requires a structured, methodical approach to bring your lab’s processes in line with the rigorous standards. Here are the 7 steps you should follow to achieve the certification.
Start by taking a deep dive into your lab’s existing operations. This will give you a clearer picture of the gaps you need to address. You can start by performing a gap analysis to compare your current practices against ISO 17025’s core requirements. Make note of any missing documents, outdated procedures, or equipment that’s out of compliance.
ISO 17025 is all about making sure your lab’s processes are repeatable, consistent, and reliable. That means every test, calibration, and measurement should produce the same high-quality results every time, no matter who performs it. To achieve this, you need a QMS, a structured framework that defines how your lab maintains quality, ensures accuracy, and meets compliance requirements. Think of it as a rulebook for everything from handling samples to reporting test results.
Management systems play a crucial role in ensuring quality and competence across various standardization and accreditation efforts, particularly within sectors that require consistent adherence to defined protocols.
A strong QMS ensures that:
✅ Every test is performed the same way, following written Standard Operating Procedures (SOPs).
✅ Equipment is regularly calibrated and maintained to ensure accuracy.
✅ Staff understand their roles and responsibilities in maintaining quality.
✅ Results are traceable, documented, and meet regulatory requirements.
To build a QMS, you can follow this checklist:
Your team plays a crucial role in achieving ISO 17025 certification. They must understand the standards and follow the procedures consistently. To help them get used to new processes, labs can organize training sessions for their teams. For example, labs can hold monthly workshops to review SOPs and explain why each step matters, so staff understand the importance of their role in maintaining lab standards.
Your lab processes should be repeatable, traceable, and compliant. A well-structured workflow prevents errors and keeps everything running smoothly. Ensuring laboratory staff have the necessary qualifications and competencies to perform testing and calibration activities effectively is crucial. Use automation where possible to reduce human error and improve efficiency. For example, instead of relying on handwritten logs, you can use an electronic system to track samples from collection to final results. This ensures full traceability and reduces paperwork errors.
Before applying for accreditation, conduct a thorough self-audit to identify and resolve any compliance gaps. Treat it as a real audit – review every process, document, and record just as an external auditor would.
ISO 17025 accreditation is crucial for laboratory testing and calibration, as it ensures that third-party enforcement agencies can conduct audits to verify compliance with industry standards. Aligning your Quality Management Systems (QMS) with these standards is essential for achieving certification.
Here’s a quick guide on conducting an effective internal audit:
If you discover any non-compliance issues, such as missing records, outdated SOPs, or calibration gaps, fix them immediately to avoid problems during the real audit.
Once your lab meets all the requirements, it's time to submit your application for official accreditation. Ensure your documentation is comprehensive and well-organized before applying.
💡 Tip: a well-maintained documentation system will greatly facilitate the accreditation process. Consider adopting a LIMS to securely record all your data, making it easy for auditors to access and verify every detail.
Once you’ve achieved ISO 17025 certification, maintaining compliance is the next challenge. That’s where LIMS comes in. These systems simplify compliance tasks, help you track every detail, and ensure you stay on top of audits and inspections with ease.
To see how LIMS helps laboratories keep up with ISO 17025 requirements, let’s take a look at 1LIMS, a cloud-based intuitive platform for keeping and tracking all lab data.
1LIMS makes it easy to maintain ISO 17025 standards by automating many of the tasks involved in compliance. Here’s how:
With 1LIMS, every action is automatically recorded, creating a transparent history of changes. Auditors can instantly retrieve complete traceability logs for any sample, test, or report.
All reports, certificates, SOPs, and calibration logs are stored in one integrated platform. No more scattered spreadsheets – everything is versioned, searchable, and ready for audits.
Eliminate paper-based approvals with legally compliant eSignatures. Lab managers can sign off on reports digitally, ensuring a faster and more secure approval process.
When test results fall outside expected parameters, 1LIMS automatically initiates a retest using the same sample. This way, potential errors are identified and corrected early, maintaining accuracy and reliability in your lab’s results.
Avoid mislabeling and tracking errors with automatic barcode assignment. 1LIMS generates QR codes for each sample, allowing you to scan and instantly access its full history from procurement to testing, ensuring complete traceability for your team and auditors.
Keep sensitive data secure by assigning role-based permissions. Lab managers control who can view, edit, or approve reports, reducing the risk of unauthorized changes or data breaches.
Now, imagine an auditor asking for a sample’s test history. Instead of digging through old spreadsheets, 1LIMS lets you pull up the full traceable record in seconds – from sample collection to the final report. No more missing documents or compliance headaches. Just smooth, efficient lab management.
Achieving ISO 17025 compliance is a structured process, but maintaining it is where the real challenge begins. The reality is, your staff can’t just work faster and make zero mistakes. It’s not humanly possible. But what is possible is giving them the right tools. With an automated data management system, you can take tedious tasks off their plate, cut down on errors, and free up hours of work every day. Compliance doesn’t have to be a struggle – it just takes the right system in place.
But not all LIMS solutions will work for you. Choosing the right one can make all the difference (check out our guide The Best LIMS Software: How to Choose the Right Solution for Your QC Lab).
In conclusion, it’s more than possible to get ISO 17025 certification in several steps.
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