ISO 17025: A Comprehensive Guide for Labs

ISO 17025 sets the benchmark for your laboratory’s technical competence, quality management, and ability to produce reliable results.

While technically not required (more on that later), ISO 17025 is an important standard to meet if you want to be included in a growing global network of accredited labs and earn your customers' trust.

In principle, it seems simple: demonstrate sound quality control practices and reliable results. If your lab is still managing data manually, though, you could have a long road ahead.  In this guide, we’ll explain the standard, show you how to meet it, and walk through how a LIMS can support compliance.  

What is ISO 17025?

ISO 17025 is an internationally recognized standard that specifies requirements for the competence, impartiality, and consistent operation of laboratories. The latest standard was revised in 2017 and reaffirmed in 2023 and is officially known as ISO/IEC 17025. The revision included updates to IT (information technology) and quality management system processes, as well as a greater emphasis on senior management responsibilities.

ISO 17025 serves as a global benchmark for laboratories wishing to demonstrate their ability to produce reliable results, enhancing confidence in their work nationally and worldwide. 

ISO 17025 can be broken down into five basic requirements:

• General requirements
• Structural requirements
• Resource requirements
• Process requirements
• Management requirements

We’ll explore these in greater detail later to guide you through the best practices for each.

Is ISO 17025 a Requirement for Labs?

No, compliance with ISO 17025 is not mandatory for laboratories, as no governing body, such as the FDA, requires it; however, it is advantageous to comply nonetheless. 

If your lab wishes to demonstrate its technical competence and reliability to existing or prospective customers, you could rely on your word, but the phrase “trust us” won’t get you very far compared to being accredited. Some companies go so far as to refuse to work with labs that aren’t ISO accredited, making this well worth the investment from both a business and a compliance perspective.

The Benefits of Meeting ISO 17025

Beyond earning the respect of companies across the globe and making it easier for potential customers to trust you, there are other benefits of meeting ISO 17025 that are worth mentioning:

• You’ll gain confidence that your test results are unbiased and impartial
• You can provide your existing customers with a tangible, objective way to demonstrate your lab's technical competence and reliability.
• You will build a better reputation domestically and internationally.
• You will be able to add another differentiator between your lab and your competitors.
• Upon passing accreditation, you will receive a seal and accreditation number that you can use in your marketing and sales collateral.
• Being ISO accredited may eliminate concerns from potential customers and requests for independent 3rd-party audits.

Not to mention the actual process of meeting the standard – improving quality control and data management within your lab – will drastically improve your operations, mitigate potential time-wasting errors, and result in smoother operations overall.

Which Labs Should Consider ISO 17025

ISO 17025 applies to all laboratories engaged in testing, calibration, and sampling activities, regardless of their size, the industry they serve, or the complexity of the analyses they perform. In short, if your lab measures something and wishes to demonstrate the reliability of those measurements, then ISO 17025 matters. 

Here are some specific examples of laboratories that need to comply with ISO 17025:

• Testing laboratories: These can include chemical, biological, microbiological, environmental, food, pharmaceutical, and materials testing labs. They perform a variety of tests across different materials and products to ensure safety, compliance, and quality.
• Calibration laboratories: Labs that provide calibration services for measurement instruments in fields such as temperature, pressure, electrical, dimensional, and optical need to comply. This ensures the accuracy and traceability of the measurement instruments they calibrate.
• Government and regulatory laboratories: Labs operated by government agencies or under their mandate, conducting tests and calibrations in the public interest, for regulatory compliance, public health, safety, and environmental monitoring.
• Research and development laboratories: Labs conducting R&D may also seek compliance if they provide testing and calibration services that require recognition of their technical competence and the reliability of their results.
• Quality control laboratories: In industries such as pharmaceuticals, manufacturing, and construction, quality control labs conduct critical tests on products and materials to ensure compliance with specified standards and regulations.

If you wish to demonstrate the reliability of your lab to your customers, there is no better way than to be ISO 17025-accredited.

What Are the Requirements for ISO 17025 Compliance?

The ISO/IEC 17025 standard is structured around the following five categories of requirements:

• General requirements
• Structural requirements
• Resource requirements
• Process requirements
• Management requirements

Each category is designed to ensure your lab operates with quality control and produces consistent, valid results. Let’s walk through these sections in depth.

General Requirements For ISO 17025

The general requirements for ISO/IEC 17025 center on two core principles. 

First, labs must demonstrate impartiality, ensuring that all work is completed without bias. Second, labs must maintain confidentiality to demonstrate that customer information is properly protected. This should already be the case in your lab, but take the time to document and reflect on it when you prepare for accreditation.

Structural Requirements For ISO 17025

The structural requirements of ISO/IEC 17025 cover your lab’s organizational foundation 

There must be evidence of a person who has management responsibility for your laboratory. Your lab must also be a legal entity, or part of a legal entity, that is responsible for its testing and calibration activities. Additionally, your lab must define a range of activities and document procedures accordingly.

Resource Requirements For ISO 17025

The resource requirements for ISO/IEC 17025 address your staff training and lab conditions.

Personnel requirements require the lab to document staff competence, including their education and work experience, while maintaining records of their training and ongoing evaluations. Facilities and environmental conditions must be suitable for the activities being performed. Finally, your lab must provide proof that all equipment is validated, calibrated, and checked before use.

Process Requirements For ISO 17025

The ISO/IEC 17025 process requirements cover operational procedures throughout the testing lifecycle. 

This includes things like:

• Test requests and contracts
• Protocols for handling samples
• Technical records for samples, tests, and inventory
• Ongoing validation and calibration of equipment
• Processes for handling complaints

Finally, data control requires the lab to have systems in place to securely store data. Ideally, these should also include audit trails and backups.

Management Requirements For ISO 17025

The management requirements for ISO/IEC 17025 focus on oversight and continuous improvement. Document control requires labs to establish and implement a system to maintain documents and the scope of their activities. Risk management requires labs to demonstrate their ability to identify, assess, and mitigate risks to procedures and operations. Internal audits must be conducted regularly to ensure ongoing compliance with ISO 17025 standards.

What Your Lab Needs to Meet ISO 17025

ISO 17025 is deliberately designed not to be prescriptive as to the tools or software you need to meet it; however, by following the above guidelines, we can break our recommendations into the following categories:

• Equipment
• Software

Equipment

This will ultimately depend on your lab, industry, and test types. However, as a rule, we would recommend investing in the following if you haven’t already:

• Some form of calibration management: All equipment used to generate results must be documented and calibrated, with traceability to national or international standards (NIST Traceable calibration). The standard doesn't care whether you're using a $500 balance or a $500,000 mass spectrometer – it cares whether you can prove it's calibrated, maintained, and fit for purpose.
• Environmental monitoring equipment. If your test methods are sensitive to temperature, humidity, or other environmental conditions, you need to monitor and record them. This often means calibrated thermometers, hygrometers, or data loggers throughout the lab.
• Sample handling and storage. Appropriate containers, refrigerators, freezers, or other storage that maintain sample integrity. Nothing fancy required—just documented evidence that your storage conditions are controlled and monitored.

The above will help ensure your lab runs smoothly; they can only go so far when you log and audit data in fallible notebooks or spreadsheets. That’s where software comes in handy, though.

Software

You can only get so far if you manage sample data, inventory, or training records manually. These days, modern labs rely on specialized software to manage data at scale. The two most common options are:

• QMS: A QMS (Quality Management System) is a software platform designed to help labs meet customer requirements and regulatory standards. This can ensure that your lab consistently and efficiently produces products and performs services.
• LIMS: A LIMS (Laboratory Information Management System) is a comprehensive software platform designed to manage and track samples, tests, and results throughout the entire lab workflow. 

No matter what software you choose, we recommend considering the following:

• Cloud vs. on-premise: Cloud-based LIMS offer faster implementation, lower upfront costs, automatic updates, and easier remote access, while on-premise systems may be preferred by labs with specific security requirements or limited internet connectivity.
• Configurability: Does the vendor require custom coding from a developer, or is it configurable so anyone on your team can log in and adjust settings to adapt the platform to your needs? Take care to evaluate a vendor’s stance on this, and ask for examples of what can be configured in the platform.
• Implementation timeline and approach: No LIMS comes “out of the box,” but some platforms are easier to implement than others. Take care to understand the vendor’s approach to implementation and requirements before you begin. Fast is not always best; some vendors offer a quick implementation with months of work after your go-live date for extended services. 
• Expertise of the team: Anyone can build a software platform and market it to labs, but how many vendors have actually worked in a lab setting before? Look for a vendor who understands your needs because they’ve walked a mile or two in your shoes. For example, at QBench, we’re proud to employ many people who have worked in your shoes and understand what lab managers and staff go through each day.

Between a QMS and a LIMS, we’d recommend a LIMS. In the next section, we’ll share how a LIMS can help you prepare for accreditation.

How Does a LIMS Support ISO 17025

We mentioned earlier that you need systems in place to manage your lab’s data.

You could use a combination of paper notebooks and spreadsheets, but neither will provide the level of support you need at scale. For that, a LIMS, whether home-grown or cloud-based, will be your best option.

A LIMS will require planning and investment on your part, so is it worth the effort? Absolutely, here’s why:

• Improved data integrity, traceability, and security
• Streamlined document control
• Support for validation and technical competence
• Support for quality control
• Automated reporting

Improved Data Integrity And Security

Of all the benefits of a LIMS over spreadsheets or notebooks, data management and security rank among the top. 

Spreadsheets, while digital, are inherently insecure and scale poorly. A LIMS, on the other hand, ensures that all data, from sample receipt to reporting results, is accurately captured and securely stored. With key features like:

• Automated data capture
• Chain of custody tracking
• Audit trails
• User access controls
• Electronic signatures
• Equipment calibration schedules and documentation

You will be able to demonstrate the reliability and trustworthiness of your data across inventory, samples, and test results.

Streamlined Document Control

Document control is a crucial management requirement under ISO/IEC 17025. 

A LIMS can help here, too, by simplifying how your lab manages documents such as SOPs, calibration records, and QC materials. You can also ensure that only the latest versions are accessible to staff, keeping your team trained on current best practices and demonstrating that level of training when you get accredited.

Support For Method Validation And Technical Competence

Method validation is a core technical requirement under ISO/IEC 17025, and a LIMS makes it far easier to manage.

A LIMS facilitates the validation of testing and calibration methods by maintaining detailed records of validation studies, including performance characteristics, uncertainty measurements, and approval status. It can also track personnel qualifications and training records, helping you demonstrate that your team has the technical competence to perform specific tests. When an assessor requests proof that a method was properly validated and that the analyst running it was qualified, your LIMS should have that documentation available for retrieval.

Managing Quality Control Procedures

A LIMS can do more than data management; some LIMS offer QA/QC features, too.

A LIMS with a built-in QMS like QBench can do the following:

• Track and resolve Issues ‍
• Track proficiency testing, risk assessment, mgmt system reviews
• Track Root Causes and Corrective and Preventive Actions (CAPA)
• Track instrument calibration, issues, and maintenance records
• Create and update Standard Operating Procedures (SOPs)
• Create and update training materials
• Store all lab documentation

All keys to demonstrating proper quality control procedures in your lab.

Automating Reporting And Customer Communication

Reporting is where all your lab's work comes together, and it's also where ISO/IEC 17025 specifies requirements for what must be included and how results are presented.

A LIMS can generate accurate, detailed reports that comply with these requirements by pulling in all relevant data (test results, uncertainty values, sample information, and method references) without manual transcription errors. 

Beyond report generation, a LIMS can also streamline customer communication by providing clients with secure portal access to view test statuses, download completed reports, and track their samples through your workflow. This level of transparency builds trust with your customers while reducing the back-and-forth emails and phone calls that eat into your team's time.

What to Expect for the Accreditation Process

The specific process you take to meet ISO 17025 standards will largely depend on your lab’s current setup, processes, and software. That said, you can break the accreditation process into the following phases:

• Gap Assessment
• System development
• Application and document review
• On-site assessment

You will need to work through the first three on your own, and then reach out to an accrediting body for an on-site audit. We’ll review the steps in more detail below.

Gap Assessment

Start by evaluating your current processes against the requirements.

This usually involves a formal gap analysis – either internal or with a consultant – that identifies what's missing: 

• Undocumented procedures
• Equipment needing calibration records
• Training documentation gaps
• Missing method validations. 

Labs that have never pursued accreditation often underestimate the extent of the foundational work this reveals.

System Development and Implementation

This is where most of your time will be spent. 

Once you’ve conducted a gap analysis, it’s time to get to work to implement the suggestions and software if necessary. This means activities like:

• Writing SOPs
• Establishing document control processes
• Creating forms and templates
• Validating methods
• Setting up calibration schedules
• Training staff
• Conducting internal audits

The timeline will vary based on the size and scope of your lab; this could take anywhere from a few weeks to several months. Don’t rush this process, though. Taking time here is key to ensuring you pass an audit.

Application and Document Review

Once you’ve taken the time to audit, improve, and document your processes, it’s time to submit your application to the appropriate accreditation body. In the US, that is typically A2LA or NVLAP, but note that other countries have their own bodies. 

The accreditation body reviews the quality manual and supporting documentation before scheduling the on-site assessment; note that this is an assessment of specific methods, parameters, and metrics, not your entire lab. They may request clarifications or additional documents during this phase.

On-Site Assessment

Now it’s time for the moment you’ve been waiting for: the on-site assessment. 

Auditors will visit your lab to verify that the documented system matches actual practice. Expect them to interview staff, observe testing procedures, review records, and check equipment. The duration of this visit will depend on the scope and complexity of your lab, so make sure to allocate enough time based on your size and the variety of test methods.

The assessors will then document their findings and raise any nonconformities requiring action. You will need to address these, submit evidence, and wait for a review. Minor findings may be cleared with a simple submission, but major findings may require a follow-up visit. 

Once your submission has been approved, congratulations are in order because you will be accredited. Then it’s up to your lab to maintain accreditation through ongoing reviews, typically conducted annually.

Common Pitfalls That Can Impact Accreditation

Before we close things out, watch out for the following common pitfalls that trip up labs when seeking accreditation. 

• Document control gaps: It’s common for labs to create SOPs and quality manuals when seeking accreditation, but they often fail to maintain them. If assessors find that procedures don’t match the actual processes in your lab, the documents have outdated revision dates, or staff resort to informal workarounds, then you will be denied accreditation.
• Incomplete training records: You need to prove that your staff receive ongoing training, not just training when joining your lab. Assessors want evidence that all personnel remain competent over time, not just once.
• Poor CAPA management: You need to go beyond flagging that nonconformities occurred and highlight the root causes and the specific measures taken to correct them. Many labs close out CAPAs administratively without verifying effectiveness.
• Lack of calibration traceability: Even if your equipment is calibrated, if there are no records to trace the calibration history or documented measures to verify readings, then you will fail. Assessors dig into this because measurement uncertainty claims fall apart without solid calibration records.

Download the ISO 17025 Compliance Guide

For a lab seeking to demonstrate its reliability and competence, there is no better standard to meet than ISO 17025. 

We’ve covered a lot of ground in this article. You’ve learned the requirements for ISO 17025, the general process for being accredited, how a LIMS can help, and what to watch out for. Now, it’s time for you to take what you’ve learned and put it into practice.

Fill out the form below to download our free ISO 17025 guide. It covers much of the material in this article, so you can share it with your team and begin the accreditation process.