No matter your industry, demonstrating your lab's reliability and ability to comply with regulations will be critical to your success.
One such regulatory standard, ISO 17025, is vital for labs wishing to demonstrate the reliability and consistency of their tests and lab orderliness. Meeting this standard builds trust, reduces the room for error, and will help your lab scale. However, it can be difficult without the right tools to equip your lab.
In this article, we will detail the requirements for ISO 17025, along with its overlap with good practice (GxP), and show you how a laboratory information management system (LIMS) can empower your lab to meet these standards.
ISO was revised in 2017 and is officially known as ISO/IEC 17025:2017. The revisions include updates to:
ISO is reviewed every five years (give or take); the 2017 version was last reviewed and reconfirmed in 2023. ISO serves as a global benchmark for laboratories wishing to demonstrate their ability to produce reliable results. While this may seem like a basic competency of any lab, meeting ISO enhances confidence in your lab — both nationally and globally.
ISO covers “reliable test results” in a lab. But what does this mean, and what are the requirements?
We’ll explore these further later and show you the steps your lab can take to get accredited. Before we outline those requirements, read on to determine whether your lab must or should comply.
Does ISO 17025 apply to your lab?
Well, if your lab is engaged in testing, calibration, or sampling activities and wishes to demonstrate the reliability of those measurements, then the answer is yes.
The short version is that if your lab measures something and wants to be recognized for being consistent and impartial in those measurements, ISO applies to you.
In terms of specific industries, this applies to:
But is ISO required for your lab to do business?
While ISO 17025 is a valuable standard for demonstrating the reliability of your lab, it’s technically not required. At least not in the way medical labs require HIPAA compliance.
That said, demonstrating competency and reliability in your lab will be essential whether you wish to earn new business or build your lab’s reputation. Because of this, meeting ISO 17025 is a good idea for most labs.
We’ll explore the specific benefits of meeting ISO standards next.
If ISO is not required, is it worth completing those five requirements and the accreditation process? For many labs, yes.
If you want to demonstrate the technical competence of your lab to customers, regulatory authorities, or accreditation bodies, then you can bet that it will be required.
In fact, some businesses will not work with a lab that is not ISO 17025 certified. Beyond esteem and new business, there are a few other significant benefits to consider as well:
And a few benefits that overlap with GxP:
So, no, ISO is not a requirement for labs. But it may effectively be a requirement. As you can see, there is a direct crossover between ISO 17025 and GxP, so let’s dig further into that next.
As you can see, many ISO requirements are simply good practices for labs to follow.
It’s pretty obvious that being able to trust your lab results is essential, but that doesn’t mean that even the most obvious things should not be documented by standards. One similar standard worth exploring more is a set of requirements bundled under GxP.
GxP was originally established by the FDA and covers a set of standards that ensure products produced by labs are safe, that they meet their intended use, and that quality standard processes are in place in the labs that manufacture them.
GxP is a generic term that covers several industry best practices. You can think of GxP as “Good <fill in an industry> Practice,” which lays out a series of standards and guidelines to follow.
GxP can be broken down into the following categories of requirements (commonly called the “5 Ps of GxP”):
Source: QBench.com
Like ISO, GxP emphasizes following and maintaining best practices in your lab to ensure reliable and trustworthy results and products. Because of this, meeting ISO standards naturally lends itself to meeting GxP standards.
All of these requirements are well and good on their own, but there’s a difference between adhering to ISO (and GxP) requirements and actually being certified.
The process is fairly straightforward (though the work to implement the requirements will depend on the current state of your lab). First, you need to ensure that you meet the requirements (more on that next), and then you will need to pass an assessment from an accreditation body (more on that later).
Let’s walk through these requirements step by step.
As mentioned earlier, the requirements for ISO 17025 can be broken down into the following five sections. Let’s walk through each of these in detail.
Your lab must be able to demonstrate that all work is completed in an impartial and unbiased manner while maintaining confidentiality.
There must be a person in charge of managing the lab and a legal entity responsible for the testing and calibrating activities. You must also document all activities and procedures.
Your lab must document compliance and ongoing education of its staff. Records of this training must be maintained and accessible. You must maintain the facilities and equipment, ensuring your workspace is clear, clean, and calibrated (remember this from GxP).
Your lab must review all requests for tests and contracts. You also need processes in place for sampling and handling items in your lab. Lab records must be maintained, and processes and procedures must be validated to demonstrate the reliability of your tests.
Your lab also needs a centralized way to manage information and ensure that backups of your lab’s data can be retrieved in the event of a failure. While many labs still rely on manual methods like pen and paper, a LIMS is highly encouraged.
Your lab must establish and implement a system to maintain documents and the scope of their activities. You must also demonstrate your ability to identify, assess, and mitigate risks to procedures and operations. It’s also recommended that you conduct regular internal audits to ensure they conform to the standards of ISO 17025.
Source: QBench.com
This is a brief overview. You can review the full set of guidelines on the iso.org website. Now, let’s put these into practice. Read on for the steps to meet ISO compliance.
With the requirements in hand, now it’s time to put them into action and certify your lab. To acquire ISO 17025 certification, you need to follow these steps:
After acquiring a copy of the ISO guidelines, read them in full and understand the obligations your lab needs to fulfill to meet them. A simple gap analysis to review where you meet the guidelines and where your lab falls short will shed light on what you need to work on before your assessment.
Often, labs will seek out a consultant to help prepare for an assessment and a review before they seek accreditation. Passing a review from a consultant does not mean you are ISO-certified, but it does help you prepare for the next step.
Once you feel your lab is in good shape and successfully meets the requirements, it’s time for an assessment.
To be certified, you’ll need a review from an accreditation body to certify that you meet the ISO standards. You will need to request it from an appropriate organization.
Select the one applicable to your lab and move on to the next step.
Reach out to the accredited body you select and request that they perform an external assessment of your lab. This assessment will typically include:
Once the accreditation body approves your lab’s ability to meet the ISO standards, they will issue you a certification, and you will be all set.
Just because your lab is certified does not mean the hard work is over. Once your lab obtains accreditation, in addition to annual audits, it is responsible for internal audits to ensure compliance.
These annual audits are usually less intensive than the initial certification assessment. However, you must undergo a more intensive recertification assessment every three years. These recertification audits ensure that you are up to date with any changes to the ISO standards and that your lab stays compliant through any organizational changes.
The four steps we outlined above may appear simple, but if your gap analysis reveals a mountain of work to do to comply and start the certification process, we have a few tactics you can follow to make accreditation easier.
Build a habit today of gathering and managing key documents in your lab. Whether these are standard operating procedures (SOPs), procedures, calibration records, or quality management manuals, implementing a process to manage and store documents in your lab can make the certification process easier.
You could do this physically, but we recommend a digital solution for document management.
Staff training and compliance are crucial to passing ISO certification; if you are not already regularly training your staff, then now is a great time to start. This education and continuous improvement process will help make your ISO process easier and help promote GxP in your lab.
The best way to simplify your ISO accreditation process is to use software to digitize your lab’s operations and streamline your workflows. With the right software, your lab can breeze through many ISO requirements. In the following sections, we’ll show you how.
Labs have been managing data and inventory with pen and paper for years, long before more sophisticated software tools hit the market.
While pen, paper, and spreadsheets may get the job done, they are not without their shortcomings:
Because of this, many labs quickly outgrow these manual methods — especially when trying to meet ISO standards.
There are a few common software platforms your lab could use:
For the remainder of this article, we’ll focus on how LIMS can help your lab meet the rigorous ISO requirements.
As you saw in the previous section, LIMS is a robust software platform. So let’s walk through the top ways that a LIMS can help your lab meet ISO standards:
Let’s walk through each of these step by step.
One of the chief benefits of a LIMS is the fact that it ensures all data, from sample receiving to results reporting, is accurately captured and securely stored in the cloud. This is due to its robust security features like:
A LIMS is a major asset in improving data security and integrity, and it can aid your lab in meeting ISO standards.
Remember that ISO emphasizes the traceability of measurements and calibration records. Manually tracking this can take a great deal of effort, but with a LIMS, you can manage calibration schedules and records and trace results to comply with ISO standards.
The best part? Much of this can be automated to reduce human error and save hours for your lab staff.
Since a LIMS can track records and trend data, the laboratory has accessible evidence to support the validity of results and meet ISO's technical requirements.
A LIMS can also automate the scheduling and recording of other quality control activities, such as internal audits, equipment maintenance, and proficiency testing.
Remember that proper document control is a critical management requirement under ISO 17025.
With a LIMS, you can digitize all of your documents, from SOPs to quality control records. This makes these documents easily accessible to your lab, meets an important ISO requirement, and improves your chances of passing certification.
If something goes wrong, ISO requires your lab to take corrective and preventive actions in response.
With a LIMS, you can record incidents while tracking progress and documenting these actions to comply. Not only does this help improve the reliability of your results, but it also demonstrates a culture of continuous improvement.
If your lab measures something and stands by reliable and trustworthy results, meeting ISO standards and getting certified is a worthwhile investment.
Not only will it demonstrate to your customers and the world that your lab can be trusted, but the process itself will transform your lab and improve your workflows. Meeting these standards manually can be extremely daunting, but solutions like LIMS can make the process much easier.
With a LIMS, your lab can digitize all of its documents, automate key processes, maintain and calibrate equipment, and demonstrate proper quality control procedures. If your lab is still relying on manual data entry, we recommend beginning a search for a LIMS right away.
Find the perfect LIMS software with the help of LIMS buyers guide. Learn more!
Edited by Jigmee Bhutia
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