If you’re running a testing or calibration lab, ISO 17025 is the gold standard that you’ll want to know. It focuses on ensuring the quality and reliability of laboratory results. Currently, thousands of labs worldwide implement it, and it’s often a prerequisite for regulatory compliance or gaining accreditation.
This guide will break down what ISO 17025 is all about, including its main requirements, as well as offering practical tips for compliance. Whether your lab is at a university, government facility, or private testing center, understanding these standards will help you improve your operations and open doors to new opportunities.
What is ISO 17025?
DIN EN ISO/IEC 17025:2017 is an internationally recognized standard that defines requirements for laboratory performance in testing and calibration. ISO 17025 ensures that laboratories work competently and generate valid results.
The standards were revised in 2017 thanks to significant changes in the market and technology since the last version was published in 2005. They are suitable for any type of lab, from government to university laboratories and are also designed to help cooperation between different labs.
An ISO 17025 checklist is a useful tool for laboratory managers to determine whether their laboratory meets the requirements for testing and calibration defined by the standards. You can browse through Lumiform’s pre-made checklists and easily customize these based on your needs.
Requirements of ISO 17025
ISO 17025 requirements fall under several key areas, with each focused on ensuring that the lab is competent and gives reliable results:
General requirements
Maintaining impartiality is at the core of ISO 17025’s general requirements. Labs must make sure that their operations are free from any biases or external pressures that might affect the validity of their result.
Confidentiality is equally important, since labs deal with sensitive data that needs careful handling to protect client privacy and intellectual property. Any breaches here can severely damage the lab’s credibility and customer trust.
To achieve both of these, labs should have clear procedures and training programs to reinforce impartiality and confidentiality across all levels. This involves conducting regular audits and reviews, as well as documenting any conflicts of interest with measures in place to resolve them.
Structural requirements
For a laboratory to work smoothly under ISO 17025, there must be a well-defined organizational structure. This involves clearly describing roles and responsibilities so everyone understands their duties, without any gaps in accountability.
The lab’s management structure must align with its operational needs, such as having:
- A robust chain of command, with clear reporting lines
- Policies for management review and measuring key performance indicators
- Defined corrective action procedures and escalation paths
Leadership should actively support the lab’s processes and quality objectives, demonstrating a commitment to excellence and continual improvement.
Resource requirements
For a laboratory to consistently deliver reliable results, ISO 17025 emphasizes the need for adequate resources across:
- Personnel – Staff must have the required qualifications, training, and experience to do their tasks effectively. They should also be well-versed in the lab’s quality management processes and ethical standards.
- Facilities – The physical and technical infrastructure of the lab must meet stringent standards. Facilities should be designed to prevent contamination, creating an environment that’s ideal for precise testing and calibration.
- Equipment – Equipment must be suitable for its purpose, regularly maintained, and calibrated to ensure accuracy.
- External services – Labs depend on external services, like suppliers of testing materials or third-party calibration providers. These vendors must be vetted and monitored to confirm that their contributions meet the lab’s quality standards.
Process requirements
ISO 17025 strongly emphasizes that testing and calibration processes should be consistent, accurate, and reliable.
Laboratories must use validated and standardized methods whenever possible, as these methods are proven to deliver reliable results. If a lab develops its own methods, these must undergo rigorous validation to confirm their effectiveness. Procedures should be meticulously documented to ensure consistency and reproducibility, even when different personnel handle the same tasks.
Beyond the methods themselves, ISO 17025 requires robust processes for handling test items. From the moment samples are received, labs must follow clear procedures for labeling, storage, and tracking to maintain their integrity. This way, results are not compromised by contamination or loss.
Reporting results is also a critical part of the process. Reports must be clear, accurate, and detailed, including all necessary information such as methodologies, uncertainties, and any deviations from protocols.
Management systems requirements
It’s crucial to have a robust management system for maintaining consistent quality. This begins with the implementation of a documented Quality Management System (QMS) that outlines the lab’s policies, procedures, and quality objectives. The QMS serves as your central framework, guiding the lab in its daily activities. Regular internal audits are another key component, enabling labs to identify areas for improvement and address nonconformities proactively.
In addition to a solid QMS, leadership is fundamental to establishing a culture of accountability and quality assurance. This includes providing the necessary resources, addressing risks and opportunities, and reviewing the performance of the QMS regularly.
By combining leadership commitment with a strong management system, labs can achieve sustained excellence and uphold their credibility in the industry.
7 practical tips for preparing for ISO 17025 certification using a checklist
It is crucial that a laboratory prepares for ISO 17025 certification. For best practices it is highly recommended to implement a checklist system for preparation.
Read the following seven tips with advice on how to become ISO 17025 accredited:
1. Communicate with team members
In order to implement a new system it is important to get everyone on board, especially the management team. Communicate and agree on the system and necessary steps. The support of management will ensure a smooth implementation process.
2. Define the plan
You should define the scope and responsibilities which are necessary to achieve a certification. Establish your laboratory’s quality policies and what specific daily activities are applicable to ISO 17025. Clearly define and document the associated responsibilities throughout the organization.
3. Identify risks
Preparing for certification is an ideal opportunity for a company to evaluate daily business and identify risks, malfunctions and potential harming factors as well as opportunities. Using a checklist for identifying risks or doing a root cause analysis to identify certain specific problems at their root helps you to improve overall performance and thoroughly prepare for a ISO 17025 certification.
4. Define all processes
Once you are aware of the specific standards and guidelines of ISO 17025, it is crucial to specifically document all correct steps when undergoing certain processes in the laboratory. By clearly stating the correct way to operate, you ensure that all personnel have access to and are aware of the standards which are required to obtain certification.
5. Keep track of the progress
After stating the specifics of each procedure it is absolutely necessary to continuously keep track of the progress and correct operations at the laboratory. An internal audit checklist for each operator when working on a specific process can be a useful tool.
6. Offer help and training
Once you have implemented the correct guidelines for each process you should offer help and training for your employees whenever necessary. Assign training personnel and make sure that all employees have the necessary help to operate correctly.
7. Review the preparing action
All actions to operate correctly and prepare for ISO 17025 certification should be reviewed frequently. This again helps to identify risks and opportunities, address nonconformance and communicate the progress of your organization with all involved parties.
Advantages of Lumiform for obtaining ISO 17025 certification
There are many ISO requirements, like the ISO 9001:2015 audit or the ISO 31000 framework for risk management. Lumiform makes it easier for you to comply with the ever-increasing legal requirements for process documentation. You can use the mobile app to document via smartphone or tablet and be guided by the system through all documentation processes.
Clean, transparent documentation helps you avoid high fines. The easiest way to do this is with a digital solution like Lumiform.
Benefits:
- All audit results are automatically bundled in a report and can be sent to relevant stakeholders. automatically.
- Generate real-time data about your processes. This makes quality and safety measurable for the first time and you can use the data to continuously improve processes.
- Create reports automatically, which saves you the need to do all the manual follow-up work.
- Increase the efficiency of your internal processes. Solve incidents up to 4x faster than before through more efficient communication within the team, with third parties and with management and faster reporting of incidents.
- Save time with easier analysis of all data and faster identification of areas that need your attention.
- Continuous improvement of quality and safety. With the flexible AI form builder, you can continuously optimize internal checks and processes.
Try Lumiform for free now and streamline your path to ISO 17025 compliance!