ISO 17025 Certification in Food Testing Laboratories using LIMS


The food testing industry has witnessed substantial growth in recent years. The increasing growth trend is expected to continue in the near future. According to reports, the food testing market is poised to grow from USD 17.0 billion in 2018 to USD 24.6 billion by 2023. An increasing number of food poisoning incidents can be observed that have led to a huge health and financial burden to society. In the United States, over 53,000 cases of illness, and approximately 2,300 deaths are reported each year due to food-borne diseases. In the United Kingdom, it is estimated that around one million people suffer from foodborne illnesses causing around 500 deaths each year. This can be attributed to the imbalance between the increasing globalization and the lack of safety measures undertaken by the food testing industry.

Food manufacturing is a global endeavor where the food industry may receive raw materials from different regions across the world, processes food samples in various facilities, and the finished products may then be exported back to a global marketplace. Thus, many stakeholders may be involved in the progression of a food sample from farm to fork. It increases the risk of adverse health, economic and legal consequences. Thus, it becomes crucial to safeguard the quality and provenance of food products. Food manufacturers across the world rely on food testing laboratories to ensure the safety and purity of the biological and chemical components of food that are processed or packaged by them.

The exponential increase in the number of samples sent for testing has created new challenges for the food testing laboratories. Furthermore, food manufacturers are facing a challenging time due to stringent regulatory requirements. A major challenge for the food testing laboratories is the need to comply with the local food safety regulations and the regulations followed by the country in which the food products are sold. Owing to the regulatory implications and customers’ requirements, there is an increasing need among the food testing laboratories to meet ISO/IEC 17025:2017 accreditation standard. Now the question arises that what is ISO/IEC 17025:2017 accreditation and why is it becoming increasingly important for the food testing laboratories to be accredited to this international standard?

ISO/IEC 17025:2017: A Pre-requisite for Food Testing Laboratories

ISO/IEC 17025:2017 is an international standard that determines the technical competence of laboratories to perform specific types of testing, measurement, and calibration. It has developed into a global benchmark to assure the precision, accuracy, and reproducibility of analytical results. ISO/IEC 17025 is used by laboratories to develop their management system for quality, administrative and technical operations. In most countries, ISO/IEC 17025:2017 accreditation is considered mandatory for a testing laboratory to be deemed as technically competent. In many cases, food processors, regulatory authorities and accreditation bodies do not accept test or calibration results from a lab that is not accredited. ISO/IEC 17025:2017 certification boosts the reputation and reduces operational costs while meeting the regulatory guidelines. It helps food testing laboratories gain a competitive advantage by demonstrating an organization’s commitment to quality and efficiency.

ISO/IEC 17025 Requirements for Food Testing Laboratories

ISO/IEC 17025 requirements can be divided into technical and management requirements. Technical requirements include comprehensive documentation of various factors responsible for influencing the quality of test results, including sampling, equipment, environmental conditions, test methods, etc. Maintaining training records of each analyst is also an integral part of the technical requirements of ISO/IEC 17025. It also requires efficient management of calibration and maintenance data of laboratory equipment to ensure that the tests are conducted on properly calibrated equipment and the test results are reliable. Management requirements, on the other hand, are primarily focused on the laboratory organizational structure. It states that access to sensitive data should be managed carefully and all crucial laboratory activities by all laboratory personnel should be tracked with a date and time stamp. According to ISO/IEC 17025 regulations, it is vital to track the food products throughout manufacture and distribution along with an improved emphasis on accurate and complete record keeping. One of the major challenges is the increased volume of samples that need to be processed in accordance with the ISO/IEC 17025 guidelines. One effective solution to overcome this challenge is to switch to laboratory information management solutions that help to eliminate many of the mundane tasks that utilize valuable resources.

LIMS: An easy solution to attain ISO/IEC 17025 Certification

With critical issues that circumvent the quality of food, where does your food testing laboratory stand in terms of ISO/IEC 17025 certification? Well, preferably, it should be at the pinnacle!

The food testing industry is an intensely regulated industry and appropriate food and beverage LIMS is a tool to attain success. There are many requirements that a food testing laboratory must fulfill to achieve ISO/IEC 17025 certification including regular audit and review of a laboratory’s quality system, monitoring of environmental factors in the laboratory, maintenance and calibration of instruments, maintenance of staff and their training records, etc. ISO/IEC 17025 has become a highly crucial standard and most of the food testing laboratories are now seeking accreditation to this international standard. An inability to achieve this accreditation is now becoming an indication of laboratory incompetency. In such a scenario, a LIMS comes to the rescue by enabling organizations to become ISO/IEC 17025 compliant. Some of the areas in which a LIMS can help in achieving ISO/IEC 17025 accreditation include:

S. No.ISO/IEC 17025 RequirementsRole of a LIMS to Meet the Requirements
1Sample ManagementIt helps manage samples, aliquots and derivatives and print labels with 1D or 2D barcodes.
2Instrument Calibration and Maintenance Data ManagementA LIMS helps manage the calibration and maintenance data of laboratory instruments and raises an alarm prior to the scheduled calibration or maintenance date. This helps ensure that the analytical instruments are not used outside their calibration/maintenance dates.
3Staff ManagementISO/IEC 17025 compliance requires food testing laboratories to record all necessary information of their staff directly or indirectly involved in performing analytical tests. A LIMS can securely track and manage all the required staff information such as their resume, training details, and certifications, etc.
4Training ManagementThis also helps to verify that a test is assigned to the analyst who has undergone the required training and is competent to perform the test. This helps to accomplish a major ISO/IEC 17025 requirement and assures the accuracy and reliability of test results.
5TraceabilityA LIMS can be used to record each step to provide documentary evidence that the tests were performed by qualified technicians on properly maintained and calibrated instruments with appropriate quality control checks.
6DashboardingA LIMS enables laboratory managers to view a variety of metrics, including the number of samples, tests conducted on samples, service requests, package and shipment details, etc.
7Inventory ManagementA LIMS facilitates efficient and quick management of all inventory supplies.
8Masking of Sensitive DataA LIMS helps mask sensitive data from unauthorized personnel by assigning role-based access rights to authorized personnel only.
9Audit TrailA LIMS helps track all laboratory activities with a date and time stamp.
10Chain of Custody (CoC)A LIMS helps maintain a CoC of samples and tests to keep track of the flow of samples within a laboratory.
11Document ManagementA LIMS helps manage all relevant documents for quality control, audits, tests performed, training, requests, etc. It also makes the access and retrieval of these documents quick and hassle-free by the proper association of these documents with tests, samples, etc.
12Monitoring of Environmental FactorsA LIMS helps monitor the laboratory environment to prevent sample contamination. The laboratory manager is immediately notified if values of the environmental parameters such as temperature, humidity, etc., cross the threshold range.

Today, the food industry is undergoing a revolutionary change and ISO/IEC 17025 acts as a strong backbone to any internationally operating food testing laboratory to enhance its credibility and market competency. A cloud-based LIMS is a complete and secure solution that helps maximize resources and profitability through efficient operations. A LIMS helps achieve ISO/IEC 17025 accreditation. It eliminates the need for supplier audits and verifies the robustness, capability and operational efficiency of workflows within a laboratory. It helps gain confidence and trust that the regulatory and safety requirements are efficiently managed. Thus, an inability to demonstrate ISO/IEC 17025 accreditation is a technical barrier to trade within the food industry and a LIMS acts as an indispensable tool to overcome this barrier.

For more information, please visit our Food & Beverage LIMS webpage, that explains how CloudLIMS can address the key challenges of your food and beverage testing laboratory and maximize investment returns.