· Author: Third Wave Analytics

Ensuring Lab Standards: Meeting ISO 17025 Requirements with LIMS

Product Testing Labs: Does your LIMS Support ISO 17025 Requirements?

The digital wave transforming various industries is also reshaping the functionality and operation of labs because of innovations like Laboratory Information Management Systems (LIMS), including Third Wave Analytics’ Lockbox LIMS—with a complete set of tools to help you meet modern lab informatics requirements.

For testing and calibration laboratories, where specific industry regulations such as the ISO 17025 standard are vital, LIMS software helps lab processes align with these exacting standards.

What is ISO 17025?

ISO 17025 is a global benchmark that defines the criteria for laboratory competence. The standard ensures accurate, dependable, and precise test outcomes.

Why is a LIMS an Asset for Lab Processes?

A well-structured and flexible LIMS becomes the backbone for ISO 17025 compliance when it streamlines complex procedures and helps a laboratory maintain granular record-keeping.

Does your lab need to comply with ISO 17025?

ISO/IEC 17025 requirements apply primarily to testing and calibration laboratories, which must demonstrate competence and the ability to produce valid test results. Some examples of labs that usually need to follow ISO 17025 requirements include:

  1. Product testing labs: Some industries, like construction and specific marketplaces like Amazon, may require test reports from ISO 17025 accredited labs for specific products.
  2. Calibration labs: Labs that perform calibration services must ensure their work is precise and accurate. ISO 17025 accreditation provides an independent examination of this proficiency in the laboratory.

These are the main lab types that usually follow ISO 17025 requirements. However, any testing or calibration laboratory that wants to demonstrate competence and produce valid test results should consider adhering to the ISO 17025 standards.

How to enhance compliance in your lab

The LIMS you choose for your lab can significantly impact your overall lab efficiency and adherence to compliance standards. Lockbox LIMS has a complete set of features that support ISO 17025 compliance requirements, including

  • Stringent system validation. Lockbox LIMS aligns with ISO/IEC 17025 validation and verification requirements. Every feature application within the Lockbox platform undergoes rigorous testing and verification to support laboratory ISO compliance.
  • Data and information storage. Lockbox LIMS data integrity management addresses the heart of ISO 17025 requirements with accurate, reliable, and secure data storage across lab workflows and processes.
  • Record of traceability. Lockbox LIMS has a complete audit trail built into the authenticated and secure platform. Transparent traceability of all actions, transactions, and system modifications in the lab enhances the audit process, so your lab can produce records showing ISO compliance.
  • Integrated quality control. Lockbox LIMS automates and integrates quality control processes, easing the task of meeting ISO 17025 criteria for uniformity and consistency in lab operations.

Deeper Dive: Detailed LIMS features that address ISO 17025 requirements

The following functionality list and detailed table outlines the Lockbox LIMs modules that can help your laboratory manage and adhere to ISO requirements. Each Lockbox LIMS module can also be customized to fit your unique laboratory requirements, processes, and environment. 

Note: The following capabilities list and detailed table references the 2017 ISO standards publication.  

  • Environmental conditions control. When your lab uses the LIMS Equipment Management features, your lab can navigate an ISO/IEC 17025:2017 requirement for environmental conditions control within your lab. Your team can then easily monitor, control, and document these critical factors.
  • Personnel management. The Training Management module within Lockbox helps your lab document competence requirements for every function that influences lab results, such as employee education, qualifications, training, technical knowledge, skills, and experience. (These competence details are required with ISO 17025).
  • Facilities and environmental conditions control. The Instrument Management module in Lockbox LIMS allow your lab to document requirements for ecological conditions necessary for lab activities.
  • Equipment management. Lockbox integrates equipment, inventory, and supplier management within the Instrument Management and Material Management modules. These modules allow complete control over equipment and visibility of the equipment used in your lab activities. Lockbox LIMS also helps increase visibility to the handling, transport, storage, and equipment maintenance needed to ensure accurate performance and contamination prevention.
  • Record maintenance. Lockbox LIMS also helps your lab manage other popular lab products and services by communicating requirements to your lab vendors, acceptance criteria (CAPA and Change Control module), and competence of personnel (Training Management module).
  • Reporting and data management. Lockbox LIMS retains documentation (Document Control module) and customizable reporting for each lab activity (Deviations/Quality Events module). The Protocol Execution module also tracks sampling data, results, and other pertinent information so you can easily repeat laboratory activities under conditions as close to the original execution.

 

Requirement

 Section

Summary

Lockbox LIMS Modules
Personnel 6.2.2 The lab must document competence requirements for each function influencing the results of laboratory activities, including education, qualifications, training, technical knowledge, skills, and experience. Training Management
Equipment 6.2.5 The lab must have procedures and retain records for determining competency requirements, selection, training, supervision, authorization, and monitoring the competence of personnel. Training Management
Facilities & Environmental Conditions 6.3.2 The lab must document requirements for environmental conditions necessary for the performance of laboratory activities. Instrument Management, Protocol Execution
Facilities & Environmental Conditions 6.3.3 The lab must monitor, control, and record environmental conditions per relevant specifications, methods, or procedures or where they influence the validity of the results. Instrument Management, Protocol Execution
Equipment 6.4.1 The lab must have access to the equipment required for the correct performance of laboratory activities, which can influence the results. Equipment includes but is not limited to measuring instruments, software, measurement standards, reference materials, reference data, reagents, consumables, and auxiliary apparatus. Instrument Management, Material Management
Equipment 6.4.3 The lab must have a procedure for the handling, transport, storage, use, and planned maintenance of equipment to ensure proper functioning and prevent contamination or deterioration. Instrument Management, Protocol Execution
Equipment 6.4.8 All equipment requiring calibration or which has a defined period of validity shall be labeled, coded, or otherwise identified to allow the equipment user to easily identify the status of calibration or period of validity. Instrument Management
Equipment 6.4.9 Any lab equipment subjected to overloading or mishandling yields questionable results and may be defective or outside specified requirements – and should be removed from service. The equipment must be isolated or clearly labeled to prevent its use until it has been verified to perform correctly. The lab must examine the defect or deviation from specified requirements and initiate management of nonconforming work procedures. Instrument Management, Deviations/Quality Events
Equipment 6.4.10 The lab must carry out intermediate checks to maintain confidence in equipment according to a procedure. Instrument Management, Protocol Execution
Equipment 6.4.11 The lab’s calibration, reference material, values, and correction factors must be updated and implemented to meet specified requirements. Instrument Management
Equipment 6.4.13 The lab must retain records for equipment that can influence laboratory activities. Instrument Management
Externally Provided Products & Services 6.6.2 The lab must retain records for externally provided products and services. The lab must have a procedure for evaluating, selecting, monitoring performance, and re-evaluating external providers. The lab will take any actions necessary arising from such evaluations, monitoring of performance, and re-evaluations of the external providers. Material Management
Sampling 7.3.3 The lab must retain records of sampling data that form part of testing or calibration. The records must include a reference to the sampling method used, the date and time of sampling, data to identify and describe the sample (number, amount, name), identification of the personnel performing sampling), identification of the equipment used, environmental or transport conditions, diagrams or other equivalent means to identify the sampling location when appropriate, deviations, and additions to or exclusions from the sampling method and sampling plan. Sample Management, Protocol Execution, Instrument Management, Deviations/Quality Events
Technical Records 7.5.1 The lab must ensure that technical records for each laboratory activity contain the results, reports, and sufficient information to facilitate the identification of factors affecting the measurement result and its associated measurement uncertainty. The lab must enable the repetition of lab activity under conditions as close as possible to the original. Protocol Execution
Technical Records 7.5.2 The lab must ensure that amendments to technical records can be tracked to previous versions or to original observations. Both the original and amended data and files must be retained with the date of alteration, an indication of the altered aspects, and the personnel responsible for the alterations. Document Control
Reporting of Results 7.8.1.2 The lab must provide results accurately, clearly, unambiguously, and objectively, usually in a report (test report, calibration certificate, or sampling report). The results must include all information agreed upon with the customer, necessary to interpret results, and required by the testing method used. All issued reports must be retained as technical records. Reports and Dashboards
Common Requirements For Reports 7.8.2 The lab must include pertinent and essential information in reports. Common requirements for reports (see ISO/IEC 17025 for full details) include title, lab information, unique identifiers, customer contact info, identification of test and method, test results, the approver of the reports, etc., Reports and Dashboards
Specific Requirements for Calibration Certificates 7.8.4 Lab requirements for calibration certificates: The lab must include measurement of the measurement result’s uncertainty, which must also be presented in the same unit or in a term relative to that of the measure. Protocol Execution
Reporting Sampling 7.8.5 Lab requirements for report sampling activity must  include the date of sampling, identification number, location of sampling, addenda to the sample (documents or pdfs), reference to the sampling plan or protocol, details of environmental conditions for sampling, and information required to evaluate measurement uncertainty for subsequent testing and calibration. Sample Management, Instrument Management, Protocol Execution
Amendments to Reports 7.8.8.2 In the lab, amendments to a report after issue must be represented in another document, or data transfer. Document Control
Complaints 7.9.1 The lab must have a documented process to receive, evaluate, and make decisions regarding complaints. Deviations and Quality Events
Nonconforming Work 7.10.2 The lab must retain records of nonconforming work and actions. Deviations/Qualifying Events, Protocol Execution, Document Control
Control of Data and Information Management 7.11.3 The lab’s LIMS must be protected from unauthorized access, safeguarded against tampering and loss, and maintained to ensure the integrity of the data and information, including recording system failures and appropriate immediate and corrective actions. Salesforce Security, Capabilities
Management System Requirements  8.1.2 The lab’s LIMS must address the following: management system documentation, control of management system documents, control of records, actions to address risks and opportunities, improvement, corrective actions, internal audits, and management reviews. Document Control, Deviations/Quality Events, CAPA, Risks & Hazards, Change Control

 

To learn more about Third Wave Analytics and our secure LIMS software, see our platform capabilities or try a Lockbox LIMS demo to discover features that can significantly improve your lab processes and management.

Sources:

  1. ISO 17025 Testing and Calibration Laboratories
  2. ISO 17025 Accreditation for Product Testing Labs: A Complete Guide
  3. Is Your Testing Laboratory Ready for ISO 17025 Accreditation?
  4. 2017 ISO 17025 General Requirements for the Competence of Testing and Calibration Laboratories

 

Disclaimer: The information contained in this blog post does not confer legal advice. Nothing in this blog post is a warranty or guarantee for compliance with ISO 17025 nor does it intend to serve as compliance guidance and should only be used to gain a broad understanding of Lockbox LIMS capabilities.