Navigating Compliance and Quality Standards Requirements With a LIMS for Water Testing Labs

Few trends have changed industries in modern history as digital transformation has. From healthcare to manufacturing, every sector is undergoing a shift today, and water testing labs are no different.

As global awareness about safe drinking water is increasing, the demand for rigorous, accurate, and – most importantly – compliant water testing has skyrocketed. Compliance with regulations and quality standards ensures water testing remains reliable and trusted.

A transformative tool that lies at the intersection of the twin trends of rapid digitization and stringent compliance is a laboratory information management system (LIMS). LIMS systems are ushering water testing labs into the era of digital transformation, ensuring they meet complex compliance requirements with ease while minimizing the turnaround time and enhancing testing throughput.

In this article, we explore the key regulations water testing labs have to follow and look at how a LIMS can help them meet compliance and quality standards. 

Figure 1: Nine key compliance and quality standards applicable for water testing labs. Credit: CloudLIMS.

What are the key accreditations and standards for water testing labs?

In this section, we will look at the various standards and regulations for water testing labs.

1. ISO standards

ISO standards ensure a certain level of quality, consistency and reliability in testing laboratories. These standards are not mandatory but meeting them makes a lab more credible and assures stakeholders of accurate results as per the scope of accreditation. Key ISO standards for water testing include:

• ISO 17381:2003: ISO 17381:2003 provides information on selecting ready-to-use methods for water testing as a faster, cost-effective alternative to standard methods. It defines guidelines for using these methods for different types of water, such as drinking, river, process and wastewater. The standard defines the safety and environmental requirements for conducting these tests and specifies the procedure. It also emphasizes the importance of training and supervision for personnel using these methods to maintain the reliability of test results.
  
• ISO 5667: ISO 5667 is a comprehensive set of standards that specifies guidelines for water quality sampling and testing methods. These standards cover various types of water, including drinking water, surface water, freshwater, seawater, wastewater-treated effluents and untreated wastewater. ISO 5667 helps labs standardize their sampling processes to ensure consistency.
• ISO/IEC 17025: ISO/IEC 17025 is one of the most important standards for water testing labs. It provides a framework for quality management and technical competence. The standard provides management and technical requirements for lab operations, ensuring labs meet regulatory compliance and improve their processes continually. Requirements include the implementation of a quality management system spanning all aspects of lab operations, regular calibration of equipment, competency and training of personnel, complete and accurate records for traceability, participation in proficiency testing, regular internal audits and more.

2. SDWA

The Safe Drinking Water Act (SDWA) is a law that was enacted in 1974. It protects the integrity of drinking water in the United States by regulating water systems and setting standards for contaminant detection. With implementation handled by the Environmental Protection Agency (EPA), key requirements of the SDWA include:

• Establishment of maximum contaminant levels (MCLs) that are acceptable in public drinking water by the EPA.
• Public water systems (PWSs) are required to monitor these contaminants regularly and ensure compliance.
• Water suppliers must prepare annual consumer confidence reports for water quality and contaminants.
• Laboratories conducting drinking water analysis are required to use testing methods approved by the EPA.

3. 21 CFR Part 11

This regulation, created by the United States Food and Drug Administration (FDA), governs the use of e-records and e-signed documents, making sure they are reliable. Water testing labs using electronic systems for data management, documentation and reporting are required to comply with this regulation. Key requirements include the following, among others:

• Systems must be verified for their accuracy, reliability and consistency.
• Systems should generate human-readable, electronic copies of records.
• Records must be securely preserved for ease of access throughout the retention period.
• Only authorized personnel should have access to the systems to authenticate, modify or add records.
• Signatures must contain the name of the signer along with the date and time of signature.
• Access to the systems should be restricted by measures such as the use of unique identification numbers or codes and passwords.

4. UCMR Laboratory Approval Program

The UCMR program collects data on unregulated contaminants in drinking water to assess potential public health risks and support EPA decisions on regulation under SDWA. The data also informs states, local governments and the public in making decisions related to health protection and environmental safety.

Each UCMR cycle is developed by revising the preceding one, with public meetings and feedback incorporated into the final rule. The current UCMR cycle, UCMR 5 (2022–2026), concluded its laboratory approval program in December 2022 and now includes PWSs collecting samples from 2023 to 2025 to monitor for unregulated contaminants.

Looking ahead, UCMR 6 (2027–2031) is expected to follow with a proposal anticipated in mid-to-late 2025, and the final rule by late 2026. Sample collection under UCMR 6 is projected to take place between 2028 and 2030.

Key highlights of the program include:

• The program typically applies to PWSs based on the population size they serve. Analytical results must be published in the National Contaminant Occurrence Database for drinking water, making them accessible to the public.
• Between UCMR 5 and UCMR 6, the EPA is likely to maintain the current approach to rule applicability, reporting timeframes for laboratories and PWSs, and flexibility in the Ground Water Representative Monitoring Plan. However, as with each cycle, UCMR 6 will likely introduce a revised list of contaminants and associated testing methods. Adjustments to the sampling design, frequency and locations will also be made based on the contaminants chosen for monitoring in the new cycle.
  
  

5. NELAP

The National Environmental Laboratory Accreditation Program (NELAP), overseen by the NELAC Institute, sets standards for environmental and water testing laboratories. Despite NELAP being predominantly national, it is carried out by state agencies known as the Accreditation Bodies. NELAP relies on industry-wide consensus standards to define the requirements for laboratory accreditation. Key requirements include:

• Labs must maintain an unbroken chain of custody (CoC) and ensure proper equipment calibration.
• Monthly internal quality audits and quarterly management reviews should be performed.
• Labs must participate in external proficiency testing.
• There are specialized protocols for asbestos, chemical, microbiological, radiochemical and toxicity testing.

6. CALA

The Canadian Association for Laboratory Accreditation (CALA) is one of the most recognized accreditation organizations responsible for the management and improvement of quality in laboratories in Canada.

• CALA requires its laboratories to be ISO/IEC 17025 accredited.
• Accredited laboratories are required to undergo regular proficiency testing.
• CALA has a rigorous assessment process and mandates laboratories to conduct internal audits and implement continual improvement strategies.
• To maintain accreditation, CALA reassesses laboratories every two years.

7. UK Environment Agency

In the United Kingdom, the role of the Environment Agency (EA) is central, especially in regulating and enforcing environmental protection measures. Laboratories conducting water testing must meet its stringent requirements:

• All the laboratories that participate in water quality assessment must achieve the ISO/IEC 17025 accreditation.
• Laboratories must participate in proficiency testing programs.
• At bathing sites, the EA employs environmental officers to collect water samples that are tested for harmful bacteria like E. coli and intestinal Enterococci. These results are made publicly available to ensure transparency.
• EA undertakes surveillance inspection of effluent discharge into water bodies. Laboratories are required to analyze water samples from various sources, including industrial and municipal discharges.
• Other requirements include the use of appropriate sampling techniques and sample handling practices, validation of procedures followed for tests and accurate reporting of results.

8. ASTM Standards

The American Society for Testing Materials (ASTM) International’s water quality testing standards provide a framework for the assessment of the techniques and facilities used for the analysis of water quality and the detection of contaminants
.

• The standards elaborate in detail several methods for water sampling and analysis of water’s physical, chemical and biological properties.
• The standards also provide guidelines for testing organic and inorganic substances, microbial and radiochemical substances, and even the corrosiveness of water.
• The standards cover various water sources, including surface water, groundwater, effluent water and process water as well as specialized areas such as water used in hydraulic fracturing fluids and filtration through membranes.

9.   40 CFR Part 141

The 40 CFR Part 141 is a segment in the United States Code of Federal Regulations. It outlines the National Primary Drinking Water Regulations. These regulations are aimed at ensuring the safety of drinking water in PWSs. Key requirements include:

• The standard recommends the MCLs for drinking water. Water from PWSs has to be routinely monitored for specific regulated contaminants, which often include waterborne pathogens like E. coli, chemical contaminants like lead and arsenic, and byproducts of chemical disinfection like trihalomethanes.
• The standard mandates labs to perform water quality monitoring and sampling regularly and submit reports to show compliance with MCLs. PWSs are required to inform the people when the amount of contaminants exceeds permissible levels.
• The regulation also outlines procedures for managing turbidity and inorganic chemicals. It outlines site requirements, limits of detection and grounds for variances and exemptions.

How does a LIMS for water testing labs help meet compliance and standards?

A LIMS can help water testing labs meet compliance and standards in the following ways:

• Sample traceability: With a water testing LIMS, labs can maintain full traceability of their samples right from the moment they receive the samples to the time they dispose of them. It helps labs maintain an unbroken CoC. This helps maintain the transparency and accountability that regulatory requirements demand.
• Automated workflows: A LIMS automates workflows, thus streamlining processes, reducing manual effort, ensuring consistency in processes and results, and helping labs comply with regulatory standards including state and local regulations.
• Data integrity: With accurate data storage and retrieval and secure audit trails, a LIMS helps maintain data integrity in labs. Furthermore, a LIMS helps create customized certificates of analysis to meet regulatory requirements.
• Quality control: Integrated QC measures in a LIMS help labs maintain quality in the results they produce by flagging out-of-specification results, thus enabling prompt corrective actions.
• Instrument and software integration: A LIMS can integrate with all lab instruments and software systems, reducing manual errors, minimizing turnaround time and allowing for accurate data reporting to regulatory bodies.
• Document management: A LIMS system centralizes document management, enabling lab managers to manage documents, such as standard operating procedures, and track their version history. This also prevents the use of outdated documents and procedures. The feature comes in handy during compliance audits. 

Conclusion

A plethora of regulatory standards govern water testing labs, some mandatory and some voluntary, and water testing labs are increasingly coming around to the fact that manual and traditional methods of lab management are inadequate for achieving and maintaining compliance with these standards.

This gaping void calls upon the use of a water LIMS that provides labs with the essential toolkit to meet and exceed regulatory requirements, with capabilities such as sample traceability, automated workflows, built-in quality control measures and more. Clearly, a LIMS for water testing labs can not only help achieve compliance with regulations but also enhance their operational efficiency and reliability.