ISO 7218 Standard: The Guide to Microbiology Requirements
What Are ISO Standards and Why Do They Matter?
The International Organisation for Standardization (ISO) develops globally recognized standards that aim to harmonize examination methods across more than 170 countries. Their goal is to guarantee quality, safety, and ethical practices for products and services worldwide.
For organizations seeking official verification, accredited bodies—such as ANSI in the United States or AFNOR in France—conduct detailed audits and issue ISO certifications. Holding an ISO certification is a non-negotiable prerequisite for gaining trust in international commerce.
ISO 7218: General Requirements for Microbiology
The ISO 7218 standard concerns the agri-food sector and delivers the general requirements and recommendations for all microbiological examinations.
This document serves as the key reference for Good Laboratory Practices (GLP) in food microbiology and handling safety. It is mandatory for any laboratory seeking accreditation from national bodies.
Since its first publication in 2007, ISO 7218 has undergone several revisions, resulting in the current, critical version: ISO 7218:2024. Each revision clarifies and updates the essential guidelines based on laboratory needs and evolving technology.
The ISO 7218 standard covers critical aspects of lab analysis, including:
- Laboratory Design and Layout: Ensuring safety during the handling of pathogenic microorganisms.
- Equipment Control: Mandating strict calibration and maintenance protocols to prevent technical errors.
- Sample Management: Procedures for transport, receipt, storage, and manipulation to ensure end-to-end traceability.
- Protocol Standardization: Ensuring consistent preparation of samples and use of an Electronic Laboratory Notebook (ELN) to facilitate pathogen identification and reduce contamination risk.
- Quality Control: Detailed internal procedures to ensure ongoing laboratory quality and compliance.
This rigor promotes more effective quality control and guarantees compliance with national and international regulatory standards.
Who is Affected by the ISO 7218 Standard?
Essential in the field of the agri-food industry, the ISO 7218 standard is addressed to:
- All laboratories performing microbiological analyses.
- Food producers and processors.
- Quality assurance services and health authorities that ensure food security and quality.
- Auditing bodies responsible for issuing certifications.
In short, any entity playing a role, directly or indirectly, in microbiological testing of food products (human or animal) is concerned with compliance.
The Critical Role of Method Validation and Verification in ISO 7218
To truly achieve ISO compliance, a laboratory must rigorously apply the concepts of method validation and method verification. These steps are the foundation of generating accurate, reliable microbiological data.
Method Validation (New Methods)
Validation is the process of confirming that a new, non-standard, or modified analytical method is fit for its intended purpose. This is necessary when adopting rapid methods (e.g., PCR tests) or when modifying a step in a standard method.
Validation involves a comprehensive study to demonstrate the method’s performance characteristics, including:
- Accuracy: The closeness of the test result to the true value.
- Precision (Repeatability and Reproducibility): How close independent test results are to each other.
- Selectivity/Specificity: The ability to accurately measure the target analyte (e.g., a specific pathogen) in a complex sample matrix.
- Limit of Detection (LOD) and Limit of Quantitation (LOQ): Crucial parameters for confirming the method’s sensitivity.
Method Verification (Standard Methods)
Verification is the process where a laboratory confirms that it can successfully perform an existing, standard method (like one published by ISO) using its own equipment, staff, and environment.
While ISO standards are validated globally, each individual lab must verify that it can meet the specified performance criteria. This typically involves running a reduced set of experiments compared to full validation, focusing primarily on:
- Repeatability: Demonstrating consistent results within the laboratory.
- Selectivity: Proving the method works effectively with their typical sample types (the matrix).
By detailing the laboratory’s verification process, a lab provides tangible evidence of its operational expertise, which directly enhances the authoritativeness of its final test results and simplifies external audits.
The Advantages of ISO 7218 Certification
Adopting the ISO 7218 standard is a real lever for performance and credibility for agri-food industry players.
With this certification, laboratory protocols become standardized, limiting the risk of errors and strengthening the reliability and precision of the results. Thanks to their international recognition, ISO 7218 certified laboratories earn trust and credibility with their partners and consumers. The standard also participates in the harmonization of practices, regulatory compliance, and overall quality improvement of laboratories across the world.
How a LIMS Assists in Obtaining ISO 7218 Standards
For a quality-driven laboratory, ISO 7218 certification is necessary to guarantee a superior service to its clients. However, ensuring constant follow-up of all requirements can be a complex and laborious task.
This is where a LIMS software (Laboratory Information Management System) becomes a true strategic ally. A LIMS manages and organizes laboratory data optimally by:
- Automating Traceability: Storing and meticulously organizing all equipment management logs, calibration records, and test data in one place. This guarantees the validity and reliability of results.
Simplifying Audits: LIMS facilitated results validation and meticulous traceability streamline internal audits and external quality controls required for certification.
TEEXMA for LIMS: Achieving Compliance, Effortlessly
While any robust LIMS can assist, TEEXMA for LIMS is specifically designed to handle the complex, granular data management required by the latest ISO 7218:2024 standard. TEEXMA ensures your laboratory can automate the logging of all calibration schedules, manage reagent and media expiry dates, and provide instant, auditor-ready reports on method validation and verification data. This dedicated compliance framework helps you move from manual tracking to a fully digital, guaranteed-traceability system, accelerating your path to ISO accreditation.
ISO 7218 in a Sustainable Development Approach
It is important to emphasize that the ISO 7218 standard is more than just a technical document; it reinforces global health and safety. By contributing to the Sustainable Development Goal No. 3 (Empowering individuals to live healthy lives and promoting well-being at all ages), it plays a major societal role. By ensuring the food supply is tested to the highest microbiological standards, the risk of foodborne illness is dramatically reduced, directly supporting global public health.
Learn More: Essential Companion Standards
The more certifications your laboratory accumulates, the stronger its credibility and quality. Additional standards are an essential asset for microbiological analysis laboratories wishing to guarantee food security and the mastery of their processes. Among the standards useful for microbiological analysis laboratories, you can find:
- ISO 22000: Food safety management systems—Requirements for any organization in the food chain.
- ISO 17025: General requirements concerning the competence of testing and calibration laboratories. A foundational standard for labs in general.
- ISO 19036: Food chain microbiology—Estimation of measurement uncertainty for quantitative determinations. A standard to ensure the quality of quantitative analyses.