ISO 16140-3:2021

Overview

ISO 16140-3:2021 specifies protocols for verifying reference methods and validated alternative methods for microbiological testing of the food chain in a single laboratory. This standard is part of the ISO 16140 series, which addresses the validation and verification of microbiological methods for food safety. It applies to the analysis, confirmation, and typing of microorganisms such as bacteria and fungi in products for human consumption, animal feed, environmental samples from production and handling, and primary production samples.

This standard ensures that laboratories can demonstrate the reliability of the methods they implement, supporting accurate detection and quantification of microorganisms and helping maintain food safety and regulatory compliance.

Key Topics

• Verification Protocols:

  • Provides step-by-step protocols for verifying both reference methods (widely recognized international or national standards) and alternative methods that have been validated through interlaboratory studies.

• Applicability:

  • Relevant for methods used on foods, animal feeds, environmental samples, and primary production samples.
  • Mainly targets verification for bacteria and fungi but can also address other microorganisms and their metabolites case-by-case.

• Verification Types:

  • Implementation verification: Confirms the user laboratory’s ability to correctly perform the validated method.
  • (Food) item verification: Confirms the method’s performance for specific matrices or food items within the laboratory’s intended scope.

• Qualitative and Quantitative Methods:

  • Distinguishes between qualitative (detection) and quantitative (enumeration) methods and details separate protocols for each.

• Alternative Methods:

  • Details protocols for verification of validated alternative methods for confirmation and typing of microorganisms.

• Non-validated Reference Methods:

  • Offers guidance for verifying reference methods that have not yet undergone full validation.

Applications

ISO 16140-3:2021 is essential for:

• Food testing laboratories: Ensures that both reference and alternative methods are fully verified for intended use, maintaining high standards of microbiological safety.
• Quality assurance teams: Supports consistent, reliable microbiological results in food safety management systems.
• Regulatory compliance: Assists in meeting international, national, or industry-specific requirements for microbial testing in food chain sampling.
• Implementation of new methods: Provides a clear process to verify new reference or alternative methods before routine implementation, reducing the risk of errors or false results.
• Scope management: Helps laboratories define and manage their claimed application scope by guiding which food categories, types, and items require verification studies.
• Continuous improvement: Encourages regular method review and verification when expanding laboratory services or when there are changes in sample matrices.

Related Standards

Several standards and normative references underpin ISO 16140-3:2021:

• ISO 16140 Series:

  • ISO 16140-1: Vocabulary for method validation.
  • ISO 16140-2: Validation of alternative (proprietary) methods against a reference method.
  • ISO 16140-4: Validation protocols for a single laboratory.
  • ISO 16140-5: Factorial interlaboratory validation for non-proprietary methods.
  • ISO 16140-6: Validation of alternative methods for confirmation and typing procedures.

• ISO 6887 (all parts): Preparation of test samples, initial suspension, and decimal dilutions.

• ISO 7218: General requirements and guidance for microbiological examinations.

• ISO 17468: Technical rules for the development and validation of standardized methods.

Laboratories implementing ISO 16140-3:2021 often work in close alignment with these related standards to ensure comprehensive method validation and verification within the food safety management framework.

Keywords: ISO 16140-3:2021, microbiological method verification, food safety, laboratory validation, reference methods, alternative methods, single laboratory, microorganism detection, food chain, method validation, bacteria, fungi, food testing standards.