Compliance with Resolution 1407 of 2007: A mandatory challenge for laboratories in Colombia

Resolution 1407 of 2007, issued by the Ministry of Social Protection of Colombia, establishes the technical and administrative requirements that laboratories must meet when performing physical, chemical, or microbiological analyses on products intended for human consumption or sanitary use. This resolution applies to tests on food, water, pharmaceuticals, cosmetics, hygiene products, among others, and aims to ensure that the results issued by laboratories are reliable, traceable, and technically validated.

What does this resolution require?

The regulation covers multiple aspects, including:

• Infrastructure conditions, internal organization, and physical resources of the laboratory.

• Competence of technical personnel, with clearly defined roles and training.

• Calibrated and validated equipment with documented maintenance.

• Complete traceability of each sample and its results.

• Internal and external quality control with verifiable records.

• Updated technical documentation on methods, procedures, and results.

However, one of the most technical and critical aspects of this resolution lies in the statistical and microbiological handling of results, especially in assessing compliance with established limits based on the type of test.

Compliance evaluation: interpreting results

In microbiological testing, each analyzed sample is compared against reference values defined in the laboratory's regulatory and technical framework. To determine whether a set of samples meets the requirements, the following variables are used:

• n: Total number of samples to be analyzed.

• c: Maximum allowed number of samples that may exceed the value m without invalidating the entire set.

m: Acceptable microbiological value that most samples should not exceed (also known as BD m1).

M: Limit microbiological value that no sample should exceed (BD m2).

• If the result is below m, the sample complies.

• If the result is equal to or greater than m but less than M, the sample partially complies.

• If the result is equal to or greater than M, the sample does not comply.

Finally, when evaluating all samples in the batch, if the number of non-compliant samples exceeds c, the set is considered non-compliant. If the number is equal to or less than c, it is considered compliant.

This statistical approach allows compliance to be evaluated not only sample by sample, but also at the batch or group level, as required by Resolution 1407.

How does LIMS Analítica 12.0 help?

LIMS Analítica 12.0 includes a module specifically designed to support compliance with Resolution 1407 by automating the registration, analysis, and verification of samples based on the technical criteria established by the regulation.

This module allows you to:

• Configure values for m, M, n, and c by type of analysis.

• Automatically compare each result against the established limits.

• Generate compliance reports by batch or group of samples.

• Automatically identify non-compliant samples.

• Record responsible personnel, methods, equipment used, and technical documentation.

• Generate reports ready to present to health authorities or clients.

With this functionality, LIMS Analítica 12.0 not only streamlines the laboratory's technical work but also ensures regulatory compliance in a clear, secure, and traceable way—eliminating the risk of manual errors and strengthening confidence in the results provided.