RDC RESOLUTION No. 512, OF MAY 27, 2021 [1], D.O.U. of 05/31/2021, provides for Good Practices for Quality Control Laboratories. This standard is very similar to ISO 17025, however, it targets product testing and requires a series of documents.
This Regulation has the objective of defining principles and requirements for the execution of analyzes with quality, reliability and safety, in products subject to Sanitary Surveillance. This Resolution does not exempt the laboratory from complying with the Resolution of the Collegiate Board – RDC No. 390, of May 26, 2020 and specific legislation in its area of operation.
The RDC applies to all public or private laboratories that analyze products subject to Sanitary Surveillance.
RDC 512 brings similar guidelines to 17025, but with two major differences:
They do not address technical requirements such as measurement uncertainty and method validations, these terms are only subjective when they are treated in the resolution as internal quality controls.
And the resolution determines, in many of its articles, the “how to do it”, while the 17025 only says that it is necessary to comply with such a requirement without demanding how it will be done.
Additionally, as it is a Sanitary Surveillance resolution, in the RDC, subjects related to biosafety, pest control and animal experimentation are addressed in small superficial paragraphs, topics that are not the scope of 17025.
Therefore, the concept of a Good Practice laboratory is:
- Test facilities, which would be the main unit;
- Test units, which would be the units where one or more phases of a study are carried out.
In summary, recognition of compliance with Good Practices must be requested by any facility and test unit. In this way, the recognition process takes place at each facility, considering the specialty area of the tests carried out there.
The laboratory must perform, at least every twelve months, internal audits of its activities that meet the requirements of this Resolution.
Laboratories that carry out experiments with animals must follow the norms related to the humane use of animals, as well as observe the procedures for the installation and operation of breeding centers, vivariums and animal experimentation laboratories, of the National Council for the Control of Animal Experimentation ( CONCEA), respecting current legislation.
The laboratory must carry out, at least every twelve months, internal audits of its activities that meet the requirements of RDC 512/2021, keeping records of audit findings and corrective actions arising therefrom. Like any implementation of resolutions, the application of an audit must always be carried out to ensure full compliance, as well as to generate opportunities for improvement and identify possible deficiencies.