Laboratory routine demands much more than precision equipment and qualified professionals. Each type of laboratory must meet specific technical, sanitary, and quality requirements, established by regulatory bodies and national and international standards.
These regulations aim to ensure the safety of professionals, the reliability of results, the traceability of processes, and the protection of public health.
In this guide, you will learn about the main standards applicable to Brazilian laboratories, understand which modalities they apply to, and what their purpose is.
Why Do Laboratory Standards Exist?
Regardless of specialization, every laboratory must adopt procedures that ensure:
- Quality of results
- Safety of professionals
- Environmental protection
- Traceability of analyses
- Standardization of processes
- Compliance with current legislation
Technical standards establish these requirements and serve as a reference for audits, sanitary inspections, and accreditation programs.
Main Standards and Regulations
| Standard / Regulation | Applies to | Purpose |
|---|---|---|
| RDC No. 786/2023 (ANVISA) | Clinical Analysis Laboratories | Establishes technical-sanitary requirements for services that perform Clinical Analysis Exams (EAC). |
| ABNT NBR ISO/IEC 17025 | Testing and calibration laboratories | Defines requirements for technical competence, quality management, and reliability of results. |
| Good Laboratory Practices (GLP) | Research laboratories and non-clinical studies | Standardizes planning, execution, recording, and archiving of studies. |
| Good Manufacturing Practices (GMP) | Industrial and pharmaceutical laboratories | Ensures quality and consistency in the manufacturing and control of products. |
| NR-32 | Laboratories in health services | Defines safety and health measures for workers exposed to biological, chemical, and physical risks. |
| PGRSS | All health services | Establishes guidelines for the management of healthcare waste. |
Standards by Laboratory Modality
Clinical Analysis Laboratories
Main references:
- RDC No. 786/2023 (ANVISA)
- NR-32
- Internal and External Quality Control Program
- Waste management standards
Objective: Ensure patient safety, quality of examinations, and traceability of samples.
Research Laboratories
Main references:
- Good Laboratory Practices (GLP)
- OECD Guidelines (where applicable)
- Institutional biosafety standards
- CTNBio requirements (when GMOs are manipulated)
Objective: Ensure the reliability and reproducibility of scientific studies.
Industrial and Quality Control Laboratories
Main references:
- ABNT NBR ISO/IEC 17025
- Good Manufacturing Practices (GMP)
- Specific industrial sector standards (pharmaceutical, cosmetic, food, etc.)
Objective: Ensure that raw materials, processes, and products meet technical and regulatory specifications.
The Importance of Standard Operating Procedures (SOPs)
Regardless of the modality, SOPs describe how each activity should be executed, ensuring standardization, traceability, and reduction of operational failures.
They are fundamental documents for laboratory organization and for meeting regulatory requirements.
Documentation and Traceability
Compliance also depends on maintaining updated records, such as:
- SOPs
- Training records
- Calibration certificates
- Maintenance controls
- Reagent identification
- Temperature records
- Batch control
These documents demonstrate that processes are executed consistently and traceably.
Products that Aid in Compliance
Regulatory compliance also depends on the materials used daily. Some items are essential to keep the laboratory organized and aligned with good practices:
- Labels for sample identification
- Chemical indicators for sterilization
- Sharps disposal containers
- Certified glassware
- Calibratable micropipettes
- PPE
- Thermometers and monitoring instruments
- Materials for organization and storage
Frequently Asked Questions
What is the main standard for clinical laboratories?
ANVISA's RDC No. 786/2023 establishes the technical-sanitary requirements for services that perform Clinical Analysis Examinations (EAC).
Is ISO/IEC 17025 mandatory?
Not always. Its application depends on the activity developed and accreditation or contractual requirements.
What are Good Laboratory Practices (GLP)?
They are principles that guide the organization, execution, monitoring, and recording of laboratory studies, especially in research.
Does NR-32 apply to laboratories?
Yes. Whenever the laboratory is part of a health service or there is occupational exposure to the risks foreseen in the standard.
Are SOPs mandatory?
In many regulatory contexts, yes. Furthermore, they are essential for standardizing procedures and facilitating audits.
Conclusion
Complying with technical standards is an essential part of laboratory routine and contributes to safety, quality of results, and process compliance.
In addition to knowledge about regulations, having calibratable equipment, appropriate consumables, certified materials, and items for identification, storage, and disposal helps the laboratory maintain an organized environment aligned with good practices.
