The National Institute for Quality Control in Health (INCQS) plays a key role in ensuring that health-related products, including medical devices, meet stringent quality and safety standards in Brazil. INCQS certification is an essential process to ensure that these products are safe for use and comply with current regulations.
Before we delve into the certification flow, we recommend that you check out the article Raising Standards: Unveiling the Pre-Analysis Evaluation Report by INCQS for Medical Devices”. This article details the INCQS pre-analysis report, which is a critical preliminary step to identify and correct potential issues prior to final certification. It offers insights into how this pre-analysis can improve the quality of medical devices and prevent future complications.
Now, let’s explore the INCQS certification process step by step:
Steps of the Certification Process
Certification Request
- Responsible: Interested company
- Description: The company must submit a formal certification request to INCQS, including all necessary documentation, such as completed forms and information about the product or service to be certified.
Request Review
- Responsible: INCQS analysis team
- Description: The INCQS team reviews the request and the submitted documentation. If there are any pending issues, the company will be notified to provide additional information.
Technical Evaluation
- Responsible: INCQS specialists
- Description: Specialists perform a technical evaluation of the product or service, which may include laboratory tests, inspections, and audits. This stage is crucial to ensure that quality standards are met.
Issuance of Evaluation Report
- Responsible: INCQS evaluation team.
- Description: After the evaluation, a detailed report is prepared, containing the test results and compliance with established standards.
Certification Decision
- Responsible: INCQS Certification Committee
- Description: Based on the evaluation report, the committee makes the decision to grant or deny certification. The company is informed of the decision and, if approved, the next steps.
Issuance of the Certificate
- Responsible: INCQS Secretaria
- Description: If certification is granted, INCQS issues the corresponding certificate, which is sent to the company. The certificate has a determined validity period and must be renewed according to INCQS guidelines.
Monitoring and Surveillance
- Responsible: INCQS monitoring team
- Description: After the certificate is issued, INCQS conducts continuous monitoring to ensure that the product or service continues to meet quality standards. This may include periodic audits and additional tests.
Conclusion
The INCQS certification process is a rigorous procedure aimed at ensuring the quality and safety of health products and services. Following this workflow helps ensure that all steps are completed efficiently and transparently, promoting consumer trust and the integrity of the healthcare system.
Learn More
For a deeper understanding of how the INCQS certification process can benefit your company and ensure consumer safety, contact the specialists at Brisa. They are ready to assist with your questions and guide you through every step of the certification process.
Get in touch now and stay informed!
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