How to implement a Quality Management System (QMS)

A Quality Management System (QMS) is an integrated set of policies, processes and controls that guarantee operational standardization and consistent product quality. To comply with ANVISA, its implementation must follow a strategic approach:

• Initial Diagnosis: Evaluate the company's current structure with reference to ANVISA requirements, identifying gaps in documents, training and quality controls.
• PDCA Cycle: Adopt the Plan-Do-Check-Act methodology:
•  Plan: Define scope, objectives and map processes;
•  Do: Implement procedures and training;
•  Check: Monitor via indicators;
•  Act: Correct faults and update protocols.
• Rigorous documentation: Draw up quality manuals, operating procedures and traceable records, essential for ANVISA audits.

I WANT TO IMPLEMENT A SGQ WITH EXPERTS

Good Manufacturing Practices (GMP) are the core of an effective QMS. They ensure that products are manufactured with safety, quality and traceability, meeting ANVISA standards. Integrating them into the QMS requires:

• Adequate infrastructure: Temperature control, equipment sanitization and segregated flows prevent cross-contamination.
• Continuous Training: Train teams in hygiene protocols, handling raw materials and recording non-conformities.
• Real-time Monitoring: Use digital tools to track critical parameters and generate automatic alerts.

Practical Impact: Companies with consolidated GMP have 70% fewer audits.

I WANT MY GOOD PRACTICES CERTIFICATION WITH NO RED TAPE

A well-implemented QMS not only avoids penalties, it also optimizes regulatory compliance. Here's how:

• Preventing fines: 80% of ANVISA's fines result from documentary failures or deviations in protocols. A QMS centralizes records and facilitates proof during inspections.
• Faster certifications: Companies with a structured QMS obtain ANVISA certification (such as CBPF) up to 60% faster, as they already have auditable processes.
• Crisis response: In the event of a recall, a QMS allows batches to be traced in minutes, minimizing damage to image and operating costs.

Scenario 2025: With new rules for household cleaning products and labels, the QMS has become indispensable for agile adaptation to changes.

Implementing a QMS in line with ANVISA requires regulatory expertise, and this is where Stone Okamont acts as a strategic partner. What we offer:

• QMS implementation: We develop systems adapted to your size and segment, from documentation to training.
• Preparation for Audits: We simulate ANVISA inspections, correcting non-conformities before the official visit.
• Certification management: We centralize processes digitally and speed up the issuing of ANVISA Certifications (CBPF, BPF)

Stone Okamont combines in-depth knowledge of health regulations with practical solutions, transforming bureaucracy into a competitive advantage. Request a diagnosis and find out how to implement an effective QMS in your operation.