05 — SERVICE
IntegratedQualityManagement.
Implementation and maintenance of quality management systems aligned with Brazilian and international regulatory requirements.
Scope
What we implement.
Complete quality systems tailored to your segment.
Management System
QMS implementation according to ISO 9001 and sector requirements.
- ISO 9001:2015
- ISO 13485 (medical devices)
- Integrated systems
Documentation
Preparation of all documentation required by quality systems.
- Quality manual
- SOPs and instructions
- Records and forms
Training
Team training on quality processes and requirements.
- QMS training
- Auditor qualification
- Periodic refresher
Internal Audits
Planning and execution of internal system audits.
- Audit program
- Audit execution
- Reports and follow-up
Inspection Preparation
Adequation and simulation for regulatory body inspections.
- Gap analysis
- Mock inspections
- Action plans
Continuous Improvement
Indicator management, CAPAs and continuous system improvement.
- Quality KPIs
- CAPA management
- Management review
How we work
A clear path, from diagnosis to approval.
The same method in every project: understand the product, chart the route and steer the process to a decision — with visibility at every step.
Diagnosis
Deep dive into the product, the operation and the applicable regulatory framework.
Strategy
Route definition: requirements, documentation, deadlines and owners.
Execution
Dossier preparation, filing and dialogue with the regulatory authority.
Approval and maintenance
Follow-through to the decision and post-approval management to keep everything valid.
Elevate your quality standard
Implement a robust management system aligned with market best practices.