The Importance of Implementing a Quality Management System

In the healthcare industry, an efficient Quality Management System (QMS) is essential to ensure regulatory compliance, product safety, and operational efficiency. Companies that adopt and certify their QMS according to recognized standards, such as ISO 13485, have a competitive advantage and reduce the risk of non-compliance.

QR Group, a specialist in health product regulation in Brazil, offers training and complete advice to companies that wish to optimize their management systems and ensure compliance with ANVISA requirements and international standards.

How QR Group Assists in the Implementation and Certification of QMS

QR Group provides a structure of specialized training aimed at training professionals in risk management, performance measurement and continuous improvement of processes. With a technical and practical approach, the company offers support in:

Training and Implementation of Good Manufacturing and Control Practices (RDC 665/2022)

RDC 665/2022 establishes essential requirements to ensure the quality and safety of health products. Training ranges from mandatory documentation to performing internal audits to ensure compliance.

Implementation of a System Based on ISO 13485

ISO 13485 certification is a differentiator for medical device manufacturers seeking access to global markets. QR Group guides the entire implementation process, ensuring that the company meets the standards required by the standard.

Risk Analysis Training According to ISO 14971

Managing risk is essential to prevent failures and increase product safety. The training offered by QR Group addresses the ISO 14971 methodology for identifying, assessing, and mitigating medical device risks.

Training in Corrective and Preventive Actions

Effective implementation of Corrective and Preventive Actions (CAPA) improves quality management and reduces process failures. QR Group trains teams to detect root causes of problems and implement effective solutions.

Benefits of Efficient Quality Management

• Regulatory compliance with ANVISA standards and international standards;
• Reducing risks and increasing product safety;
• Continuous improvement of processes and operational performance;
• Access to international markets through ISO 13485 certification.

Ensure Compliance and Efficiency with QR Group

If your company wants to implement an effective Quality Management System and obtain certification, count on QR Group’s expertise. Contact us to learn more about our training and advisory services.

Source: QR Group