Quality Management System Certification

ISO 13485

ISO 13485

Quality of medical devices

 

The ISO 13485 certificate proves the organization’s commitment to the quality of its medical devices. It demonstrates that a quality management system has been evaluated and approved, all in accordance with regulatory requirements and the customer’s needs.

The implementation of ISO 13485 provides practical foundations to manufacturers to help them meet the technical standards of medical devices, regulations and responsibilities, as well as demonstrate commitment to safety.

About ISO 13485

ISO 13485 is a standard for Medical devices — Quality management systems — Requirements for regulatory purposes, based on the PDCA process model of ISO 9001 – Quality Management Systems and developed for regulatory compliance. Thus, it is naturally more prescriptive and needs a better documented quality management system.

It is an internationally recognized standard, applicable for quality management systems of companies that manufacture medical devices. The standard specifies the requirements for a quality management system where an organization needs to demonstrate its ability to provide medical equipments, as well as related services that always meet the customers’ needs and the applicable regulatory requirements. ISO 13485 was created in order to be used by organizations for the design and development, production, installation, maintenance, sale and distribution of medical products.

The main objective of ISO 13485 is to facilitate harmonization of regulatory requirements for medical devices for quality management systems. It was created to support manufacturers of medical devices in the development of quality control systems that set and maintain the effectiveness of their processes. This ensures the consistency of design, development, production, installation and delivery of safe medical devices.

ADVANTAGES OF THE CERTIFICATION

ADVANTAGES OF THE CERTIFICATION

If the organization intends to operate internationally or expand its local operations, the ISO 13485 certification can help you improve your overall performance, eliminate uncertainties and expand market opportunities. Companies with this certification express their commitment to quality, both for clients and for regulatory bodies.

Highlights:

  • Meet regulatory requirements and customer expectations
  • Access to global markets with the certification
  • Constant search for improvement of your processes, covering the entire organization
  • Increases efficiency and monitors supplier performance
  • Demonstrates that you manufacture safer and more effective medical devices

STEPS OF THE CERTIFICATION PROCESS

STEPS OF THE CERTIFICATION PROCESS

Issued certificates

Issued certificates

CERT NºREVIEWVALIDITYDESCRIPTIONREGULATIONSTATUS
QC-1203-190008/May/2021Quality Management SystemISO 13485:2016Active
QC-0211-180031/May/2022Quality Management SystemISO 13485:2016Active
QC-2009-190005/Dec/2022Quality Management SystemISO 13485:2016Active
QC-2209-190006/Dec/2022Quality Management SystemISO 13485:2016Active
QC-2109-190013/Dec/2022Quality Management SystemISO 13485:2016Active
QC-1808-190016/Jan/2023Quality Management SystemISO 13485:2016Active
QC-2504-190011/Feb/2023Quality Management SystemISO 13485:2016Active
QC-2501-200002/Mar/2023Quality Management SystemISO 13485:2016Active
QC-1005-200029/May/2023Quality Management SystemISO 13485:2016Active
QC-4501-200025/Jun/2023Quality Management SystemISO 13485:2016Active
QC-2004-200014/Jun/2022Quality Management SystemISO 13485:2016Active
QC-0203-200028/Nov/2021Quality Management SystemISO 13485:2016Active

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+55 (19) 3778-9864
comercial@qccert.com.br
Av. Antônio Artioli, 570 | Zug | Sl. 15
Swiss Park - Campinas

                    

+55 (19) 3778-9864
comercial@qccert.com.br
Av. Antônio Artioli, 570 | Zug | Sl. 15
Swiss Park - Campinas