Quality Management System Certification
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.
Quality Management Systems
An ISO 9001 Quality Management System certificate will help your organization to continuously monitor and manage the quality across the enterprise, so areas for improvement can be promptly identified.
An ISO 9001 certificate proves your company’s ability to consistently provide products and services that meet your customers’ requirements, as well as applicable statutory and regulatory requirements.
With the ISO 9001 certification, you will be able to optimize your operations, reducing costs, in addition to making your organization nationally and internationally more competitive!
About the ISO 9001 standard
The ISO 9001 standard defines criteria for implementing a Quality Management System (QMS) and provides the infrastructure, procedures, processes and resources to help companies manage and improve their performance, efficiency and customer service. It is internationally recognized, helping organizations to monitor and organize their processes.
It was created as a set of requirements with greater focus on continuous process improvement and customer satisfaction. However, it is a general quality management standard and can be implemented by any company, regardless of its sector or size. It’s accepted in the healthcare sector at various organizational levels, not limited to the type of service provided.
ADVANTAGES OF THE CERTIFICATION
ADVANTAGES OF THE CERTIFICATION
If the organization intends to operate internationally or expand its local operations, the ISO 13485 and ISO9001 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.
- 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 offer safer and more effective products and systems