As the international standard for Quality Management Systems in the medical device industry, Adopting ISO 13485 provides a practical foundation for manufacturers to address the regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices. ISO 13485 has already been tested and proven. Companies that have achieved certification can show proof to potential clients that they comply with best practices, and with regulatory requirements.
ISO 13485 Certification
Quality Management Systems-Medical Device
And, along the way, your company will naturally enjoy better control over its processes, and continual improvement – driving continual ROI.
This is a process-based standard: you use it to control your processes, then your end product should meet the desired results.
What is ISO 13485 Standard?
ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment. While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance. It is more prescriptive in nature and requires a more thoroughly documented quality management system.
ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.
Benefits of ISO 13485 Certification:
Whether you are looking to operate internationally or expand locally, ISO 13485 Certification can help you improve overall performance, eliminate uncertainty, and widen market opportunities. Companies with this certification communicate a commitment to quality to both customers and regulators.
- Increase access to more markets worldwide with certification.
- Outline how to review and improve processes across your organization.
- Increase efficiency, cut costs and monitor supply chain performance.
- Demonstrate that you produce safer and more effective medical devices.
- Specific requirement for inspection and traceability for implantable devices.
- Specific requirement for documentation and validation of process for sterile medical devices.
- Meet regulatory requirements and customer expectations.
Certification Process:
The certification process is defined in multiple steps, here is following steps briefly described:
- Application form for certification from the client
- Proposal from the ardent
- Contract and agreement signed between the part
- Stage-1 certification audit
- Stage-2 certification audit
- Issue certificate after successfully completed certification audit.
- Surveillance audit at defined interval
- Recertification audit at defined interval
Ardent’s services:
Ardent will conduct certification audit with competent auditors and technical experts to ensure that the organization fulfilling the customer, statutory and regulatory requirement. And certify the organization to promote continual improvement culture and enhance customer satisfaction.