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ISO 13485

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ISO 13485 Certification

The ISO 13485 standard is closely related to the ISO 9001 standard, which provides guidance and standards for creating a quality management system. As technology advances, medical equipment must fulfill high quality standards for health and safety. ISO 13485 is a worldwide medical device standard that can be applied to any company in any country. This guideline outlines quality management in medical device manufacturing facilities to ensure high-quality products and compliance with FDA regulations, including Current Good Manufacturing Practices (CGMP).

What is ISO 13485?

ISO 13485 is a quality management system standard for the medical device industry, derived from ISO and necessary for regulatory purposes. 9001:2008. The ISO 13485 standard outlines quality management system criteria for organizations to continuously supply medical devices and services that meet customer and regulatory standards. This standard applies to organizations at various stages of the life cycle. ISO 13485 can be utilized by suppliers and external parties who offer products and services to businesses.
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WHAT ARE THE BENEFITS OF ISO 13485

ISO 13485 certification is specifically designed for medical device manufacturers. A certificate issued by an independent, qualified certification authority certifies that a quality management system has been implemented, recorded, used, maintained, and improved by the supplier or manufacturer of medical equipment. . Benefits of 13485 certification:  Guarantees high quality of provided services and products  Reduces production loss rate  Trust in you as a safe supplier or producer  reduces operational costs.  Provides an acknowledged management system as part of the Route to Conformity for CE marking.  Effective training tool for employees and staff. Safety and performance of medical devices are paramount in this highly regulated industry; this is why quality management systems are a regulatory or legal requirement in many countries. ISO 13485 can help organizations involved in any part of a medical device’s life cycle: • Demonstrate compliance with regulatory and legal requirements • Ensure the establishment of QMS practices that consistently yield safe and effective medical devices • Manage risk effectively • Improve processes and efficiencies as necessary Many countries consider this a legal obligation. ISO 13485 supports organizations across the medical device life cycle. • Show conformity with Regulatory and legal requirements. • Implement QMS practices for safe and effective medical devices. • Manage risks effectively. • Improve processes and efficiency as needed. • Gain a competitive advantage. • Gain a competitive advantage

Start your journey to ISO 13485 certification

Contact our team today to receive a free no-obligation competitive quotation from our dedicated business development team. We will devise a comprehensive quote that will align with your occupational health and safety requirements. We tailor our quotes to meet your needs, and we support a range of ISO standards, including ISO 27001, ISO 9001 and Cyber Essentials. Learn more about Certification Europe’s accreditations, discover our client testimonials and find out more about working with us.

The Certification Journey

5
Certification Achieved

Successful certification is communicated to the client. Certificates are issued.

4
Certification Review & Decision

The organisations files are reviewed by an independent and impartial panel and the certification decision is made

3
Recommendation for Certification

At this point in the process we review any corrective actions taken to address findings raised at Stage 1 & 2. Certification may be recommended.

2
Stage Two

The second assessment determines the effectiveness of the system, and seeks to confirm that the management system is implemented and operational.

1
Stage One

The initial assessment determines if the mandatory requirements of the standard are being met and if the management system is capable of proceeding to Stage 2.

Certification Achieved

Successful certification is communicated to the client. Certificates are issued.

Certification Review & Decision

The organisations files are reviewed by an independent and impartial panel and the certification decision is made

Recommendation for Certification

At this point in the process we review any corrective actions taken to address findings raised at Stage 1 & 2. Certification may be recommended.

Stage Two

The second assessment determines the effectiveness of the system, and seeks to confirm that the management system is implemented and operational.

Stage One

The initial assessment determines if the mandatory requirements of the standard are being met and if the management system is capable of proceeding to Stage 2.

ISO 13485 FAQ's

ISO 13485 requires organizations to establish processes for post-market surveillance and feedback to monitor the performance of medical devices once they are in the market. This includes collecting and analyzing data on device safety and performance, addressing customer feedback, and implementing corrective actions as necessary.

Yes, ISO 13485 certification is widely recognized internationally and can help organizations access global markets for medical devices. Many countries and regulatory bodies require ISO 13485 certification as a demonstration of compliance with quality management standards for medical devices.

ISO 13485 requires organizations to maintain documented procedures and records to demonstrate compliance with the standard. This includes documentation related to quality management system processes, risk management, design and development, production, and control of non-conforming products.

Yes, ISO 13485 can be integrated with other management systems, such as ISO 9001 for quality management or ISO 14001 for environmental management. This integrated approach, known as an Integrated Management System (IMS), can help organizations streamline processes, reduce duplication, and improve overall efficiency.

ISO 13485 includes specific requirements for the control of sterile medical devices, such as establishing procedures for sterilization, packaging, and maintaining sterility throughout the distribution chain. These requirements are essential to ensure the safety and effectiveness of sterile medical devices.

ISO 13485 is specifically tailored for organizations involved in the design, production, installation, and servicing of medical devices, while ISO 9001 is a more general quality management standard applicable to various industries. ISO 13485 places a strong emphasis on regulatory compliance and risk management specific to the medical device industry.

ISO 13485 sets out the criteria for a QMS specific to the medical device industry. It helps organizations demonstrate their ability to provide medical devices and related services that meet customer and regulatory requirements.

ISO 13485 is not a legal requirement in all countries, but many regulatory bodies around the world recognize it as a benchmark for ensuring the quality and safety of medical devices.

To obtain CE marking—which indicates conformity with safety standards for products sold in the European Economic Area—medical device manufacturers must get ISO 13485 certified with a notified body and have a quality management system in place.

Quality management system ,Management responsibility,Resource management,Product realization, Measurement, analysis, improvement. ISO 13485 includes requirements for design and development, risk management, production and post-production processes for medical device companies.

ISO 13485 is an internationally agreed upon set of standard quality management system (QMS) requirements for any company involved in the design, production, installation, servicing and manufacturing of medical devices.