Standard ISO 13485

Quality Management System – Medical Devices

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ISO 13485

Accredited by: ČIA
Provided by: LL-C (Certification) Czech Republic a.s.

The quality assurance of medical devices is vital to ensure compliance with regulatory requirements and requirements of customers. These issues are covered by standard ISO 13485.

ISO 13485:2016 will help you detect critical points and set up and monitor individual processes to ensure the continuous quality of medical devices, including their design, production, assembly and maintenance.

ISO 13485 is recommended to organizations whose activities involve medical devices in any stage of their supply chain.

Requirements of ISO 13485

  • Implementation of extensive requirements for medical facilities.
  • Definition and monitoring of relevant. processes in view of legal requirements
  • Validation of processes.
  • Assuring traceability of products.

Benefits of the Certification 

  • Assuring the necessary quality of medical devices in the entire supply chain. 
  • Improved risk detection and better solutions.
  • Improved competitiveness.
  • Greater trust of your clients. 
  • Compliance with all legal and regulatory requirements.
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The most requested certification

ISO 9001

Quality Management Systems

As the competitiveness of business environment grows, clients demand greater quality of goods and services. Standard ISO 9001 has been developed by International Organization for Standardization (ISO) with the aim to implement the international standardized system for quality management. Quality management systems in compliance with ISO 9001 will enable you to improve the quality of your goods and services, to make your company procedures more efficient and it will also allow you to participate in procurement procedures announced by public administration bodies. Standard ISO 9001 is one of the best known and most widely used international standards. This certification is recommended to organizations of any size or sector whose activities include production or provision of services.

ISO 14001

Environmental Management Systems

If you care about the environment, you should seek to adapt your relevant company processes to management systems based on the internationally recognized standard ISO 14001. The certification based on ISO 14001 will enable you not only to fully control the impact your company has on the environment, but it will also help you reduce operational costs in an efficient way. Moreover, your company will get better awareness of environmental issues. The certification for ISO 14001 is recommended particularly to manufacturing companies of any size or sector that wish to take control of their environmental impact. At the same time, you can combine it with the certification for ISO 9001 to get an integrated management system.

ISO 45001

Management Systems of Occupational Health and Safety (OHS)

Occupational safety is an integral part of successful business activities. The internationally recognized standard ISO 45001 aims to improve occupational safety and protection of health at work, while also minimizing the risk of occupational diseases. Standard ISO 45001 has fully replaced the original standard OHSAS 18001. By implementing this standard, you will be able to achieve an enhanced occupational safety, to prevent occupational diseases and, the last but not least, to minimize the risk of business interruption in your organization. Prevention is always cheaper than remedy. The certification for ISO 45001 is recommended to all companies that seek to improve safety of processes for all their workers. ISO 45001 can be integrated together with standards ISO 9001 and ISO 14001.

ISO 27001

Information Security Management Systems

ISO 22301

Business Continuity Management Systems

ISO 20000

IT Service Management Systems (ITSM)

A successful audit represents the verification of a correctly implemented and well-functioning management system based on ISO 13485. If you want to learn more, please contact us.

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