ISO Certification for Medical Devices | ISO 9001,13485,14971,45001

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ISO Certification for Medical Devices

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How ISO Certification helpful for medical devices

ISO certifications for medical devices guarantee that every organization or management system has all the requirements for standardization, quality assurance, and consistency. ISO certifications are helpful for almost every organization regardless of its size, type or process. ISO standard for medical devices is helpful for medical devices because it helps in the improvement of your product quality, efficiency, builds international credibility, and so on.

Why do medical devices need ISO Certification?

All organizations that manufacture or fabricate medical devices are required to prove their efficiency and safety to the customers. In that regard, ISO Certification for medical devices is very much essential for those organization’s. ISO standards for medical devices will help your organization to maintain the overall quality of your products. It also helps your organization to identify all the risks related to your devices and also helps you to find measures to mitigate those risks.

ISO Certification process for Medical Devices

  • Application & contract 
  • Audit team Assignment 
  • Document view 
  • Certification Audit Independent review 
  • Notification of Certification
  • Surveillance audit
  • Re-Assessment

The certification process goes further. click here to view the next steps to ISO certification Process

Benefits of ISO certification for Medical Devices

Having ISO Certification for medical devices manufacturing organizations is very much profitable. Some of the primary profits of achieving ISO Certificate are listed below:

  • ISO Certification for medical devices reduces the rework of the processes in your organization, which in return encourages cost savings in your organization.
  • ISO standard for medical devices is very profitable for your organization because it assesses and identifies all the risks-related to your processes and finds a way to mitigate them from your organization.
  • ISO certification is widely accepted in medical devices industries as compared to other business competitors as it helps your organization to meet all the expectations of the customers.

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    Which standards or ISO certificates are required for medical devices?

    The International Organization for Standardization (ISO) publishes certain standards that help in implementing management systems for delivering quality products and services as well as enabling compliance to the related legislations. The most required ISO standards that are appropriate for medical devices are listed below:

    ISO 9001 certification is an internationally recognized standard for quality management systems. This ISO standard for medical devices industries is helpful for maintaining a rigorous quality management system in the organization. Having this ISO Certification for medical devices ensures cost-effective management, improvement of accountability, facilities for growth, fulfilling customer’s expectations, etc. in your organization.

    ISO 13485 certification is a globally recognized standard specially designed for quality-assured medical devices manufacturers. The organization's compliance with ISO 13485 standard ensures that its products are of the best quality that can meet the expectations of the customers. This ISO standard for medical devices helps with the overall efficiency, quality-control, valid processes, and risks management system in your organization.

    ISO 14001 Certification is the general standard for Environment Management Systems. This ISO Certification for medical devices industries helps to cut down their toxic waste management, reduction in their overall carbon footprints, and conservation of overall energy use. It helps your organization to ensure the customers that your processes meet all requirements for a safe and healthy environment.

    ISO 50001 Certification is an internationally accepted standard for energy management systems. This ISO standard for medical devices helps to improve your overall energy management and can reduce costs and operating expenses. In that regard, your company will be able to enhance its reputation as compared to other robust competitors.

    ISO OHSAS 18001 / ISO 45001 Certification standard outlines the framework for Occupational Health and Safety Management Systems. This ISO standard for the medical device industry is very much crucial because it helps to reduce business-related risks, improves organizational accountability, and also reduces the rates of accidents and other liability issues in the organizations.

    ISO 27001 Certification is an accredited standard for Information Security Management Systems. This ISO certification for medical devices will help your organization to identify and assess cyber risks in your organization and find ways to mitigate them.

    ISO 14971 Certification is a specially designed standard for reducing and managing risk related to medical devices. It helps in assessing and identifying the device-related risk associated with your organization and helps to establish the necessary controls to prevent or mitigate those risks from your organization.

    FAQs

    What ISO certificates are required for the medical devices industry?

    • The most commonly required standards that are applicable for Medical Device Industries are as listed below:
    • ISO 9001 Standard: Quality Management System.
    • ISO 14001 Standard: Environmental Management System.
    • ISO 27001 Standard: Information Security Management.
    • ISO 45001 Standard: Occupational Health and Safety Management System
    • ISO 50001 Standard: Energy Management System.
    • ISO 13485 Standard: Quality Management System for Medical Devices.

    How do ISO regulations affect medical devices?

    There is always a positive effect of ISO regulation on the Medical Devices industry. This is so because, The ISO certification for medical devices makes the production, development, and supply of products and services more effective and efficient and also helps in reducing the adverse impact of your activities on the environment. It gives confidence to the customers that the products that they are using are of premium quality.

    How do we become ISO Certified for medical devices?

    Achieving ISO Certification is no big deal in today’s upgraded systems. The basic steps to become ISO Certificate for Medical Devices are as follows:
    • Firstly, you need to prepare all the relevant information about your company in a systematized way (It is always best and safe to hire a legal consultant.)
    • Secondly, you need to document all the relevant information about your business.
    • Thirdly, you have to implement all the documented information in your organization.
    •  Fourthly, get ready for the internal audits which are performed first during the certification process and then periodically after.
    •   Lastly, if the certifying body approves your management system then you will be awarded the required ISO standard.

    How long is an ISO certificate valid for?

    Generally, an ISO Certificate is valid for 3 years. And during this time period of 3 years, a surveillance audit is conducted on an annual basis to ensure that ISO quality standards are being maintained by the organization.

    How can I apply for ISO Certification for medical devices?

    • Firstly, select the type of ISO certification you want for your medical devices industry.
    • Secondly, selecting a recognized and credible ISO certification body (ISO Registrar)
    • Thirdly, make an application in the prescribed form which should include liability issues, confidentiality, and access rights.
    • Fourthly, the ISO certification body will review all the documents related to various policies and procedures being followed in the organisation. If there are any existing gaps, the applicant has to prepare an action plan to eliminate these gaps.
    • Then, the ISO registrar will conduct a physical onsite inspection to audit the changes made in the organisation.
    • As soon as the certifying body approves your management system, you will be awarded the required ISO standard. 

    How much does it cost for ISO certification?

    Basically, when you approach a certifying body for ISO Certification and they approve your management systems and all your processes, they will then quote an amount for the certificate. Moreover, the cost for achieving ISO certification depends mostly on your organization, such as the no. of employees in your organization, No. of branches your organization has, and many more.

    To help your organization boost its performance in all spheres then apply ISO Certification for medical devices. Choose SIS CERTIFICATIONS and take your company to the next level by achieving ISO certification for Medical Devices. It will not only help you win new customers but also helps you to retain those customers for a longer period. By maintaining effective management you can reduce costs and use of energy to a greater extent which will be beneficial for your company’s growth. You will be able to manage work-related risks in your organizations creating a healthy environment in your company.

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