How to select an ISO 13485 Registrar.

Selecting the right ISO 13485 registrar (also known as a certification body or registrar) is a crucial step in achieving and maintaining ISO 13485 certification, which focuses on the quality management system for medical devices. Here's how to select an ISO 13485 registrar:

  1. Understand Your Certification Needs:

    • Clearly define your organization's objectives and reasons for seeking ISO 13485 certification. Consider the scope of certification and the specific medical devices you manufacture or handle.
  2. Compile a List of Potential Registrars:

    • Create a list of potential registrars by:
      • Asking for recommendations from industry peers who have undergone ISO 13485 certification.
      • Searching online for accredited ISO 13485 registrars in your region or country.
      • Contacting relevant regulatory authorities or industry associations for recommendations.
  3. Check Accreditation and Recognition:

    • Ensure that the registrars on your list are accredited by a recognized accreditation body for ISO 13485. Accreditation bodies assess the competence and impartiality of registrars. Look for accreditation specifically related to medical devices.
  4. Evaluate Medical Device Experience:

    • Assess the experience and expertise of potential registrars in accrediting organizations in the medical device industry. Registrars with a strong background in this field are better equipped to understand your organization's unique needs.
  5. Review Customer Feedback:

    • Research customer feedback and testimonials for each registrar. This can provide insights into their reputation, performance, and customer satisfaction in the context of ISO 13485 certification.
  6. Request Proposals:

    • Contact the registrars on your list and request detailed proposals. The proposal should include information about the certification process, timeline, fees, auditor qualifications, and any additional services they offer.
  7. Assess Auditor Competence:

    • Inquire about the qualifications and experience of the auditors who will assess your organization during the certification process. Ensure they have relevant expertise in medical devices.
  8. Compare Costs:

    • Compare the costs associated with certification, including initial certification fees, surveillance audit fees, and any additional charges. Ensure that you have a clear understanding of the pricing structure.
  9. Consider Location and Availability:

    • Evaluate the registrar's geographic coverage and auditor availability. Choose a registrar with auditors who can easily travel to your organization's locations if necessary.
  10. Assess Communication and Support:

    • Evaluate the registrar's responsiveness and communication. A reliable registrar should provide clear and timely communication and support throughout the certification process.
  11. Understand Certification Mark Usage:

    • Clarify the rules and conditions for using the ISO 13485 certification mark after successful certification. Ensure that you understand and can comply with these requirements.
  12. Check for Conflicts of Interest:

    • Verify that there are no conflicts of interest that could compromise the registrar's impartiality during the certification process.
  13. Visit Registrar Offices (Optional):

    • If feasible, consider visiting the registrar's offices or meeting their representatives in person. This can help you establish a more direct relationship and gain a better understanding of their operations.
  14. Request References:

    • Ask registrars for references from organizations they have previously certified for ISO 13485. Contact these references to gather insights into their experiences with the registrar.
  15. Make Your Selection:

    • After evaluating and comparing all the information, select the ISO 13485 registrar that best aligns with your organization's needs, scope of certification, and offers a competitive package.
  16. Negotiate and Sign a Contract:

    • Once you've made your selection, negotiate the terms and conditions of the certification contract. Ensure that all agreements are documented in a formal contract.
  17. Initiate the Certification Process:

    • Work closely with your chosen registrar to initiate the ISO 13485 certification process. This typically includes preparing your quality management system, undergoing assessments, and working towards achieving ISO 13485 certification.

Choosing the right ISO 13485 registrar is essential for the success of your organization's certification and ensuring the quality and safety of your medical devices. Take the time to research, evaluate, and make an informed choice to help your organization achieve and maintain ISO 13485 certification effectively.

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