ISO 13485 certification

Background on ISO 13485:

ISO 13485:2003 (Medical devices - Quality management systems - Requirements for regulatory purposes) is essentially ISO 9001 adapted to meet the requirements of the medical device industry and it addresses most FDA requirements (21CFR820). The main difference between ISO 9001 and ISO 13485 is that ISO 13485 is more focused towards ensuring medical device safety and efficacy rather than enhancing customer satisfaction and continual improvement. Once you implement processes and procedures that comply with the requirements listed in ISO 13485:2003, you can be audited by a third party organization called Registrar such as TUV or UL who will certify your organization to this standard. It will also meet most of the FDA requirements to have a Quality System in compliance with the QSRs set forth by 21CFR820.

ISO 13485!

Normalized trends in ISO 13485 popularity and interest since 2004:


Among the companies we helped in their certification and compliance projects:


ISO 13485:2003 Certification consulting:

We offer 2 types of consulting options depending on the resources you wish to allocate for the implementation of ISO 13485:2003. They are SATISFACTION GUARANTEED.

1/ ISO 13485 Turnkey certification consulting:

If your company wishes to have CALISO drive the implementation to comply and be certified with ISO 13485, we offer an implementation service that follows a 5-step methodology: Gap assessment, quality management system upgrade, training, internal audit, and certification audit. We will provide and generate all the required documentation to meet the requirements of the standard. The implementation usually involves streamlining and simplification of your operation to take full advantage of the benefits of the standard. We have consultants in almost all the different states, Canada, and Mexico. Also check-out our Success Stories and References.


2/ ISO 13485 Desk audit:

If your company has internal resources (management representative, QA/RA Manager) and needs exacts guidance on what needs to be done, we offer desk audits combined with online training that will help you comply with the standard you choose at minimal cost. We basically review all your operational documentation to identify any requirements not being met. You will need to send us a copy of your QA Manual or policies (Level 1), procedures (Level 2), and your organizational chart for a thorough audit/review on our part. The review will be under non-disclosure agreement and will maintain full confidentiality. We will then issue a detailed checklist of the modifications your system requires to comply with ISO 13485:2003. The checklist will be very specific to what needs to be done. We will also provide you with templates for the QA Manual (Level 1), a Continual Improvement Plan, and an Internal Audit Checklist that you can customize to meet the new requirements of the standard. Once the modifications are made, you will need to implement the changes in accordance with the recommendations in the report.

We also provide you licenses for ISO 13485 online training, ISO 13485 Auditor training, and ISO 13485 Lead Auditor training.

To start your implementation you would need to fax us a PO at 509-756-6053 and e-mail us your Level 1 (QA Manual) and Level 2 (Procedures) to training@caliso9000.com


For both options, we can also assist and consult to:
  • Achieve cGMP compliance integrated with ISO 13485 or build on your current cGMP compliant quality system to become ISO 13485 certified.
  • Assist you for your conformity to the Medical Device Directive (MDD) and CE marking of your product. ISO 13485 and CE Marking can be parallel processed, to optimize time to market for your product.
  • Assist you for your FDA 510k clearance.
  • We guarantee your certification provided you follow our recommendation in a timely manner. The Desk Audit and the Turnkey Consulting are satisfaction guaranteed. If you are not satisfied with our work, you will get a full refund upon return of all the documentation generated or provided. The refund covers the latest billing period for onsite consulting.

    You will also have 1 year of free e-mail consulting support, where we will answer any questions you may have to help you successfully complete your certification.

    To start your implementation call us at 1-800-306-1366 or fax us a PO at 509-756-6053. For Option 1, there are no travel or accommodation expenses if we have a consultant in your area, otherwise, they are billed at cost. You will also need to e-mail us your Level 1 (QA Manual) and Level 2 (Procedures) and product specifications for the gap assessment preparation to training@caliso9000.com

    Link to the ISO 14971 certification consulting information. ISO 14971 is the risk management standard for medical devices.