ISO 13485 Implementation Time and Cost
QRC provides ISO 13485 implementation assistance to organizations that want to be certified to the ISO 13485 Standard.

The ISO 13485 Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

The time required to implement the ISO 13485 Standard is typically 7 months when using QRC's implementation assistance.

You may call to request information and a fixed-price quote for assistance.

QRC's ISO 13485 assistance program provides:
  • Reasonable fixed-price quotes
  • Pre-agreed timeline
  • Record of 100% first-time certification
  • Minimum disruption of your present operation
  • Most efficient use of your staff resources

Timeline for ISO 13485 Implementation:   Print out detailed Timeline here.

Quality Resource Center's Implementation Program
QRC has assisted more than 350 organizations to implement ISO quality systems since 1993. Following are reasons why organizations select QRC to assist them in achieving ISO 13485 certification:

  • Minimum time to first-time certification
    • The standard time for implementing an ISO 13485 system is 7 months. The events on the "Timeline for ISO 13485 Implementation" chart can be extended over more than 7 months or shortened by speeding up the documentation/review process that takes place in the first 3 months of the project.

    The standard time for implementing ISO 13485 without outside assistance ranges from 18 months to two years.

  • Pre-agreed timeline
    A calendar of events is prepared based on considerations defined by your organization.

  • Co-Project Management
    The Implementation Project is jointly managed by an ISO Coordinator from your company and QRC's ISO 13485 specialist. The ISO Coordinator schedules the activities and access to personnel that is needed for the activities shown on the timeline. QRC does most of the work for you and ensures that your personnel know how to operate and maintain the ISO quality system.

  • Most efficient use of your staff resources
    Your personnel provides input and approval of documentation that is prepared by QRC. The amount of time required for these activities is minimal compared to allocating release time for key personnel (and replacing those people) while they work on documentation.

  • Minimum disruption of your present operation
    QRC's implementation approach recognizes that you must continue to run your company at the same time you are setting up the ISO 13485 quality system. This is why QRC does almost all of the work for you.

  • Record of 100% first-time certification
    All companies that have used QRC's full-service implementation program have received certification following their first audit by a Registrar.

  • Request a Quote
    Companies investigating ISO 13485 may request a quote for implementing an ISO 13485 quality management system. Companies report that QRC's quoted cost is significantly less than it would cost them to do the work themselves.

    A quote is provided following a short phone conversation.

To request more information or a quote for implementation services:

Contact: Jane Birkenstock
Phone: (408) 371-9995
Email: Jane Birkenstock <janebirk@qrccentral.com>

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