ISO 13485 Full Service Consulting

Kelmac Group’s Full Consulting Approach for achieving ISO 13485 Certification is a perfect option for small sized businesses that want a consultant to perform 80% of the work on their behalf. This is the best option for companies that have limited resources or a tight deadline for obtaining certification.

This is a new consulting offering for 2018. For over 14 years, Kelmac Group have been supporting clients achieve ISO 13485 Certification. In recent times, we have largely worked with medium-large enterprises who were more interested in applying the principles of ISO enterprise-wide and going beyond just achieving ISO 13485 Certification. This has provided us with both broad & invaluable experience of how much a well-implemented ISO system can benefit many different types of organizations and industries. However, such solutions – as they involve significant time & effort - are often beyond the means of small-medium businesses.

For 2018, we have decided to introduce a range of consulting support options specifically tailored to the small business market, where we will bring our considerable expertise to offer competitive solutions to organizations looking to build the foundations for future success, using ISO 13485 Certification as a platform

Service Summary

  • Full consulting support
  • Dedicated consultant
  • Built on a 3 or 4-month schedule
  • 100% successful for certification

Certification Benefits

  • Improve Statutory & Regulatory Compliance

    Demonstrate compliance with current and future statutory and regulatory requirements.

  • Consistently Safe & Effective Medical Devices

    Ensure the establishment of QMS practices that consistently yield safe and effective medical devices.

  • Attract New Customers

    Many companies look to adopt ISO 13485 due to a customer contract requirement or tender. It is normally the number 1 reason. By getting ISO 13485 Certification, you will enhance your reputation and this can attract new customers and help you expand into new markets.

Service Coverage

If opting for this service, you are signing up to a comprehensive full consulting support package. This approach will see the Consultant do the majority of the work, but the client will still play an important part in the project.

  • Onsite Gap Analysis

    At the start of the project, our consultant will perform an onsite gap analysis of your organization against ISO 13485:2016 including report.

  • Project Management & Coordination

    With the gaps defined, we will provide you with a weekly project plan for the 3- 4 month project showing tasks and deadlines from start to finish. Our consultant will project manage from start to finish.

  • Onsite Training

    At the start of the project, we will provide ISO 13485 training for your managers and project team.

  • Sample Set of ISO Documents [Worked Examples]

    You will gain access to a set of documentation templates to assist you during the project and this will help save time.

  • Coaching & Mentoring Calls with the Consultant

    Throughout the project, you will have access to coaching and mentoring calls with the Consultant (as required).

  • Professional ISO Documentation

    Our consultant will lead the preparation and generation of the documentation needed for successful ISO 13485 Certification

  • Onsite Internal Audit & Management Review

    Our consultant will conduct an onsite internal audit required in advance of the Stage 1 Certification audit, plus host & facilitate the Management Review

  • Onsite Implementation Support

    With the design phase complete, our consultant will provide support during the implementation phase of the project

  • Registrar Coordination

    Our consultant can help you get a number of quotations from accredited Registrars. You make the final decision!

  • On Call Support for Registrar Audit

    During the audits, our consultant will be available if you or the Registrar’s Auditor has any questions you need assistance with answering.During the audits, our consultant will be available if you or the Registrar’s Auditor has any questions you need assistance with answering.

Why Choose Kelmac Group® Consulting

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