Kelmac I Group, Inc

Kelmac I Group, Inc

- ISO 13485 Certification - Shared Work Approach Services



Kelmac Group’s Shared Work Approach for achieving ISO 13485 Certification is a perfect option for small-medium sized businesses that want to play a significant role in the project and keep consulting costs to a minimum.ive (GFSI).

This is a new consulting offering for 2018. For over 20 years, Kelmac Group have been supporting clients achieve ISO Certification across a broad range of disciplines. 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-medium 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.

The Shared Work Approach is our most cost-effective approach where the work is split between your staff and our consultant and enables you to keep costs on the project to a minimum. The support provided is a blend of onsite and remote (virtual) support) during the design, development and implementation phase.

Service Summary

  • Lower cost by sharing the work
  • Dedicated consultant (as needed)
  • Built on a 3 or 4-month schedule
  • 100% successful for certification

Certification BenefitsImprove 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.

If opting for this service, you are signing up to an affordable, effective alternative to full consulting. This approach does place significant responsibility on each client but we will provide guidance and support through the process.

  • 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.

  • Detailed Weekly Project Plan

    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 continue to monitor the project and help you stay on track.

  • 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.

  • ISO Document Review/Preparation

    Our consultant will review the documentation your team creates and provide feedback during the preparation.

  • Onsite Internal Audit

    Our consultant will conduct an onsite internal audit required in advance of the Stage 1 Certification audit.

  • 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.

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