ISO 13485 Certification – Shared Work Approach
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.
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.
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.
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.
Why Choose Kelmac Group® Consulting
Proven Track Record Since 1996 we have helped many organizations achieve successful ISO certification. We have a 100% success record.
Unmatched Experience Unlike many of our competitors, we have worked with clients in over 46 countries around the globe from small to medium businesses, government & non-profit organizations including up to Fortune 500 companies.
Flexible Options Each client decides the best support package to meet their needs. We offer all clients a range of support options geared towards providing the support YOU want, built around your specific needs & preferences.
Fixed Fee We understand how important it is to have confidence and certainty when financially planning for ISO Certification. All projects are fixed fee to ensure that there are no surprises.
See What The Kelmac Group® Can Do For You
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