ISO 13485:2016 Gap Analysis Service
Service Summary
- Dedicated consultant
- Audit Scheduling & Planning Assistance
- Remote and Onsite Available
- Full Documented Report Included
Service Coverage
A service for companies that are interested in adopting ISO 13485:2016 and want to quantify the scope of work, resources and timeline to achieve certification
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Gap Analysis Agenda
To ensure that you are fully ready for the gap analysis, we will issue an agenda in advance to ensure you are fully prepared and all resources are available for the agreed date & time that the gap analysis will take place.
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Onsite Gap Analysis
Our consultant will conduct either an onsite gap analysis versus ISO 13485:2016 Requirements.
At the closing meeting (end of audit), the Consultant will informally advise you of all findings & recommendations. -
Full Documented Report
We will provide a detailed, full documented report on all findings & recommendations as part of the service.
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Follow Up Call & Discussion
Our consultant will schedule a follow up call with you to go through the report & discuss any findings and/or recommendations. Additional assistance will also be available.
Why Choose Kelmac Group® Auditing
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Proven Track Record
Since 1996 we have helped many organizations achieve successful ISO certification. We have a 100% success record.
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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.
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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.
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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.
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