ISO 13485:2016 Auditing Services
ISO 13485:2016 Auditing for Small, Medium & Large Businesses
We provide over 24 years’ experience in Quality auditing, consulting & training to offer you a comprehensive range of professional auditing services to meet your exact needs. Whether a gap analysis, internal audit, supplier audit or special/unannounced audit - we have got you covered!
ISO 13485:2016 is an internationally recognized standard for Quality Management. ISO 13485 Certification will help clients’ to continually monitor and manage Quality across part or the whole organization and supply chain, if required. As the world’s most widely recognized Quality Management standard, it outlines ways to achieve improved competitiveness, as well as benchmark, consistent performance and service.
We have worked in over 46 countries around the globe, with organizations of all types including many leading multinationals.
The below auditing services are available.
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Onsite Gap Analysis
For: Any Organization
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
- Provided remotely and onsite
Service Includes:
- Dedicated Consultant
- Advance Preparation / Documentation Desktop Review
- Visit Agenda (provided in advance for planning resources availability)
- Onsite Gap Analysis
- Full documented report on all findings & recommendations
- Follow Up Call & Discussion on any findings and/or recommendations
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Onsite Internal Auditing
For: Any Organization
Sometimes its good to get an outside assessment. This is a service for companies looking for support with a once off or annual support with their internal audit program.
- Provided remotely and onsite
Service Includes:
- Dedicated Consultant
- Internal Audit Schedule Planning (optional)
- Advance Preparation / Documentation Desktop Review
- Visit Agenda (provided in advance for planning resources availability)
- Onsite Internal Audit
- Full documented report on all findings & recommendations
- Follow Up Call & Discussion on any findings and/or recommendations
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Onsite Supplier Auditing
For: Any Organization
A service for companies who need support assessing or managing their supply chain.
- Provided remotely and onsite
Service Options Available:
- Dedicated Consultant (Team if required)
- Supplier Audit Schedule Planning (optional)
- Advance Preparation / Documentation Desktop Review
- Visit Agenda (provided in advance for planning resources availability)
- Onsite Supplier Audit
- Full documented report on all findings & recommendations
- Follow Up Call & Discussion on any findings and/or recommendations
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.
Would you like us to call you back to discuss it?
