ISO 13485:2016 Supplier Auditing Service

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.

Service Summary

  • Dedicated consultant
  • Audit Scheduling & Planning Assistance
  • Remote and Onsite Available
  • Full Documented Report Included

Service Coverage

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.

  • Internal Audit Planning & Scheduling [Optional]

    We can assist with preparing your internal audit schedule. For example, whether you want to conduct a single, full system internal audit per year or wish to break out your audits in a systematic way throughout the year.

  • Initial Call with the Consultant

    As part of the planning phase, our consultant will arrange a call with you to ensure you are ready, brief you on our process and answer any questions that you might have about the process or service.

  • Internal Audit Agenda

    To ensure that you are fully ready for the internal audit, we will issue an internal audit agenda in advance to ensure you are fully prepared and all resources are available for the agreed date & time that the internal audit will take place.

  • Advance Desktop Review [Optional]

    Our consultant will complete an initial desktop review of key documentation in advance of the scheduled internal audit date.

  • Onsite Internal Audit

    Our consultant will conduct either an onsite internal audit of your QMS based on 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.

  • 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

  • Proven Track Record

    Since 1994 we have helped many organizations with ISO conformity, compliance & certification

  • 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. All projects are fixed fee to ensure that there are no surprises.

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