ISO 13485:2016 Supplier Auditing Service

A service for companies who need support assessing or managing their supply chain.

Service Summary

  • Dedicated Lead Auditor or Audit Team
  • Audit Scheduling & Planning Assistance
  • Remote and Onsite Available
  • Full Documented Report Included

Service Coverage

A service for companies who need support assessing or managing their supply chain.

  • Dedicated Lead Auditor or Audit Team

    On every assignment, we will assign a dedicated Lead Auditor or Audit Team that will work with you as we complete assessments of your suppliers on your behalf.

  • Advance Preparation, Scheduling Assistance & Documentation Review

    Every audit requires advance preparation. Our Lead Auditor will work with you to ensure everything is prepared including reviewing any audit / supplier documentation including scheduling assistance with the Supplier (s).

  • Supplier Audit Agenda

    We will issue an agenda in advance to ensure each Supplier is aware of the audit scope & can ensure all required resources are available for the agreed date & time that the audit will take place.

  • Onsite Supplier Audit

    Our Lead Auditor will conduct an onsite audit versus ISO 13485:2016 Requirements.

    At the closing meeting (end of audit), the Lead Auditor will informally advise the Supplier 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.

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.

See What The Kelmac Group® Can Do For You Get in touch with us today!

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