ISO 13485 Resources

Here are some pages that will help you get started:

13485store.com provides resources to help you understand ISO 13485, and what it takes to implement a QMS in your organization. We also partner with companies who provide external resources and services. Wherever your company is in its certification process, we are here to simplify.

ISO 13485 Registrars
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ISO 13485 Consulting
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ISO 13485 Software
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Independent Quality and Standards Related Organizations

International Organization for Standardization (ISO)

ISOISO TC/176 The International Organization for Standardization’s (ISO) Technical Committee 176 on Quality Management and Quality Assurance — the committee responsible for developing the ISO 9000 series of standards and guidance documents.


Exemplar Global designs, develops, and delivers personnel and training certification for various standards (ISO 9001, etc.)


ASQASQ is the world’s leading membership organization devoted to quality.


ANABANSI-ASQ National Accreditation Board (ANAB) is the US accreditation body for QMS certification. They offer a directory of Registrars and other resources.


SAESociety for Automotive Engineering (SAE) is a non-profit educational and scientific organization dedicated to advancing mobility technology.


SQASociety for Quality Assurance – Research and Regulatory Information


ANSIAmerican National Standards Institute – American National Standards Institute (ANSI) web site offers up-to-date resources on national and international standards activities.


The Institute of Internal AuditorsIIA


U.S. Government Organization