ISO 13485 Resources
Here are some pages that will help you get started:
- ISO 13485 Quick Start Kit
- Steps to ISO 13485
- ISO 13485:2016 Requirements
- Global Medical Device Standards
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
Our Registrar Finder provides you with a quick and simple way of receiving multiple quotations from up to three different registrars at one time.
ISO 13485 Consulting
Our products are designed so that you can use them as a do-it-yourself implementation tool. However, we know that sometimes you might want to consult an expert to help you on your project or a portion of it.
- Our Consultant Finder provides an efficient and effective way to reach a trusted and competent consultant without having to spend hours looking for them.
ISO 13485 Software
Affordable Web-based and Enterprise-wide software solutions that don’t require an upfront software investment or ongoing maintenance and internal support. Choose the type and format that is right for your organization.
Our partner, Federal Flags, provides the following self-promotion ISO certification tools using ISO acceptable identity standards.
Independent Quality and Standards Related Organizations
International Organization for Standardization (ISO)
ISO 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.)
ASQ is the world’s leading membership organization devoted to quality.
ANSI-ASQ National Accreditation Board (ANAB) is the US accreditation body for QMS certification. They offer a directory of Registrars and other resources.
Society for Automotive Engineering (SAE) is a non-profit educational and scientific organization dedicated to advancing mobility technology.
Society for Quality Assurance – Research and Regulatory Information
American 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 Auditors
U.S. Government Organization
- National Institute of Standards & Technology – a federal technology agency that works with industry to develop and apply technology, measurements, and standards.
- National Center for Standards and Certification Information (NCSCI)
NCSCI provides standards and standards-related information such as certification bodies, standards organizations and publications.