ISO 13485:2016 Resource Center

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Everything you need to learn, transition, and implement ISO 13485:2016

Start here for steps to streamline your entry into ISO 13485:2016. And before going too far, sign up for our useful “Quick Start Kit” to keep you moving down the road to certification.

Key Concepts

Things to know about implementing an ISO 13485:2016 Quality Management System

General Quality Management
  • 2015-resource-middle-boxes-quality-mgtWhat is a Quality Management System?
  • Continuous Improvement
  • Document Control
  • Customer Focus & Customer Satisfaction
  • Internal Audits
  • Finding a Problem’s Root Cause
ISO 13485:2016 Specific
  • ISO 13485 2016 specific resourcesWhat is “Risk Planning”?
  • Top Management Expanded Role Under ISO 13485-2016
  • Measuring Performance According to ISO 13485-2016
  • How to Operate Your Organization According to ISO 13485 2016
  • Resources Needed Under ISO 13485-2016
  • Documentation Requirements for ISO 13485-2016
  • Understanding Organizational Context

The Value of ISO 13485:2016

Let ISO 13485:2016 Help Your Business As It Has Countless Others

For over 20 years, the ISO 13485 quality management standard series has been helping companies the world over in countless industries create a common “language” of consistent quality achievement. Not only has this opened up opportunities for each of these organizations to expand their reach, but it has given the world a means for continuously improving their operations. Even against a backdrop of vast economic fluctuation, companies seeking ISO 13485 certification has been growing. (See accompanying table)

Making It Easier for You To Get Certified

The 13485 store (through its parent group Standard Stores) was created to help simplify gaining certification to a range of ISO standards, including ISO 13485. We do this by creating time and money saving materials to help you plan, document and implement your system. These include a wide range of templates, instructions, manuals, training guides, classes and more. Here are a few key products that everyone considering ISO 13485:2016 Certification should consider:

Value Packs

These time saving certification support packages include up to 16 different modules including specific procedures (written according to ISO 13485 standard guidelines) that can be quickly modified for your business. Other modules include workflow mapping to understand and document your processes, employee training materials, audit-preparation exercises and the all important GAP checklist, to determine where improvements need to be made prior to going through the auditing process. As with all modules, free support is included.

Free ISO 13485 Training Classes

We list many ISO13485 training classes completely FREE of cost from the industry’s top ISO training providers. Save time and money by finding the right ISO training course in the right place at the right time. Free ISO 13485 Training Details