Home » ISO 9001 to 13485 for Small Business

ISO 9001 to ISO 13485 Certification for Small Business

ISO 13485 = ISO 9001 + a few additional requirements. It also subtracts a few requirements. This package helps your organization achieve ISO 13485 and ISO 9001 Certification.

Our ISO 9001 and ISO 13485 All in One Documentation and Training Package is our most popular product - for good reason: It gives you all you need to prepare for registration.

But what if you only have 10 people in your company?
Do you plan to hire out your internal audits and don't need training?

Quite often the same people play many roles in the implementation, so some of the training becomes redundant. The smaller business looking for ISO 13485 certification needs an affordable, streamlined product. We have designed this package with you in mind.

It's small in price but packs a punch!

The ISO 9001 to ISO 13485 Small Business Package includes:

	ISO 9001 and ISO 13485 Quality Manual 27 Procedures describing a COMPLETE Quality System to meet ISO 13485 requirements 41 Forms and tables referenced by the Procedures - not random unneeded forms..
	ISO 9001 to 13485 QMS Upgrade Instructions
	ISO 9001 and ISO 13485 Gap Analysis Checklist - complete toolkit to help you plan your project.
	ISO 9001 and ISO 13485 Internal Audit Checklist & Toolkit Conduct your own audits
	ISO 13485 Employee Training for 20 people so your entire organization understands ISO 13485 and how it will impact them.
	ISO 13485 Presentation Materials Clause by Clause review of ISO 13485 for groups
	ISO 13485 Step-by-Step Guide PDF
	Document Control PowerPoint
	ISO 13485 Internal Auditing PPT
	Implementing ISO 13485 PowerPoint
	Complete Support throughout your project We don't abandon you after the sale

This is a downloadable product. You also have the option of purchasing the files on CD-Rom.

You can add additional products or training seats at another time, and we'lll always let you upgrade for the difference should you need more.