ISO 13485 2016

Medical Device Quality Management

Apply a quality-management framework tailored to medical-device organizations and regulated product environments.

ISO 13485Edition 2016
OVERVIEW

What this standard or pathway addresses.

ISO 13485 focuses on consistent product and process controls for organizations involved in medical-device design, manufacture and related services.

Potential benefits when effectively implemented

  • Medical-device quality controls
  • Documented process discipline
  • Supplier and production oversight
  • Regulatory-oriented management system

Typical organizational fit

For medical-device manufacturers, component suppliers, contract manufacturers and organizations supporting the medical-device lifecycle.

TYPICAL JOURNEY

From requirement to certificate access.

The exact assessment route and certification decision depend on the external certification provider and the applicable standard.

01

Define the requirement

Confirm the standard, scope, sites and reason for seeking certification.

02

Prepare the management system

Establish the applicable processes, responsibilities, controls, documented information and operational evidence.

03

Complete third-party assessment

Follow the applicable assessment route and address required findings or follow-up before a certification decision is made.

04

Upload and access the issued certificate

After the final certificate is issued externally, an administrator records its details and uploads the source file for controlled customer access.