QMS Overview

ISO stands for

• International Standard Organizer

• International Standardization Organization

• International Organization for Standardization

• International Organizer Standard

What is NOT the main purpose of a Quality Management System (QMS)?

• To provide confidence that quality requirements will be fulfilled

• To reduce paperwork

• To improve productivity

• To fulfill regulatory requirements and maintain product quality

It is the on-site verification activity to ensure compliance to requirements

• Examining

• Authenticating

• Auditing

• Inspecting

The QMS of Berovan is:

• ISO 14001:2018

• ISO 13485:2016

• ISO 9001:2015

• ISO 13485:2013

ISO 13485: 2016 is the QMS for:

• Environmental Management System

• Healthcare Management System

• Occupational Health & Safety Management System

• Medical Device Quality Management System