Online Safety Community

A Process Approach to Quality Management Systems

ISO 13485:2016 describes a process approach to Quality Management Systems for Medical Devices.  This 6 -hour virtual seminar will help you to understand the process approach and develop an effective Quality Management System (QMS) for Medical Device Companies.  A well-structured QMS meets the requirements of the Quality System Regulations and is both effective and efficient.  The regulations require that manufacturers “establish and maintain a quality system that is appropriate for the specific medical device(s) designed and manufactured”.  

This webinar will cover the basics of how to establish and maintain a suitable QMS including:

  • The basic requirements
  • Management Responsibility
  • Quality System Processes
  • Process Ownership, Management, and Control
  • Roles and Responsibilities
  • QMS structure
  • Standard Operating Procedures, Work Instructions, Forms, etc.

An efficient, effective QMS sends a message to the FDA and other regulators that your QMS is complete, accurate, and consistently followed.  More importantly, it ensures that your personnel can consistently and accurately meet requirements resulting in correct outcomes and quality work.  It ensures that processes are well defined, managed, and controlled yielding predictable and acceptable results.  A controlled quality management system avoids unpleasant surprises and resulting rework, delay, and cost.

An ineffective QMS can lead to serious compliance and quality issues including 483 observations, warning letters, and even consent decrees.  Even worse it can lead to inconsistent or poor product quality including non-conformances, complaints, and even recalls.  And an inefficient QMS leads to confusion, inconsistency, excessive rework, corrective and preventive action, and increased cost of quality.  An inefficient QMS results in wasted time, money, and missed opportunities. It is imperative that medical device companies can effectively and efficiently establish a QMS.  

In this 6-hour virtual seminar, we will explore the fundamentals of a Quality Management System and how you can incorporate a process approach to take your program from surviving to thriving.  A thriving QMS can help you achieve your compliance objectives and improve product quality, leading to higher customer satisfaction and business results.

Views: 26

Comment

You need to be a member of Online Safety Community to add comments!

Join Online Safety Community

Take our poll!

Take our poll!

Latest Activity

Training Doyens posted an event
Thumbnail

Optimize Your Employee Onboarding: Techniques to Improve and Enhance the New Employee Experience at 26468 E Walker Dr, Aurora, Colorado 80016

June 18, 2019 from 1pm to 2pm
OVERVIEWIn this webinar, we will learn the reasons onboarding experience for new hires is important today. We will learn that the terms orientation and onboarding new employees are not interchangeable. We will learn that orientation is in reality just one step in the onboarding process. We will learn that the HR onboarding process begins before the hire is made.WHY SHOULD…See More
yesterday
Mark Nilson posted events
yesterday
Training Doyens posted events
Tuesday
Mark Nilson posted events
Monday

Forum

Green Smart Technical 800+ Turnkey Projects in UAE – Rope Access Company in Dubai

Green smart is an ISO 9001: 2015 QMS, OHSAS 18001: 2017 OHSMS, ISO 14001: …Continue

Tags: window, cleaning, services, facade, companies

Started by Manikandan Apr 23.

Workplace safety for workers other than your own 2 Replies

Do your workplace/traffic safety plans include safety measures for workers who are not your own employees? Do they take into account the safety of those who will be - or could be - at your workplace,…Continue

Tags: emt, paramedics, emergency, occupational, health

Started by John Petropoulos Memorial Fund. Last reply by Tara safe Mar 1.

What % of Dollars should be bugeted for All Safety Training for a "Heavy Equipment Road Construction" company with 100 employees? 1 Reply

I have been at a Highway and Road Construction company for six months. I am developing a (first) complete training program. I am the 1st full time safety hire for this company. I need to develop a…Continue

Started by JTurpening. Last reply by Jen McDade Feb 19.

Technology and Safety 1 Reply

What are the most useful tools to have at your fingertips? -Toolbox Talks-JSA-JHA-Daily Reports, etc. What is falling through the cracks that could be an easy fix? Safety Managers, Coordinators and…Continue

Tags: safety

Started by Drew stone. Last reply by Jen McDade Feb 15.

Important of Warning sign 1 Reply

Warning sign is a type of traffic sign that guide a hazard ahead on the road. Having proper warning sign on the road provide a healthy environment.Continue

Tags: Signs, Workplace, Safety, Sign, Warning

Started by healthandsafetysigns. Last reply by Jen McDade Jan 14.

Badge

Loading…

© 2019   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service