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: 39

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

Profile IconDigital Krishnendu and bradly anderson joined Online Safety Community
yesterday
bradly anderson posted discussions
yesterday
swethakumar posted a blog post

Government Approved Fire Safety Course in Cochin

Government Approved Fire Safety Course in CochinFire and Safety Training in Cochin is the basic qualification for everyone who wishes to start their career prospects in HSE sector of many reputed industrial organizations in India as well as abroad and it has various aspects such as,Diploma in Fire Engineering & Safety ManagementDiploma in Fire FightingAdvanced Diploma in Fire & Industrial Safety ManagementPost Graduate Diploma in Fire & Industrial Safety Management…See More
yesterday
HrishikeshRam posted a blog post

Career Prospects in Occupational Nebosh Course

NEBOSH Course in Mumbai is a credited form of Industrial Health and Safety Management and has two major certifications such as the NEBOSH International Diploma (IDIP) and NEBOSH IGC Course in Mumbai.These course certifications are highly demanded in HSE sectors of both Private and Government industrial organizations in India as well as Abroad.Read More……See More
yesterday

Forum

How to Fix and Recover QuickBooks Error Code C 51

QuickBooks is a robust accounting software that helps you in managing all your…Continue

Tags: recover, repair, recovery, data, quickbooks

Started by bradly anderson yesterday.

How to Fix and Recover QuickBooks Error Code C 51

QuickBooks is a robust accounting software that helps you in managing all your…Continue

Tags: recover, repair, recovery, data, quickbooks

Started by bradly anderson yesterday.

QuickBooks Errors File Repair

If you are unable to resolve the issue following the steps suggested by Intuit or you have any related queries regarding the QB error code C=9, the you shoudl use this efficient…Continue

Tags: repair, recovery, data, quickbooks, recover

Started by bradly anderson yesterday.

QuickBooks Errors File Repair

If you are unable to resolve the issue following the steps suggested by Intuit or you have any related queries regarding the QB error code C=9, the you shoudl use this efficient…Continue

Tags: repair, recovery, data, quickbooks, recover

Started by bradly anderson yesterday.

EDB to PST converter 1 Reply

Get help of this EDB to PST Converter software which can convert Exchange Server EDB files into MSG and EML…Continue

Tags: migrate, edbtopst, pst, to, edb

Started by william webb. Last reply by Diana Carvalho yesterday.

Badge

Loading…

© 2019   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service