What is a Quality Management System?


QMS As a Structure

A Quality Management System (QMS) is structured collections of

  • policies,
  • processes,
  • procedures,
  • responsibilities

for achieving quality policies and objectives. It is a set of internal rules, written protocols. It has to be followed by the personnel in the Medical Device company. 

QMS As a Method

A Quality Management System is also a method by which MedDev companies can ensure:

  • schedules
  • responsibilities
  • contracts
  • relationships
  • agreements

A QMS helps to coordinate and direct their activities to meet customer and regulatory requirements while improving its effectiveness and efficiency.

QMS as a Process

A Quality Management System process is started with the first management planning stages of a company, in which the goals of the medical device company will be defined, including what services or products the company will be offering. The system than deals with all processes needed, from sales of the product or service through the creation and finally delivery of the product or service to the customer.

Nothing but benefit from QMS

Research confirms that implementing a Quality Management System can offer benefits to organizations that are adopting it.

The study focused on organizations that achieved ISO certification found that these MedDev companies have:

  • higher rates of sales
  • employment growth and
  • wage increase

than organizations that haven’t implement the standard.

The main reasons why MedDev companies seek ISO 13485 certification are:

  • business processes are improved
  • a better-quality product is created
  • it aids in marketing and selling products or a customer demands it

 Implementation of a quality management system can benefit you, for example:

  • it will increase production and financial performance
  • reduce rework and waste
  • save your time

Being Confident with QMS

If your company meets the customer’s requirements, it will help to inspire confidence in the organization, increasing confidence will lead to more customers, more sales, and more repeat business. While meeting the organization’s requirements, will ensure compliance with regulations and provision of services and products in the most cost- and resource-efficient manner, creating room for growth, profit, and expansion.

There is a fair amount of QMS standards that you could use to establish a quality management system in your organization and the use of these guidances is voluntary. But for some companies, it turns out to be “mandatory”.

Medical device companies are the most regulated organizations.

If you are included in one or more steps of a medical device’s life cycle, read all about the QMS implementation according to ISO 13485:2016 requirements in our next articles.

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2 replies to “What is a Quality Management System?”

  1. Keith A. says:

    It seems as very hard for the implementation and time consuming. Well, not just for implementation, for managing it as well. Its additional burden on the team.

  2. Denise V. says:

    I really enjoyed reading this article about QMS! It’s clear, understandable and informative. I like other articles too! It’s like all in one place if you are in the beginner in a medical device industry. I am searching for examples as well, if you want to consider including it!

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