In today's dynamic business world, quality management is a fundamental pillar to ensure that your products and services meet the highest standards.  

In this article, we share different ways to ensure the quality and safety of your processes and production tasks, according to your possibilities.  

How to start managing quality?

Having a solution specially designed to control and manage quality systems is the best alternative to ensure compliance with good practices and achieve the corresponding quality certifications.

A QMS (Quality Management System) is a solution that offers the necessary tools and resources to optimize the organization's processes, prioritizing the quality of the product or services offered.

To market medical devices and in vitro diagnostic (IVD) medical devices in the EU, manufacturers must implement a QMS that guarantees compliance with the safety and performance requirements established in MDR 2017/745 and IVDR 2017/746. The ISO 13485:2016 standard is the recognized benchmark standard to demonstrate compliance with these requirements.

If you are a medical device manufacturer, you can rely on the international standard ISO 13485:2016 to establish your QMS. If you market in the United States, you must comply with FDA 21 CFR Part 820, which is in the process of alignment with ISO 13485 for greater global harmonization.

The implementation of a Quality Management System is essential for optimizing processes, ensuring regulatory compliance, and improving operational efficiency. However, the choice between a manual or electronic QMS will depend on organizational maturity and available resources.


A Quality Management System or QMS adapted to your needs

 A Quality Management System (QMS) is a set of processes, policies, and procedures designed to guarantee quality within an organization. However, depending on the resources and maturity of the company in terms of digitalization, quality management can be carried out manually or through an electronic system.  

QMS: Manual quality management

A traditional QMS is usually managed manually through physical documents or unintegrated digital files, which can make traceability and real-time access to information difficult. On a more basic level, this type of system provides significant benefits, such as:

  • Regulatory compliance and risk reduction: Helps ensure that operations and products comply with applicable regulations, minimizing the risk of sanctions.
  • Improvement of staff motivation: By establishing clear roles and providing proper training, the team understands its impact on quality, reinforcing their commitment.
  • Efficient risk management: Allows identifying threats and applying preventive and corrective actions more quickly.
  • Competitive advantage: The ability to maintain high quality standards sets the company apart in the market.

eQMS: Digitalization and automation of the QMS

As companies seek to optimize processes and improve traceability, an Electronic Quality Management System (eQMS) becomes the natural evolution of the manual QMS.

It is a digitalized and automated version that uses specialized software to centralize and manage all aspects of quality. Its main advantages include:

  • Participation and collaboration: Facilitates the involvement of the entire team in quality management, fostering a culture of continuous improvement.
  • Operational efficiency: Automates manual tasks, reducing errors and optimizing times, in addition to strengthening regulatory compliance through electronic records, change control, and automated audits.
  • Regulatory compliance and audits: Simplifies compliance with regulations and facilitates preparation for internal and external audits.
  • Centralized management: Allows real-time visualization of all quality processes on a single platform.
  • Control and traceability: Ensures detailed monitoring of each stage of the product life cycle.

Both a manual QMS and an eQMS are valuable tools for managing quality in an organization. The choice between one or the other will depend on your company's ability to adopt digital solutions, as well as the level of automation you wish to implement.

While a manual QMS remains a viable option for companies in initial stages, an eQMS represents a strategic investment that drives efficiency, traceability, and competitiveness in today's market.

Our solutions adapted to your possibilities

As experts for over 20 years in digital solutions and regulatory and quality consultancy services for the Life Science sector, at Ambit BST we have designed two specialized services that can facilitate quality management in your organization.

Our solutions adapt to different levels of automation and regulatory needs, ensuring regulatory compliance efficiently:

1) QMSuite

First, if quality management in your company is still done manually and you want to ensure it is aligned with current regulatory standards, we have a solution for you: QMSuite.

QMSuite is a set of Quality Management System (QMS) templates designed to facilitate regulatory compliance for companies developing Software as a Medical Device (SaMD) and other medical devices, ensuring alignment with ISO 13485 and FDA 21 CFR Part 820 standards.

If you would like to request more information about this solution, click here.

2) eQMS

Second, if you want to optimize your processes and manage all aspects related to the quality of your products or services with eQMS software, we have a specialized service: eQMS.

With integrated functionalities for product development, document control, and training, our eQMS allows you to optimize processes and ensure regulatory compliance. Furthermore, we provide continuous support to guarantee an effective implementation and maintenance of the digital tool. You will have the guidance you need!

If you would like to request more information about this solution, click here.

At AMBIT BST, we have been experts for over 20 years in developing strategies and IT solutions.

  • We help the pharmaceutical, medical device, and IVD (in vitro diagnosis) medical device sectors comply with regulations throughout the entire product life cycle.
  • We offer consultancy, audit, and specialized training services to help you excel in the regulated sector.
  • We design and implement innovative infrastructures thanks to a global service offering as an enabling lever for digital transformation.

Keep reading! 

If you have reached the end and want to keep learning about this topic, we suggest some articles that might also interest you: