A simple definition of QMS.
A Quality Management System (QMS) is a formalized system that documents the policies, procedures, documentation requirements, and processes that MedTech companies use to ensure that their products are both safe and effective for the end-user.
Organizations across multiple industries depend on their QMS to manage the quality, safety, and effectiveness of their product or service over a period of time, verifying and validating its ongoing performance and ability to meet the needs of customers.
When someone refers to their quality system, they are referring to the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management. You create these policies yourself, based on your business needs, the customer's needs, the perceived risk of your device, the specific requirements of your device, and in compliance with industry regulations.
A quality management system is the set of tools that your company uses to manage the quality system processes and activities that take place throughout the product life cycle to ensure quality standards are consistently being met.
What is an electronic quality management system (eQMS)?
An electronic quality management system (eQMS) replaces existing, outdated versions of QMS tools that often consist of physical paper stored in physical storage locations, like filing cabinets and desk drawers. The modernized version of a quality management system that we see today with an eQMS eliminates the cumbersome nature of non-electronic QMS tools by providing a single source of truth for organizations to manage the quality of their product or service.
Who is responsible for the QMS?
It used to be that medical device companies consisted of a quality manager and filing cabinet.
Today, the QMS gives everyone – from quality, engineering, manufacturing, leadership, or other MedTech teams – a single source of truth to manage the quality of their product.
A QMS tool lets you store key quality documents and artifacts, track corrective and preventative actions (CAPAs), promote effective product development, continually monitor process improvement, and adhere to industry standards and regulations - all in one central location to make information available to anyone at your organization who might need it.
With visibility and easy access to quality records and data, it’s easier to collaborate and make quality a shared responsibility throughout your organization. Everyone in your company can see the documented controls for supplier management, production processes, labeling, packaging, handling, and even storage of your product, so you can maintain complete centralized control over the products that you create. Your organization's quality management system is the architecture that you build to show all the activities you do that comply with quality regulations, which makes an indisputable QMS especially beneficial to companies where teams look to achieve more with less.
Here’s why QMS matters to your business.
QMS requirements vary by geographic region with each market having a designated regulatory authority in charge of enforcing QMS regulations and standards. Below are six regulations and standards with specific QMS requirements for medical devices:
- FDA 21 CFR Part 820
- FDA 21 CFR Part 11
- ISO 14971
- ISO 13485
- IEC 60601
- IEC 62304
FDA QUALITY SYSTEM REGULATION (QSR) — 21 CFR PART 820
In the United States, a quality management system for medical devices is regulated by the Food and Drug Administration (FDA). FDA provides a framework of basic, non-prescriptive requirements for manufacturers in 21 CFR Part 820, the Quality System Regulation (QSR) for medical devices.
FDA defines a quality system as, “[T]he organizational structure, responsibilities, procedures, processes, and resources for implementing quality management.” According to FDA, medical device manufacturers are required to develop a quality management system that is consistent with the:
- Level of risk presented by the medical device
- Complexity of the medical device
- Complexity of medical device manufacturing processes
- Complexity and size of manufacturing facility
The quality management system requirements provided by FDA serve as a shared set of standards by which medical device companies must adhere to when developing each one’s own QMS procedures.
It is, however, ultimately up to the manufacturer to assign roles and responsibilities of the persons who will be executing such processes using a risk-based approach. Risk mitigation and reduction methods, when done effectively, can have a strong positive impact on both the customer and the business.
FDA quality management system requirements state that the manufacturer is responsible for creating their organization’s policies based on the needs of the customer, business, perceived product risk, and requirements specific to the device and applicable regulations and standards.
ISO 13485:2016 MEDICAL DEVICES — QUALITY MANAGEMENT SYSTEMS
ISO 13485:2016 is the international standard for quality management systems for medical devices. The globally harmonized standard specifies requirements for medical device manufacturers to obtain certification of their QMS in accordance with customers and the applicable regulatory requirements.
ISO 13485 QMS requirements apply to every stage throughout the entire lifecycle of a medical device and can be applied by medical device manufacturers, suppliers or any other third-party entity that provides QMS-related services to the primary medical device organization.
To comply with ISO 13485 QMS requirements, manufacturers must ensure all contents within the QMS align wmith applicable requirements of the standard and those specific to the market in which your medical device is manufactured and sold.
