QMS

What is a QMS?

A QMS, shorthand for quality management system, is a formalized tool used for formal documentation of policies, procedures, requirements, and processes used by an organization to produce and manage a product and/or service offering.

A QMS should reflect the unique needs of the organization and be used to manage the system processes and personnel activities that take place throughout the product life cycle to ensure quality standards are consistently being met.

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.

Quality management, as a system, relies on certain key quality functions from within in order for it to operate. Quality assurance and quality control are two fundamental components of a QMS and each depend heavily on one another for effective quality management to be achieved.

Quality Assurance refers to the activities that ensure quality in the processes by which products are developed. And while a large portion of a QMS is focused on assuring the quality of processes, Quality Control represents a set of activities that revolve around identifying defects in the products that are created.

QMS STRUCTURE

There are five main functional areas of a medical device QMS:

1. Document control
2. Management responsibility
3. Resource management
4. Product realization
5. Measurement analysis and improvement

Under the document control subsystem is where key documents and artifacts will live. There are varying degrees of importance for each and the order in which they fall in the QMS hierarchy does matter.

^{Example of a QMS hierarchy}

A QMS is made up of a set of components, such as company policies, procedures, forms, and work instructions accompanied by their sequence, interactions, and resources, of which are operational requirements within the medical device company. Finally, the quality records are the company’s proof that all aforementioned items exist within the QMS and are being carried out effectively.

Management is at the heart of any QMS and its processes. The important role this group has in the success of a QMS has a direct impact on nearly every subsystem of a QMS.

A valuable best practice for maintaining a strong and reliable QMS is to continually monitor its effectiveness and ensure that the QMS is adjusted as necessary. An effective means of doing so is by establishing key performance indicators for the processes within the QMS.

There are a number of different methods for QMS monitoring which are used by organizations across multiple industries to improve the quality of their systems and processes. 

One commonly practiced method is the PDSA Cycle, also commonly referred to as the Deming Cycle (named after one of the pioneers of Quality as it relates to a QMS, W. Edwards Deming.

^{PDSA Cycle and Model for Improvement, Deming/API}

This model for improvement involves four major stages with key considerations and recommended practices listed for each:

1. Plan
   • Plan to carry out the cycle — who, what, where, when
   • Define objective
   • Come up with questions and predictions
2. Do
   • Carry out the plan.
   • Document problems and unexpected observations
   • Begin data analysis
3. Study
   
   • Complete the data analysis
   • Compara data to predictions
   • Summarize what was learned
4.  Act
   • What changes need to be made?
   • Next cycle?

• 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 with applicable requirements of the standard and those specific to the market in which your medical device is manufactured and sold.

An 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. 

All documents, procedures, policies, and records are able to be kept up-to-date at all times in a single, easily accessible location. Specific to the medical device industry, one major added benefit of an eQMS is that document version control is automatic. 

In addition, an eQMS can provide key stakeholders with full visibility into the key details of any artifact within the QMS, such as the review and approval status of a key document and important historic data.

QUALITY MANAGEMENT SYSTEM SOFTWARE

Like an eQMS, quality management system software brings an organization’s QMS online, allowing it to become the single source of truth for everything related to an organization’s product or service offering, which leads to optimal outcomes for the business.

There are many benefits medical device manufacturers can experience upon implementing a best-in-class QMS software, including:

• Full visibility of entire quality management system
• Closed-loop traceability throughout entire quality management system
• Continuous improvement of products, services, and processes

A QMS for medical devices is an industry-specific solution that’s designed from the ground up to address and cater to the specific needs of the medical device industry. These purpose-built QMS solutions often come with compliance protocols built into the system that are specific to the niche vertical market of medical devices.

A medical device QMS provides the architecture needed to demonstrate closed-loop quality system traceability and prove that all procedures, processes, and activities comply with quality regulations specific to the market in which a medical device is sold.

The best QMS software allows medical device manufacturers to easily keep up-to-date records, makes documents easily accessible to all key stakeholders, and has dedicated workflows built-in to the system that align with industry standards and regulations.

THE ONLY MEDICAL DEVICE-SPECIFIC QMS SOLUTION

Greenlight Guru is the only medical device quality management system built specifically for medical device organizations. The medical device quality management system comes out of the box with industry regulation and standard best practices built into the architecture of the QMS that gives manufacturers the guardrails to work within, making compliance easy.