What Is QMS?

QMS Ensures
Regulatory Compliance

WHAT IS A QUALITY MANAGEMENT SYSTEM?

A quality management system (QMS) provides a formalized system to document policies, processes, responsibilities, and procedures to meet FDA, ISO, and other regulatory standards. QMS enables regulated companies to qualify, sell, and sustain safe and effective life-enhancing devices.

QMS Video

WHat is a qUALITY MANAGEMENT SYSTEM?

QMS Video

A quality management system (QMS) provides a formalized system to document policies, processes, responsibilities, and procedures to meet FDA, ISO, and other regulatory standards. QMS enables regulated companies to qualify, sell, and sustain safe and effective life-enhancing devices.

WHAT IS THE PURPOSE OF A QMS?

FDA Compliant

The FDA mandates that medical device, biotechnology, and other life sciences companies must establish and follow quality systems to ensure their products consistently meet applicable requirements and specifications for the U.S. market. Other agencies like the European Medicines Agency (EMA) also govern regulations required to sell into markets outside the U.S.

While quality management system definitions vary, the FDA’s quality system regulation establishes that manufacturers of FDA-regulated products must establish and follow current good manufacturing practices (CGMP’s) for the design, manufacture, installation, and servicing of safe and effective devices. 21 CFR Part 820 further defines requirements that should be followed for class I, II, and III devices.

Current Good Manufacturing Practice
Regulations

Whether you are a medical device manufacturer, biotechnology company, or part of another regulated industry—the purpose of a QMS is similar. Quality management systems help establish compliance with ISO, FDA, CE, UL, and other agency regulations. QMS solutions help eliminate nonconformance issues, reduce audit risks, and improve new product development processes by improving quality controls and documenting policies, procedures, and practices.

A SINGLE SOURCE OF TRUTH

The key to effective quality management is having one system, or a single source of truth, for both quality and product design records. Doing this in the Cloud makes it easier for your internal teams, suppliers, and auditors to have the latest information whenever it is needed—reducing friction, confusion, and risks.

Single Source of Truth

WHY CONNECTED QMS SOLUTIONS ARE BETTER

Quality Product BOM Diagram

Document-centric approaches to managing quality records fail to connect the underlying product design record (parts, assemblies, or bills of materials). QMS software should strengthen design controls and improve quality management processes from new product development through commercialization—providing enhanced visibility, traceability, and continuous improvement.

WHAT PRODUCT-CENTRIC QMS DOES

A product-centric quality management system connects quality records directly to the product design in a single system. This helps you document and track closed-loop quality processes for device master records (DMRs), design history files (DHFs), training records, and corrective and preventive actions (CAPAs) in context to the entire product record and bill of materials (BOM).

Produces Safe, HIgh-Quality Products

  • Simplifies compliance, improves design control, and reduces your audit risks
  • Fosters continuous improvement with traceable quality processes
  • Enhances visibility and traceability by managing quality processes throughout the entire product lifecycle

Creates a Single System of Truth

  • Leverages a single quality management system connected to the product design
  • Manages critical documents for training, SOPs, DMRs, DHFs, and CAPAs
  • Leverages closed-loop quality processes to speed resolution of issues

Drives Compliant Development Processes

  • Avoids confusion throughout new product development and introduction
  • Ensures employees and partners are trained with proven competence
  • Unifies your quality management process to reduce FDA and ISO compliance risks

KEY QMS BENEFITS

  • Ensures compliance to FDA, ISO, and regulations
  • Establishes strong design controls
  • Provides closed-loop CAPA processes
  • Improves training record management
  • Controls DHFs, DMRs, SOPs, and key quality documents
  • Connects product and change process
  • Drives faster product development and launches
  • Mitigates audit risks
  • Enhances supplier collaboration
  • Improves visibility, traceability, and business insights

HOW DO YOU SELECT THE RIGHT QMS?

Now that you know why connected QMS solutions are critical for regulated company compliance, how do you select the right software solution? Here are some key considerations:

MEETS YOUR REQUIREMENTS

WHAT?:
Define your core business challenges and compliance needs.

PROOF POINTS:
Website, trials, live demos

CUSTOMER SATISFACTION

WHAT?:
What do real customers think? Don’t just rely on hand-picked customer references from software vendor.

PROOF POINTS:
Check independent customer review sites like G2 and TrustRadius

DEPLOY AND IMPLEMENT

WHAT?:
Does QMS software require significant I.T. support, local installation, coding, or customization?

PROOF POINTS:
Talk to references and read reviews

EASE OF USE

WHAT?:
Can internal teams and suppliers use with little to no training?

PROOF POINTS:
Demo, trials

QUALITY & PRODUCT RECORDS MANAGED TOGETHER?

WHAT?:
Does the QMS solution manage the quality records in context with the product design record?

PROOF POINTS:
See how items, documents, bills of materials (BOMs) are created, reviewed, and released.

Core quality management needs covered?

WHAT?:
Closed-loop CAPA, training management, supplier management, quality management, issue management, design controls, etc.

PROOF POINTS:
Review capabilities for CAPAs, complaints, changes, suppliers, training, issues, and key quality records (DMRs, DHFs, SOPs, etc.)

7 PRINCIPLES FOR A ROCK-SOLID APPROACH TO QMS

Quality Manager Eyes

The burden to introduce compliant and innovative medical devices to market is great. And as regulatory standards, market requirements, and device complexities have evolved, so too has the weight of the burdens these leaders face. For medical device companies, document control is critical to success. Despite that absolute, traditional stand-alone QMS systems address only a subset of what’s needed.

Read the “7 Principles of Product-Centric Quality Management” ebook to learn how connected quality and product processes are better.

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