What Is QMS?

QMS Ensures
Regulatory Compliance

WHAT IS A QUALITY MANAGEMENT SYSTEM (QMS)?

A QMS provides a formalized system of documenting responsibilities, processes, and procedures to develop products that meet customer requirements as well as compliance with regulatory standards.

QMS Video

WHAT IS THE PURPOSE OF A QMS?

A QMS enables regulated companies to qualify, sell, and sustain safe and effective life-enhancing products. Quality management systems should align with an organization’s goals and provide a systematic approach to help improve quality controls, eliminate nonconformance issues, reduce audit risks, and streamline new product development processes.

Why Is QMS Important?

Quality management systems help drive continuous improvement and establish compliance with International Organization for Standardization (ISO), U.S. Food and Drug Administration (FDA), European Medical Device Regulation (EU MDR), Underwriters Laboratories (UL), and other regulations or standards.

ISO 9001 Compliance
ISO 9001:2015 is a standard within the ISO 9000 family of international quality standards that is considered the most widely adopted approach to quality management systems. Other ISO standards related to QMS include:

  • ISO 13485 (QMS for medical devices)
  • ISO 14971 (Risk management for medical devices)
  • ISO 9004 (Continuous improvement/guidance to achieving sustained success)
ISO Standards
ISO Standards

ISO 9001 Compliance
ISO 9001:2015 is a standard within the ISO 9000 family of international quality standards that is considered the most widely adopted approach to quality management systems. Other ISO standards related to QMS include:

  • ISO 13485 (QMS for medical devices)
  • ISO 14971 (Risk management for medical devices)
  • ISO 9004 (Continuous improvement/guidance to achieving sustained success)
FDA Compliant Graphic

U.S. Food and Drug Administration (FDA) Compliance
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.

The FDA’s Title 21 CFR Part 820 quality system regulation establishes that medical device manufacturers must implement and follow current good manufacturing practices (CGMPs) for the design, manufacture, installation, and servicing of safe and effective devices. Title 21 CFR Part 820 further defines requirements that should be followed for Class I, II, and III devices. The FDA is expected to revise its current Title 21 CFR Part 820 to more closely align with ISO 13485.

FDA Compliant Graphic

U.S. Food and Drug Administration (FDA) Compliance
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.

The FDA’s Title 21 CFR Part 820 quality system regulation establishes that medical device manufacturers must implement and follow current good manufacturing practices (CGMPs) for the design, manufacture, installation, and servicing of safe and effective devices. Title 21 CFR Part 820 further defines requirements that should be followed for Class I, II, and III devices. The FDA is expected to revise its current Title 21 CFR Part 820 to more closely align with ISO 13485.

EU MDR Compliance 
Regulatory standards for medical devices in the European Union (EU) are established through the EU Medical Device Regulation 2017/745 (EU MDR) by the European Commission. Medical devices and other products covered under the EU MDR are required to have a Conformitè Europëenne (CE) Mark in order to be sold in the European Economic Area (EEA).

European Commission Logo
European Commission Logo

EU MDR Compliance 
Regulatory standards for medical devices in the European Union (EU) are established through the EU Medical Device Regulation 2017/745 (EU MDR) by the European Commission. Medical devices and other products covered under the EU MDR are required to have a Conformitè Europëenne (CE) Mark in order to be sold in the European Economic Area (EEA).

QUALITY TALK

Sanjay Banerjee, COO at Potrero Medical, shares insights about quality and compliance strategies.

List of Quality Management Principles

Key Elements of an Effective QMS System

  • Quality policy and objectives
  • Quality manual
  • Organizational structure and responsibilities
  • Internal processes
  • Customer satisfaction
  • Continuous improvement
  • Document control
  • Enterprise quality management system (eQMS) software
List of Quality Management Principles

Key Elements of an Effective QMS System

  • Quality policy and objectives
  • Quality manual
  • Organizational structure and responsibilities
  • Internal processes
  • Customer satisfaction
  • Continuous improvement
  • Document control
  • Enterprise quality management system (eQMS) software

How Enterprise Quality Management Software Works

eQMS software provides a controlled and automated way to manage product and quality processes throughout the product lifecycle. It brings quality records and the product design (i.e., mechanical, electrical, and software) into one shared platform—enabling dispersed teams to collaborate on the entire design before passing it to downstream systems (i.e., ERP, MES, CRM).

QMS Platform Collaboration

Cloud-based QMS solutions sold under software-as-a-service (SaaS) subscription models eliminate collaboration latency, data errors, and security issues with a persistent digital thread that leads to greater audit confidence and faster product launches.

Intelligent BOM Management

The bill of materials (BOM), which includes the entire assembly and all associated components, files, drawings, and specifications required to build a finished product, is aggregated into a single shared system. This enables product teams and supply chain partners to create, import, share, change, compare, and approve product designs throughout the entire lifecycle.

Multilevel BOM Tree

The bill of materials (BOM), which includes the entire assembly and all associated components, files, drawings, and specifications required to build a shippable product, is aggregated into a single shared system. This enables product teams and supply chain partners to create, import, share, change, compare, and approve product designs throughout the entire lifecycle.

Multilevel BOM Tree

Automated Change Order Process

The engineering change order (ECO) approval process is accelerated through automated routings and review cycles. Internal and external team members are notified allowing them to review, collaborate, and approve changes quickly.

Automated Change Order Process

Closed-Loop Corrective and Preventive Action (CAPA) Process

Corrective and Preventive Action (CAPA) Process

Corrective and Preventive Action (CAPA) Process

All tasks and assignments associated with CAPA quality processes are electronically linked to the appropriate part of the product record—enabling impacted teams to quickly identify and resolve product issues. Solutions to product defects or nonconformance issues are established, reviewed, approved, and documented via the ECO process.

All tasks and assignments associated with CAPA quality processes are electronically linked to the appropriate part of the product record—enabling impacted teams to quickly identify and resolve product issues. Solutions to product defects or nonconformance issues are established, reviewed, approved, and documented via the ECO process.

Who Uses QMS Software?

Quality management software serves manufacturers in the life sciences and similar regulated industries—including medical device, biotechnology, and pharmaceutical companies. As engineering, quality, manufacturing, and procurement teams work to develop and launch new products, quality management system software provides a way to keep everyone aligned at all times, regardless of where teams and suppliers are located.

Whether you’re a small startup or Fortune 500 company, QMS software addresses the common challenges facing most regulated companies today:

  • Collaborating with dispersed teams, suppliers, and contract manufacturers
  • Disconnected systems limiting visibility into quality and product information
  • Developing effective design controls to comply with quality system regulations
  • Streamlining and simplifying audit processes
  • Delivering high-quality products ahead of the competition

Explore how life sciences companies are adopting quality management system software to boost productivity, reduce audit risks, and accelerate time to market (TTM).

Portrero

Achieving Commercialization and Compliance Success

Pulse Biosciences

Achieving Closed-Loop Design Control Across the Organization

IntraOp

Driving Quality Across Supply Chain to Highest Levels

QMS Software Essentials

BOM Management

The ability to effectively manage your bill of materials (BOM) ensures that the most current product revisions are always controlled and accessible by all members of the quality, product, and extended supply chain teams. It also ensures that device master records (DMRs), design history files (DHFs), parts, standard operating procedures (SOPs), and drawings are linked to the product record, making it easier to manage closed-loop quality processes.

Item and BOM Management
Engineering Change Management Flowchart

Engineering Change Management

Engineering change management provides controlled design change processes that speed product development. Product team members can process formal engineering change requests (ECRs) and engineering change orders (ECOs) more efficiently with automated approval routings. Team members can also document changes as they are released and track the status of change orders throughout the entire product lifecycle.

Document Management

To meet the demands of highly regulated environments,  companies must be able to store, track, and manage all of the documentation associated with product and quality records. This includes product specifications, assembly instructions, SOPs, quality policies, and training records. Document management allows for the centralized storage of documentation, as well as the establishment of audit trails and revision control.

Documentation Management
Medical Device Compliance Safety

Regulatory Compliance

To mitigate compliance risks, QMS software should enable the implementation of closed-loop corrective and preventive action (CAPA) processes to speed resolution of product issues and prevent future occurrences of nonconformance. QMS should also provide complete control and traceability of product and quality records including DMRs, DHFs, SOPs, and training records.

Design Controls

Effective quality management software solutions should establish and track design control elements such as user needs, design inputs, design processes, and design outputs. This helps simplify your review, verification, and validation processes. More importantly, a QMS should help you demonstrate compliance with policies, procedures, and FDA Title 21 CFR Part 820 as you move from early design phases through commercialization.

Design Control Elements
Requirements Management

Requirements Management

Requirements management helps teams ensure that product development objectives are met during the course of a product lifecycle. The ability to link requirements to the product record enables organizations to manage and track issues, defects, and customer needs throughout the entire lifecycle and innovate more rapidly.

Training Management

Product companies must maintain an employee training program to demonstrate compliance with FDA, ISO, safety, internal procedures, and other regulatory standards. Having an efficient, automated system to create employee training plans, assign training records, and generate progress reports helps simplify audits and reduce compliance risks.

Training Management
Quality Product BOM Diagram

Product-Centric Framework

Product-centric QMS solutions connect quality records directly to the product design in a single system. This helps you document and track closed-loop quality processes for DMRs, DHFs, training records, and CAPAs in context to the entire product record and BOM.

QMS Software Essentials

Item and BOM Management

BOM Management

The ability to effectively manage your bill of materials (BOM) ensures that the most current product revisions are always controlled and accessible by all members of the quality, product, and extended supply chain teams. It also ensures that device master records (DMRs), design history files (DHFs), parts, standard operating procedures (SOPs), and drawings are linked to the product record, making it easier to manage closed-loop quality processes.

Engineering Change Management Flowchart

Engineering Change Management

Engineering change management provides controlled design change processes that speed product development. Product team members can process formal engineering change requests (ECRs) and engineering change orders (ECOs) more efficiently with automated approval routings. Team members can also document changes as they are released and track the status of change orders throughout the entire product lifecycle.

Documentation Management

Document Management

To meet the demands of highly regulated environments,  companies must be able to store, track, and manage all of the documentation associated with product and quality records. This includes product specifications, assembly instructions, SOPs, quality policies, and training records. Document management allows for the centralized storage of documentation, as well as the establishment of audit trails and revision control.

Medical Device Compliance Safety

Regulatory Compliance

To mitigate compliance risks, QMS software should enable the implementation of closed-loop corrective and preventive action (CAPA) processes to speed resolution of product issues and prevent future occurrences of nonconformance. QMS should also provide complete control and traceability of product and quality records including DMRs, DHFs, SOPs, and training records.

Design Control Elements

Design Controls

Effective quality management software solutions should establish and track design control elements such as user needs, design inputs, design processes, and design outputs. This helps simplify your review, verification, and validation processes. More importantly, a QMS should help you demonstrate compliance with policies, procedures, and FDA Title 21 CFR Part 820 as you move from early design phases through commercialization.

Requirements Management

Requirements Management

Requirements management helps teams ensure that product development objectives are met during the course of a product lifecycle. The ability to link requirements to the product record enables organizations to manage and track issues, defects, and customer needs throughout the entire lifecycle and innovate more rapidly.

Training Management

Training Management

Product companies must maintain an employee training program to demonstrate compliance with FDA, ISO, safety, internal procedures, and other regulatory standards. Having an efficient, automated system to create employee training plans, assign training records, and generate progress reports helps simplify audits and reduce compliance risks.

Quality Product BOM Diagram

Product-Centric Framework

Product-centric QMS solutions connect quality records directly to the product design in a single system. This helps you document and track closed-loop quality processes for DMRs, DHFs, training records, and CAPAs in context to the entire product record and BOM.

Why Product-Centric QMS Solutions Are Better

Unlike traditional document-centric platforms which only provide basic document management capabilities for SOPs and other files—product-centric QMS software platforms manage linked relationships between DMRs, DHFs, BOMs, individual components, approved manufacturer/supplier lists (AMLs/ASLs), documentation, product history, and any changes or quality issues. This enables full visibility and traceability throughout new product development and introduction (NPDI) and ensures regulatory compliance.

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

7 Keys to Success When Selecting QMS Software

Consider these key factors when evaluating what it takes to implement a QMS software solution successfully:

  1. Software Validation
    Does the QMS software vendor provide a software validation service to help you meet the installation qualification (IQ) and operational qualification (OQ) requirements set forth by the FDA? Will the vendor provide the necessary IQ and OQ documentation set with every software release to support an FDA audit or submittal?
  2. Security
    Is the QMS solution designed with a multilayered security model to ensure that your intellectual property (IP) is always protected? Are there safeguards or access controls in place to further protect product information and privacy?
  3. Disaster Recovery
    Is the QMS software designed with built-in redundancies to quickly recover from a wide range of system failures?
  4. Implementation and Training
    What resources are required from the QMS vendor and your team to complete the software implementation? How much time is needed to configure, test, and go live? What is the QMS vendor’s approach to training? Is it a train-the-trainer approach, or will your key stakeholders need to participate in the initial onboarding process? Is training provided via live or recorded sessions? 
  5. Ongoing Customer Education and Support
    Do you have access to adequate support and educational resources (e.g., best-practice information) after go-live? Are live, dedicated support staff (e.g., customer success coaches, customer service representatives) available to answer your questions to help drive your successful adoption and expansion of the QMS platform? 
  6. Scalability
    Is the QMS platform designed to easily accommodate additional users, suppliers, and/or functionality as your company continues to grow and product processes evolve?
  7. Total Cost of Ownership (TCO)
    Your TCO should include not only up-front software costs—but costs associated with ongoing maintenance. Determine if there are additional costs for annual maintenance and/or new software releases. If so, what is the estimated frequency of upgrades? Also identify any costs associated with training and customer support. SaaS platforms include customer support as part of the software subscription, and there are no additional charges to take advantage of regular software enhancements.

READY TO LEARN MORE?

To learn even more about QMS software, check out our Ultimate QMS Guide.

READY TO LEARN MORE?

To learn even more about QMS software, check out our Ultimate QMS Guide.