Product Management
Product Marketing
News & Updates
Follow Us!

Quality Management System (QMS): What Is It?

A Quality Management System (QMS) gives teams a better way to deliver on the continuous improvement of their products to the benefit of their customers.

A Quality Management System (QMS) give teams a better way to deliver on the continuous improvement of their products to the benefit of their customers.

A Quality Management System (QMS) is a framework for product and service development that optimizes for the continuous improvement of quality. The approach builds on clear documentation of responsibilities and procedures for each team, then adds a collaborative means for individuals to deliver on their core competencies—all while continuously evaluating the process for quality.

Shrugging off errors does nothing to prevent them from recurring. It also undermines corporate culture by teaching an organization that quality is not valued. Ignoring small issues exacerbates risks in core management areas where failures can compound. Further, accepting failures inhibits an organization from pushing quality requirements out to component vendors and other suppliers.

QMS gives an organization the tools to address challenges such as:

  • Continuous change in customer requirements, supplier components, or product deliverables sows chaos in communications and planning.
  • Lack of information about risks undermines quality, management, and planning.
  • Customer usage data, feedback, and requirement changes are lost so that development can’t incorporate them into roadmaps and planning.
  • Rework increases as changes are only caught late in production.
  • Errors introduced with manual data entry as changes are added late in development cycles.  

This document provides a high-level view of QMS software and how companies use it to drive a culture of continuous improvement deep into their operations. While QMS software creates an opportunity to manage change, combining it with product lifecycle management (PLM), product information management (PIM), and customer relationship management (CRM) tools presents a particular benefit to product and service companies.

Learn more about Propel's QMS solution here.

Why Is QMS Important?

QMS is important because while change is certain, the impact of change is not. A QMS framework recognizes failures as opportunities for improvement. Documenting procedures across functional areas is the first step to management oversight of change. Organizations that routinely respond to change are able to continuously improve quality control.

The international specification for QMS by the International Organization for Standardization, ISO 9001, begins with international standard documentation so that operational teams can review expectations against quality objectives and requirements and continuously evaluate them for improvements. In organizations, mistakes and errors are usually a symptom of an underlying process problem. QMS and ISO standards refocuses a team on quality using a methodology that can be managed in quantifiable metrics.

Once they are anticipated in a company culture, changes and corrections to nonconformance can be clearly documented to ensure that referred products are consistent in feature and functionality. Ease of correction also creates an environment that encourages innovation and incorporates suggestions for continuous improvement.

This QMS approach documents design controls and risk management to give organizations an inherent resilience and a better ability to meet their quality goals. Risks created through product and staffing changes can be better managed because the collaborative approach documents changes and ensures training along the way. Individual contributors and managers enjoy new opportunities for advancement as innovations are adopted and implementers are recognized.

You may come to QMS to comply with regulations, but you’ll stay for the competitive advantage. Many organizations start focusing on QMS systems because regulatory agencies, top management or customer RFPs require it. For some businesses, the process benefits may be enough to justify investment in systems for quality improvement.

In the development of medical devices for example, the leading edge of innovation can require the collaboration of a cross-functional team of experts in technology, medicine, and other fields. Working in a QMS framework can speed collaboration on product development and simplify regulatory compliance. When regulatory approvals are required and delays are costly, alignment with requirements can be crucial to timely approvals.

Failures and errors happen naturally. Left to fester, they become an opportunity for the competition to swoop in and meet customer expectations faster. As companies integrate their corporate policies and procedures to comply with QMS criteria, management teams start to appreciate the broader competitive advantages. At an executive level, the approach creates a framework for how business operations work and how they will respond to errors and changes.

How Companies Use QMS Software

The advent of QMS software introduced a means for quality management systems to escape the documentation room and reach into the daily functions of customer-centered companies. QMS software can allow a greater customer focus, track tasks and changes, manage document control, compliance and training, and alert executives of issues that arise affecting manufacturing, delivery, and support of products and services.

When errors occur, an effective quality management structure provides the framework for process re-evaluation and improvement. By documenting business processes, expectations and deliverables for key processes, a baseline can be re-evaluated and corrective action defined. This sets up procedures for a range of tools from Corrective Action/Preventative Action (CAPAs) to Device Master Records (DMRs) so that subtle changes in procedures can directly affect quality and safety.

With a process approach and a structure for continual improvement, customers can be assured that the design controls and management tools are in place to keep the focus on delivering products with the quality customers demand.

The QMS defines and documents expectations and deliverables for key processes like new product introductions, employee training, and customer support. By tracking support tickets, corrective action forms, and other compliance elements, QMS software grows with a company as new products are released or the organization changes in response to a marketplace.

QMS software transforms an organization and focuses its creative energy on innovations that can have a positive impact on quality. As modern cloud-based systems add functions like blockchain, artificial intelligence, or machine learning, QMS software can use these tools to track and do internal audits on operations, and alert managers before issues become problems. It can also shape how customers experience a brand with an integration of communication tools and tracking of customer information.

Five key management areas reveal the following compelling benefits.

Risk Management

By stretching across an organization, QMS software provides a means to manage risk for both individual tasks and cross-functional procedures. By capturing data related to changes, deviations, and errors, the impact can be measured and tracked. Over time, change audits can reveal risks for mitigation, improvement opportunities, or unintended consequences.

In environments where regulatory approvals or customer contracts mandate compliance to standards, QMS provides a vital tool for managing incremental failures and errors. Changes to supply chains can be a daily routine for manufacturing companies. Yet small changes at the component level can affect end-product recyclability or require that hazards be included on Safety Data Sheets. Changes at that level can also affect compliance to mandated standards like RoHS, WEEE, and REACH that are captured on product labels.

By requiring ISO 13485 support, the FDA has baked quality standards into medical device approvals. That means that implementation of a QMS system is no longer optional for device manufacturers—they now must address the requirement before releasing a product or risk regulatory action during auditing.

Requirements Management

Every day, formally or informally, customers tell companies what they want and need. The most successful companies recognize this routine feedback in a structured way through requirements management systems and informed decision making. These systems sift through informal feedback from sales, marketing, and support teams, as well as formal specifications defined in RFPs, regulations, and other materials. The framework creates a way to document, analyze, and prioritize what stakeholders expect and is critically important to informing future product roadmaps.  

Requirements management functions can go further to provide a means to visualize the details and anticipate conflicts. Experienced engineers recognize that quality is fundamentally a balance between scope, cost, and time. The challenge usually boils down to that old saying, “Good, Cheap, or Fast — pick two.”

Manufacturing and Supplier Data Management

The quality produced by modern manufacturing companies is fundamentally dependent on the quality of the components in their supply chain. Customer complaints or minor changes in form-factor, material, or software components can have a direct impact on quality but are often invisible to a production system without a clear definition of compliance and rigorous change control. Component changes and software updates can improve quality, but they have to be documented in order to manage inventories, training, and other implications of changes.

The process begins with evaluations of suppliers and their qualifications which can include not only conformance to specifications but also systems integrations and procedures.

  • Once parts are sourced, quality assurance (QA) equipment needs to be calibrated so that conformance tests can be validated.
  • First article inspection, and the corrective action process behind it, ensure that specifications match production.
  • Tools like Non-Conforming Material Reports (NCMRs) and Supplier Corrective Action Requests (SCARs) form a complete closed loop.

The idea is to go from issue report to development, then manufacturing to field service. It’s then closed as it loops back to the customer with the issue.

Continuous Improvement

The potential for continuous improvement makes QMS especially powerful. Tools like Change Requests (CRs), Change Control Boards (CCBs) and Corrective Action Preventive Actions (CAPAs) create a consistent means to identify and change or correct components and procedures in hardware, software and services. The approach ensures that knowledge and insight are shared across an organization and that continuous improvement becomes part of the culture of the organization.

Post-market surveillance, including support feedback, customer interviews and complaints all provide opportunities to drive product improvements that can be tracked and managed through tools like CCB and CAPAs.  In some product segments, enterprise customers can expect that product versions shipped to them conform to specific corrective actions, or that release notes document any kind of change. At scale, corrective action tools are the only way to address that kind of requirement.

From e-scooters to sneakers, today’s IoT-based products pose a new set of challenges because of the way they integrate components from multiple systems, or connect to customer equipment. Without continuous management, changes from component vendors or from customers can introduce failures or unanticipated risks. Further, IoTs—like all software that captures usage data—create unique opportunities to leverage that information to understand behavior patterns and improve products. Continuous information about product use has been one of the most powerful benefits of cloud-based software as it fuels the best companies to continuously improve their products.

Training and Certification

Historically, individual managers and human resources departments have had an incentive to track adherence to training and certification programs. Individuals have been awarded with compensation or promotion based on completion of training programs or the attainment of certifications.

As systems become more complex and technologies advance, however, companies have started to rely on the knowledge level of its employees. New hires, promotions, and retirements make managing the expertise level of the team all the more difficult. The addition of training and certification management to a QMS ensures that dependencies can be identified and new hires or training programs can be prioritized.

Benefits of QMS Software

QMS software benefits an organization with a means to monitor and manage the core business elements that affect the quality of its products and services. It gives the organization a way to continually improve quality by creating a specific means to turn feedback into improvements, and mistakes into process corrections. The system also provides management teams with the structure to track and control the direction of change so that it benefits customers with improved product quality.

Key benefits include:

  • Lower risks: By managing information about change, and routinely applying analysis tools to mitigate risks to quality, the overall risk is lowered.
  • Higher product quality: By anticipating change, the system commits an organization to continuous product improvement pushing product quality higher with each iteration.
  • Improved customer satisfaction: Once customer feedback cycles are a continuous part of development, satisfaction can be monitored and improved.
  • Less rework: With changes anticipated and considered in a supply chain, less money is spent on rework or inventory loss.
  • Continuous improvement: A system that ensures a continuous flow of feedback means that changes will drive continuous improvement in the product or service.  
  • Can eliminate manual data entry: Data collection becomes part of the workflow eliminating manual data entry and its inherent risks for errors.
  • Transparency: QMS promotes transparency in operations and decision-making, which can enhance trust and accountability both internally and externally.

The Next Generation of QMS Software

Traditional PLM and PIM software suites solve point problems for manufacturers. PLMs have addressed the need for manufacturers to track components in hardware design and hand changes off to manufacturing. PIM systems have focused on the late stages of development when new products or added features are incorporated into sales and channel information systems. While both functions are vital, they miss the larger challenge of integrating customers, suppliers, and vendors into a closed loop process focused on quality.

This next generation of QMS software integrates PLM and PIM to drive closed loop processes. It is cloud-based and mobile ready to take advantage of the scalability and collaborative benefits of the architecture and integrations with IoT and advanced CRM. The approach also allows customers and suppliers to participate in product design by allowing for feedback cycles from concept to end-of-life.

QMS from Propel

Propel uniquely combines Salesforce CRM with PLM tools to deliver that next generation of cloud-based QMS software. Customer information like software, hardware, and IoT installations, contract commitments, and privacy policies, can all affect product design and deployments. With Propel’s quality management system, teams can leverage this information to improve quality planning, delivery and support of the product. Learn more here.

Share This Article
Post by
Chuck Serrin
VP of MedTech & Life Sciences Industry Marketing, Propel

Chuck is the VP of MedTech and Life Sciences Industry Marketing at Propel. Formerly, as a Solution Architect and Program Manager at Stryker Corporation, he implemented and supported global PLM, QMS, and digitalization projects. Chuck has deep domain expertise on the development, compliance, and commercialization of medical device products, along with providing high-quality support in launching new products. Over 20 years of experience across senior positions in enterprise software solutions with companies such as Agile Software, Oracle, and PTC.

View All From
Chuck Serrin