What is a Quality Management System (QMS)?

A quality management system (QMS) is a formal framework used to document and organize the processes, procedures and responsibilities needed to achieve an organizations’ required quality standards and policies. In a way, it’s the blueprint companies use to ensure that they’re consistently meeting quality standards and delivering what customers expect from their product or service offerings. 

A QMS serves a critical purpose in ensuring that quality isn’t left to chance and doesn’t vary by stage, team or trend in the marketplace. Instead, a QMS ensures that the same quality processes are followed in every market condition and as often as possible. This means creating and following a standardized, repeatable system that maintains quality standards regardless of who is performing the work or when. 

Today, most agile QMS implementations follow a “Plan-Do-Check-Act” model that inherently creates a continuous feedback loop: 

• Plan: Establish quality objectives and identify the processes needed to deliver results 
• Do: Implement the planned processes and collect data 
• Check: Monitor and measure processes against policies, objectives and requirements 
• Act: Take necessary actions to continually improve process performance

Often, QMS processes and standards are molded after internationally recognized criteria, such as ISO 9001, which is a globally accepted quality framework. Various industries and types of products and services have their own frameworks that can also be the foundation of an organization’s approach to QMS.

A QMS works by forming a closed-loop system that continuously monitors, measures, analyzes and improves quality across organizations or teams. Rather than operating in isolation, modern QMS platforms integrate with existing technologies and platforms to create a high-level view of quality performance.

The core of a QMS focuses on systematic data collection and analysis. Quality metrics flow from multiple sources, including production lines, customer feedback, supplier assessments and internal audits, into holistic dashboards that provide real-time visibility into various trends.

Put together, that means a QMS works by giving the most broad, comprehensive view of quality processes and standards at an organizational level. From there, a company or team can make changes or directional decisions as needed.

With an effective QMS, organizations can see benefits across internal operations, external relationships and strategic capabilities and outputs. 

Internally, the benefits of a QMS help an organization reduce variabilities and maintain and deliver more consistent quality products or services. Consistency is key here: with a QMS, it’s all about repeating measurable processes and systems that deliver expected results over time. 

A QMS also helps teams spend less time figuring out what should be done to improve processes and more time evaluating what’s working in order to make more efficient feedback loops. QMS practices can help organizations catch delays, errors or other disruptions much quicker than they could without it, which means companies can spend more time on other priorities. 

Externally, a QMS ensures organizations can consistently meet the demands of their customer base, as well as those of vendors, partners, suppliers and other professional relations. Consistent quality builds trust, loyalty and advocates for a brand’s output, which all leads to scalable growth. 

The automated documentation and processes that come with QMS also make it easier for organizations to meet and exceed external compliance and regulatory standards that come naturally with complex industries. In this case, being able to consistently meet compliance standards can become a competitive advantage that might slow down less agile organizations. 

Finally, a QMS can add strategic benefits downstream of an organization’s product development processes. With more data-driven decision-making occurring at high-levels, companies can, in theory, create more sustainable, efficient and profitable goods that are closer matched to customer needs and wants. When this scales, it means reduced costs and streamlined processes, like faster time-to-market metrics, that improves strategic performance. 

Essentially, QMS helps organizations optimize and adapt in order to continue improving their quality and products over time.

The core elements of a QMS often include quality policy and objectives that are set by an organization, as well as documented processes, procedures and a quality manual. Elements can also include risk management and compliance management controls, as well as processes to manage internal audits, non-conformance and competency tracking.

Finally, to complete the continuous quality feedback loop, a QMS contains elements of customer feedback and integration. When this cycle is complete, it allows organizations to incorporate recent feedback directly into quality controls and standards in order to avoid future issues. 

Organizations start their QMS journey, most times, by clearly defining what “quality” looks like in their operations. Although this may seem simple, it can actually be complex and time-consuming to fully outline, formalize and document what “quality” looks like in an organization’s procedures and workflows. 

Comprehensive process documentation ensures consistency regardless of who performs the work. Modern QMS platforms make this documentation interactive and searchable, often including multimedia training materials and real-time guidance.

These elements are common in QMS implementations but it’s also worth noting that organizations may have software-specific requests and elements that are geared toward their product lines, industry or regulatory standards. In this case, dashboards, reporting and documentation can be created to ensure the organization follows these more specific and personalized standards.

QMS formats commonly used by organizations include paper-based systems, digital systems and modular systems that integrate with multiple software platforms, including product lifecycle management solutions. 

Traditional paper-based systems rely on physical documents, checklists and manual record-keeping to implement quality controls. These low-tech systems have minimal upfront costs and are familiar to many organizations but they’re increasingly inadequate for modern quality requirements. Paper systems can make data analysis difficult, create version control challenges and can’t provide real-time visibility into quality performance trends.

On-premise digital QMS solutions provide maximum control and customization but require reliable IT infrastructure and ongoing maintenance. These systems work well for organizations with strict data control requirements or complex integration needs but they often require more significant upfront investments and dedicated technical resources.

For more lean and agile digital operations, cloud-based QMS platforms offer the advantages of software automation without the infrastructure requirements of on-premise solutions. These systems typically provide faster implementation, automatic updates and built-in scalability. They’re also effective for organizations that need to support remote teams or multiple locations.

Some of the most sophisticated digital QMS systems are modular and integrative, which means they can “slot” into a technological ecosystem based around an existing platform, such as product lifecycle management software or manufacturing execution systems (MES). 

These modular, highly customizable QMS systems can adapt to meet the needs of an organization’s entire product lifecycle, ensuring quality requirements are considered from initial design through end-of-life.

Different types of QMS include a number of standardized systems that vary by industry, organization, scope and location. Various use cases require different types of QMS approaches, each tailored to specific regulatory requirements and business needs. 

Here’s a look at some common retail QMS types. 

ISO 9001 QMS

ISO 9001 represents the most widely adopted QMS, applicable across virtually any and every industry. It provides a flexible framework that organizations can adapt to their specific needs while maintaining international recognition and credibility. 

Good Manufacturing Practices (GMP)

GMP-based QMS implementations are essential for pharmaceuticals, cosmetics and personal care, food and beverage and other industries where product safety is critical to the health and safety of consumers. These systems include specialized documentation requirements, batch record management and validation protocols.

Custom QMS for Software and Consumer Products

Many software companies and consumer goods manufacturers develop custom or proprietary QMS approaches that align with agile development methodologies and rapid iteration cycles. These systems emphasize flexibility, automation and integration with development tools.

Finally, many organizations implement QMS standards for sustainability in order to meet their own or their customers’, demands for sustainably produced and distributed products.

A QMS is implemented with a strategic approach that addresses high-level needs and detail-oriented processes and workflows. Here’s where it all starts.

Needs Assessment

Organizations can begin by conducting thorough quality needs assessments to establish a “quality baseline.” This assessment should include stakeholder interviews, process mapping and analysis of existing quality data.

QMS Selection

Companies select the QMS approach that best fits their industry requirements, organizational size and technical capabilities. Organizations consider factors like regulatory requirements, integration needs and long-term scalability when making this decision.

Process Documentation

Teams create detailed process maps that document their typical workflows and identify opportunities for improvement in efficiency, quality and structure. This step often reveals process inconsistencies and opportunities for standardization that weren’t previously apparent.

QMS Software Deployment

Next, companies implement their final QMS of choice, including data migration, system configuration and integration with existing business systems. Modern cloud-based platforms typically support rapid deployment, often within weeks rather than months.

Training and Assigning

Comprehensive and practical, on-the-ground training ensures that employees understand both the technical aspects of the QMS platform and their specific roles in maintaining quality standards. Role-based training helps ensure that each person receives relevant, actionable guidance.

Tracking and Improving

Organizations conduct systematic internal audits to verify that processes are working as designed and gather feedback to identify opportunities for improvement. Organizations continuously monitor quality metrics, analyze trends and implement improvements based on data insights. 

Regular feedback collection helps identify usability issues and process gaps that weren’t apparent during initial design. Successful QMS implementations evolve continuously, adding new capabilities and expanding scope as organizations mature.

This might look easy but effective QMS implementation is a massive undertaking that requires full cooperation between teams and stakeholders. Common challenges to implementation include resistance to change, which can be embedded deep into a company, as well as integration complexities and data challenges. 

Organizations that have traditionally had siloed data systems may find it difficult to fully integrate a QMS approach without overhauling many of their longstanding data-focused processes. That said, many organizations experience tremendous growth opportunities after doing so. 

The key to QMS success lies in choosing the right approach for an organization’s specific needs and goals, then implementing it as an integrated component of a broader business strategy. Very quickly, a QMS becomes a cornerstone of an organization’s approach to operations in general. 

Having a modern, agile QMS strategy empowers teams and processes to innovate confidently while operating more efficiently. In the end, that translates to more satisfied customers that know what to expect from an organization. 

By combining powerful quality tools with end-to-end product lifecycle visibility, Centric PLM enables organizations to unify quality processes, automate compliance tasks and drive constant improvement from product ideation to end-of-season retirement.