Christine Hansen
Director, Product Marketing
Against a fiercely competitive landscape, implementing a Quality Management System (QMS) is essential. An advanced quality management system can enhance productivity and consistency in all production phases and help ensure regulatory compliance. An advanced QMS can also meet customers' soaring expectations and outshine your competitors.
This article will address the components of a quality management system and how it can continually enhance performance, quality, consistency, and customer satisfaction and shape an excellence-driven culture.
Quality management isn't a new idea; the concept of quality management has existed since the time of guilds maintaining strict standards of perfection for finished goods and services. With increasing industrialization and the production of more vital goods and services (i.e., medical care or World War II ammunition), people began to document guidelines, standards, and best practices.
Before, Not After, Approach
Initially, quality management was about catching mistakes or after-the-fact error detection. Over time, that approach has shifted to being more about error prevention. Changes in business culture—accelerated timelines, increased international competition, increased customer expectations—have necessitated this more proactive approach.
Birth of Quality Management Systems
The need for an error-prevention approach to quality management gave rise to quality management systems. More holistic approaches to quality management began to emerge. Rather than a team of quality inspectors examining finished goods after the fact, the trend shifted to involving the entire organization in maintaining and upholding quality.
Increasingly, quality management systems have merged with compliance themes (across multiple international zones), sustainability, and transparency.
A quality management system (QMS) is a set of documents and processes to produce products in a safe, effective, and consistent way that meets regulatory requirements and customer expectations.
At its core, a QMS provides the framework for effective communication and collaboration throughout all business units in your organization.
Key business departments that use QMS software are:
Numerous companies have a quality management system in place to define standards, satisfy customers, and maintain compliance. Everyone cares about quality and has their own playbook or quality manual; however, universal standards are essential.
Countries have consumer safety standards for products and services, and they are increasingly rigid for high-stakes industries like healthcare, infant formula, or automobiles.
Adherence to an internationally recognized body of standards is tremendously important. Adhering to QMS standards can:
Many formally standardized systems are in place for quality management, including Total Quality Management (TQM) and the Malcome Baldridge National Quality Award.
Predominantly, though, when people talk about quality management systems, they are referring to the ISO 9000 Quality Systems Standards.
The ISO 9000 QMS refers to a set of quality management standards developed by the International Organization for Standardization in Geneva, Switzerland. These ISO 9000 standards provide a uniform foundation for implementing and improving quality management.
Adherence to these intentionally recognized standards for quality management is beneficial in a global market. Businesses that obtain certification gain consumer trust and entry into new markets and with new business partners.
Unifying Origins
The creation of the European Community and its push toward one large market drove the need for universal product standards and a more harmonized approach to safety and liability. Numerous countries around the globe have adopted these standards, although there is a concern that some U.S. companies need to catch up to other countries.
Having ISO 90000 certification doesn’t mean that all products and services are 100% without defects, which no system can deliver, but it shows a commitment to continual quality maintenance and improvement.
Barriers and Benefits to Adoption
Process change and business cost are the two significant (perceived) barriers that deter companies from adopting ISO standards and seeking registration. The break-even point for each business (when the economic gains match the fees for implementing), can vary widely. While the fees may range from $50,000 to $500,000 or more, the benefits may well be worth it.
Bethlehem Steel, for example, adopted ISO 9000 in 1996. Its profit earning efficiency (PEE) was negative 10% at that time. Shortly after implementation, they had an improvement of over 11 points. Overall company profits improved from negative $463.5 million in 1991 to positive $280.7 million by 1998. Within 1-2 years, Bethlehem Steel broke even on its investment in ISO certification and increased its overall company profitability by the end of 2 years.
Most Companies Are Mostly There Already
While every company will have its own results and experience in making the transition, companies with quality control measures in place are most of the way there in terms of ISO 9000 compliance. For these companies, it's commonly a matter of documenting the current quality management approach. Many companies have 90% or more of the core information or processes required to become compliant.
Additionally, many ERP systems are designed to support businesses that meet ISO 9000 standards. Epicor Kinetic, for example, is an ERP software that aligns with ISO 9000 through quality control, process documentation, traceability, reporting, and other processes.
Overall, most companies that have registered for ISO 9000 believe that the benefits far outweigh the initial costs and business disruption in terms of:
Beyond ISO 9000 specifically, there are many general advantages to quality management systems, with the three core themes being satisfaction, quality, and efficiency.
Enhanced Customer Satisfaction
A QMS helps companies consistently meet customer expectations by delivering uniform, high-quality products and services that have been rigorously tested. This will garner loyalty, contract renewals, and referrals.
Improved Quality of Product
Adherence to standardized procedures improves the consistency and quality of your products and services. This will minimize product waste, recalls, or process redundancies and enhance your reputation.
Increased Operational Efficiency
QMS systems streamline business processes to identify bottlenecks and increase time-to-market.
Quality management systems share some general components related to documentation, risk management, and process measurement.
Document Control
Document control is essential to maintain current, accessible data for all organization stakeholders. It helps ensure consistency, error reduction, and an effortless exchange of information for all business units. This is required for audits, QMS certifications, or compliance.
Risk Management
Risk assessment and mitigation are core elements of QMS. This proactively identifies areas of concern to address and minimize risk. This maintains your business reputation and ability to deliver a consistent product.
Process Measurement
This helps ensure you can measure and prove the effectiveness of your QMS processes. Organizations can benchmark and track performance, analyze trends, and proactively take action to adapt to changing trends, process enhancements, and general continuous improvement.
Implementing a quality management system (QMS) is a must for businesses that want to improve overall quality standards and achieve the standardization required to meet government regulations and customer expectations across international markets. Here's a short overview of the steps needed to go through implementation.
Make sure to keep leadership informed and engaged at every phase of the process. Top leadership will set the tone for the roll-out of your QMS, and their enthusiastic support is critical to ensure that employees at all levels will embrace new processes for quality manual documentation, production, and other facets of the QMS.
Whether you're new to learning about QMS systems or have decades of experience, you'll want to continually explore new trends and resources to stay up-to-date in the field. Case studies, white papers, business articles, books, and other publications can be helpful.
Here's some recommended reading to learn more:
