Quality management system (QMS) software isn't an expense, it's an asset to life science companies.
The key to achieving success with quality systems is a change in mindset. Many companies in the pharmaceutical and medical device markets think of quality from a compliance vantage point. It's something you have to take care of to get through the FDA or ISO.
By shifting your viewpoint and approaching quality from a competitive advantage angle, you can use a QMS to drive better products, gain happier customers, and improve profitability.
The adjustment from compliance-driven to quality-driven can change the course of your organization. You'll no longer see meeting regulatory guidelines as the quality end goal but as a minimum requirement. Success comes when you treat those compliance requirements as the starting line of your quality operations and run a race of continual improvements which lead your company to the top of the industry.
13 Quality Management System Benefits That Will Boost Your Bottom Line
A QMS is a solution to fix the problems that arise from disconnected systems, data sources, and tools. With a quality-driven mindset and the right QMS, you will move towards uniting your team, tools, and data to improve the quality of products, collaborate more effectively, and enter profitable new markets.
1. Consistent Product Quality
Product quality can be measured by characteristics of performance, reliability, and durability for device manufacturers. For pharmaceutical companies, quality is measured by the success of clinical trials, patient outcomes, and other quality metrics.
QMS software is designed to simplify the process of producing consistently high-quality products which meet regulatory requirements and patient needs from the earliest phase of product development. Systems provide greater visibility over inconsistencies and defects and facilitate proactive change management.
2. Minimized Mistakes and Rework
The cost of poor quality, including rework and recalls, can range from 15 to 35 percent of total business costs in many regulated industries. Externally discovered product failures which are found by customers or regulatory bodies are generally 5 to 10 times more expensive than mistakes discovered earlier in the process.
In the life sciences and pharmaceutical industries, rework can have a ripple effect. Delayed time to market can result in a loss of competitive advantage, brand devaluation, or other lasting disadvantages.
A QMS reduces rework with a number of approaches to discovering potential quality issues earlier. Digitized work instructions allow organizations to streamline certification and calibrate tools. The result is more opportunities to discover quality issues before they result in costly rework.
3. Crowdsourced Intellectual Property
The most innovative life sciences organizations integrate crowdsourcing and design thinking approaches to leverage the best thinkers and subject matter experts from product development, market, and sales fields. ISO encourages the use of "....engaged people at all levels throughout the organization to enhance its capability to create and deliver value." A QMS can provide a platform for crowdsourcing intellectual property within the organization, which can result in better-informed and more effective products.
4. Increased Efficiency
Quality management systems can increase operational efficiency by improving the use of time and resources throughout the product lifecycle. By linking processes, organizations are able to turn planned activities into results and drive continuous improvements with closed-loop analytics.
5. Improved Customer Satisfaction
ISO includes a number of requirements related to customer satisfaction, which include but aren't limited to:
- Clause 8.2.1. communicating with customers to obtain feedback, including complaints
- Clause 9.1.2 monitoring customer perceptions of the extent to which their needs have been met
- Clause 9.1.3.b obtaining, monitoring, measuring, analyzing, and evaluating customer satisfaction.
Using the QMS as a tool to measure and analyze customer satisfaction is required by standards. Greater customer understanding can drive more customer-focused business practices to improve patient outcomes, reduce complaints, and increase profitability.
6. More Effective Marketing
The capabilities of a QMS for customer satisfaction measures can be used to reveal more than just the perception of end users. It can be extended to include distributors and other stakeholders throughout the supply chain.
A QMS can unveil opinions of product value, on-time delivery, packaging, and pricing, as well as details of documentation and customer support. Translating this data into insights can be an important tool for improving brand credibility and strengthening sales and marketing activities.
7. Venturing Into New Markets
A QMS can simplify the process of quickly scaling to enter new markets, territories, and sectors by providing a comprehensive system that can expand to meet new compliance requirements or accommodate new global stakeholders. This can allow organizations to move with agility in a competitive landscape and focus on innovation and building business relationships, instead of creating compliant systems from the ground up.
8. Smarter Employee Onboarding
A QMS centralizes global collaboration by providing a single portal for onboarding and compliance-required training among talent. It also eases collaboration with rich document management features.
9. Improved Employee Communications
Poor-quality communications are a risk. If an employee doesn't understand the information, the communication is not valuable. If the information is incorrect, communications can result in quality issues or a loss of profit. A QMS is a centralized channel for employee communications, with rich document management features to preserve the integrity of information.
10. A Continuous Improvement Culture
A culture of continuous improvement is a component of the ISO standards. A QMS can enable organizations to establish both iterative and significant improvements to products, services, and processes with greater visibility. Specific tools within the QMS for creating a continuous improvement culture can include internal audit capabilities, root cause analysis and CAPA, and mistake proofing.
11. Data-Driven Decision Making
Decision-making is a complex process, particularly at organizations that operate in pharmaceutical, life sciences, and medical device verticals. Business decisions can involve an enormous number of inputs from disparate data sources, due to the complexity of product processes. QMS software centralizes these inputs and simplifies the process of turning data into actionable insights with simple dashboards and graphs for decision-making.
12. Increased Profits
Implementing a QMS has costs, but the process carries a return on investment in increased profits and diminished wastes. QMS software can increase profitability in numerous ways, which include:
- Strategic, agile planning in response to real-time insight
- Using quality objectives to improve processes
- Finding opportunities to increase efficiency and reduce wastes
- Using operational improvements to minimize delays
13. Better Supplier Relationships
ISO dictates the development of mutually beneficial supplier relationships. “An organisation and its suppliers are interdependent, and a mutually beneficial relationship enhances the ability of both to create value.” This can be realized when both the supplier and the organization are able to respond more quickly to changing market conditions or customer feedback while optimizing costs and resources.
A QMS enables mutually beneficial supplier relationships by establishing open communication through the system around cooperative development and control processes. It can create transparency around customer needs, feedback, and key performance indicators. A QMS shares information and goals in real-time, allowing suppliers to respond to requirements.
What Happens if You Don't Get a Quality Management System?
Not getting a quality management system can reduce expenditures on software, technology training, and implementation. However, it's likely to cost your organization more than it saves. There are risks associated with failing to get a QMS or delaying that acquisition.
One of the key disadvantages is related to compliance and standards. Without a QMS system that is built to simplify the fulfillment of regulatory requirements and certification, your organization will be at higher risk of regulatory delays or costly fines. Not using an ISO QMS is a barrier to receiving ISO certification. Other risks can include:
- Loss of competitive advantage due to agility and quality issues
- Difficulty scaling to grow or expand product lines
- More wasted resources due to manual quality processes
- Frustrated employees due to poor systems for collaboration
- Inconsistent product quality, resulting in customer complaints and other risks
A QMS isn't an expense; it's an asset to your business which can safeguard against many of the common quality issues that create barriers to profitability for organizations in pharmaceutical and medical device manufacturing verticals. By implementing a QMS, you can achieve an advantage and drive improvements and benefits throughout the product lifecycle and operations.
Turn your disconnected quality data into a streamlined advantage for total quality management. To learn more about Qualio, a QMS designed for life science companies with 5-250 employees, request a Demo.