How Much Does an ISO 9001 Quality Management System Cost?

Are you searching for an ISO 9001 quality management system but worried about overspending?

If you choose a platform that's too costly and doesn't deliver the required features and functions, you could end up wasting valuable time and capital.

And when it comes to time and capital—as many growing life science startups know too well—both are in short supply.

The question is this: What can your medical device company do to find the very best ISO 9001 quality management system without overspending on unnecessary or outdated features?

How Much Does an ISO 9001 Quality Management System Cost?

How much should your company really spend on an ISO 9001 quality management system?

The cost of software implementation depends on a variety of factors—including the size of your organization, the complexity of its processes, and more.

Qualio offers pricing plans to support your unique organization. Annual plans start at $14,000. Qualio pricing extends across three major tiers:

  • Starter is designed for startups and small teams getting started with quality and building out their systems. It provides access to documents, training, and pre-market activities.
  • Growth is geared toward businesses that need powerful automation and reporting to support them as they scale. This plan includes access to everything in Starter, plus quality events, single sign-on, and API and integration support.
  • Enterprise offers everything you need for an enterprise-wide rollout to improve collaboration and key metrics. This plan comes with access to everything in Growth, enterprise deployment with SLAs, and dedicated account managers.

Additionally, each plan comes with concierge onboarding for a smooth, fast start, helping you become quality-driven in record time.

Each onboarding project is managed through a dedicated customer success manager whose job is to guide you seamlessly through setup, data migration, validation, and training.

As you begin your search for an ISO 9001 quality management system vendor, here are some of the factors that affect system costs:

1. Ease of use. Some eQMS solutions are more complicated than others. Mid-sized companies and startups tend to implement leaner eQMS solutions that deliver seamless configuration and smooth onboarding process.

2. Automation. The best eQMS solutions include automated workflows which can help reduce non-compliance risk. This enables organizations to monitor quality and complaints and respond to them rapidly.

3. Reporting capabilities. With access to robust, end-to-end reporting, you can gain visibility into the entire product lifecycle. As a result, your team will have in-depth insights into audits, ongoing relationships with suppliers and contractors, critical internal documents, and more.

4. Team size. Your eMQS should make it easy for all necessary team members to collaborate effectively. When it comes to price, that ability often translates to the number of users that have licenses to use the platform.

Getting Started with Qualio

Qualio is the first cloud-based electronic quality management system (eQMS) built for the entire life sciences ecosystem. We make it easy for companies to bring their teams and processes together to get products to market quickly and scale successfully.

Since 2015, Proscia has been building software solutions for pathology and cancer research. The company recently decided to apply their software to a clinical setting to enable pathologists to work more effectively by moving from microscope-based workflows to a slide image management system that imports and reads digitized slides from multiple scanning sources, making it easier for doctors to store, retrieve, manipulate, and annotate them from any location where there is internet access.

To ensure the transition to the new market was a smooth one, Proscia needed a complete and compliant electronic quality management system that was cost-effective and could be implemented rapidly.

With Qualio, Proscia got a robust eQMS that has already delivered a number of benefits to the organization.

Are you ready to get started with Qualio? We recommend downloading our free guide: 12 Questions to Ask Before You Buy an eQMS. We'll show you which questions to ask as you evaluate your eQMS options.