Nonconforming product software — available anytime, any place.

The nonconforming product module in QT9 QMS helps you reduce poor cost of quality with easy dispositioning and trending of historical data.

Automate nonconformance

Eliminate manual processes, Excel, & Word using real time data and alerts.

User-friendly reporting

Assist with data mining & trend analysis with charts & graphs.

Connect & collaborate online

Link to the supplier portal and use tasks to get everyone involved.

Total synchronization

Link nonconforming product records to multiple modules.

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Free up time with nonconforming product tools.

QT9's nonconformance management software seamlessly links to audit findings, customer feedback records, inspections, management review issues and corrective actions.

Manage Approvals

Assign approver/s and approve, reject or verify submitted nonconforming products.

Email Alerts

QT9 QMS sends users email alerts and reminders based on your settings.

Real-Time Reporting

Track your nonconforming products by any field. Create charts and export reports to Excel.

Paperless Made Effortless

Easily export and email copies of nonconforming products.

Link Modules

Link to multiple modules including CAPA, Customer Feedback, Inspections, etc.

User-Defined Fields

Create unlimited custom fields for tracking your company-specific information.

Overdue Alerts

QT9 QMS sends email alerts when nonconforming products are overdue.

Attach Related Files

Attach unlimited files to any nonconforming product records.

Manage Priorities

Set priority levels for nonconforming products based on due dates within your organization.

Root Cause Analysis

Optional root cause analysis is included with the nonconforming product module.

Assign Credits

Assign credit information by putting dollars and cents to poor quality.

Supplier Web Portal

Assign nonconforming products to suppliers in the supplier web portal.

Explore 25+ Modules Included

Frequently Asked Questions: Nonconforming Products

What are nonconforming products?

Nonconforming products are those that deviate from a specification, standard or expectation so that the end result does not meet requirements. Other names for nonconforming products include nonconformance and nonconformity.

How can you identify nonconforming products?

There are a variety of ways that nonconforming products are identified, including regular evaluations against key performance indicators (KPIs), inspections, audits and customer feedback.

What is the process for addressing nonconforming products?

In ISO 9001, handling nonconforming products is crucial to maintaining quality standards. Key processes involved include:

  1. Identification: Clearly defining what constitutes a nonconforming product. This involves establishing criteria against which products are evaluated for conformity.
  2. Documentation: Properly documenting nonconformities, including details such as the nature of the nonconformity, its location and any associated documentation or records.
  3. Evaluation: Assessing the significance of the nonconformity to determine its impact on product quality, safety or regulatory compliance.
  4. Segregation: Physically segregating nonconforming products to prevent unintended use or delivery. This may involve quarantine areas or designated storage locations.
  5. Investigation: Investigating the root cause of the nonconformity to identify underlying issues in the production process, materials or other factors.
  6. Disposition and Approval: Identifying the disposition of the nonconforming product such as scrap, use as is, rework, etc., and approving the disposition and follow-up action of completing the required disposition.
  7. Record Keeping: Maintaining records of nonconformities, corrective actions and their outcomes for traceability and continuous improvement purposes.

By following these processes, organizations can effectively manage nonconforming products, minimize risks and maintain customer satisfaction and compliance with ISO 9001 requirements and beyond.

What are potential impacts of nonconforming products on my business?
  1. Safety Hazards: Nonconforming products may pose safety risks to users or consumers if they do not meet specified quality or performance standards. This could result in accidents, injuries or even fatalities.
  2. Compliance Violations: Nonconforming products may fail to meet regulatory requirements or industry standards. This can lead to compliance violations, fines, legal actions and damage to the reputation of the manufacturing organization.
  3. Customer Dissatisfaction: Nonconforming products may fail to meet customer expectations in terms of quality, functionality or reliability. This can result in customer complaints, returns, warranty claims and loss of customer trust and loyalty.
  4. Production Delays: Nonconforming products may disrupt production processes, leading to delays in manufacturing schedules and shipment deadlines. This can impact overall production efficiency, increase costs and affect customer satisfaction.
  5. Waste and Rework: Nonconforming products may need to be scrapped or reworked to bring them into compliance. This results in wasted materials, resources and labor, increasing production costs and reducing profitability.
  6. Supply Chain Disruptions: Nonconforming products can cause disruptions throughout the supply chain, affecting suppliers, distributors and other stakeholders. This can lead to delays in product delivery, inventory management issues and strained relationships with business partners.
  7. Reputational Damage: Persistent issues with nonconforming products can damage the reputation of the manufacturing organization. Negative publicity, social media backlash and word-of-mouth criticism can tarnish the brand image and impact future sales and partnerships.
  8. Loss of Market Share: If nonconforming products persistently affect quality and reliability, customers may switch to competitors' products that offer better quality assurance. This can result in a loss of market share and competitiveness in the industry.

Addressing nonconforming products effectively is essential to mitigate these risks and ensure the long-term success and sustainability of manufacturing operations. This involves implementing robust quality management systems, conducting thorough root cause analyses, implementing corrective actions and continuously improving processes to prevent recurrence of nonconformities.

What are the FDA and ISO standards for nonconforming products?

Several common standards address nonconforming products, including FDA 21 CFR Part 820, ISO 9001:2015 and ISO 13485: 2016.


FDA 21 CFR Part 820 requires manufacturers to establish and maintain procedures to control product that does not conform to specified requirements. The procedures address the identification, documentation, evaluation, segregation and disposition of nonconforming product.


ISO 9001 standards seek to prevent the unintended delivery or use of a nonconforming product (or service) by ensuring manufacturers control and correct nonconformities. It also requires an organization to evaluate the need for actions that will prevent the recurrence of a nonconformity.


ISO 13485 requires medical device manufacturers to address nonconforming products and ensure they are not distributed for use. The process needs to be documented and corrective actions undertaken.

Why should I use QT9 QMS for my nonconforming products?

QT9 QMS has 25-plus interconnected modules that come standard, including a Nonconforming Products module that connects with other key applications, such as audits, risk management, customer complaints, deviations and supplier management. Its cloud-based platform allows you to easily communicate and synchronize records with anyone, anywhere.


QT9’s QMS software is a highly rated, affordable, easy-to-use quality management system that excels at all of the processes that go into providing high-quality goods and services that are FDA and ISO compliant.


With QT9 QMS you get unlimited scalability and traceability at a great price, so you can bring quality products and services to market in the most efficient way.


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Sign in online anytime, anywhere to access your QT9 QMS Nonconforming Product Software.

Built-In Dashboard

Quickly view the status of nonconforming product records from the QT9 dashboard & easily personalize the view.

FDA & ISO Compliant

The QT9™ QMS nonconforming product software will keep you compliant with all FDA and ISO requirements.

Traceability & Transparency

QT9™ QMS includes web portals for customers, suppliers and employee training.

QT9™ QMS is flexible for your business.

QT9 lets you choose modules based on what's best for your organization.

Modules for any business size

With multiple modules to choose from, there's solutions for nearly anyone.

A solution that scales with you

Whether you are a large corporation or a small start-up you can use as many modules as you want.

Cross-Platform Support

Whether you use Android, iOS or Windows, QT9 works from virtually any web browser.

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