How to Identify Nonconformities in Your ISO 9001 System

Talking about quality management for medical devices in 2025 – you cannot afford to miss the role of AI in making quality processes better, simpler, and smarter. 

Before we move on to discuss technological advancements, we must ensure we are not missing the basics. 

And, of course, what “basics” we are referring to. 

Despite the internet flooded with so much information, templates, hacks, and what not about identifying and reporting nonconformities in your quality management system – the companies are still missing the silent risks. 

The reasons could range from outdated systems to too lengthy NCRs, and fragmented quality systems. In this blog, we will have a detailed discussion about what exactly ISO 9001 nonconformities are - with some examples. We will also look at the significance, types, and costs of ignoring nonconformities. 

Towards the conclusion, we will also share some tips to help you prevent future nonconformities in your QMS. These tips will actually work and save you from FDA warnings, penalties, adverse events if followed rigorously enough. 

So, what is meant by QMS Nonconformity? 

A nonconformity per ISO 9001 is any deviation from a requirement in your QMS—a gap where procedures fail to align with documented standards and processes. These deviations can lead to product recalls, patient harm, and even regulatory scrutiny. 

For example: Imagine you're reviewing production records for a batch of medical devices. You find that a crucial document demonstrating testing according to the established Standard Operating Procedure (SOP) is missing. This oversight, however small it may seem, is a nonconformity and highlights the importance of diligent record-keeping and adherence to established procedures. Nonconformities, regardless of their perceived severity, should be promptly identified, investigated, and addressed to prevent future occurrences and ensure product quality and patient safety. 

Nonconformities act as red flags, signaling areas where your QMS is falling short and can range from minor documentation errors to major system failures. 

They can be categorized as: 

• Minor Nonconformities: These are smaller issues that don’t directly affect product quality or customer satisfaction but could escalate if ignored. For instance, incomplete training records or outdated documentation. 

• Major Nonconformities: These are critical deviations that pose a significant risk to your QMS, such as failing to perform required audits or consistently delivering non-compliant products. 

It is very important to identify the minor and major nonconformities to ensure that you escalate the right problems to the next step i.e. CAPA. Or you will end up dedicating too much of your resources and productive time to the peripheral issues.  

Difference between minor and major non-conformances  

Understanding the key differences between minor and major nonconformances helps you spot the issues that can lead to catastrophic events, jeopardizing the patient safety and customers' confidence in your brand. 

Aspect	Minor Non-Conformance	Major Non-Conformance
Definition	A deviation that does not significantly impact the QMS's ability to meet requirements or achieve intended results.	A significant failure in the QMS that affects its ability to meet requirements or achieve intended results.
Impact on QMS	Limited or isolated impact; usually localized and not systemic.	Systemic issue or widespread impact on the effectiveness of the QMS.
Examples	- A single missed record for a training session.  - Minor procedural lapse without direct impact on quality.  - Typographical errors in documentation.	- Absence of a required procedure.  - Failure to address customer complaints consistently.  - Non-compliance with a regulatory requirement.
Severity	Low; unlikely to lead to serious consequences if left unaddressed.	High; could result in product recalls, regulatory fines, or risks to customer safety.
Frequency	Usually isolated incidents.	Repeated or systemic failure indicates deeper issues.
Requirement for Correction	Requires correction but not necessarily urgent.	Requires immediate corrective action and a systemic review to prevent recurrence.
Audit Findings	Auditor may note it as a minor issue needing improvement.	Auditor will escalate it as a critical finding requiring urgent attention.
Follow-Up Actions	- Correction of the specific issue.  - Monitoring to ensure recurrence is avoided.	- Comprehensive corrective action plan.  - Management review and potential re-audit.
Examples of Clause Impact	May impact a single clause or element, e.g., training records under Clause 7.2.	Could impact multiple clauses, e.g., lack of documented processes impacting Clause 4 (Context), Clause 6 (Planning), and Clause 10 (Improvement).
Consequences of Not Addressing	May lead to inefficiencies or minor disruptions in operations.	May lead to loss of ISO certification, customer trust, or regulatory non-compliance.

QMS Nonconformity Example: Giving You the Right Context and Understanding

As already mentioned above, a small oversight could lead to major nonconformance. We will understand with the example of sterilization validation process. 

Let’s consider the case of a leading manufacturing company that decided to diversify its product portfolio by introducing a new line of precision-engineered hydraulic valves used in industrial machinery, construction equipment, and agricultural systems. These valves were marketed for their ability to improve efficiency, reduce downtime, and withstand high-pressure environments. The launch was supported by extensive R&D, marketing campaigns, and significant investment in state-of-the-art production facilities. 

However, during a routine quality audit aligned with ISO 9001 requirements, it was discovered that the final pressure testing process for these valves had not been adequately validated. This oversight violated Clause 8.5 (Production and Service Provision) of ISO 9001, which mandates organizations to establish controlled conditions for production processes, including validation of special processes that impact product quality and safety. 

What Happened Next? 

Shortly after the valves were delivered to customers, complaints began to surface regarding premature valve failure under operational conditions. Reports cited leakage and compromised structural integrity, causing significant equipment downtime for customers in critical applications. 

Investigations revealed that the unvalidated pressure testing process allowed valves with micro-cracks in critical components to pass inspection. These flaws, which could have been detected with a robust testing protocol, compromised the product’s performance and safety. 

This led to a massive product recall, tarnishing the company’s reputation, straining customer relationships, and incurring significant financial losses. Key customers paused future orders, citing a lack of confidence in the company’s quality management processes. Additionally, the company faced internal challenges, including increased warranty claims, production disruptions, and a need for urgent corrective actions. 

Lessons Learned: The Importance of Process Validation 

This case demonstrates that even in industries not bound by highly regulated standards like ISO 13485 or FDA requirements, process validation is critical to ensure consistent product quality, safety, and customer satisfaction. Failure to validate critical processes can lead to: 

• Non-Conformities: Allowing defective products to enter the market. 
• Operational Risks: Disrupting customer operations and causing financial strain. 
• Reputational Damage: Eroding customer trust and loyalty. 
• Financial Losses: Resulting from recalls, warranty claims, and lost revenue opportunities. 

Importance of QMS Nonconformity in Regulated Industries 

Addressing QMS nonconformities is crucial for maintaining quality, compliance, and operational efficiency. Nonconformities left unresolved can lead to violations of regulations such as ISO 13485, FDA 21 CFR Part 820, and EU MDR. Regulatory bodies may issue warnings, impose fines, or revoke product certifications. 

Did you know - Each year, the FDA receives over two million medical device reports of suspected device-associated deaths, serious injuries, and malfunctions? 

Each MDR submitted contributes to the FDA's broader post market surveillance, providing essential data to monitor device performance and assess risks. 

However, the submission of an MDR doesn't automatically imply the device caused the adverse event. The FDA evaluates MDRs in context, considering all information, including supplemental reports, while recognizing the limitations of this passive surveillance system—like under-reporting and lack of verification. 

These limitations place even greater responsibility on manufacturers and quality professionals to proactively identify and address nonconformities within their systems. Without such vigilance, organizations risk becoming part of these statistics, with repercussions for patient safety and regulatory compliance. 

Next, we’ll explore how to spot nonconformities, understand their impact, and prevent them from jeopardizing both compliance and patient outcomes. By learning from real-world data like FDA MDR trends, you’ll be equipped to strengthen your QMS and play a vital role in improving patient safety. 

How to Spot Nonconformities in QMS 

Spotting ISO 9001 nonconformities is essential to ensure compliance and continuous improvement. Here’s a concise guide: 

• Internal Audits: Regularly conduct internal audit leveraging checklists and trained auditors to identify deviations from requirements. 

• Customer Feedback: Analyze complaints, returns, and satisfaction surveys for recurring issues and unmet expectations. 

• Operational Data: Monitor KPIs, defect rates, and downtime logs to uncover hidden process failures. 

• Process Reviews: Ensure processes align with documented procedures through periodic reviews and observations. 

• Material and Product Inspections: Inspect incoming materials and finished goods for compliance with specifications and standards. 

• Nonconformance Reports (NCRs): Encourage employees to nonconformance report deviations and review trends for systemic issues. 

• Audit Findings: Leverage third-party or certification audit results to address major and minor nonconformities. 

• Risk-Based Thinking: Use tools like FMEA to identify risks and prevent potential nonconformities. 

• Employee Engagement: Train and empower staff to recognize and report quality concerns. 

Regular monitoring and proactive reporting ensure your QMS remains compliant and effective. 

What Happens if You Ignore QMS Nonconformities: A Cost of Quality Perspective 

Ignoring nonconformities in an ISO certified system can significantly harm your organization's operational and financial performance. Understanding this through the lens of the Cost of Quality (CoQ) framework—comprising Prevention, Appraisal, and Failure Costs—provides a compelling case for proactive management. 

1. Escalating Failure Costs 

Nonconformities represent failures within your quality system. By neglecting them: 

• Internal Failures: Defects and process inefficiencies go unresolved often increasing rework, scrap rates, and delays. These inefficiencies escalate operational costs and erode resource utilization. 

• External Failures: Undetected issues reach customers, leading to complaints, product recalls, warranty claims, and damage to reputation. External failures typically cost significantly more to address than internal ones, straining both finances and customer relationships. 

2. Missed Opportunities for Prevention 

ISO emphasizes a proactive approach to quality management. Ignoring nonconformities means: 

• Prevention Costs: Investments in training, process improvements, and root cause analysis are underutilized, leading to recurring issues. 

• Missed opportunities to avoid long-term costs through early detection and system optimization. 

3. Increased Cost of Non-Conformance (CoNC) 

According to the CoNC model, nonconformities directly contribute to the costs of poor quality. Over time, these costs: 

• Increase with each repeated failure. 

• This leads to inefficiencies that prevent the organization from achieving "high quality–low cost" outcomes. 

• Diverted resources that could otherwise be used for innovation and strategic initiatives. 

4. Regulatory and Certification Risks 

Nonconformities left unaddressed jeopardize compliance with ISO standards. Potential consequences include: 

• Loss of ISO  certification. 

• Regulatory penalties or legal liabilities. 

• A tarnished reputation in industries where certification is a competitive differentiator. 

5. Impact on Operational and Financial Performance 

The research identifies ISO 9001 as a driver of operational and financial benefits when implemented effectively. Ignoring nonconformities: 

• Reduces operational efficiency by allowing systemic issues to persist. 

• Prevents financial gains such as improved revenue, reduced waste, and lower cost of goods sold. 

• Erodes customer trust, impacting sales and market access. 

Address Nonconformities for Sustained Success 

QMS nonconformities indicate deeper systemic flaws. Addressing them proactively aligns with the Preventive-Appraisal-Failure (PAF) model to: 

• Significantly reduce failure costs. 

• Optimize resource allocation. 

• Ensure sustainable operational and financial performance. 

Prioritizing nonconformance management can help you transform quality management systems into strategic assets, driving continuous improvement and business excellence. 

This approach ensures compliance while minimizing the Cost of Quality, enhancing overall competitiveness in today's demanding markets. 

Tips for Preventing Future QMS Nonconformities in Medical Devices 

Preventing nonconformities requires a proactive and systematic approach, particularly in the highly regulated medical device industry. Here are actionable tips: 

1. Implement Robust Quality Management Systems (QMS) 

• Use a modern EQMS Suite to streamline quality processes like document control, corrective actions, and audits. 

• Ensure your QMS aligns with both ISO 9001, ISO 13485 standards and 21 CFR Part 820 regulation. 

• Leverage features like automated workflows, real-time monitoring, and alerts. 

2. Conduct Regular Internal Audits 

• Schedule frequent audits to identify gaps in processes and ensure compliance with ISO requirements. 

• Use audits to review the effectiveness of corrective and preventive actions (CAPA). 

3. Leverage Risk Management Tools 

• Use tools such as Failure Modes and Effects Analysis (FMEA) to identify and mitigate risks early. 

• Implement a risk-based approach to prioritize critical processes and components. 

4. Train Employees on Quality Standards 

• Provide comprehensive training on ISO 9001, ISO 13485, and other relevant standards. 

• Ensure employees understand their roles in identifying and reporting nonconformities. 

5. Enhance Supplier Quality Management 

• Use supplier audits, scorecards, and monitoring tools to ensure suppliers meet quality standards. 

• Establish clear communication channels to address supplier-related nonconformities promptly. 

6. Standardize and Document Processes 

• Create and maintain SOPs for key processes to minimize errors and inconsistencies. 

• Use document control systems to ensure employees access only the latest, approved versions of documents. 

7. Use Real-Time Data Analytics 

• Leverage data analytics to monitor quality trends, detect anomalies, and predict potential nonconformities. 

• Integrate data-driven insights into your quality management practices. 

8. Foster a Culture of Continuous Improvement 

• Encourage employees to report issues without fear of blame. 

• Use root cause analysis to address the underlying causes of nonconformities. 

• Regularly review and update processes based on lessons learned. 

9. Automate Nonconformity Management 

• Use software like Qualityze Nonconformance Management to automate the identification, tracking, and resolution of nonconformities. 

• Implement features like automated alerts, workflows, and real-time dashboards. 

10. Monitor Post-Market Feedback 

• Establish effective post-market surveillance to track customer complaints, adverse events, and product performance. 

• Use this feedback to identify and address nonconformities in real-time. 

11. Involve Cross-Functional Teams 

• Collaborate with departments like R&D, manufacturing, and supply chain to identify and resolve nonconformities. 

• Ensure all teams understand the quality requirements and contribute to compliance efforts. 

By proactively managing nonconformities, medical device manufacturers can reduce risks, ensure regulatory compliance, and safeguard patient safety. 

Take the first step towards proactive nonconformance management by getting your personalized demo scheduled and experience Qualityze difference today.  For more information, feel free to speak to our customer success team at 1-877-207-8616 or write to us at info@qualityze.com.