FDA issued 303 drug warning letters in FY 2025 — a 59% spike. Learn what 2026 cases reveal about quality system failures and how to prevent them. […]
Quality Management
The Real Cost of Poor Quality: How to Build the Business Case for Digital Audits
COPQ consumes 10–20% of revenue — yet 90% stays hidden. Learn to calculate your quality costs and build a CFO-ready ROI case for digital audits in this practical guide. […]
VDA 6.3 in 2026: What Automotive Suppliers Need to Know About the 2023 Changes
Learn what the VDA 6.3:2023 changes mean in 2026, including auditor upgrade training, evaluation updates, and how to standardize supplier process audits. […]
ISO 9001 Revision 2026: How to Start Your Transition Planning Now
ISO 9001:2026 publication is expected later this year. Quality teams that start transition planning now will have a significant advantage. […]
A Mark of Excellence: Certainty Software Achieves Multiple 2025 Recognitions from Capterra, Software Advice and GetApp
What a year! We’re thrilled to announce that Certainty Software has received multiple accolades across Capterra, Software Advice, and GetApp throughout 2025. Certainty is an audit and inspection management platform designed to help organizations streamline and digitize their audit, inspection, and checklist processes. It enables users to collect data, manage corrective actions, and generate real-time […]
Why Certainty Software Outperforms Traditional Audit Approaches
Certainty Software is designed for modern compliance, giving enterprises real-time visibility, multilingual data collection, automated workflows, and centralized management that traditional paper forms and Excel spreadsheets cannot match. […]
Offline or Off Track: Why Mobile Capability is Critical for Enterprise Inspections
https://certaintysoftware.com/why-not-use-checkit-with-imca-guidance-documents […]
The Higg Index: Fashion’s Sustainability Measurement Standard
Discover why major retailers rely on the Higg Index to benchmark and index their sustainability efforts. […]
11 Common Mistakes When Building Audit Checklists in Excel
Summary: Building audit checklists in Excel introduces significant risks to quality management programs, including version control failures, data entry errors, lack of real-time visibility, and difficulty maintaining compliance with ISO 9001, IATF 16949, and other standards. These common mistakes can inflate audit completion times, compromise data integrity, and make it nearly impossible to track corrective […]
Quality Assurance vs. Quality Control
Summary: Quality Assurance (QA) and Quality Control (QC) are complementary but distinct disciplines within a quality management system — QA focuses on preventing defects through process design and standardization, while QC detects defects through testing and inspection of finished outputs. Together, they form a comprehensive approach to quality that drives first pass yield improvements, reduces […]
[Podcast] Compliance Talks Episode 1: The Cost of Enterprise Non-Compliance (How Automation Prevents These Steep Costs)
In this debut episode of Compliance Talks, we dig into the true cost of non-compliance—financial penalties, operational disruptions, and reputational damage—and explore how Certainty Software’s automation is changing the way enterprises tackle these challenges. […]
Guide to Pre-Shipment Inspections
Summary: Pre-shipment inspections (PSI) serve as a critical final quality gate that verifies products meet all specifications, standards, and contractual requirements before they leave the facility. When integrated with quality frameworks like ISO 9001 and ISO 2859-1 sampling standards, PSI provides systematic, evidence-based verification that protects both the manufacturer and the customer. Implementing digital pre-shipment […]
How Risk-Based Thinking Aligns with ISO 9001:2015 Requirements and Other Global Quality Assurance Regulations
Summary: Risk-based thinking is a foundational principle of ISO 9001:2015 that requires organizations to identify, assess, and address risks and opportunities throughout their quality management system. Rather than treating risk management as a separate activity, ISO 9001:2015 embeds it into every process — from planning and operations to performance evaluation and improvement. Adopting risk-based thinking […]
Audit vs. Inspection: Learn Their Key Differences
Summary: Audits and inspections are both essential quality management activities, but they serve fundamentally different purposes within a quality management system. Audits evaluate the effectiveness of management systems and processes against standards like ISO 9001, while inspections verify that specific products or operations meet defined requirements on the production floor. Understanding when to deploy each […]
How to Make an Audit and Inspection Checklist in Microsoft Excel
How to Make an Audit and Inspection Checklist in Microsoft Excel […]
