Statement on Quality Management Standards No. 1, A Firm’s System of Quality Management, becomes effective on Dec. 15, 2025, and the required documentation surrounding that system’s design, ...

Outsourced execution commonly yields “complete” deliverables that are not defensible because deviations, change control, raw data, and rationale are not traceably linked. Regulatory and quality ...

Many small firms and sole practitioners are unclear about how exactly to fulfill the monitoring and remediation requirements in Statement on Quality Management Standards (SQMS) No. 1, A Firm’s System ...

How often and how much does your firm think about quality? Every auditor is, by nature, committed to quality. Every firm has final quality control steps built into its production process. However, ...

Documentation failures create an evidence problem, but their larger effect is risk and uncertainty. While you may assume a missing signature, disconnected training record, or unexplained spreadsheet ...

The manufacturing industry is more competitive than ever, rewarding forward-thinking manufacturers who successfully accomplish quality, safety and environmental responsibility in their operations.

Owners must manage capital projects well to keep costs under control and ensure a high-quality product is delivered on time. Good communication, sound procedures and processes, and high-tech tools can ...

Quality management systems are really just about one thing: quality. But assuring quality in your products and services has a nice ripple effect of increasing customer satisfaction and keeping them ...

GuidedSMILE™ has earned ISO 13485:2016 certification, an internationally recognized quality management standard specifically designed ...