White Paper: Tools and Tips for Writing Effective Nonconformity Statements During Quality Management System Audits of Medical Device Manufacturers
March 17, 2022
As a medical device quality management system auditor, one of the most important (if not the most important) responsibilities of your role is to effectively communicate identified nonconformities to the auditee organization.
For medical device quality management system auditors, effectively communicating nonconformities to the auditee organization is essential. Without clearly written nonconformity statements, the potential for an auditee organization to misunderstand the nonconformity increases. This can lead to difficulty investigating the nonconformity and, in turn, difficulty implementing necessary containment, corrections, corrective actions and systemic corrective actions. However, it is possible to write effective nonconformity statements that are easy to read and easy to understand. In this informative paper, we have compiled a few simple tools and tips to help you consistently create clear, concise and precise nonconformity statements.
How NSF Can Help You
Get in touch to find out how we can help you and your business thrive.
What’s New with NSF
Information Systems Security Association (ISSA) Welcomes NSF’s Brian Schultz into the 2026 Hall of Fame
September 10, 2026Lifetime achievement recognition honors exceptional leadership and lasting contributions to the cybersecurity profession.NSF Welcomes Nicole Parent Haughey to Board of Directors
September 10, 2026NSF's appointment of Nicole supports the organization's continued focus on long-term growth and transformation.
NSF Launches Independent Certification Standard for Compact Products
August 25, 2026New third-party certification verifies products cutting materials and shipping impacts while maintaining safety and performance.
CELSIUS® Products Earn NSF Certified for Sport® Certification
August 20, 2026CELSIUS® has earned NSF Certified for Sport® certification for select products, including the CELSIUS VIBES line, reinforcing the brand’s commitment to quality, transparency and consumer trust.