Most Common Noncomformities Written During ISO 13485 Audits

Navigating an ISO 13485 audit requires more than just following a checklist; it demands a deep understanding of medical device-specific requirements and a robust commitment to documentation. In this webinar, we explore why organizations are often deemed “not ready” during Stage 1 and identifies the most frequent Non-Conformance Reports (NCRs) issued during Stage 2 and surveillance audits.

Avoiding Stage 1 Pitfalls: Ensuring Readiness

A successful certification journey begins with a solid Stage 1 foundation. Common reasons for being deemed unready to proceed include:

• Poor Planning: Organizations often fail to leave enough time between Stage 1 and Stage 2. PJR recommends a window of six weeks to 90 days to address any concerns identified in the initial phase
• Missing Documented Procedures: Unlike ISO 9001:2015, which has reduced its reliance on formal procedures, ISO 13485 maintains a heavy requirement for documented processes due to the critical nature of the industry
• Immature Objectives: Quality objectives must be measurable, and auditors need to see enough data to identify trends and evaluate the organization’s response to those trends
• Shared Space Delineation: If an organization shares a facility with other companies, the boundaries and scope of the medical device management system must be clearly defined

Common NCRs During Stage 2 and Surveillance

Once an organization moves past Stage 1, several “big hitters” frequently lead to non-conformities:

• Software Validation: A common oversight involves off-the-shelf software, such as Microsoft Excel. If these tools are used for QMS-related tracking or calculations, they must be validated for their specific application before use
• Risk-Based Supplier Control: Supplier evaluation criteria should not be based solely on cost. Instead, selection and monitoring must be proportionate to the risk the supplier’s product poses to the final medical device
• Identification and Traceability: Auditors frequently find issues with product status identification throughout production and the failure to distinguish non-conforming or suspect returns from conforming stock
• Preservation of Product: This includes monitoring shelf life and ensuring that constituent parts or reagents have not expired
• Document Control: Typical issues involve unapproved documents or unauthorized “reference only” versions being used by personnel on the shop floor

The Evolution of Auditing: Remote and Hybrid Models

This video also addresses the transition to virtual auditing. While face-to-face interaction remains highly valuable, PJR offers flexible options for partially virtual audits.

• Benefits: Remote auditing can save clients money on travel costs and reduce the “intrusiveness” of the audit on daily operations
• Scope: Records like design files, complaints, management reviews, and risk analyses are particularly well-suited for virtual review via screen-sharing platforms

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