Have you scheduled your 2024 internal audit?

Don't Wait - Schedule Your 2024 Internal Audit Today!

As 2024 wraps up, many companies are scrambling to complete their internal audits before the end of the year. The internal audit process plays a vital role in ensuring your Quality Management System (QMS) remains compliant, effective, and aligned with your company’s unique operations. Beyond being an annual requirement for many standards, it serves as a foundation for continuous improvement, helping identify areas for enhancement and ensuring your processes are audit-ready year-round.

At Rook Quality Systems (RookQS), our team of 13 Certified Quality Auditors bring extensive expertise in conducting internal audits across various standards and regulations, including FDA 21 CFR 820, ISO 13485:2016, MDSAP, and CE Mark under MDR.

With the end of the year fast approaching, now is the time to schedule your internal audit. Completing this essential task not only helps you maintain compliance but also sets the stage for a strong and successful 2025.

Why Internal Audits Matter

Internal audits provide an opportunity to identify and address gaps in your QMS before they escalate into non-conformities during external audits or inspections. For startups seeking ISO certification or established companies maintaining their compliance, the internal audit process ensures that your QMS meets all necessary regulatory and operational standards.

Audits also foster continuous improvement by:

• Highlighting areas that need attention or refinement.
• Providing insights into the effectiveness of implemented processes.
• Ensuring alignment with updated regulatory requirements.
  

Key Components of an Effective Internal Audit Program

An effective internal audit program should be thoughtfully structured to pinpoint areas for improvement and uncover potential non-conformities within your QMS. Addressing issues during an internal audit is significantly more advantageous than discovering them during an FDA or ISO audit, where the stakes and consequences are much higher.

To make the most of your internal audit, we recommend implementing a robust internal program that includes the following documentation and records to demonstrate compliance:

1. Internal Audit SOP: A documented procedure outlining the audit program, including auditor selection criteria, qualification requirements, and applicable standards or regulations.
2. Internal Audit Schedule: A planned timeline for audits, reviewed annually during management reviews to ensure relevance
3. Internal Audit Checklist: A comprehensive tool that ensures all aspects of the QMS are reviewed for procedural and record compliance.
4. Internal Audit Report: A summary of findings, including a detailed action plan to address identified gaps or non-conformities.

Preparing for an Internal Audit

Proper preparation is critical for a successful internal audit. At RookQS, we recommending following these steps to ensure your company is audit-ready:

• Run Through the Internal Audit Checklist: This includes reviewing records to ensure they are complete and available for management review, audit schedules, supplier certifications, and training records. Identify any open or incomplete items such as Corrective Actions (CAPA), Non-Conformities (NC), or Change Orders (CO).
• Assess Trending and Quality Objectives: Review CAPA, NC, and other quality data to evaluate trends and ensure quality objectives are being met.
• Evaluate the Design History File (DHF): Determine if your DHF is post-market, undergoing design changes, or related to new products. This ensures you’re prepared for any audit focus on product development or lifecycle management.
• Verify SOP Approvals: Confirm all Standard Operating Procedures (SOPs) are approved and up-to-date, especially if there are any in-process revisions.
• Locate Documentation: Ensure you know the location of all necessary documents and records, including design, risk, and regulatory files. This keeps the audit moving efficiently.
• Pre-Identify Audit Findings: Review your system in advance to identify potential issues. Often, you can address findings proactively by opening a CAPA, staying one step ahead of the auditor.

Don’t Wait Until It’s Too Late

With the year drawing to a close, ensuring your internal audit is complete should be at the top of your priority list.

At RookQS, we bring extensive experience to the table, having conducted over 100 remote internal audits for companies of all sizes. Our team is ready to assist your organization in completing audits efficiently and effectively before the end of 2024.

If time or resources are limited, RookQS is here to help. Our seasoned auditors provide:

• Comprehensive reviews of your Quality Management System.
• Timely and efficient audit completion to meet regulatory deadlines.
• Development and refinement of internal audit SOPs.
• Tailored checklists and schedules to streamline the audit process.
• Detailed audit reports with actionable recommendations.

Ready to complete your internal audit? Click the button below to schedule your internal audit and make 2025 your most compliant and efficient year yet. Together, we can ensure your QMS is strong, compliant, and ready to support your success in 2025 and beyond.