ISO 13485 Control of Records: Understanding Documentation Requirements

Want to launch your medical device in global markets? Compliance with ISO 13485 is your ticket. Many jurisdictions require it, making it key to securing faster regulatory approvals and ensuring product quality. That means a simple paperwork oversight could lead to product failures, compliance violations, and even safety hazards for end users. 

Maintaining accurate and reliable records under ISO 13485 control of records is about safeguarding product integrity, avoiding costly errors, and ensuring seamless audits. Effective record management can be the difference between operational success and a compliance nightmare.

In this blog, we will explore the key documentation requirements under ISO 13485, breaking down the necessary steps to maintain compliance. You'll learn how to structure records throughout their life cycle, best practices for document control, and the essential standards that ensure regulatory adherence. By the end, you'll have a clear understanding of how to effectively manage records and streamline compliance efforts within your organization.

Making Sense of Record Control in ISO 13485

Section 4.2.5 of ISO 13485 control of records outlines the requirements for managing records. Organizations must establish documented procedures to maintain records in a controlled manner, ensuring their integrity, accessibility, and compliance with regulatory guidelines. 

With regulatory expectations evolving, U.S. companies must align their Quality Management Systems (QMS) with ISO 13485 standards by February 2, 2026, following the FDA’s final rule issued on February 2, 2024. This transition reinforces the need for robust record control systems to meet compliance requirements and avoid regulatory risks.

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Key requirements include:

• Identification: Records should be clearly identified and categorized for easy retrieval.
• Storage: Proper storage methods must be in place to prevent damage, deterioration, or loss.
• Protection: Security measures should be implemented to prevent unauthorized access or modifications.
• Retention: Organizations must define retention periods based on regulatory requirements and business needs.
• Disposition: Secure disposal methods should be established for records that are no longer required.

By following these guidelines, organizations can not only meet regulatory expectations but also strengthen their ISO 13485 control of the records system, minimizing risks and improving operational control. If you’re new to ISO 13485 and want a clearer understanding of how it applies to different aspects of medical device development, including software, check out our guide on Applying ISO 13485 to Software for Medical Device Development. This will help you see how compliance requirements impact both physical products and software solutions in the medical field.

Ensuring compliance is just the beginning—effective record management requires a proactive approach throughout the entire document life cycle. Let's now explore how to manage records from start to finish.

Managing Records from Start to Finish

Effective record management is more than just storing and retrieving documents. It’s about ensuring records remain accurate, secure, and accessible throughout their entire life cycle. From their initial creation to their final disposal, each phase plays a vital role in compliance and operational efficiency. A well-maintained record system helps prevent compliance issues, enhances traceability, and ensures smooth audits.

Key Phases in Record Management

Managing records effectively involves several key stages. Here’s a quick breakdown:

• Creation: Ensuring records are accurately documented at the point of origin.
• Storing: Implementing secure and organized storage solutions.
• Use and Modification: Controlling how records are accessed and updated while maintaining accuracy.
• Copying: Managing duplicate records to prevent inconsistencies.
• Archiving: Storing inactive records securely for long-term retention.
• Deletion: Safely disposing of records that are no longer required while ensuring compliance.

By effectively managing the full life cycle of records, organizations can minimize compliance risks, prevent data loss, and ensure a seamless audit trail. However, proper record management doesn't stop there. It requires a structured approach to ensure consistency and accessibility. This brings us to the next crucial step: setting up a strong record control system.

Setting Up a Strong Record Control System

An effective record control system is the backbone of compliance, ensuring that records are well-organized, easily accessible, and securely maintained. Without a structured approach, organizations risk inefficiencies, compliance failures, and data loss. By implementing standardized processes, businesses can enhance record integrity, streamline audits, and improve overall compliance management.

Defining a Record Control Plan

A structured record control plan is key to maintaining compliance and efficiency. It ensures records are handled consistently, securely, and in alignment with regulations. By establishing clear procedures, organizations can reduce risks and simplify audits. Let's break down the key elements of a strong record control plan:

• Establish clear procedures for creating, storing, retrieving, and disposing of records.
• Assign responsibilities to ensure accountability in record management.
• Set guidelines for document security and access permissions.
• Implement role-based access controls to ensure only authorized personnel can modify or retrieve sensitive records.

Keeping Procedures Up to Date

Staying compliant requires continuous updates to your record control procedures. As regulations evolve and business needs shift, ensuring that your procedures remain current is essential for maintaining efficiency and compliance. Below are the essential steps to ensure your procedures stay current and compliant.

• Regularly review and update record control processes to align with changing regulatory requirements.
• Conduct periodic audits to identify gaps and ensure compliance.
• Implement version control to track changes and maintain historical data integrity.

A well-structured record control system not only improves efficiency but also strengthens compliance with ISO 13485. By implementing a clear plan, assigning responsibilities, and maintaining up-to-date procedures, organizations can reduce risks and ensure their records are audit-ready.

Is your record control system causing compliance headaches? Without clear processes, compliance risks increase, audits become challenging, and efficiency drops. BPRHub provides an automated, centralized solution to help you manage records effortlessly, ensuring compliance and accessibility. Have more questions? Mail us at hello@bprhub.com.

Compliance isn’t just about managing records—it’s also about maintaining them in a way that meets ISO 13485 requirements. Let's understand how organizations can meet compliance requirements with proper record-keeping.

Ensuring Compliance with ISO 13485 Record-Keeping

The global medical devices market is projected to reach approximately $671.49 billion by 2027, growing at a CAGR of 6.2% from 2021. With such growth, regulatory compliance has never been more critical. Proper record-keeping under ISO 13485 ensures traceability, minimizes compliance risks, and supports regulatory approvals, positioning organizations for long-term success in this expanding market.

Key Documentation Requirements for ISO 13485

Organizations must follow ISO 13485 by maintaining records that verify compliance, ensuring audit readiness, and securing documents against unauthorized access. To comply with ISO 13485, organizations should:

• Provide Clear Evidence of Compliance – Maintain records that verify adherence to ISO 13485 clauses and regulatory mandates.
• Ensure Audit-Readiness – Keep records well-structured and accessible for internal and external audits.
• Secure and Manage Records Efficiently – Store records in a way that prevents loss, unauthorized access, or damage.

By following these guidelines, organizations can build a structured quality management system that ensures both internal alignment and regulatory compliance. But compliance alone isn't enough. Organizations must also focus on transparency and traceability to maintain full control over their records. Up next, let’s explore how these factors contribute to effective record-keeping.

Keeping Records Transparent and Traceable

Transparency and traceability are fundamental to effective record management. They ensure accountability, prevent errors, and enhance compliance by keeping a clear history of document changes. To achieve this effectively:

• User Attribution: Records should clearly identify the individuals performing activities, along with timestamps for verification.
• Audit Trails: Metadata tracking should be implemented to monitor record changes, including modifications, deletions, and approvals.
• Change Management: Implement systems that track and manage document revisions while preserving historical versions.
• Record Validation: Regularly review and validate records to ensure accuracy and compliance with ISO 13485 standards.
• Access Logs: Maintain detailed logs of who accessed or modified records to enhance security and accountability.

By integrating strong attribution and audit trail mechanisms, organizations can maintain accountability, ensure records remain trustworthy, and strengthen compliance efforts. Accurate and traceable records are essential, but without proper organization, retrieving and utilizing them efficiently can be a challenge. A cluttered or poorly managed record system can lead to inefficiencies, errors, and compliance risks. To ensure records remain accessible and functional, implementing structured organization strategies is key.

Best Practices to Keep Records Organized

Maintaining organized and accessible records is crucial for ISO 13485 compliance. Proper document control not only ensures accuracy but also streamlines audits and regulatory checks. Below are key best practices to keep your records structured and compliant:

• Version Control: Maintain a system for tracking document revisions to ensure that only the most current versions are in use.
• Access Control: Restrict modification rights to authorized personnel to protect document integrity.
• Distribution Control: Ensure that relevant documents are accessible to the appropriate personnel at the right time.
• Periodic Review: Regularly review and update documents to ensure accuracy and relevance.
• Training: Educate staff on document control procedures to promote consistency and compliance.
• Regular Audits and Reviews: Conduct periodic checks to ensure that all record-keeping practices align with ISO 13485 requirements and improve process efficiency.

By implementing these practices, organizations can maintain a well-structured QMS, reduce compliance risks, and enhance overall efficiency. However, managing compliance documentation manually can still be a challenge. This is where leveraging the right tools can make a significant difference. Let's explore how BPRHub supports ISO 13485 documentation and simplifies compliance management.

How BPRHub Supports ISO 13485 Documentation

Managing compliance documentation manually can be time-consuming and prone to errors. BPRHub offers a cloud-based compliance management platform designed to streamline record control while ensuring adherence to ISO 13485 documentation requirements. With features such as:

• Live Compliance Tracking: Get real-time updates on compliance status from R&D to final distribution for complete oversight.
• Accurate and Traceable Documentation: Simplify eLog recording and Batch Manufacturing Records (BMR) to track changes, approvals, and deviations.
• Automated Maintenance Logs: Maintain detailed records of equipment upkeep and calibration to minimize compliance risks and audit issues.
• Inventory Record Accuracy: Track stock levels, batch numbers, and expiration dates to prevent errors and regulatory violations.
• Multi-Standard Compliance: Standardize record-keeping across 30+ industry standards, including ISO 13485 and FDA, for faster compliance.

BPRHub simplifies compliance by reducing inefficiencies, minimizing risks, and keeping records audit-ready. With automated workflows and real-time tracking, organizations can ensure accuracy, enhance traceability, and stay compliant without the burden of manual processes.

Struggling with manual record management and compliance bottlenecks? BPRHub simplifies ISO 13485 control of records by automating workflows, enhancing traceability, and ensuring audit readiness—all in one platform. Take control of your compliance processes and eliminate inefficiencies. Get Started with BPRHub Today.

FAQ’s

Q1: Why is record control important for ISO 13485 compliance?

Proper record control ensures regulatory compliance, supports audits, and improves traceability, reducing risks of non-conformance and product recalls.

Q2: What types of records need to be maintained under ISO 13485?

Organizations must maintain design history files, manufacturing records, risk management reports, supplier evaluations, and corrective action reports.

Q3: How long should records be retained under ISO 13485?

Retention periods vary, but most regulations require records to be kept for at least 10 years, or 15 years for implantable devices.

Q4: How can organizations ensure records remain audit-ready?

Using structured storage, version control, and automated compliance tools like BPRHub can help maintain organized and easily accessible records.

Q5: What are the best practices for managing electronic records under ISO 13485?

Best practices include using secure digital storage, tracking modifications with audit trails, restricting unauthorized access, and implementing automated workflows.