Document Control

Document Control

Document Control

Document Control in general

Document control is a critical aspect of quality management systems in the medical device industry, as outlined in ISO 13485:2016 and reinforced by EU MDR 2017/745 and EU IVDR 2017/746. Here’s an overview of document control requirements according to these standards:ISO 13485:2016 Document Control Requirements:

  1. Establish and maintain documented procedures for controlling all documents required by the quality management system.
  2. Review and approve documents for adequacy prior to issue.
  3. Review, update as necessary, and re-approve documents.
  4. Ensure that changes and current revision status of documents are identified.
  5. Ensure that relevant versions of applicable documents are available at points of use.
  6. Ensure that documents remain legible and readily identifiable.
  7. Prevent the unintended use of obsolete documents and apply suitable identification if they are retained.

Document control requirements according to EU MDR 2017/745 and EU IVDR 2017/746

While these regulations don’t provide as detailed requirements for document control as ISO 13485, they emphasize the importance of documentation and record-keeping throughout the product lifecycle:

  1. Maintain documentation related to the quality management system, including procedures and records.
  2. Keep technical documentation up-to-date and readily available for regulatory authorities.
  3. Ensure traceability of all versions, updates, and changes to documentation.
  4. Maintain records of post-market surveillance activities and any corrective actions taken.
  5. Retain documentation for a period of at least 10 years after the last device has been placed on the market (15 years for implantable devices).

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Document control requirements according to ISO 13485

  • Establishing, implementing, and maintaining documented procedures to control all documents required by the quality management system.
  • Ensuring that documents remain legible, readily identifiable, and retrievable.
  • Ensuring that documents are periodically reviewed and updated as necessary.
  • Ensuring that changes to documents are reviewed and approved by authorized personnel.
  • Ensuring that relevant versions of applicable documents are available at points of use.
  • Ensuring that documents are adequately protected against unauthorized access, use, and loss.
  • Retaining documented information for a specified period.

These requirements help ensure that the organization’s documented information is managed effectively to support the quality management system.

Document Control – Relevant Chapters according to ISO 13485

These sections outline the requirements for establishing and maintaining a document control system within a medical device quality management system. It includes aspects such as creating, updating, controlling documents, and ensuring proper documentation of processes and activities.

  • Section 4.2: Documented Information
  • Section 4.2.4: Control of Documents
  • Section 4.2.5: Control of Records
  • Section 7.5: Documented Information
  • Section 7.5.1: General
  • Section 7.5.2: Creating and Updating
  • Section 7.5.3: Control of Documented Information

Key Aspects of Document Control:

  • Version Control: Implement a system to track document versions and revisions.
  • Access Control: Ensure that only authorized personnel can modify documents.
  • Distribution Control: Manage the distribution of documents to ensure the right people have access to the most current versions.
  • Retention: Establish policies for document retention in line with regulatory requirements.
  • Electronic Document Management: If using electronic systems, ensure they meet the requirements for data integrity and security.

Document Control Process

A document control process according to ISO 13485:2016 involves systematic and comprehensive management of all documents required by the quality management system (QMS). Below is a detailed outline of what this process should include:

1. Establish Documented Procedures

  • Create and maintain documented procedures for controlling all QMS documents. This ensures consistency and compliance with ISO 13485:2016 requirements.

2. Document Review and Approval

  • Review and approve documents for adequacy prior to issuance. This step ensures that all documents are accurate, complete, and meet regulatory requirements before they are used.

3. Document Updates and Re-approval

  • Review and update documents as necessary, and re-approve them. This involves periodic reviews to ensure documents remain current and reflect any changes in processes, regulations, or standards.

4. Identification of Changes and Revision Status

  • Identify changes and the current revision status of documents. Implement a version control system to track document revisions and ensure that users can easily identify the latest version.

5. Availability at Points of Use

  • Ensure relevant versions of applicable documents are available at points of use. This means making sure that employees have access to the most current documents needed for their tasks.

6. Document Legibility and Identifiability

  • Ensure documents remain legible and readily identifiable. This involves maintaining document quality so that they are easily readable and recognizable.

7. Control of Obsolete Documents

  • Prevent the unintended use of obsolete documents. Implement procedures to remove outdated documents from points of use and mark them clearly if they need to be retained for any reason.

8. Version Control

  • Implement a version control system to track document versions and revisions. This helps in maintaining a clear history of changes and ensures that only the most current documents are in use.

9. Access Control

  • Ensure that only authorized personnel can modify documents. Implement access controls to restrict document editing to qualified individuals, thereby maintaining document integrity.

10. Distribution Control

  • Manage the distribution of documents to ensure the right people have access to the most current versions. This involves controlled dissemination of documents to relevant stakeholders.

11. Document Retention

  • Establish policies for document retention in line with regulatory requirements. For example, retain documentation for at least 10 years after the last device has been placed on the market, or 15 years for implantable devices.

12. Electronic Document Management (eDMS)

  • If using electronic systems, ensure they meet requirements for data integrity and security. An eDMS can enhance efficiency by automating workflows for review, approval, and distribution while ensuring compliance with regulatory standards like 21 CFR Part 11.

13. Integration with Other QMS Processes

  • Integrate document control with other QMS processes such as design controls, risk management, supplier management, production controls, and CAPA. This ensures that document control supports the overall effectiveness of the QMS.

14. Training and Competence

  • Provide training on document control procedures. Ensure that all personnel are competent in handling documents according to established procedures, which is crucial for maintaining compliance and quality.

15. Audit Trail and Traceability

  • Maintain a clear audit trail for documents. Keep records of document changes, approvals, and distribution to support traceability and facilitate audits.

16. Performance Metrics and Continuous Improvement

  • Monitor performance metrics for document control. Use key performance indicators (KPIs) to assess the efficiency and effectiveness of the document control process and drive continuous improvement.

17. Regulatory Inspections and Audits

  • Prepare for regulatory inspections and audits. Organize documentation for easy retrieval and demonstrate compliance with ISO 13485:2016 requirements during audits.

Implementing these practices ensures that the document control process is robust, compliant with ISO 13485:2016, and supports the overall quality and safety of medical devices.

Other relevant Processes and SOP’s related to ISO 13485, EU MDR and EU IVDR

The document control process is just one of many important processes. In the following article you will find more detailed information.

Conclusion

Implementing robust document control helps medical device manufacturers maintain compliance with regulatory requirements, ensure product quality and safety, and facilitate efficient operations. It’s crucial to establish a systematic approach to document management that aligns with the specific requirements of ISO 13485, EU MDR, and EU IVDR while also meeting the unique needs of the organization.

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