infoRouter provides ISO Document Control features that are required for any organization seeking certification with ISO. Documentation control and total quality management (TQM) is a must to get and maintain an ISO certification.
What is Required for Effective Document Control
For an effective document control process, several key requirements must be met to ensure access to documents, their protection, and proper documentation practices:
- Controlled documents must be available to all stakeholders, ensuring internal communication and ease of document access when needed.
- Controlled documents must be protected from unauthorized access, edits, or deletion, ensuring the control of documents is properly managed.
- Document naming must be consistent to maintain clarity and facilitate the document control process.
- Documents must be in a readable format to ensure they provide evidence of conformity with relevant standards and regulations.
- Documents must be reviewed and approved before they are finalized, ensuring they meet quality standards.
- They must be periodically reviewed, and a record of the review must be preserved to show ongoing compliance and continual improvement.
- Controlled documents must be securely distributed to all authorized users, ensuring only the appropriate personnel have access to documents.
- Permissions must be properly set to protect documents from unauthorized edits or deletion, ensuring document integrity is maintained throughout the process.
- When changed, a formal approval process must be in place for the final version, ensuring it meets required standards before being published.
- All edits and revisions must be logged, and document versions must be identifiable by the person who made the change and when they made it, ensuring transparency and accountability in the control of documents.
- Documents must be retained, archived, and properly disposed of when no longer needed, adhering to established documentation practices for lifecycle management.
These requirements ensure that the document control process is efficient, secure, and supports compliance with regulatory standards.
How does infoRouter Address ISO Document Control Requirements?
infoRouter provides a comprehensive solution for ensuring compliance with ISO standards and managing an effective document control system. Documents are always available to authorized users, and the powerful search features allow users to instantly locate them. infoRouter’s document control procedures include military-grade security to protect against unauthorized access.
- Documents are managed with version control, ensuring that authorized users can access both current and previous versions. infoRouter supports all formats and manages documents in their native format, streamlining document revisions in line with the requirements of ISO.
- The system's built-in workflows support the approval process for documents, guiding them through the necessary document control procedures. Additionally, infoRouter includes a recurring review mechanism that alerts users or groups when it is time for a document review, promoting continuous improvement and keeping documents compliant with quality management systems.
- The distribution system in infoRouter ensures documents are routed to the right people within the organization, while its security system allows granular permissions to be assigned to documents and folders, maintaining tight control over access.
- An extensive audit trail is kept for all documents, tracking every action taken and supporting internal audits. InfoRouter's Retention and Disposition Schedules safeguard documents against accidental deletion, while obsolete documents are properly disposed of after their useful life has ended, ensuring full compliance with ISO document retention guidelines.
Periodic scheduled review of ISO Procedure Documents
Anyone involved in ISO certification and quality management knows that one of the most difficult tasks is building a mechanism in which procedure documents are managed and periodically reviewed. ISO compliance can only be maintained with the help of an industrial-strength document management system.
infoRouter ISO periodic review module allows authorized users to mark documents for periodic review. When a document is marked for periodic review, infoRouter keeps track of these documents and sends out review requests to the right people when the review is required. The review task is tracked and user comments are recorded for audit purposes.
Use Case Scenario: Implementing an Effective Document Control System for ISO Compliance
A manufacturing company seeking ISO 9001 certification needed a solution to automate their document control procedures, particularly for pricing documents and internal quality processes. To meet the requirements of ISO standards and ensure continuous improvement in their quality management systems, they implemented an electronic document management system (EDMS) using infoRouter. This system helped them streamline document control processes, internal audits, and management reviews while maintaining compliance with regulatory requirements.
Scenario 1: Managing Procedure Documents for ISO Compliance
- Organizing Documents: A primary folder was created to store all procedure documents, with sub-folders for different departments and activities.
- Periodic Review Tasks: Each document in these folders was assigned a periodic review task, ensuring it was reviewed every 3 months as required by the company's quality objectives.
- Automatic Reminders: infoRouter's document management software sent automatic reminders to the responsible users, alerting them to upcoming document reviews based on the predefined timelines.
- Version Control: As documents were reviewed, any updates were captured, and new versions were stored, maintaining a complete document history for document revisions.
- Regular Audits: Each step in the review process was logged for future internal audits, ensuring compliance with ISO standards and supporting management reviews.
This automated system eliminated the risk of outdated documents circulating within the company and improved the accuracy and reliability of their quality processes.
Scenario 2: Automating the Review of Pricing Documents
- Centralized Document Storage: A folder was created in infoRouter to house all pricing documents related to various products.
- Automated Workflows: A periodic review task was assigned to each document, triggering an approval workflow involving multiple departments. This workflow ensured that all stakeholders reviewed and approved the documents before they were finalized.
- Approval Process and Control of Records: Each review task required approval workflows, where users could comment on the changes. The system tracked and logged each comment, creating a full audit trail for document revisions and document approval procedures.
- Access Control: To ensure security, access control measures were put in place to restrict access to sensitive pricing information, allowing only authorized users to view or edit the documents.
- Archiving of Documents: Once the documents were approved and finalized, they were archived according to the company’s document retention policy, ensuring a clear process for the eventual disposition of records.
By implementing this effective document control system, the company maintained compliance with ISO standards, streamlined their document approval processes, and gained a competitive edge by reducing errors and ensuring consistent, up-to-date pricing information.
Did You Know That...
Over 1 million organizations in over 170 countries enjoy the benefits of ISO certification?
infoRouter can not only assign a task to an individual to perform the review, it can even automatically start a complex workflow which will ensure that a marked document goes through a series of tasks assigned to multiple individuals. The entire process is tracked and logged so you can easily see the history of the ISO document review process.
The periodic review features can be used in cases where ISO does not apply. Internal procedures, pricing documents and other types of documents that need to be reviewed on a regular basis can be marked for periodic review.
For information on Regulatory compliance and why ISO Quality Control should matter, visit infoRouter Regulatory Compliance Solutions