ISO Document Control and Quality Management

What is ISO Document Control

ISO Document Control refers to the standards and practices for managing documents as defined by the International Organization for Standardization (ISO). It ensures that documents are properly created, reviewed, approved, distributed, and maintained throughout their lifecycle. The purpose is to ensure consistency, accuracy, and compliance, making sure that only the most up-to-date and relevant documents are accessible to users, which helps organizations meet quality and regulatory requirements.

Why is ISO Document Control Important?

ISO Document Control ensures that everyone within an organization operates under the same rules and procedures by standardizing how documents are created, managed, and used. This uniformity helps maintain quality, ensures compliance, reduces errors, and improves overall efficiency by making sure that all team members follow consistent and approved processes.

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 requirements and practices for lifecycle management.

These requirements ensure that the document control process is efficient, secure, and supports compliance with regulatory standards. Learn more about how infoRouter helps with Regulatory Compliance.

infoRouter ISO document control and management

How does infoRouter Address ISO Document Control Requirements?

infoRouter provides a comprehensive solution for ensuring compliance with ISO international 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 the current version 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 workflow 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.
A comprehensive audit trail is kept for all documents, tracking every action taken and supporting internal audits.
In addition to the comprehensive audit trails, infoRouter maintains a separate "ISO Log" specifically for ISO review transactions, making it very easy to check if all required actions and approvals for compliance have been properly completed and documented.
The document 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.
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 document control 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.

“Implementing infoRouter has greatly improved our efficiency and accuracy. The periodic review reminders ensure we never miss our scheduled reviews of critical documents, and the automatic submission of controlled documents to workflows has streamlined our processes. Tremendous improvement over our previous manual methods.”

Eugene Coleman, Presolutions Inc.

Advanced Version Control

The infoRouter Advanced Version Control System effectively manages all document versions, enabling document owners to determine which version is served when accessed by users. The "revision status" of each document is transparent and easily controlled.

Document owners have the ability to select any version as the "current" one, allowing, for example, an approved version to be designated as current while authors continue making changes. These changes create additional revisions but are treated as "work in progress" and are not shared until they receive approval.

The approved version is made accessible to all users, whereas newer versions in development are labeled as "draft" and remain hidden. Throughout the process, all edits and modifications are meticulously logged, ensuring a "comprehensive audit trail" that can be reviewed at any time.

Click here to learn more about our Advanced Version Control features.

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How Document Templates Help with ISO Document Control

Using document templates helps with ISO Document Control by providing a consistent format and structure for creating documents. Here's how templates contribute to ISO compliance:

Standardization: Templates ensure all documents follow the same layout, terminology, and style, making it easier to maintain uniformity across the organization.
Accuracy and Consistency: Predefined sections, required content, and specific formatting in templates reduce errors and omissions, ensuring that all documents meet ISO standards.
Faster Document Creation: Templates streamline the process of creating new documents, reducing time and effort while ensuring they align with established procedures.
Easy Updates and Revisions: When changes are needed, updating the template ensures that all future documents are compliant, reducing the risk of outdated or non-compliant content.

Overall, templates help maintain control over the document lifecycle by ensuring that all documents are created correctly, consistently, and efficiently, which is crucial for meeting ISO standards. Click here to learn more about our Form Templates.

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.
Document Archiving: Once the documents were approved and finalized, they were archived according to the company’s document Retention and Disposition 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.

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.

ISO Document Control Software - Quality Management