While common features provide consistency across the QMS, each document type has unique capabilities designed for its specific purpose.
2.2.1 Standards Unique Features
Standard Business documents in 1factory QMS store external requirements and regulatory standards that your organization must comply with, such as ISO 9001:2015, AS9100D, FDA regulations, or customer-specific requirements. These controlled documents serve as the foundation for your quality management system by establishing the compliance framework that all other QMS documents must support. Standards are typically issued by external organizations like ISO, SAE, FDA, or your customers specific requirements, and maintaining current versions is critical for regulatory compliance and certification maintenance. These documents support the Quality Manual and other QMS documentation throughout your organization.
PDF Reference Document
- Upload external regulatory documents in PDF format
- Access through Reference Document feature in editing mode
- Supports PDF format only
2.2.2 Quality Manual Unique Features
1Factory provides a powerful Quality Manual solution that transforms isolated Standards and Procedures into an integrated compliance framework. Unlike standalone documents, the Quality Manual creates systematic linkage between external requirements and internal implementation, delivering comprehensive compliance visibility essential for regulated organizations.
Step 1: Select Procedure for Quality Manual Creation
Select the Procedure document that will serve as the foundation for your Quality Matrix design. Navigate to the top right corner of your profile and click the dropdown menu to select Settings.
Navigate to QMS Settings and use the dropdown menu to select the appropriate Procedure document, or type directly in the search box to locate the specific Procedure number. Click the Save button at the bottom of the Settings page to confirm your selection.
Step 2: Access the Selected Procedure Document
Navigate to the QMS module and click the Documents tile. Within Business Documents, select the Procedures tab to locate the Procedure document selected in Step 1.
Important: Select the Draft Revision (typically marked in yellow) rather than the Released version (marked in green).
Step 3: Access Quality Matrix Function
On the left menu bar, locate and click the MATRIX icon. An empty grid interface will open, allowing you to design your Quality Matrix. The matrix displays Standard Clause numbers in one column with corresponding references to Quality Manual Sections and implementing Procedures.
Step 4: Configure Quality Matrix Elements
Select the required Standard document from the dropdown menu at the top of the page. For example, select ISO 9001 if applicable to your organization.
Configure the following elements:
- Standard Clause: Enter the specific clause number from external standards (such as ISO 9001:2015, AS9100D, ISO 13485, or FDA 21 CFR Part 820). This field creates direct traceability links and transforms your Quality Manual into a compliance navigation tool. For example, entering "4.4.1" links that section to ISO 9001's process approach requirements.
- Quality Manual Sections: Select the appropriate section from the dropdown menu that corresponds to your Procedure document content. This section links directly with the document body content you are developing.
- Implementing Procedures: Use the dropdown menu to specify the Procedures that support the Standard Clause and Quality Manual Section. This field creates traceability links between high-level Quality Manual policies and specific procedures that execute those policies in operations.
Step 5: Manage Quality Matrix Items
1factory provides Insert and Remove functionality to add or delete matrix items as needed. The system automatically saves changes during matrix operations (entering or modifying Standard Clauses, selecting Quality Manual Sections, or changing Implementing Procedures). Progress indicators showing "Saving change" and "Change Saved" appear in the top left corner.
To simplify setup, open the attachment at the bottom of this section titled “Standard Clauses – For Quality Matrix” This file includes clauses from common standards (ISO 9001:2015, AS9100D, ISO 13485:2016, IATF 16949:2016, and 21 CFR Part 820). Simply copy and paste the clauses your organization is required to meet directly into the Quality Matrix.
Step 6: Release the Quality Manual
Upon completing the Quality Matrix configuration, navigate to the Manage button on the left menu bar to release this Procedure document as your organizational Quality Manual. Follow the standard document release workflow and click the Save button to finalize the process.
Important: Once the Quality Manual is released, the Quality Dashboard will automatically update to display the Quality Matrix relationships, providing real-time compliance mapping between your external standards (ISO 9001, AS9100, etc.) and internal procedures for audit preparation and management reviews.
2.2.3 Procedures Unique Features
The Procedures module in 1factory QMS is designed to store and manage internal documents that outline the operation of your Quality Management System. These are the core operational documents that define how your organization executes its quality processes.
The Procedures essentially serve as the backbone of your QMS documentation hierarchy, sitting between high-level Standards (external requirements) and detailed Work Instructions (step-by-step tasks).
Automatic Linkage from Standards
Procedures can be selected and linked directly to Standards clause via the Quality Matrix within your Quality Manual, creating traceable compliance demonstration.
Impact Assessment
Organizations can configure a standard list of Impact Assessment Questions under Master Data in the Tables tile. The Tables tile is only visible to users with the Manage Settings and LOV permission. To configure questions, navigate to Master Data > Tables, select the Impact Assessment Questions row, and enter your questions in the free-text table. Each row represents one question. To delete a question, clear its text and click Save. All changes to the question list are tracked in audit history and can be viewed from the command bar on the Tables detail page.
Note: The question format is intentionally open-ended. If your organization wishes to number questions, do so manually within the question text itself.
When at least one Impact Assessment Question has been configured, an Impact Assessment icon appears in the command bar for every Procedure in Draft status. The icon is not shown when a document is flagged as a Minor Update in the Manage tab, as minor updates do not require an impact assessment.
Completing the Impact Assessment
Click the Impact Assessment icon to open the slideout. The table presents each configured question with three columns: the question text (read-only), a Yes/No/N/A response dropdown, and a free-text comments field.
The following rules apply when completing the assessment:
- Every question must have a response of Yes, No, or N/A selected before the document can be routed for approval. Responses of Yes or No additionally require a comment to be entered. Leaving a response empty or leaving a required comment blank will block the document from being moved to Pending Approval status. If validation fails, the Versioning control in the Manage slideout will display an error and prevent the status change.
- The Impact Assessment table is editable only while the document is in Draft status and only by users who have edit access to the document. Once the document moves to Pending Approval or beyond, the table becomes read-only and can be viewed but not modified. All changes made to the table are recorded in the document's audit history.
- Each new revision of a Procedure starts with a blank assessment. Answers from previous revisions are not carried forward, ensuring each revision is evaluated independently.
2.2.4 Work Instructions Unique Features
Work Instructions in 1factory QMS are detailed, step-by-step documents that provide specific guidance on how to perform individual tasks within your quality management system. These documents serve as the operational level of your QMS hierarchy, sitting below Procedures and providing the detail needed for consistent task execution. Work Instructions are particularly critical in regulated industries where standardized execution of quality processes is essential for compliance with standards such as ISO 9001, AS9100, ISO 13485, and FDA regulations.
Cross-Reference in Procedures
- Automatically creates bidirectional links when referenced
- Supports detailed "how-to" documentation structure
- Maintains consistency when procedures change
2.2.5 Record Types Unique Features
The Record Type list is used to store documents that will later become Records within 1factory. These Record Types are typically referenced by other QMS documents such as Work Instructions, Procedures, or Process Instructions. For example, a Work Instruction for "Creating a New Supplier in the QMS" may reference a Record Type called "New Supplier Audit Form." When users need to document supplier evaluations, they would create Records using this controlled form template. Record Types are also in 1factory QMS are controlled documents that serve as templates for creating Records within your quality management system.
Record Creation Configuration
- Click Records tile on left menu
- Configure user roles and permissions
- Click Go to save configuration
Important: Must complete this step to create records from this Record Type
Form Download
- Click FORM download tile
- Downloads the template file uploaded during creation
- Used as blank form for creating records
No Training Assignment
- Training features not available for Record Types
- Records themselves serve as evidence of completed activities
2.2.6 Manufacturing Standards
Manufacturing Standards are technical reference documents that define specifications, requirements, and acceptance criteria for production operations. These documents establish standardized methods for manufacturing processes, material requirements, inspection protocols, and quality characteristics specific to your manufacturing operations. Examples include industry process standards (ASTM B580, ASTM B841), customer-specific manufacturing requirements (packaging specifications, part marking standards), and internal production specifications.
Unlike Standard Business documents that support organization wide QMS compliance, Manufacturing Standards operate exclusively within the manufacturing realm.These documents do not support the Quality Matrix feature but instead provide production-level technical guidance that ensures consistent manufacturing execution and product conformance.
PDF Reference Document
- Upload external regulatory documents in PDF format
- Access through Reference Document feature in editing mode
- Supports PDF format only
2.2.7 Courses Unique Features
A new machine operator joins the floor and needs to be authorized on lockout tagout procedures before touching any equipment. Instead of reading a written procedure, they watch a short training video, then answer a few questions to confirm they understood it. That training assignment, video, and quiz all live in a Course.
Courses are a QMS document type built specifically for delivering training content. They live in their own tile on the QMS tab and follow the same document control backbone as every other QMS document type: numbering, approvals, access control, and training assignment all work the same way.
Accessing Courses
Courses are managed from QMS Tab > Courses tile. This tile is only visible to users with the Manage Courses permission. Regular users do not see the Courses tile directly. They only interact with Course content through their assigned training in My Training.
Numbering
Courses can be assigned a custom prefix if your organization uses its own numbering scheme. If using 1factory numbering, Courses are automatically assigned the fixed prefix CSE.
Content Types
Courses are restricted to external content, the same model used for Standards. There is no native content editor for Courses. Supported content types are:
- PowerPoint
- Video (max file size 100MB)
When a Course contains a video file, the document screen displays a video player instead of the standard PDF viewer.
Uploading a file is optional. If your training content is hosted externally, simply add the link to the Description field instead of uploading a file.
Linking Courses to Other Documents
Courses can be linked to and from other QMS documents the same way Forms and other external documents are linked. A Work Instruction can reference a Course, and a Course's description field can reference back to related QMS documents.
Standard Document Features
Courses retain the full set of standard document features, including:
- Training: Assign Courses to roles through a training plan, the same as any other QMS document.
- Approvals: Courses follow the same approval workflow as other documents, with one difference described below.
- Access Control: Restrict Course visibility by role or organization.
- Federation: Courses are visible across federated organizations the same way other QMS documents are.
Mandatory Course Approver
Courses use a separate mandatory approver role from regular QMS documents. This is configured in QMS Settings as the Mandatory Course Approver Role, and works the same way the Mandatory Approver Role does for documents: it is automatically included as a required approver on every Course, and controls release authority if Mandatory Approver Controls Release is enabled. Organizations can select any QMS role for this setting, including the same role used as their Mandatory Approver Role for documents, if they don't need separate approval authority for training content.