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Quality Management (QM) Module

The Quality Management (QM) Module transforms your traditional quality management system into a structured, digital environment. Instead of managing scattered documents and spreadsheets, CertHub provides a cohesive system where processes, documentation, and data work together.

Core Components from a Regulatory Perspective​

The QM Module consists of three main building blocks, each serving specific regulatory needs:

1. Standard Operating Procedures (SOPs)​

High-level processes that define your quality system's core workflows. These are required by regulations like ISO 13485 and FDA QSR to document your key quality processes.

Typical SOPs include:

  • Design Control Process
  • Document Control
  • CAPA Management
  • Risk Management
  • Change Control
  • Internal Audit Process
  • Management Review
  • Training Management

Each SOP includes:

  • Visual process flows using BPMN
  • Clear responsibilities and roles
  • Links to required documentation and data
  • Background Information
  • Goal & Scope and so on

Docx SOP documents can also be auto-extracted using our smart logic. It intelligently identifies and organizes key elements, such as process flows, goals, and backgorund information. This seamless automation minimizes manual effort and ensures consistency across your SOPs. For more details SOP Document Extraction Module.

2. Work Instructions​

Detailed step-by-step guides that support SOPs. While SOPs define what needs to be done, Work Instructions explain how to do it.

Common Work Instructions include:

  • How to Conduct Design Reviews
  • Product Testing Procedures
  • Document Approval Steps
  • Supplier Evaluation Process
  • Equipment Calibration Steps

Workinstructions can be directly linked to a specific process steo inside an SOP.

3. Forms & Records​

Tools for collecting and maintaining quality records, which are required evidence of your quality system's operation.

Typical Forms include:

  • Complaint Records
  • CAPA Records
  • Training Records
  • Audit Findings
  • Nonconformity Reports

The QM Handbook: Your Quality System's Foundation​

At the heart of the QM module is the QM Handbook, which provides a structured way to organize your entire quality management system. This is where you'll maintain all your SOPs in a logical, audit-ready structure.

QM Handbook Overview The QM Handbook organizes your processes into Categories (like "Product Realization") and Sections (like "Design & Development"). This creates a clear hierarchy that matches regulatory requirements and your organization's structure.

Editing the Structure​

You can customize the handbook structure using the edit mode:

Edit QM Handbook Click the "Edit" button to modify your handbook structure. You can add, remove, or modify categories and their sections.

When editing sections within a category:

Edit Section 1. Remove existing sections using the delete button 2. Add new sections using the "Add Section" button Each section can contain SOPs relevant to that area.

Viewing Processes​

You can access your SOPs in two ways:

  1. Through the QM Handbook's structured view (recommended for audits)
  2. Via the complete process list (useful for quick access)

SOP Overview *The process list shows all SOPs in a category/section. From here you can:

  • View process details
  • Create new processes
  • Duplicate existing ones
  • Edit or delete processes as needed

Getting Started​

To begin implementing your quality system in CertHub:

  1. Customize Your Structure

    • Modify the default categories and sections to match your organization
    • Create categories that reflect your key business areas
    • Add sections that align with your team's workflows

  2. Start With a Familiar Process

    • Choose a process your team knows well, ideally one that generates product data
    • For example, start with your Design Control process which:
      • Creates technical documentation for a specific product
      • Involves multiple team members and approvals
      • Generates data that flows into your Technical Documentation

  3. Experience the QM-TechDoc Connection

    • See how process outputs automatically populate technical documents
    • Test the traceability between quality records and product documentation

The following chapters provide detailed guides for:

  • [Creating and Managing Processes](2. Modules Overview/1. QMS/managing-processes)
  • [Working with Forms and Records](2. Modules Overview/2. Product Module/managing-schemas)
Best Practice

Start with a process that creates product-specific data, like Design Control or Risk Management. This helps you understand how CertHub connects quality processes with technical documentation while working with familiar content.