Quality Manual

What is a Quality Manual?

A quality manual is essentially the rulebook for how a company handles quality across everything it does. It's a high-level document that lays out an organization's quality management system, covering the quality policy, objectives, key processes, and the procedures that tie them all together.

For years, having an ISO 9001 quality manual was a must-have for certification. The manual describes the framework and guiding principles behind how an organization manages its quality management system processes. Now, with ISO 9001:2015, you're technically not required to have one as a standalone document anymore. That said, most organizations still keep one around because it works. It's probably still the most important piece of any modern quality management system, giving stakeholders like employees, customers, auditors, and regulators a clear picture of how quality gets managed.

Think of the quality manual as sitting at the top of your documentation pyramid. Rather than spelling out every procedure step by step, it points to more detailed work instructions, procedures, and forms like standard operating procedures and procedure manuals. You'll find information about the organization's administrative and technical operations, its strategic direction, goals, mission, and how it plans to keep customers happy by meeting their requirements consistently.

Key Characteristics of a Quality Manual

• Scope Definition: Spells out exactly what the quality management system covers, including which business activities, products, services, and processes fall within its boundaries, and notes any exclusions.
• Policy Framework: Lays out the organization's quality policy statement and objectives, showing management's commitment to quality and the strategic quality goals they're aiming for.
• Process Overview: Describes the main processes, how they connect, and how they line up with ISO 9001 requirements without getting into the nitty-gritty procedural details.
• Responsibility Structure: Maps out who's responsible for what when it comes to quality, often including org charts and clarifying who has authority over quality-related decisions.
• Reference Architecture: Points to all the supporting documentation, such as procedures, work instructions, forms, and records, where people can find the detailed how-to guidance.

Quality Manual Examples

Example 1: Manufacturing ISO 9001 Quality Manual

Consider a manufacturing company that makes precision components. Their quality manual defines a quality management system covering design, production, and delivery. It includes a quality policy committing to zero-defect manufacturing, defines the scope across all production facilities, and shows an org chart with quality responsibilities from the CEO down to production supervisors. The manual outlines seven core processes: customer requirements management, design control, supplier management, production control, inspection and testing, corrective action, and continual improvement. Each section references specific procedures and work instructions while staying at a high level, giving auditors a clear view of how the entire quality system fits together.

Example 2: Healthcare Quality Management Manual

A medical device company might maintain a quality manual that tackles both ISO 13485 requirements and FDA Quality System Regulation compliance. Their manual defines a quality policy centered on patient safety and regulatory compliance, scopes the QMS manual to cover design, manufacturing, and post-market surveillance of Class II devices, and maps each ISO requirement to internal processes. It explains how design controls protect patient safety, how production processes maintain sterility, and how complaint handling feeds into corrective and preventive actions. During regulatory inspections, this quality manual example gives inspectors a roadmap for understanding how the organization keeps products safe and up to quality standards.

Quality Manual vs Procedure Manual

Both document types are important, but they operate at very different levels of detail.

How Glitter AI Helps with Quality Manuals

Glitter AI makes it easier to create and maintain all the supporting documentation your quality manual references. The quality manual itself stays high-level, but it points to dozens of detailed procedures and work instructions that show how quality objectives actually get achieved on the ground. Glitter handles these supporting documents through screen recording that automatically generates visual, step-by-step procedures.

When your quality manual references specific procedures for process control, inspection methods, or corrective actions, Glitter keeps those referenced procedures accurate and current. The platform's automatic version control and audit trail fit naturally with quality management system requirements for document control. When quality objectives shift, you can quickly update the referenced procedures so your entire documentation structure stays audit-ready.