The ISO 9001 quality manual was once the flagship document of a quality management system (QMS). Under ISO 9001:2008 and earlier editions, organizations were required to maintain a documented quality manual outlining their quality policy, scope, processes, and the interaction between those processes. This made it a central reference for auditors and stakeholders alike.
However, with the transition to ISO 9001:2015, the standard dropped the explicit requirement for a quality manual. This has led many organizations to ask, “Do we still need a quality manual?” The answer, like much in systems thinking, is: it depends.
Let’s explore what a quality manual is today, whether it’s still necessary, and how you can build or update one that adds value—not just shelf weight—to your management system.
Understanding the Quality Manual in Modern QMS
While ISO 9001:2015 no longer mandates a quality manual, many organizations continue to maintain one voluntarily. Why? Because when done right, the quality manual becomes more than a compliance artifact—it becomes a useful communication tool, a reference document, and even a training aid.
What is a Quality Manual?
A quality manual is a high-level document that outlines an organization’s commitment to quality and its approach to meeting ISO 9001 requirements. Traditionally, it served three primary purposes:
1. State the scope of the QMS
2. Describe the interaction of the processes
3. Reference documented procedures and responsibilities
Common Components of a Quality Manual:
a. Introduction and scope
b. Quality policy and objectives
c. Organizational context
d. Process overview and interactions (often with flow diagrams)
e. Roles and responsibilities
f. References to documented information and procedures
For organizations new to ISO 9001, a quality manual can serve as a roadmap, offering structure and clarity. For mature systems, it provides continuity and serves as a training tool for new personnel.
Is It Still Required Under ISO 9001:2015?
Here’s the straightforward answer: No, the ISO 9001:2015 standard does not require a quality manual.
Clause 7.5 of ISO 9001:2015 requires “documented information necessary for the effectiveness of the QMS,” but leaves it up to the organization to decide the form and structure.
That said, the Annex SL harmonized structure introduced in ISO 9001:2015 offers flexibility. Organizations can integrate quality management requirements with other management system standards (e.g., ISO 14001 or ISO 45001). In such integrated systems, a quality manual—or an “Integrated Management System Manual”—can be invaluable for mapping requirements and demonstrating conformance.
At QMII, we often advise clients to retain a quality manual where it supports understanding, onboarding, and consistency across teams. But we also help them tailor it so it reflects their unique processes and adds value. For the quality manual should not be a direct re-write of the standard.
Pros and Cons of Maintaining a Quality Manual
Benefits
- Clarity and Consistency: A well-written manual helps connect the dots among the various processes and departments of the system.
- Training Aid: New employees can use the manual to understand what the organization does, how it does it and their role in it.
- Auditor Friendly: While not mandatory, many auditors still appreciate the manual as a starting point during audits. It helps outline the connection between the sections of the standard and the organization’s system.
- Customer Confidence: Some customers may request a copy as part of their supplier qualification process.
- Foundation for Integrated Systems: A single manual can describe compliance with multiple standards.
Limitations
Outdated Information: Without regular updates, the manual can become obsolete and misleading.
Perceived Bureaucracy: If viewed as a “tick-box” document, the manual adds no real value and becomes a burden.
Duplication of Information: Poorly designed manuals may repeat content already available elsewhere in procedures or work instructions.
The key is to strike a balance—keep it concise, relevant, and aligned with the organization’s operations. See this short video.
How to Create or Update a Quality Manual
Whether you’re creating a manual from scratch or updating one from the ISO 9001:2008 era, here’s a practical step-by-step approach:
Define the Purpose: Decide whether the manual will be a simple summary document or an integrated system manual.
- Define the Purpose: Decide whether the manual will be a simple summary document or an integrated system manual.
- Establish the Scope: Clearly define the boundaries of your QMS, including exclusions (e.g., design and development).
- Include the Quality Policy: Ensure the policy aligns with the organization’s strategic direction.
- Map Key Processes: Include a high-level process map showing interactions.
- Reference Documented Information: Don’t duplicate procedures; link to them instead.
- Identify Roles and Responsibilities: Describe who is accountable for maintaining the system.
- Keep it Lean: Use visual aids like diagrams or tables where possible.
- Review and Approve: Treat the manual as controlled documented information.
A simple spreadsheet matrix or Word document may suffice for smaller organizations, while larger enterprises may choose a digital format integrated with document control systems.
Real-World Examples of Effective Manuals
Let’s look at a few brief industry-specific examples to illustrate how the quality manual can be used effectively:
Aerospace Supplier
Here, the manual serves to map ISO 9001 and AS9100 requirements, helping the organization demonstrate alignment with customer-specific quality clauses. It includes a matrix showing clause-to-process linkages.
Small Manufacturing Firm
In this case, the manual is a 12-page document summarizing policies, objectives, and key processes. It references existing procedures and work instructions without duplicating them. Management uses it for quarterly QMS reviews and internal audits.
Each of these manuals reflects the organization’s context and needs. None of them are bloated. All of them are used—not just filed away.
Conclusion
So, do you still need a quality manual under ISO 9001:2015? Technically, no. Practically? Often, yes—when it adds value. The ISO 9001 quality manual can be an effective tool for system navigation, training, integration, and audit readiness. But only if it’s tailored to your organization’s reality.
At QMII, we help our clients build quality manuals that aren’t just compliant—they’re strategic, dynamic, and useful. If your manual is written to the clauses of the ISO 9001 standard and does not reflect the way you work, now is the time to reassess and revitalize it.
Need help creating or improving your quality manual? Reach out to QMII today and build a system that works for you—not the other way around.
