AS9100 quality management. As the aerospace and defense industries evolve, the standards that govern quality management systems must adapt. The AS9100:2016 (also known as 9100:2016) revision represents one of the most significant updates to the standard, reflecting modern challenges in quality, risk, and operational complexity. Below, we address the most frequently asked questions related to the 9100:2016 series to help organizations understand, implement, and maintain compliance effectively.
Why Was 9100:2016 Introduced?
Business conditions have changed drastically since ISO 9001’s last major revision in 2000. With increased customer expectations, technological advances, complex global supply chains, and a focus on sustainability, a more robust and flexible standard was needed. AS9100:2016 incorporates these new realities while remaining accessible for both small and large organizations.
What’s Changed in the Structure and Language?
The standard now follows the ISO Annex SL structure—ten clauses built on the Plan-Do-Check-Act (PDCA) cycle—streamlining integration with other ISO standards. Key differences include:
- Emphasis on risk-based thinking.
- Greater flexibility in documentation.
- Applicability to both product and service-based organizations.
- A shift from mandatory quality manuals to more tailored documented information.
Do We Still Need a Quality Manual?
While no longer a mandatory requirement under AS9100:2016, quality manuals remain a valuable tool for many organizations. The revised standard removes the explicit obligation to maintain a traditional quality manual, instead focusing on the need for documented information that supports the operation and control of processes.
However, Clause 4.4.2 acknowledges that many companies still benefit from a consolidated document that outlines their quality management system (QMS). Organizations are permitted to retain a quality manual if it suits their operational structure, simplifies internal training, or fulfills contractual or customer requirements.
In practice, many aerospace and defense contractors continue to use quality manuals to:
- Present a high-level overview of their QMS for internal and external audiences
- Map standard clauses to internal processes
- Provide clear guidance to employees and auditors
- Satisfy customer flow-downs or regulatory expectations
Ultimately, the choice to maintain a quality manual is strategic. If it adds clarity, improves communication, or helps demonstrate compliance during audits, it remains a useful and accepted document within the framework of 9100:2016.
What Is Risk-Based Thinking?
Risk-based thinking is one of the most significant shifts introduced in the AS9100:2016 revision. Unlike traditional risk management—often treated as a standalone activity—risk-based thinking is meant to be embedded throughout the entire quality management system (QMS). It moves risk awareness from a periodic assessment to a continuous mindset applied across all planning, operations, and decision-making processes.
This approach encourages organizations to identify, evaluate, and respond to risks and opportunities at every stage of their workflows, from design and procurement to production and service delivery. The intent is not just to protect against potential failures, but to build resilience, strengthen processes, and drive continual improvement.
While formal risk management tools like Failure Mode and Effects Analysis (FMEA), Fault Tree Analysis (FTA), or risk matrices can support this mindset, they are not required under the standard. What matters is that risk-based thinking is demonstrated through proactive measures—such as:
- Considering risk when setting objectives or changes to processes
- Prioritizing preventive actions in planning and resourcing
- Using historical data and trend analysis to avoid recurring issues
- Involving leadership and frontline staff in identifying potential disruptions
In high-stakes industries like aerospace and defense, where even minor nonconformities can have serious consequences, risk-based thinking helps ensure that safety, performance, and customer satisfaction are maintained at the highest levels.
Auditors will look for evidence that risk is not only assessed but actively managed as part of everyday operations—making it a foundational element of both compliance and long-term business success under AS9100:2016.
How Should We Handle Documentation?
Documents and records are now collectively referred to as “documented information.” Organizations must:
- Maintain current, controlled information for processes.
- Retain records as evidence of conformity.
The required level of detail depends on organizational complexity and regulatory needs.
Is Management Review Still Required?
Yes, but it’s now placed under “Performance Evaluation” (Clause 9.3) to better align with the PDCA model. This change emphasizes using objective data to evaluate QMS performance before management reviews it.
Why the Shift from “Product” to “Product and Service”?
AS9100 now explicitly includes “service” to reflect its broader application beyond manufacturing. This wording reinforces the standard’s relevance to maintenance providers, testing labs, design firms, and other service-based businesses.
What Are the Benefits of 9100:2016?
- Enhanced focus on outcomes rather than procedures.
- Improved integration with environmental, health & safety, and business continuity systems.
- Better applicability for service and knowledge-based industries.
- Reinforced leadership accountability.
- Streamlined documentation requirements.
- More structured approach to risk and opportunity management.
Common Clause-Specific Questions
Context of the Organization (Clause 4)
Organizations must consider both internal and external factors—like political, regulatory, technological, and cultural environments—when defining their QMS. Understanding this context ensures better alignment with strategic goals.
Interested Parties (Clause 4.2)
Companies must identify relevant stakeholders and their requirements, including customers, regulators, and suppliers, as they relate to the QMS.
Human Factors (Clauses 7.1.4, 8.5.1g, 10.2.1.b.2)
The standard emphasizes work environments that reduce stress and errors. This includes mistake-proofing tools (Poka-Yoke) and addressing human behavior in root cause analysis.
Organizational Knowledge (Clause 7.1.6)
Knowledge management is essential. Organizations must capture and share critical knowledge—such as lessons learned, task instructions, and expert insights—to prevent loss and maintain operational excellence.
Key Implementation Areas
Product Safety (Clause 8.1.3)
Every organization must understand how their products are used and the safety implications of failure—even raw material providers. Managing critical items, ensuring engineering compliance, and fostering a culture of accountability are essential.
Counterfeit Part Prevention (Clause 8.1.4)
Requirements include traceability, verification testing, obsolescence monitoring, and training to detect and avoid counterfeit components.
Control of External Providers (Clause 8.4)
Purchasing has been reframed to include any externally provided processes, products, or services, including those from corporate affiliates or third-party volunteers.
Post-Delivery and Service Support
Clause 8.5.5 clarifies that organizations may be responsible for their products post-delivery. This could involve technical support, maintenance, or product recalls, depending on agreements or regulations.
Performance vs. Effectiveness vs. Efficiency
- Performance refers to how well a process produces its intended results.
- Effectiveness measures the achievement of planned objectives.
- Efficiency evaluates the optimal use of resources.
These metrics are central to improving and demonstrating the value of the QMS.
Transition Period and Global Alignment
AS9100:2016 aligned its transition period with ISO 9001:2015, ensuring organizations wouldn’t need to undergo separate transitions or audits. This decision helped streamline certification and compliance efforts across sectors.
Final Thoughts
The 9100:2016 revision isn’t just a compliance requirement—it’s an opportunity to strengthen quality, leadership, and risk resilience across the aerospace and defense supply chain. By focusing on real-world business challenges and flexible application, the standard encourages smarter systems and more sustainable growth.
If your organization is preparing for the AS9100D certification, already certified, or simply reviewing best practices, understanding these FAQs is a critical step toward long-term success.
Ronnie Lee Roberts II has worked in the Department of Defense (DoD) quality space since 2017, supporting programs at Patuxent River and Webster Field (NAWCAD/NAVAIR). He has worked as a certified AS9100:2016 Rev D Lead Auditor (2022-2025), ISO/IEC 20000-1:2018 Lead Auditor (TPECS [2023]), and a Certified CMMI® Associate (2025) with experience supporting CMMI-DEV Level 3 environments. His expertise spans technical writing, document control, CAD design, logistics management, and quality control. Ronnie specializes in inspecting to specification, ensuring contract compliance, and preparing teams for success in high-stakes, audit-ready environments.