If you’re a small or medium-sized manufacturer (SMM) working in the aviation, aerospace, or defense industry — or if you’re planning on breaking into this sector — it can be difficult to achieve a comprehensive understanding of the regulatory standards that govern this niche.
This is especially true for the AS9100 Standard, a particularly stringent certification that, while not required for all SMMs in the space, can provide significant advantages to industry players.
This blog will serve as a general overview of AS9100. We’ll explore the standard, the quality management system (QMS) manufacturers will have to build, the benefits of certification, basic steps in the certification process, and more.
What is AS9100?
So, what is AS9100? AS9100 — also known as AS9100D, the most recent update to AS9100 from 2016 — is a unique, rigorous set of standards that govern some aerospace, aviation, and defense manufacturers.
The International Aerospace Quality Group (IAQG), along with industry representatives from around the world, developed the standard for a variety of reasons:
- To standardize quality and QMSs in the industry
- To encourage safe development, production, and sale of parts
- To improve overall quality and optimize manufacturers’ costs
AS9100 expands upon the principles of another, more general certification — ISO9001.
ISO9001 provides QMS standards, encourages continuous improvement and optimization, and prioritizes the process approach — but, any industry can seek certification. AS9100, on the other hand, is only applicable for aerospace, aviation, and defense manufacturers.
What is a Quality Management System (QMS)?
Manufacturers don’t have to be AS9100 certified to implement a Quality Management System. Regardless of industry or niche, manufacturers of all sizes can benefit from a sound QMS.
At its core, a QMS is a formalized system with two major purposes:
- To improve the overall efficiency and effectiveness of production processes
- To ensure regulatory compliance and customer satisfaction
In addition, a QMS features two significant components:
- The documents that govern procedures, oversight, internal auditing, and overall quality control efforts (similar to standard operating procedures, or SOPs)
- The actual processes that those documents describe — day-to-day, operational activities that promote quality production
A QMS is a significant component of the AS9100 certification, and manufacturers that pursue accreditation must create, maintain, and enforce a QMS that meets regulatory requirements.
More broadly, a QMS can be a part of a company’s general quality assurance strategy.
Who is AS9100 For?
As noted above, AS9100 required procedures only apply to three general industries — aviation, aerospace, and defense. Within these, various companies can pursue certification, including:
- Manufacturers of parts, software, or materials
- Aerospace, aviation, and defense product or component designers
- Third-party quality management organizations that help companies maintain a QMS
However, you can apply for the certification even if your company doesn’t exclusively supply or work within or adjacent to these industries. For instance, if you manufacture sheet metal that is used in both aviation and automotive industries, you can seek AS9100 accreditation that governs your aviation-related operations.
Is AS9100 Required By Law?
AS9100 certification isn’t a legal requirement for manufacturers, designers, or other industry players, but it can provide a bevy of business benefits for companies that will be discussed later.
An AS9100 certification gives companies increased access to major players in the aerospace, aviation, and defense industries — many large-scale or high-visibility original equipment manufacturers (OEMs) exclusively pursue suppliers with the certification. Others may prefer or prioritize contracts with AS9100 certified manufacturers. So, a manufacturer could pursue certification to access more robust supply chains and larger-scale customers.
As for the companies that don’t seek certification, they can still use the AS9100 framework to improve or build their QMS, quality assurance program, or both.
What Major Components Inform AS9100?
AS9100 standards are quite comprehensive, touching every element of production and distribution – internal and external. Let’s explore some of the major criteria certified companies must meet:
- Risk-Based Thinking: A new addition to the standards, risk-based thinking is more than risk management. It describes a day-one approach to mitigation where every step of the manufacturing process prioritizes reducing, responding to, and planning for risks.
- Management Review: Management review is one of AS9100’s components of performance evaluation. Upper-level company leaders must review QMS effectiveness routinely, making changes when necessary and transparently reporting shortcomings.
- Organization Context: Organizational context describes the entire organization’s understanding of the issues, risks, strengths, and shortcomings of their operations. Auditors seek company-wide understanding, from low-level employees to executives.
- Training and Organizational Knowledge: AS9100 stipulates that an organization’s employees should be trained in a standardized fashion that prioritizes QMS knowledge. In addition, it recommends that organizations train all staff involved in AS9100 implementation and maintenance.
- Product Safety: Clause 8.1.3 defines product safety as “the state in which a product can perform its designed or intended purpose without causing an unacceptable risk of harm to persons or damage to property.” Organizations must identify safety concerns that impact the entire lifecycle of a product, reporting and addressing any issues.
- Counterfeit Parts Prevention: As counterfeiting continues to impact the industry, AS9100 describes various methods and training to prevent the exchange (purposeful or otherwise) of imitation goods. The certification stipulates controls for acquisition, traceability of parts, verification methods, and training.
- Configuration Management: This standard requires that companies monitor the form, fit, and function of the products they make or design. It describes configuration auditing procedures, the creation of tolerances, and systems to address high-impact items.
- Awareness and Ethics Training: In 2016, the IAQG added a new metric — awareness. It requires that organizations and their staff remain aware of their contribution to individual and industry-wide systems and their company’s ethical practices.
- Supplier Monitoring: AS9100 requires that companies track both the quality of their suppliers’ products and the timely delivery of their orders. Certified companies are encouraged to inform their suppliers of improved QMS features to ensure high-quality materials exchange.
- Communication: Communication is a key element of AS9100 standards. Accredited companies must create, maintain, and audit their communication processes and the efficacy of any third-party tools. Communication flows should be modified if companies discover inefficiency or risks in their current systems.
- Human Factors: AS9100 requires that companies understand how humans, their relationship to machinery, their interactions, and their workplace experiences impact the QMS and product output as a whole. For instance, companies must be aware of circumstances that impact morale and take steps to mitigate human-related risks.
This is only a basic overview of AS9100 requirements — the framework is robust, and companies should carefully review the entire rubric before seeking accreditation.
How Does AS9100 Affect SMMs Specifically?
SMMs face unique challenges with AS9100 implementation, auditing, and compliance. In particular, the following elements common to most SMMs have the biggest impact on their ability to fully function within the system:
- Reduced Scale: Your business simply may not be big enough to manage AS9100 requirements. The standards demand a sizable, high-quality workforce, enhanced quality assurance infrastructure, and available time to prioritize compliance.
- Insufficient Cash Flow: While implementing AS9100 procedures can improve a company’s efficiency — improving the bottom line — it takes time and resources to reach the maintenance phase. Early time and financial investments can present a significant up-front cost that smaller manufacturers may not be ready to pay.
However, achieving AS9100 certification is an impressive feat that likely won’t go unnoticed by your industry or potential customers. The competitive advantage carries significant weight for smaller companies, arguably providing more benefits than it does for their larger counterparts.
What Are the Benefits of Being an AS9100 Certified Manufacturer?
AS9100 certification can provide the following key advantages to manufacturers large and small:
- Recognition and global brand awareness potential
- Improved customer satisfaction
- Reduced operating costs as a result of improved efficiency and reduced risks
- Access to larger OEMs and their contract opportunities
- Heightened stakeholder relationships within a company’s structure
- Ability to secure more contracts and win additional business
- Proven, verifiable quality and service credentials
As mentioned above, some OEMs exclusively work with AS9100 certified suppliers and manufacturers. So, when your business achieves accreditation, you’ll automatically increase your business opportunities, potentially resulting in increased profits and company growth.
How Can SMMs Become AS9100 Certified?
AS9100 certification requires three major steps:
- Contacting a Certification Body: The standards are written by the IAQG, but third-party certification bodies perform the application reviews, audits, and acceptance or rejection. Thus, the first step to accreditation is securing a body to complete the process.
- Completing Assessments: The accreditation process takes time. Companies must complete two mandatory preliminary visits and a two-stage Initial Certification Audit. We’ll discuss this in more detail in the next section.
- Awaiting a Decision from the Certification Body: After the audits are complete, your certification body will review their findings to determine whether or not your company is eligible for certification.
Plus, once the process is complete, companies must maintain their certification via yearly surveillance audits and a recertification audit after three years have elapsed.
What is an AS9100 Gap Analysis?
In the previous section, we noted a major step in the certification process — audits. An AS9100 gap analysis is one of these audits — a preliminary assessment of your compliance readiness.
As you complete this stage, you’ll explore three major elements:
- Your company’s current standing
- Your specific AS9100 certification goals
- The steps you need to take in order to ensure eligibility
For instance, in your preliminary AS9100 audit, you might discover that your training program doesn’t address risks as thoroughly as the certification requires. This would indicate that you’re not ready to become fully certified. As such, you’ll have to create a plan for implementing increased training initiatives, ensuring that they’re in place before your final audit is complete.
How Can a Manufacturing Consultant Help SMMs Achieve AS9100 Certification?
Especially for small companies, securing an AS9100 certification can be a daunting task. The requirements are substantial, and they demand careful review for adequate implementation.
In addition, many SMMs may not have completed as robust a certification as AS9100 before — thus, their lack of prior experience with accreditations at large could put them at a disadvantage. Executing implementations and assessments takes significant time. Your company might not currently have the bandwidth or staff to spare for significant procedure overhauls.
To improve their chances for success, SMMs should strongly consider working with a manufacturing consultant. These consultants typically perform two major functions:
- They generally develop and help to implement efficiency, safety, and quality improvements.
- They help manufacturers secure the certifications that will improve their business prospects.
Consultants are experts on the certification process, and their experience with accreditation — especially for AS9100 — is invaluable.
CMTC: Helping California Manufacturers Grow in a Compliance-Focused World
AS9100 certification is no small feat — companies must carefully review the requirements, create a plan of attack for widespread structural and procedural changes, and keep up with annual reviews and changes to the requirements.
If your business is ready to pursue certification — or simply improve your overall workflow — it’s time to consult the experts. CMTC is your go-to organization for manufacturing support, bolstering your manufacturing operation with three decades of industry experience. We help California manufacturers with all elements of AS9100 implementation and certification.
Contact us today to streamline your compliance.
About the Author
Gregg Profozich is a manufacturing, operations and technology executive who believes that manufacturing is the key creator of wealth in the economy and that a strong manufacturing sector is critical to our nation’s prosperity and security now, and for future generations. Across his 20-year plus career in manufacturing, operations and technology consulting, Mr. Profozich helped manufacturing companies from the Fortune 500 to the small, independents significantly improve their productivity and competitiveness.