Designers looking for manufacturers with a quality management system (QMS) fit for aerospace manufacturing need look no further than AS9100. AS9100 broadly acts as an extension of ISO 9001; whereas ISO 9001 offers a general approach to QMS, AS9100 layers additional requirements unique to the aerospace industry. By definition, all AS9100 manufacturing fits the requirements for ISO 9001 manufacturing (but not vice versa). As with any standardization of QMS, an AS9100 manufacturer aims to streamline its processes by providing a framework for operations that enshrines customer service and highlights the structure necessary for organizations to continually grow their business in competitive markets.
| An AS9100 Manufacturer QMS At-a-Glance | |
|---|---|
| Clause | Summary |
| Organizational Context | The goals of an organization (including how it satisfies its customers) and the scope of its QMS. |
| Leadership | The responsibilities of leadership are to instill a robust QMS with a workplace culture where quality is the focus. |
| Planning | How organizations approach risk/opportunity and quality objectives used for standardizing operations. |
| Support | All equipment, training, etc., rendered to the workforce necessary to meet current and future quality benchmarks. |
| Operation | Organizations must fully control all aspects of internal processes and external inputs. |
| Performance and Evaluation | Feedback provides the basis for improvement; organizations must also catch nonconformity when it occurs and identify its root causes. |
| Improvement | Organizations must commit to continual improvements that drive innovation and efficiency. |
AS9100: Specializing QMS for Aerospace
As a descendant of ISO 9001, AS9100 operates under a few core tenets:
- Customer focus – Organizations cannot operate without customer patronage. Therefore, to maintain a healthy customer base, it’s necessary to meet customers’ current needs, anticipate future demands, and outperform expectations.
- Leadership – For any organization of sufficient size and complexity, a leadership group helps maintain the company’s vision and performance. Leaders need to provide sufficient structure and guidance to foster unity.
- Engagement – Ensure all levels of the organization have the tools and training necessary to excel.
- Process – It’s easier to pinpoint deviations and optimize outcomes by breaking down large systems into bite-sized instructions.
- Improvement – A dedication to improvement keeps the organization healthy by investing in itself.
- Decisions-by-Data – Using quantitative measurements supports organizations with the best possible path forward.
- Relationships – No organization is an island; businesses that cultivate and sustain these connections can leverage their reputation.
A Brief Overview of an AS9100 Manufacturer
A QMS standard lives and dies by its auditable facets; while the motivation for improvement is crucial, methods for independent, quantifiable success must be available. AS9100 contains seven auditable claims that provide concrete guidance for organizational implementation. Much like with ISO 9001, there is significant leeway for organizations to realize their path towards success, so long as they meet the outlined criteria:
- Organizational context
- Understanding the organization – Determine external and internal issues relevant to its strategic direction and overall purpose.
- Understanding third-party needs – Organizations have to craft their QMS to match the requirements of the industry’s customers.
- Scope of QMS – By carefully considering the boundaries and applicability of their QMS, organizations can streamline their approach while ensuring conformity with all relevant items of AS9100.
- QMS processes – Organizations need to implement all of the systems and ancillary support for the QMS (including documentation) to ensure processes are successful by AS9100.
- Leadership
- General – Leadership must be accountable for the QMS implementation and efficiency while aligning with the organization’s individual needs. A customer-focused approach is the intent of any leadership’s goals.
- Quality policy – The quality policy outlines the organization’s quality objectives, providing a basis for impartial measurements.
- Roles and responsibilities – All members of an organization must have clear guidance on their responsibilities and how it affects the larger enterprise. Members need the appropriate level of authority to establish their expertise.
- Planning
- Risks and opportunities – Organizations must determine, consider, and evaluate risks/opportunities with an appropriate action plan.
- Quality objectives – Mapping out benchmarks for success by evaluating process results.
- Changes—When the need to adapt the QMS arises due to evolving regulations or business pressures, a thorough approach ensures a seamless transition.
- Support
- Resources – An organization requires the synergy of a talented workforce with the necessary equipment for processes. The facilities/environment also play an outsized role in process outcomes; maintenance of these locales is essential.
- Competence – A knowledgeable workforce is an effective workforce. Education dictates the minimum level of information necessary to perform tasks and helps workers identify quality, nonconformance, etc., during processes.
- Awareness – All organization members should be aware of the relevant sections of the QMS that improve the quality of the processes they’re directly involved in.
- Communication – The QMS should indicate how to share information, what information to share, where information should go, etc.
- Documentation – Record-keeping of all changes to the QMS preserves repeatability in processes with traceability and version control.
- Operation
- Operation planning – Organizations must account for all factors impacting processes through a thorough analysis stage and necessary controls.
- Requirements – Organizations must offer clear customer communication while meeting the claims of the products/services offered.
- Design and development – An organization must establish, implement, and maintain a controlled process for creating new products and services.
- Controlling external inputs – Organizations must ensure that all externally sourced products and services conform to regulations and quality standards.
- Production and service – Organizations monitor and measure activities to track adherence to acceptance criteria. If problems occur after rendering services or product delivery, an organization takes appropriate action to rectify the situation.
- Performance evaluation
- Analysis – An organization must provide a detailed process for measuring quantifiable and qualifiable metrics, including when to take measurements.
- Internal audit – An organization must conduct regular, planned audits
- Management review – In concurrence with audit results, management must review the QMS to assure adherence and identify areas for improvement.
- Improvement
- General – Organizations must strive to implement system improvements to processes that produce meaningful results. Customer satisfaction should always be at the heart of improvement goals.
- Correcting nonconformity – Identifying nonconformity is the baseline for improvements; organizations must implement protocols to assess and respond to instances of nonconformity.
- Continuous improvement – An organization is responsible for improving its overall process effectiveness for the client’s benefit.
Your Contract Manufacturer’s Commitment to Quality
An AS9100 manufacturer indicates a commitment to quality, customer responsibility, and a desire to improve processes – all factors that make them highly attractive to potential product designers. Much like ISO 9001 (from which it inherits the bulk of its framework), AS9100 gives customers confidence that manufacturers will treat their design with the utmost care and attention to detail. VSE focuses on maintaining a top-of-the-line QMS for general and specific industry standards like AS9100 and ISO 13485. We’re a team of engineers committed to building electronics for our customers, including a dedication to manufacturing quality throughout our operations. We’ve been realizing life-saving and life-changing designs for over forty years with our manufacturing partners.
