Upgrading from ISO 9001 to AS9100: Six Key Considerations for Manufacturers
by Sally Wilk, Owner
WCH Professional Services
Standards and Implementation Experts
For manufacturers currently certified to ISO 9001, upgrading to AS9100 is a crucial step to meet the Quality Management System requirements of the aerospace industry. AS9100 incorporates all of ISO 9001’s requirements, and introduces additional, more specific criteria related to the aerospace sector. Here are six key considerations for manufacturers preparing to make this transition:
- Understand the Added Aerospace-Specific Requirements and Perform a Formal Gap Analysis
AS9100 retains all ISO 9001 requirements and adds additional clauses that cater specifically to the aerospace industry. Manufacturers must familiarize themselves with these specialized requirements and assess the gaps between their current ISO 9001 Quality Management System and the new AS9100 standard. Conducting a Gap Analysis can help identify areas that require adjustments or enhancements to meet the aerospace-specific criteria. A Formal Gap Analysis, performed by a Qualified individual, provides a clear roadmap for necessary changes and helps ensure a smooth transition.
- Focus on Risk Management in Design and Development and Manufacturing
While ISO 9001 encourages a risk-based approach, AS9100 places a stronger emphasis on managing risks in the design and development phase. AS9100 requires manufacturers to address risks related to product life cycles, design changes, and unforeseen hazards. The ability to identify, assess, and mitigate risks during product design and manufacture is a key differentiator in AS9100, making it crucial for manufacturers to integrate these practices into their operations.
- Set Quality Objectives with On-Time Delivery in Mind
ISO 9001 requires quality objectives to be measurable and aligned with the quality policy. AS9100 explicitly mandates that on-time delivery (OTD) be a consideration in setting these objectives. This reflects the aerospace industry’s focus on reliability and schedule adherence, where delays can have cascading effects on production timelines and customer trust. To comply, organizations may need to review current quality objectives and integrate OTD as a key performance metric. It may be a good idea to update planning processes to ensure resources, workflows, and supplier coordination support this objective, and document how progress is monitored and reviewed.
- Emphasize Product Realization and Traceability
AS9100 demands enhanced traceability and control over products, especially when it comes to product conformity and verification. This includes the requirement for manufacturers to maintain precise records for the entire lifecycle of a product, from design to production and through post-delivery. Organizations may need to upgrade processes to include detailed documentation of product realization stages, including first article inspections (FAI) and traceability of materials and components. This level of traceability is vital in the aerospace industry to ensure that each component meets stringent safety standards and can be traced back to its origin.
- Strengthen Supplier Oversight with Flow-Down Requirements
AS9100 places significant emphasis on supply chain control, going beyond ISO 9001’s supplier management expectations. A key difference is the concept of “flow-down” requirements, where organizations must ensure that customer and regulatory specifications are passed down to suppliers and sub-tier suppliers. This includes detailed communication of technical, quality, and delivery requirements—such as compliance with aerospace standards (e.g., AS9100 itself or NADCAP), material certifications, or specific testing protocols.
- Train Internal Audit Team and Conduct Internal Audits
Transitioning to AS9100 requires staff awareness of the new requirements. Organizations will need to provide training to bridge knowledge gaps and ensure that Internal Auditors are qualified. Before seeking certification, organizations will need to conduct internal audits in accordance with AS9100 criteria and resolve any concerns that arise during the audit. This will help to ensure a successful external audit. Note that Internal Audits may also be performed by a qualified third party.
These are just some of the differences that need to be considered when ISO 9001 certified organizations plan to pursue AS9100 certification. For additional information, please contact MRC.
About the Author
Sally Wilk and her team of qualified WCH consultants partner with MRC to provide ISO training and consulting services in regulatory compliance, certification, and registration.
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