What is AS9120:2016/AS9120B?
Prepared by the International Aerospace Quality Group (IAQG), with representatives from aviation, space, and defense companies in the Americas, Asia/Pacific and Europe, AS9120:2016/AS9120B standardizes quality management system requirements. It can be used at all levels of the supply chain by organizations around the world to improve quality, cost, and delivery performance.
AS9120:2016 is intended for use by organizations that procure parts, materials, and assemblies and resell these products to a customer in the aviation, space, and defense industries. This includes organizations that procure products and split them into smaller quantities, including those that coordinate a customer or regulatory controlled process on the product. This standard is not intended for organizations that maintain or repair products, or for organizations that perform work that affect or could affect product characteristics or conformity.
This standard includes ISO 9001:2015 quality management system requirements and specifies additional aviation, space, and defense industry requirements, definitions and notes.
What’s new with AS9120:2016?
All of the AS9100 series of standards underwent significant change in late 2016. Though a number of those changes were necessitated by a change in the base standard, ISO 9001:2015, many of the aviation, space and defense industry requirements were also modified and enhanced. Following the structure of ISO 9001:2015, AS9120:2016 includes requirements specific to:
- Context of the organization
- Performance Evaluation
Within these sections of the AS9120:2016 standard, new requirements above and beyond those specified in the previous revision AS9120A address:
- Risk Based Thinking – The concept of risk has always been implicit in ISO 9001 but AS9120:2016 makes it more explicit and builds it into the whole management system. It ensures that risk is considered from the beginning and throughout and makes “prevention” part of strategic and operational planning.
- Clause 6.1 – is related to risks in the quality management system such as new customers, new market, company partnerships, business localizations etc.
- Concept of Change – Provides a framework which evolves to enable organizations to adapt to their changing environments or circumstances. The benefits of a robust process to control change are that business continuity is maintained and potential consequences of change are appropriately considered.
- Organizational Knowledge – Knowledge specific to the organization is gained by experience and conveyed through lessons, identification of experts and the implementation of succession planning. AS9120:2016 can help you safeguard the organization from loss of knowledge, (e.g., through staff turnover; failure to capture and share information) and encourages your organization to acquire (e.g., learning from experience, benchmarking) and share knowledge (e.g. mentoring of newcomers).
- Product Safety – including requirements to address product safety considerations throughout the product lifecycle.
- Counterfeit Parts Prevention – Provides requirements to mitigate the effects of the growing threat of counterfeit / fraudulent product while recognizing the emerging counterfeit/fraudulent statutory/regulatory requirements on AQMS processes.
- Awareness – AS9120:2016 now requires employees to be aware of their contribution to product or service conformity, to product safety and the importance of ethical behavior.
- Human Factors – Requires the consideration of human factors in the root cause analysis for nonconformities. To do that you must understand the interactions between people, machines and each other and their impact on human performance. Human factors could include physical fitness, physiological characteristics, personality, stress and fatigue to name just a few.
- Obsolescence – In the planning process, you must consider the consequences of product obsolescence.
- Project Management – Requires that you must plan and manage product and service provision in a structured and controlled manner including scheduled events performed in a planned sequence.
- Design and Development of Products and Services – AS9120:2016 now includes a requirement that an organization is to establish, implement, and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services. An organization can determine that this (and any other requirement) is not applicable if its decision will not result in failure to achieve conformity of products and services (see AS9120 4.3 and annex A A.5).