If your project involves developing electronics for aviation, space or defence applications, you must comply with the AS 9100D quality management standard. The easiest way is to use suppliers that are already certified to that standard, as Circuitwise is for electronics manufacturing.
To understand your regulatory obligations, it is best to take a step back and examine quality management systems in general, as set out by the ISO 9001 standard.
Most people understand that quality management systems are about identifying and managing the processes used to deliver a product or service. These processes include planning actions, monitoring them, checking the results, and then continually improving the system.
ISO 9001 is broadly applicable in any industry and aims to deliver consistent quality. AS 9100D narrows this applicability to the needs of the aerospace industry.
For example, while both standards require risk management processes to address risks, AS 9100D has some more specific requirements relating to safety, performance, and airworthiness. A greater emphasis on human factors heightens the focus on training, competence, and situational awareness for all team members.
Similarly, AS 9100D emphasises the role of materials, processes and traceability of parts in delivering safety and requires much stricter controls over these. For electronic devices, this relates to the components and manufacturing processes.
In particular, aerospace applications demand that all parts used in a product be genuine, with processes to verify their authenticity. So, the standard requires stringent controls to prevent counterfeit parts from being used.
Similarly, the risk management process for aerospace applications places a much greater emphasis on any “special requirements” aerospace manufacturers may have, as they are usually very demanding and challenging to meet.
Particular attention must be paid to critical items that have a significant effect on the provision and use of the product, including the safety and performance of the device. Such critical items can include factors that affect the item's service life or the risk of fracture leading to failure of the item.
When products are being developed, there are usually several different iterations and prototypes before the product is finalised. For example, components may change from one version to the next, even after the product has been launched to the market. AS 9100D requires explicit configuration management controls to be in place, which the more general ISO 9001 does not.
Like its close cousin, the ISO 13485 quality management standard for medical devices, AS 9100D has very prescriptive requirements for documentation of all processes and retention of records. This can be as detailed as measurement data from suppliers (on parts) to operator witness marks on every single screw.
AS9100D rules out any reliance on trust or belief that something was done; it must be proven to have been done. This documentation will be scrutinised during audits and, in the worst case, investigations into a failure.
This is just a brief overview of what is a very detailed standard. For more information, view our Aerospace page or contact Circuitwise to understand how our quality management systems can help you comply with your AS 9100D obligations.
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