Internal audits (a requirement of the AS9100 Rev D Standard) are intended to verify the compliance and effectiveness of the organization's quality management system. Internal auditors must be knowledgeable of these requirements and the expectations as identified in the standard. In addition, the audit requirements outlined in the AS9101 Standard have significantly changed the way auditors are expected to conduct audits in the aviation, space and defense industries.
Individuals responsible for quality management system, implementation, and auditing to the AS9100:2016 series of standards for Aviation, Space, and Defense will require an understanding of the requirements for the preparation and execution of the audit process as defined in these revised standards. Management and implementers of AS9100:2016 Rev. D within these organizations must also be aware of what these requirements mean for their company.
This one-day program is designed to provide introductory information for those organizations who are considering transitioning from the Aeronautic, Space and Defense industry to the Food & Drug Administration (FDA), Medical Device Manufacturing market. Reviewing essential information necessary to understand and successfully begin the journey to FDA Medical Device approval, this course will examine many of the controls between the AS9100 Standard and FDA Regulations and identify the similarities.
This Engineering Bulletin and its annexes provide guidance on the application of Human Engineering principles and practices to the analysis, design, development, testing, fielding, support, accident investigation, and training for military and commercial products throughout their intended life cycles.
This document recommends standard gland design criteria and dimensions for dynamic radial O-ring seal applications specifically for engine and engine control systems operating at pressures up to a maximum of 1500 psi (10342.14 kPa) and provides recommendations for modifying these glands in special applications. There are no provisions in this document for anti-extrusion devices. NOTE: The criteria set forth here are similar to but not identical with those in MIL-G-5514 and AS4716. This document is not intended to replace MIL-G-5514 or AS4716 for hydraulic applications.
Evolving to MedDev provides a new opportunity for executives in aerospace, automotive and medical devices companies to connect and develop long-term growth strategies and find ways to meet the increased short-term demand for medical supplies