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THE KAVON RESOURCE CENTER

Detailed Standard Description

Name:

AS9100

Revision:
C
Title:
Quality Management Systems - Requirements for Aviation, Space and Defense Organizations
Release Date:
2009-01-15
Status:
ACTIVE
Description:
This International Standard specifies requirements for a quality management system where an organization:
  1. needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and


  2. aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.


NOTE 1 In this International Standard, the term "product" only applies to:
  1. product intended for, or required by, a customer,

  2. any intended output resulting from the product realization processes.
NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.

Cite SAE.org

Standard FAQ

Question
  Answer

Do you think that organizations, which implement an ISO Quality Management System, do it for the benefits that compliance brings, or is it only for certification?
 

In my experience, I have found that a number of companies & organizations go for ISO certification only because they have to or it is a customer requirement to do business. For medical device manufacturers in the US, FDA GMPs, harmonized with ISO, are mandatory. Top Managements usually look primarily at their bottom lines and see ISO as an expense, not a benefit. They may hire a QA or Engineering Manager to be responsible for ISO enforcement, documentation, and compliance - but primarily to keep the companies out of trouble with customers, government, and regulatory auditors. Only token management support is provided and when they're caught in a non-conformance situation or with a deficient product, they expect the assigned compliance person to get them out of trouble.


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