Specifications that Del Straight has Expertise
in Designing and Implementing
ISO 9001:2015
The latest version of the standard and most beneficial. Because it is a risk based system,
your system is customized based on your businesses unique risks. Low risk requires less control and High Risk requires
more control, etc.
AS 9100 Rev D
The
latest version of the standard incorporates the requirements of ISO 9001:2015 and add some new requirements relevant to the
Aerospace Industry. It expands on risk assessment requirements. As well as being more specific about FOD and Counterfeit
Parts. In addition, many of the requirements of ISO 9001:2015 have been enhanced and require tougher enforcement.
IATF 16949
The ISO/TS 16949 specification
is being replaced with IATF 16949. The Auto Industry is taking control of there own standard. It does still incorporate
the requirements of ISO 9001:2015. It adds requirements and incorporates common customer specific requirements, as well.
This standard contains quite a bit of non-value added content. Unless you are making parts that will become part of
a vehicle, you should consider ISO 9001:2015 which is still acceptable to many tier one and tier two customers.
ISO 13485:2016
Incorporates the requirements of ISO 9001:2015
and adds requirements relevant to medical devices.
ISO 17025
Basic requirements for the operation of a laboratory.
ITAR
Requirements for securing a facility involved in sensitive or proprietary
product development or processing such a product for a customer’s proprietary or sensitive product.
CFR
This is the designation for specific government regulated products. There are a variety of CFR numbers depending on the type of product involved. These requirements are used by agencies like the Food and Drug Administration and the Nuclear Regulatory Agency.