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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.

A SYSTEM SHOULD NEVER LOOK LIKE THIS!!!!
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A system can function effectively as one 30 page document!