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ISO 9001 & ISO/TS 16949

4.0 Quality Management System
5.0 Management Responsibility
6.0 Resource Management
7.0 Product Realization
8.0 Measurement Analysis Improvement































 

 

 

 

ISO 9001:2000 and ISO/TS 16949:2002
Description of 4.0 Quality Management System

Description
ISO 9001:2000 specifies the requirements for a quality management system where an organization:

  • Needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and

  • 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 regulatory requirements.

The standard recognizes that the word "product" applies to services, processed material, hardware and software intended for, or required by your customer.

Subclauses
4.1 General Requirements
4.2 Documentation Requirements

EwQMS® Modules
Below are the Enterprise-wide Quality Management System® modules which address this clause of the standard:

Process Pro - building the process model, review of process metrics and managing process variation. 4.1, 4.2
Document Pro - document management. 4.2

News Headlines
FMEA 4th Edition is Coming! Are You Ready? Omnex Is!
AIAG will be rolling out the 4th Edition FMEA Reference Manual on July 22, 2008. To help you get up-to-date with the changes made in the latest revision, Omnex has scheduled a webinar on August 5, 2008 1pm-4pm EDT. Click here for more information. A recording of this webinar and/or a hardcopy of the presentation material will be available for purchase if you cannot attend this online session.

All our FMEA-related courses such as Manufacturing Process Development using PFMEA, APQP & DFMEA including Robust Design Linkages, FMEA/Control Plan including Robust Design Linkages and Advanced Product Quality Planning also incorporate the FMEA 4th Edition. See our Training Offerings and Training Schedule for more information.

Spring 2008 Navigator Newsletter
With features on QMS conformance vs. sustainability, the new release of OHSAS 18001, using the d-two-star table in statistics, and auditing the process focus.

Multimedia Overview
EwQMS® Multimedia Overview

Training & Consulting
Omnex Training & Consulting

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