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Quality Assurance by D. H. Stamatis

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Basic OEM Quality System
Overview
In today’s world of globalization, OEMs must have some criteria for qual-
ity, capacity, delivery, and performance. Those criteria, depending on the
organization and product, do vary; however, all of them have four basic
characteristics and requirements. They are
1. Certication to ISO 9001 standard (ISO 2008)
2. Certication to ISO 14001 standard
3. Certication to industry standards, that is, ISO/TS 16949–automotive;
AS 9100–aerospace; and others
4. The organization’s own standards, that is, Ford Motor Company’s Q1
(Ford Motor Company 2013), Chrysler’s Pentastar, and GM’s Global
Quality
The rst three are generally the basic prerequisites of a supplier being cer-
tied in order for a customer to pursue doing business with a particular
supplier. In fact, for Ford Motor Company, unless the supplier is certied to
ISO/TS, it will not be qualied for the Q1 certication. (In special cases, this
requirement is waived; however, this is not common.) Let us examine these
four certications in a cursory approach.
International Industry- and Customer-Specific Standards
Certification to ISO 9001
This is a general and very basic standard dealing with overall quality in
any organization. The effectiveness of the standard in any organization
is based on third-party certication. The customer’s supplier engineer is
responsible for making sure that the third-party auditor is authorized by
14 Quality Assurance
the International Automotive Task Force (IATF) and validating the certi-
cate of the certication (date and scope). Specic follow-up may be required
if during the customer audit there are signicant deciencies in the sup-
plier’s quality system. The standard is made up of the following elements
(clauses):
1. Scope
2. Normative reference
3. Terms and denitions
4. Quality management system
5. Management responsibility
6. Resource management
7. Product realization
8. Measurement, analysis, and improvement
Annex A: Control Plan Requirements
What is important about these elements is that (1) items a–c are not certi-
able, (2) items d–h are certiable, (3) the annex is a guide to a control plan,
and (4) the certiable items include four specic words with specic mean-
ing. They are
“Shall” indicates a must requirement.
“Should” indicates a recommendation.
“Note” is a guideline for understanding.
“Such as” are examples given for guidance only.
In addition to these special words, the standard is revised (updated) every
5years and it is up to the user to keep up to date. The current standard is the
ISO 9001:9008; however, the draft for the ISO 9001:2015 is available and there
are some pending changes.
Part of this certication process to the ISO is the need for most organi-
zations to follow the ISO 14001 environmental standard as well. Both stan-
dards (ISO 9001 and ISO 14001)
Focus on the achievement of results.
Satisfy the needs, expectations, and requirements of the customer.
Facilitate planning and allocation of resources.
Evaluate the overall effectiveness of the organization (system,
not product). This is very important to differentiate and part of
the reason the industry standards were developed was to ll that
void.

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