Process development for new products and customers are essential for the Automotive companies, emphasizing defect prevention, reduction of variation and waste (Lean). This paper presents an approach for using ISO/TS 16949 Quality Management System – Particular requirements for application of ISO9001 for automotive production and service part organizations to achieve this goal

1. Leadership through Technical Specification ISO/TS 16949:2002
Carlos E. DaSilva, Roger Carl, and Tom Rooke
MSBU, LOWELL, MA
Abstract — Process development for new products and The ISO (from Greek isos, meaning "equal") is a
customers are essential for the Automotive Sensors and network of the national standards institutes of 147
Telematics Product Group growth, emphasizing defect countries. Through worldwide acceptance and use, the
prevention, reduction of variation and waste (Lean). This
paper presents an approach for using ISO/TS 16949:2002
ISO 9000 family of standards provides an effective
Quality Management System – Particular requirements for means for improving the performance of individual
application of ISO9001: 2000 for automotive production organizations and providing confidence to people and
and service part organizations to achieve this goal organizations that products will meet their expectations
thereby enhancing trade, global prosperity and individual
I. INTRODUCTION well-being.
The Automotive Sensors and Telematics Group will
The telematic and sensor applications for the be applying the ISO/TS 16949:2002 to our Quality
automotive market are increasing worldwide, and the Management System, which was jointly developed by the
new age for the Intelligent Transportation Systems (ITS) International Automotive Task Force (IATF) and the
is only beginning. Japan Automobile Manufacturers Association (JAMA)
The automotive companies (OEM’s) are continually members and submitted to the ISO/TC 176 for approval
implementing techniques throughout the supply chain, and publication. This document provides a common
related to defect prevention and the reduction of variation automotive quality system requirements catalog based on
and waste, like Lean Manufacturing (from Toyota ISO 9001:2000, AVSQ 94 (Italian), EAQF 94 (French),
Production System) and QS 9000 (Ford, GM and QS-9000 (U.S.) and VDA6.1 (German) automotive
Daimler-Chrysler) [1] standards. ISO/TS 16949:2002, coupled with customer-
The International Organization for Standardization specific requirements defines quality system
(ISO) created ISO/TS 16949:1999, as a technical requirements for use in the automotive supply chain, also
specification that reflects some of the aspects listed with the Lean thinking by eliminating waste through
above and offers different technical solutions, provided fundamental process improvements .
that they do not conflict with existing international
standards (ISO9001). The new ISO/TS 16949:2002
revision offers a process–based quality management
system, as related to automotive production, including III. THE CUSTOMER ORIENTED PROCESS
opportunities for improvement and leadership in the We are currently certified to QS9000:1998, 20
competitive and global market. elements, without the “new” process-based approach, and
now do we need to rethink all of our quality management
II. A SILENT REVOLUTION system?
When we look back, the industrial revolution increased TABLE I
a “particular” behavior in western society, the Cartesian SEVEN MANDATORY PROCEDURES ISO/TS 16949
view, which by the way, all of us have been explicitly or 4.2.3 CONTROL OF DOCUMENTS
implicitly trained in, and has dominated the belief that 4.2.4 CONTROL OF RECORDS
there is a clear separation between mind and body; 6.2.2.2 TRAINING
between the thinkers and the doers; between management
and the employees; between product and processes. 8.2.2 INTERNAL AUDIT
Now, the approach is the integration of these systems, 8.3 CONTROL OF NONCONFORMING PRODUCT
a Holist view [2] that has started changes for society and 8.5.2 CORRECTIVE ACTION
companies around the world. This process should be
8.5.3 PREVENTIVE ACTION
painless, when we can understand how to manage this
transition and how to apply the right tools.

2. The answer is “no”. We are also ISO9001:2000 continually improve performance while addressing the
certified, which encouraged us to implement the needs of all interested parties. Managing an organization
external/internal customer oriented process, with less encompasses quality management amongst the other Key
focus on documentation and more focus on fulfilling a Management disciplines (Top Management, People/Plant
customer requirement. To implement the ISO/TS Resources, Sales and Marketing, Engineering,
16949:2002, there are seven mandatory procedures or Purchasing, Operations/Manufacturing and Quality).
process’ (see table I), that require implementation. These A process based Quality Management System looks at
include the identification of all business processes (not “all” the business disciplines and also, the eight
just production, support functions must be included), a principles [3] that form the basis for standards within the
clear understanding of the organization, and to lead and ISO9001:2000 and ISO/TS 16949:2002 (see table II).
operate an organization successfully, it is necessary to
direct and control it in a systematic and transparent
manner. Market leadership can result from implementing
and maintaining a management system that is designed to
TABLE II
EIGHT QUALITY MANAGEMENT PRINCIPLES
PRINCIPLE KEY BENEFITS
• Increased effectiveness in the use of the organization's resources to
Customer focus enhance customer satisfaction.
• Improved customer loyalty leading to repeat business.
• People will understand and be motivated towards the organization's goals
and objectives.
Leadership
• Activities are evaluated, aligned and implemented in a unified way.
• Miscommunication between levels of an organization will be minimized.
• Motivated, committed and involved people within the organization.
• Innovation and creativity in furthering the organization's objectives.
Involvement of people
• People being accountable for their own performance.
• People eager to participate in and contribute to continual improvement.
• Lower costs and shorter cycle times through effective use of resources.
Process approach • Improved, consistent and predictable results.
• Focused and prioritized improvement opportunities.
• Integration and alignment of the processes that will best achieve the desired
results.
System approach to
• Ability to focus effort on the key processes.
management
• Providing confidence to interested parties as to the consistency,
effectiveness and efficiency of the organization.
• Performance advantage through improved organizational capabilities.
• Alignment of improvement activities at all levels to an organization's
Continual improvement
strategic intent.
• Flexibility to react quickly to opportunities.
• Informed decisions.
Factual approach to • An increased ability to demonstrate the effectiveness of past decisions
decision making through reference to factual records.
• Increased ability to review, challenge and change opinions and decisions.
• Increased ability to create value for both parties.
Mutually beneficial • Flexibility and speed of joint responses to changing market or customer
supplier relationships needs and expectations.
• Optimization of costs and resources.

3. IV. ISO/TS 16949 IMPLEMENTATION Clause 7 - Product Realization; Clause 8 - Measurement,
Analysis and Improvement (see table III).
To implement ISO/TS 16949:2002, a detailed gap
Continual improvement must drive the implementation
analysis must be performed, using as baseline the ISO
process, as a fundamental concept, to increase the
9001:2000. QS9000 can be used as reference point of all
probability of enhancing the satisfaction of our
previous experience, because the new approach is process
customers, both external and internal.
based [4].
Creation and release of documentation should not be
Our study identified some potential gaps for the five
an end in itself (as promulgated by ISO9000: 1994), but
clauses listed at ISO 9001: Clause 4 - Quality
must be a value-adding activity, improving the
Management System; Clause 5 - Management
communication and providing consistency of actions.
Responsibility; Clause 6 - Resource Management;
TABLE III
POTENTIAL GAP TO IMPLEMENT ISO 16949
PROCESS POTENTIAL GAP
4.2.3.1 THE TIMELY REVIEW FOR ENGINEERING SPECIFICATIONS SHALL NOT EXCEED TWO WORKING WEEKS.
5.1.1 TOP MANAGEMENT SHALL MONITOR EFFECTIVENESS AND EFFICIENCY
QUALITY PERSONNEL SHALL HAVE THE AUTHORITY TO STOP PRODUCTION AND MUST BE PRESENT (OR REPRESENTED)
5.5.1.1
ON ALL SHIFTS
5.5.2.1 CUSTOMER REPRESENTATIVE
5.6.1.1 QUALITY MANAGEMENT REVIEW WITH COST OF POOR QUALITY
5.6.2.1 ANALYSIS OF ACTUAL AND POTENTIAL FIELD FAILURES AND EFFECT ON QUALITY, SAFETY OR ENVIRONMENT.
6.2.2.3 PROVIDE ON THE JOB TRAINING FOR PERSONNEL IN NEW/MODIFIED JOBS AFFECTING PRODUCT QUALITY
TO MOTIVATE QUALITY OBJECTIVE ACHIEVEMENT, CONTINUAL IMPROVEMENTS AND ENVIRONMENT TO PROMOTE
6.2.2.4
INNOVATION, WITH METRICS (MEASUREMENTS)
6.3.1 NOTE RECOMMENDS FOCUS ON LEAN MANUFACTURING PRINCIPLES
CUSTOMER REQUIREMENTS/TECHNICAL SPECIFICATIONS SHALL BE INCLUDED IN THE PLANNING OF PRODUCT
7.1.1
REALIZATION.
7.2.2.2 MUST DOCUMENT MANUFACTURING FEASIBILITY AND INCLUDE RISK ANALYSIS
PRODUCT DESIGN INPUT SHALL DOCUMENT TARGETS FOR PRODUCT QUALITY, LIFE, RELIABILITY, DURABILITY,
7.3.2.1
MAINTAINABILITY, TIMING AND COST
MANUFACTURING PROCESS DESIGN INPUT SHALL DOCUMENT TARGET FOR PRODUCTIVITY, PROCESS CAPABILITY, AND
7.3.2.2
COST
7.3.3.2 MANUFACTURING PROCESS DESIGN OUTPUT IS LISTED.
7.3.4.1 MONITORING AT DESIGN AND DEVELOPMENT REVIEW
7.3.6.3 PRODUCT AND MANUFACTURING PROCESS APPROVAL SHALL ALSO BE APPLIED TO SUPPLIERS
7.4.1.2 SUPPLIERS SHALL BE THIRD PARTY REGISTERED ISO9001: 2000. CUSTOMER MAY MANDATE ALTERNATIVES
PREVENTIVE AND PREDICTIVE MAINTENANCE RELATED WITH EFFECTIVENESS AND THE EFFICIENCY OF PRODUCTION
7.5.1.4
EQUIPMENT
8.1.2 BASIC STATISTICAL CONCEPTS SHALL BE UNDERSTOOD AND UTILIZED THROUGHOUT THE ORGANIZATION
8.2.1.1 MONITOR THE CUSTOMER SATISFACTION
8.2.2.2 MANUFACTURING PROCESS AUDIT TO DETERMINE ITS EFFECTIVENESS
MANUFACTURING PROCESS IMPROVEMENT ONCE THE PROCESSES ARE CAPABLE AND STABLE, OR PRODUCT
8.5.1.2
CHARACTERISTICS ARE PREDICTABLE AND MEET CUSTOMER REQUIREMENTS

4. V. THE SUPPLY CHAIN AND LEAN PRINCIPLES VI. CONCLUSION
The implementation process has been initiated in the The automotive companies are looking for partners to
Automotive Sensors and Telematics Product Group, and be a worldwide supplier of solutions, with low costs and
will be involving all of our suppliers. The development market leadership, as result of defect prevention and
of a new Supplier Management System, with a Quality reduction of variation and waste (Lean) [5]. The
Assurance Agreement must be planned in conformity implementation of the ISO/TS 16949:2002 is the
with the ISO/TS 16949:2002. All our supplies shall be in innovation and improvement necessary to optimize our
conformity with ISO 9001:2000 as their first step. Quality Management System (ISO 9001:2000) and to
The lean principles, as mentioned at table III – Process create a new management and business culture. The
6.3.1, are recommended as reduction of variation and review of the 22 new opportunities listed in table III will
waste, some this tools and techniques are: guide us to achieve the implementation goal. Our
• Housekeeping – The five steps for workplace Automotive Customers require us to be certified to
organization and standardization (5S) ISO/TS16949:2002 but this standard is good for our
• Visual Management – All tooling, parts, business and EBIT performance. We want to run our
production activities and indicators are in view so business as efficient as possible.
every one involved can understand the status of the
system
ACKNOWLEDGEMENT
• Teams – In the lean environment, the emphasis is
on working in teams, whether improvement teams The authors wish to acknowledge the assistance and
or daily work teams review from Bob Phillips – Business Process Manager
• In Process Inspection – Inspection and process (MSBU).
control is carried out by operators so they are
certain the product passed on to the next process is
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