Lecture Quality Management

02 Normative Quality Management Systems

Prof. Dr.-Ing. Robert Schmitt

Dipl.-Ing. Eike Permin
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Contents

1 Total Quality Management (TQM)

2 Quality Management and Standards

3 Basics of Quality Management Systems

4 Implementation of QM Systems

5 Documentation of QM Systems

6 Auditing and Certification

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Change in the Understanding of Quality
Quality of Performance Preparation

Total Quality
Concepts (TQM)
Extent of QM

Quality Actions in
all Sectors

Quality Testing
with Statistical
Basis (SPS)

Quality Control
and Sorting

1900 1930 1960 1980 2000 Time

Examination Focus
Manufacturing Development Value Adding Company
Product
Process Process Chain Overlapping
QM-Character

Reactive Steering Preventive Integrative Strategic

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The Term „Total Quality Management“

QUALITY
TOTAL  Quality of the company
 Process orientation  Quality of work
Trans-sectoral  Quality of potentials
 Customer orientation  Quality of processes
Good relationship to
customers and suppliers
 Employee orientation
Involvement of the whole
T Q  Quality of results

MANAGEMENT
CIP  Quality as leadership task
personnel of the
organization - Well-considered actions
 Society orientation  Leadership quality
Dialogue- and participation- (exemplar role)
oriented public relations
M - Team- und learning
capability
- Perseverance
CI: Continuous Improvement

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Characteristics of TQM

T CIP
Q

M
Normative Quality Strategic Quality
Management Systems (L2) Programmes (L3)
• DIN EN ISO 9000ff. • EFQM
• ISO/TS 16949:2002 • Six Sigma
• et cetera • AC-QM-M
• et cetera

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Contents

1 Total Quality Management (TQM)

2 Quality Management and Standards

3 Basics of Quality Management Systems

4 Implementation of QM Systems

5 Documentation of QM Systems

6 Auditing and Certification

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Industry-Specific Requirements for QM Systems

Demands for
QM systems

DIN EN ISO 9001

ISO TS 16949
VDA 6.1
VDA 6.2
VDA 6.4
KTQ
DIN EN ISO 13485
ALS 9100
TL 9000
HACCP

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DIN EN ISO 9000ff.

DIN EN ISO 9000 QMS – Fundamentals and Vocabulary

DIN EN ISO 9001 QMS – Requirements

QMS – Guidelines for

DIN EN ISO 9004
Performance Improvements

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Quality Management Principles

Customer Focus

Leadership

Involvement of People

Process Approach

System Approach to Management

Continual Improvement

Factual Approach to Decision Making

Mutually Beneficial Supplier Relationships

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DIN EN ISO 9001:2015 Process Model
Environ- Continuous Improvement
ment

Leadership
Customers Customer
& Satisfaction
other QMS
relevant
Stakeholder Evaluation &
Planning
Performance

Require- Products/
Operations
ments Service

Supporting Processes Source: ISO 9001

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Contents of DIN EN ISO 9001:2015

Leadership
• Leadership and commitment of top management
• Capturing and meeting customer requirements
• Determine quality policy
• Definition of responsibilities and authorities as
well as convey this as information
Planning Evaluation & Performance
• Measurements to handle risks and chances • Define content, extent, method of measurement
• Determine quality objectives for relevant of customer’s satisfaction
functional areas, levels and processes • Verify costumer perception
• Provide necessary changes planned and • Analyses of data and information Regular
systematically to the QMS evaluate QMS
Operations
• Plan, control and implement processes for
meeting the costumer requirements
• Define and introduce processes for costumer
communication
• Implementing or processes to meet costumer
requirements
• Definition of development processes
• Ensure extern processes, products and services
meet the requirements
• Controlled conditions for production and service

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ISO/TS 16949:2002 for the Automotive Industry

1994 ISO 9001:2000 ISO 9001:2008 ISO 9001:2015

AVSQ

EAQF
ISO/TS
16949:2002
ISO/TS 16949

1994 1995 QS 9000:1998

VDA 6.1

1994 1996 1998 2000 2002 2004 2006 2008 2010 2012 2015 ...

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Contents

1 Total Quality Management (TQM)

2 Quality Management and Standards

3 Basics of Quality Management Systems

4 Implementation of QM Systems

5 Documentation of QM Systems

6 Auditing and Certification

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Factors in a QM System
Factors controlled by a
QM System
 Employee
 Methods and procedures
 Processes and activities
 Machinery and plant
 Information and experience
 Organizational unit
 Other systems
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Tasks of an effective
QM System
 Identification of the factors
 Documentation of the factors
and their interaction
 Design and control of each
factor
 Coordination of the factors
 Maintenance of the system
factor
Slide 14
Quality Management Systems Approach

1. Determine the needs and expectations of customers and other interested parties.
2. Establish the quality policy and quality objectives of the organization.
3. Determine the processes and responsibilities that are necessary to achieve the
quality objectives.
4. Determine and provide the resources necessary to achieve the quality objectives.
5. Establish methods to measure the effectiveness and efficiency of each process.
6. Apply these measures to determine the effectiveness and efficiency of each
process.
7. Determine means of preventing nonconformities and eliminating their causes.
8. Establish and apply a process for continuous improvement of the quality
management system.

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Contents

1 Total Quality Management (TQM)

2 Quality Management and Standards

3 Basics of Quality Management Systems

4 Implementation of QM Systems

5 Documentation of QM Systems

6 Auditing and Certification

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Potential Approach to Implement a QM System

Strengthen
Establish Direction Manage Transition
Advantages

1 2 3 4 5 6

Manage- Aims Identify Quality

Structure Continuous
ment and Require- Oriented
System Improvement
Decision Visions ments Reorganization

Top-Down Approach Preponderates Bottom-Up Approach Preponderates

Project Planning

Preplanning Rough Planning Detailed Planning

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Management Decision

 Management Decision

 Training Managers

 Informing Employees

www.gettyimages.de
www.gettyimages.de

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Strategy Planning
Customer Focus
+
Who are our stakeholders? And what do they want?

Strategic Objectives
What will the organization achieve in the future?
+

Deduce Sub Objectives

+
How can we achieve higher objectives?

Objectives Coordination
What are the conflicts between the objectives? +
How can they be eliminated?

Key: Management Managers Employees

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Identify Requirements

Define
Deduce internal
success critical
requirements
processes

Document and
structure
requirements

Determine
Identify external
external
requirements
requirements

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Structuring System
Process Map

Core Processes
Customer Input Output Customer

Processes
Support
Management
Processes

The QM System defines:

 Responsibilities and authorities
 Equipment and resources
 Objectives and measures
 Methods and tools

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Structuring System
Company
Processes

Management Core Support

Processes Processes Processes

Human Resources
Strategy Planning

Product Develop.
Internal Audits

Marketing

IT
...

...

...
Sub Processes

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Quality Oriented Reorganization
Phase 1: Analysis

Determine Show need Plan

actual state for action approach

Phase 2: Design
Plan
Develop Document
Build teams implemen-
actions results
tation

Involved area: Phase 3: Realization

Enterprise Adjust Establish Follow up

actions actions effects
Teams

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Contents

1 Total Quality Management (TQM)

2 Quality Management and Standards

3 Basics of Quality Management Systems

4 Implementation of QM Systems

5 Documentation of QM Systems

6 Auditing and Certification

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Types of Documents

Quality Manuals Information about the Quality Management System

Quality Plans Description how Quality Management is applied

Specifications Requirements

Guidelines Recommendations or suggestions

Documented Procedures, Information, how to perform activities and

Work Instructions, et cetera processes consistently
Objective evidence of activities performed or
Records
results achieved

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Electronic Documentation of a QM System

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Contents

1 Total Quality Management (TQM)

2 Quality Management and Standards

3 Basics of Quality Management Systems

4 Implementation of QM Systems

5 Documentation of QM Systems

6 Auditing and Certification

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Audit Objective
 Proficiency review of procedures and processes for product development, production and
dispatch according to internal goals and external constraints
 Use and efficiency review of the documented procedures and arrangements

Development Production Supply

Process Description QM Documentation

In this context
 weak points are identified,

 interface problems are identified,

 potential process improvement defined and

 organizational improvements (e.g. qualification action) determined.

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Avoidance of Error Rates by Quality Audits

Degree of performance of requirements

CIP

Quality
Audit
Quality Avoided
Audit Deviation
Quality
Audit Avoided
Deviation

Avoided
Deviation

1 2 3 Time
Quality Audits support the CIP through regularly review of usage and effectiveness of
documented process instructions and regulations.
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Audit Forms

Internal Audit External Audit

First-party Audit Second-party Audit Third-party Audit

Saving or Objective
Improvement … Evidence …

… of the Quality Capability

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Audit Types
Quality System Audit Process Audit Product Audit

Completeness and
Purpose

Quality capability evaluation of Quality characteristic

effectiveness evaluation of the
the processes for special evaluation of a specific number
basis requirements to the
products and product groups of end products and/or parts
management system

Procedural Structural Relevant Personnel Individual parts or products

organization organization processes
Regarded
Object

 Quality manual  Processes (Development,  Quality directives

& Optimization
Documentation

 QM instruction production, dispatch)  Inspection and

Potential

 Order documents  Documents of process manufacturing procedures,

 Directives of the performance, monitoring and documents and equipment
management inspection  ...
 ...  ...

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Certification Procedure
Company / Organization Certification Body
Select certification body

Provide information about organization Revise existing documentation

Sign contract Submit an offer

Plan project
Approve project plan
Checking of the QMS-documentation
If not serious deficiencies

Realize audit

Evaluate organization

Write report
If not serious deficiencies

Issue certificate
After 1st and 2nd year
Conduct surveillance audit
In 3rd year

Conduct reassessment
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 Exercise Quality Management
02 Normative Quality Management Systems
Exercise: 19.10.2017
16.15 pm – 17.45 pm
PPS H2, Hörsaalzentrum
Professor-Pirelt-Straße, EG 001

Contact:

Dipl.-Ing. Hannes Elser

Phone: 0241/ 80-26940
Email: h.elser@wzl.rwth-aachen.de

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