ISO/TS 16949:2009

Quality Management Systems Introduction

Note: Words in italic is ISO/TS

16949 requirements.

Establish TRAINING
Document IN
Implement ISO/TS 16949 PROGRESS

Monitor
Maintain Quality Management
Improve
System Introduction

Participant:…………………………..
Trainer:………………………………..
Date:…………………………………..

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 ISO/TS 16949:2009
Quality Management System Introduction

Note: Words in italic is ISO/TS

16949 requirements.
ISO/TS 16949:2009 Course Objectives
Third Edition
> Understanding the ISO9001 & ISO/TS 16949 terms.
Introduction : 0.1 General > Able to interpret the requirements.
0.2 Process Approach > Know what to focus on when doing implementation.
0.3 Relationship with ISO 9004 > What type of documents are required.
0.4 Compatibility with other Management System > Conscious on quality issues.
0.5 Goals of Technical Specification

Introduction

Quality Management System : Requirements 01. General : Design of the management system is
based on individual needs. This standard does not
1. Scope : 1.1 General intent to imply uniformity in the structure of quality
1.2 Application management systems or uniformity of
2. Normative Reference documentation.
3. Terms and Definitions
4. Quality Management System
02. Process Approach : Using process approach
5. Management Responsibility
and manage an activity with the inputs and
6. Resource Management
7.Product Realization outputs. Provides linkage between the individual
8. Measurement, Analysis and Improvement processes within the system of processes as well
as over their combination and interaction.

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 ISO/TS 16949:2009
Quality Management System Introduction

Note: Words in italic is ISO/TS

16949 requirements.
ISO/TS 16949:2009
Third Edition

Introduction : 0.1 General

0.2 Process Approach
0.3 Relationship with ISO 9004
0.4 Compatibility with other Management System
0.5 Goals of Technical Specification
02.1 Process Approach : Plan-Do-Check-Act (PDCA)
can be applied to all processes.

Plan : Establish Act : Take

Do : Implement Check : Monitor
Objectives and actions to
the Processes and Measure
Processes improve

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 ISO/TS 16949:2009
Quality Management System Introduction

Note: Words in italic is ISO/TS

16949 requirements.
ISO/TS 16949:2009
It promotes the application of the process approach in the
Third Edition implementation of a QMS, where a process or a system of
processes is managed by controlling its inputs, outputs
and activities. This approach is fundamentally adopted (in
Introduction : 0.1 General
whole) from the Shewhart/Deming Cycle of "Plan-Do-
0.2 Process Approach
Check-Act".
0.3 Relationship with ISO 9004
0.4 Compatibility with other Management System
0.5 Goals of Technical Specification
Check

5.6 Management review

7.3.5 Design and development verification
7.3.6 Design and development validation
7.5.2 Validation of processes for production and service
provision
8.2.1 Customer satisfaction
8.2.2 Internal audit
8.4 Analysis of data.

Plan : Establish Act : Take

Do : Implement Check : Monitor
Objectives and actions to
the Processes and Measure
Processes improve

4
 ISO/TS 16949:2009
Quality Management System Introduction

Note: Words in italic is ISO/TS

16949 requirements.
ISO/TS 16949:2009
Third Edition
Introduction : 0.1 General
0.2 Process Approach
0.3 Relationship with ISO 9004
0.4 Compatibility with other Management System
0.5 Goals of Technical Specification

02.2 Process Approach (octopus diagram)

Input: Customer has an

Input: Customer has a order
complaint.
Output: Customer receive
the order.
Output: Customer receive corrective
action on its complaint. Automotive
Manufacturing
Plant 1. You need to identify all the activities
related to receiving customer order.

2. You need to identify all the activities

(support process) need to be done that
will ensure the customer receive the order.
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aqc publication
ISO/TS 16949:2009
Quality Management System Introduction

Note: Words in italic is ISO/TS

16949 requirements.
ISO/TS 16949:2009
Third Edition
Introduction : 0.1 General
0.2 Process Approach
0.3 Relationship with ISO 9004
0.4 Compatibility with other Management System
0.5 Goals of Technical Specification

02.3 Process Approach : (turtle diagram)

With what? With who?

Materials/Equipments. Personal involved.

Output
Process What should
we deliver.

How many?
Performance Indicator.

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 ISO/TS 16949:2009
Quality Management System Introduction

Note: Words in italic is ISO/TS

16949 requirements.
ISO/TS 16949:2009
Third Edition 02.4 Process Approach Classification
Introduction : 0.1 General
0.2 Process Approach
0.3 Relationship with ISO 9004 > identify what is the customer oriented process
0.4 Compatibility with other Management System : owner identify.
0.5 Goals of Technical Specification :
: is documented.
Customer Requirements
& Order Request
: linkages are established.
:
Automotive Industry : is records maintained.
Suggested Customer
Oriented Process: > Identify all the support process.
:
1) Market Analysis/
Tooling Facility Management : output.
Customer Requirements.
Purchasing : who. Flow chart must indicate
: these requirements.
: how many.
:

9) Delivery. > identify the management process.

Management Review : approval.
10) Payment.
Internal Audit
11) Warranty/Service
Continual Improvement
:
12) Customer Feedback : continual improvement. 7
 ISO/TS 16949:2009
Quality Management System Introduction

Note: Words in italic is ISO/TS

16949 requirements.
ISO/TS 16949:2009
Third Edition
Introduction : 0.1 General
0.2 Process Approach
0.3 Relationship with ISO 9004
0.4 Compatibility with other Management System
0.5 Goals of Technical Specification

02.5 Process Approach : Continual Improvement of the

Quality Management System.

Management
Responsibility

Customers
Measurement, Satisfaction
Customers Resource
Analysis and
Management
Improvement

Require-
Product Output
ments Product
Realization 8
Input
 ISO/TS 16949:2009
Quality Management System Introduction

Note: Words in italic is ISO/TS

ISO/TS 16949:2002 16949 requirements.
Second Edition

Introduction : 0.1 General

0.2 Process Approach
0.3 Relationship with ISO 9004
0.4 Compatibility with other Management System
0.5 Goals of Technical Specification

0.3 Relationship with ISO 9004 : ISO 9001 and ISO

9004 are designed to complement each other. ISO
9001 focuses on the effectiveness of the quality
management system in meeting customer
requirements. ISO 9004 gives guidance on a wider
range of objectives of a quality management system
than does ISO 9001.

0.4 Compatibility with other Management System : Is

aligned with ISO 14001:2004 environmental
management system standards

0.5 Goals of Technical Specification

Provides for continual improvement, emphasizing
defect prevention and the reduction of variation
and waste in the supply chain
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 ISO/TS 16949:2009
Quality Management System Introduction

Note: Words in italic is ISO/TS

16949 requirements.
ISO/TS 16949:2009
Third Edition
Quality Management System : Requirements

7. Product Realization
4. Quality Management System
7.1 Planning of Product Realization
4.1 General Requirements 7.2 Customer-related Processes
4.2 Documentation Requirements 7.3 Design and Development
7.4 Purchasing
5. Management Responsibility 7.5 Production and Service Provision
7.6 Control of Monitoring and Measuring Devices
5.1 Management Commitment
5.2 Documentation Requirements 8. Measurement, Analysis and Improvement
5.3 Quality Policy
5.4 Planning 8.1 General
5.5 Responsibility, Authority and Communication 8.2 Monitoring and Measurement
5.6 Management Review 8.3 Control of Nonconforming Product
8.4 Analysis of Data
6. Resource Management 8.5 Improvement

6.1 provision of Resources

6.2 Human Resources
6.3 Infrastructure
6.4 Work Environment
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 ISO/TS 16949:2009
Quality Management System Introduction

Note: Words in italic is ISO/TS

16949 requirements.
ISO/TS 16949:2009
Third Edition 4.1 Guidance
Quality Management System : Requirements
> structure the system
> define the process
4. Quality Management System
4.1 General Requirements 4.1 General Requirements > flow chart of interaction
4.2 Documentation Requirements > set your requirements
> document, establish, implement, > monitor your processes
maintain And improve a quality > take action, improvement plan
management system and > define criteria of subcontractor on
continually improve. those processes do outside.
> identify the processes, determine the
sequence and interaction of these processes.
> determine criteria and methods needed.
> availability of resources and information necessary.
> monitor, measure and analyse these processes.
> implement actions to achieve planned results.

Ensure control of outsource process and the control must

be identified within the quality management system.

4.1.1 General Requirements

> ensuring control over outsourced processes shall not
absolve the organization of the responsibility of conformity
to all customer requirements.
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 ISO/TS 16949:2009
Quality Management System Introduction

Note: Words in italic is ISO/TS

16949 requirements.
ISO/TS 16949:2009 4.2.1 Guidance
Third Edition
QP
Quality Management System : Requirements
QM
4. Quality Management System Procedure
4.1 General Requirements 4. 2 Documentation Requirements
4.2 Documentation Requirements Work Instruction
4.2.1 General
> quality policy and objective. Records
> quality manual.
> documented procedures.
> documents need to ensure effectiveness of system.
FMEA or Control Plan comes > records.
first when doing these
documents formation. * documented means the procedure is established,
documented, implemented and maintained.

4.2.2 Quality Manual

> scope of quality management system.
> Justification for any exclusions.
> documented procedures established or and reference.
> description of the interaction between processes.

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 ISO/TS 16949:2009
Quality Management System Introduction

Note: Words in italic is ISO/TS

16949 requirements.
ISO/TS 16949:2009
Third Edition
Quality Management System : Requirements
4.2.4 Guidance
4. Quality Management System
4.1 General Requirements 4.2 Documentation Requirements > list of records.
4.2 Documentation Requirements > disposal method.
4.2.4 Control of Records
> shall be established and maintained.
> legible, readily identifiable and retrievable.
> documented procedure established to identify, storage,
protection, retrieval, retention time and disposition and
disposal records.
Is FMEA and Control Plan a
controlled records? 4.2.4.1 Records Retention
>satisfy regulatory and customer requirements.

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 ISO/TS 16949:2009
Quality Management System Introduction

Note: Words in italic is ISO/TS

16949 requirements.
ISO/TS 16949:2009
Third Edition
Quality Management System : Requirements

7. Product Realization
7.2 Customer-Related Processes 7.2.2 Guidance
7.1 Planning of Product
7.2.2 Review of Requirements related to > customer purchase order needs
Realization
the product. to be reviewed .
7.2 Customer-related Processes
> Need to review contract before > authorised person to review.
7.3 Design and Development
acceptance. > communication method on
7.4 Purchasing
> Records of results of review and actions changes.
7.5 Production and Service
must be maintained.
Provision
> no customer documented statement,
7.6 Control of Monitoring and
confirmation by the organization before
Measuring Devices
acceptance.
> changes to requirements relevant
personnel are made aware.
How you conduct your 7.2.2.1 Review requirements to product
manufacturing feasibility related to product.
study? > waiving any customer agreed
requirement shall require customer
authorization.
7.2.2.2 Organization manufacturing
feasibility 14
> risk assessment to assess the potential
and effects of failure.
 ISO/TS 16949:2009
Quality Management System Introduction

Note: Words in italic is ISO/TS

16949 requirements.
ISO/TS 16949:2009
Third Edition
Quality Management System : Requirements

7. Product Realization 7.2.3 Guidance

7.2.3 Customer Communication
> Communication with customers on
7.1 Planning of Product > identify responsible person.
product information.
Realization > communication method.
> enquiries, contract or order handling.
7.2 Customer-related Processes > identify types of communications
> customer feedback, including customer
7.3 Design and Development needs.
complaints.
7.4 Purchasing
7.5 Production and Service
7.2.3.1 Customer Communication
Provision
> as per customer request shall have the
7.6 Control of Monitoring and
facility to support electronic data exchange.
Measuring Devices

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 ISO/TS 16949:2009
Quality Management System Introduction

Note: Words in italic is ISO/TS

16949 requirements.
ISO/TS 16949:2009
Third Edition
Quality Management System : Requirements

7. Product Realization
7.3 Design and Development
7.1 Planning of Product
Realization
7.2 Customer-related Processes
7.3.2.2 Manufacturing process design 7.3.2.2 Guidance
7.3 Design and Development
input.
7.4 Purchasing
> product design output data. > put into the APQP plan all
7.5 Production and Service
> targets for productivity, process requirements.
Provision
capability cost.
7.6 Control of Monitoring and
> customer requirements
Measuring Devices
> experience from previous
developments.

7.3.2.3 Special Characteristics 7.3.2.3 Guidance

> include all special characteristic in the
Does all customer key control plan. > recommended symbols
characteristic need to monitor > customer specified symbols > ( § ) product characteristic or
by control chart? > in FMEA, drawings, operator work process parameter safety,
instruction. regulatory.

Note: product characteristics and process

parameters. 16
 ISO/TS 16949:2009
Quality Management System Introduction

Note: Words in italic is ISO/TS

16949 requirements.
ISO/TS 16949:2009
Third Edition
Quality Management System : Requirements

7. Product Realization
7.5 Production and Service Provision 7.5.1.2 Guidance
7.1 Planning of Product
7.5.1.2 Work Instruction > where is the right place to put.
Realization
> documented work instructions that > is the operator able to follow.
7.2 Customer-related Processes
impact quality.
7.3 Design and Development
> accessible for use at work station.
7.4 Purchasing
7.5 Production and Service
7.5.1.3 Verification of Job-Set-ups
Provision 7.5.1.3 Guidance
> verification of initial run of job.
7.6 Control of Monitoring and
> material change.
Measuring Devices > IPQC buy-off.
> process parameter change.
> job change. > machine set-up approval.
> work instruction for set-up personnel.
> last-off-part comparisons
How you control you first and recommended
last piece production

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 ISO/TS 16949:2009
Quality Management System Introduction

Note: Words in italic is ISO/TS

16949 requirements.
ISO/TS 16949:2009
Third Edition
Quality Management System : Requirements

7. Product Realization
7.5 Production and Service Provision
7.5.3 Guidance
7.1 Planning of Product
7.5.3 Identification and Traceability :
Realization > accept and reject stickers
> where appropriate, identify product by
7.2 Customer-related Processes > reject area, reject box.
suitable means.
7.3 Design and Development > part number identification.
> identify product status with respect to
7.4 Purchasing > lot number, manufacturing date.
monitoring and measurement requirements.
7.5 Production and Service
> traceability requirement is a requirement.
Provision
control the unique identification of the
7.6 Control of Monitoring and
product.
Measuring Devices
7.5.3.1 Identification and Traceability
> must have identification.
How is your recall methods
within your company and on
the field?

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ISO/TS 16949:2009
Quality Management System Introduction

Note: Words in italic is ISO/TS

16949 requirements.

End of
Training
ISO/TS 16949
Quality Management
System Introduction

THANK YOU FOR YOUR PARTICIPATION

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 ISO/TS 16949:2009
Quality Management System Introduction

Note: Words in italic is ISO/TS

Work Study 5: Name all the customer oriented process. ( Score 0, 1 or 2 ) 16949 requirements.

aqc publication : tel:04-8902212 fax:04-8982212 email:[email protected] h/p:0124890690

Work Study 6: Name all the support process. ( Score 0, 1 or 2 )

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 ISO/TS 16949:2009
Quality Management System Introduction

Note: Words in italic is ISO/TS

16949 requirements.
Work Study 7: You need to design a new manufacturing line. What are the manufacturing requirements
need to be established. ( Score 0, 1 or 2 )

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 ISO/TS 16949:2009
Quality Management System Introduction

Note: Words in italic is ISO/TS

16949 requirements.
Work Study 10: Give reasons why and the usefulness of work instructions. ( Score 0, 1 or 2 )

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 ISO/TS 16949:2009
Quality Management System Introduction

Note: Words in italic is ISO/TS

16949 requirements.
TRAINING EFFECTIVENESS EVALUATION

Title of Subject:

Department: Name:

Badge No: Training Date:

Evaluated By: Approved By:

Total Score =
Subjects: Score
% Score = total score/20, X 100
Work Study 1
Work Study 2 Grading of Effectiveness: The terms effectiveness means the
Work Study 3 participant understanding of the subject.
Work Study 4
Work Study 5 Not Effective: 0%-49%
Work Study 6 Effective but needs improvement in understanding: 50%-75%
Work Study 7 Effective : 76% -100%
Work Study 8
Work Study 9 Score decision making: A score of 50% or more is considered as
Work Study 10 as a minimum knowledge required in effectiveness evaluation.

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