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What is difference between normal ISO standards and ISO /
TS standards?
Prepared by
International Automotive Task Force-IATF
Japan Automobile Manufacturers Association Inc.-JAMA
Supported by ISO/TC 176
Base Document is ISO 9001 : 2005
Forward
For This Training:
Requirements of ISO 9001:2005 are in Normal Text
Introduction
Eight Quality Management Principles:
Customer Focused Organization
Leadership
Involvement of People
Process Approach
System Approach to Management
Factual Approach to Decision Making
Continual Improvement
Mutually Beneficial Supplier Relationship
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Introduction
Goals of Technical Specification
Development of fundamental quality systems that provide for
continual improvement,
emphasizing defect prevention and
the reduction of variation and waste in the supply chain
To avoid multiple certification and provide common approach
2. Normative Reference
ISO 9000:2005
Quality Management System -Fundamentals and vocabulary
Customer -
Product -
Site -
Understanding the
Process Approach
Process: Set of interrelated or interacting activities which
transforms inputs into outputs
Inputs and outputs may be tangible or intangible
Inputs and outputs can be
Materials
Equipment
Components
Information
Energy
Financial Resources,
Process Approach:
A desired result achieved more efficiently when activities and
related resources are managed as a process
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Typical Network of
Interacting Processes
A P
C D
Input E
Output E
PROCESS E
Input A
PROCESS A
AA PP
CC DD
AA PP
CC DD
Output A
Input C
PROCESS C
AA PP
CC DD
Input B
PROCESS B
AA PP
CC DD
PROCESS D
Output C AA PP
CC DD
Output B
Input F
Internal
Customer
Output D
Input D
PROCESS F
AA PP
CC DD
Output F
Internal
Customer
Feedback
Process Approach
Continual Improvement of the Quality
Management System
Resource
management
Requirements
Customers
(ISO 9001)
And other
Interested
Parties
(ISO 9004)
Management
Responsibility
Customers
(ISO 9001)
And other
Interested
Parties
(ISO 9004)
INPUT
Product
realization
Measurement,
analysis and
improvement
Product
Satisfaction
OUTPUT
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4. Quality Management
System
monitoring, measuring and analyzing these processes,
implementing actions necessary to achieve planned results and
Continual Improvement of the processes
Identify and control outsource processes
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4. Quality Management
System
4.2 Documentation Requirements
4.2.1 General :
QMS documentation to include
quality records
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4. Quality Management
System
4.2.2 Quality Manual
Establish & maintain Quality Manual
the scope of QMS, including details of, and justification for
any exclusions
documented procedures established for QMS or their
reference
a description of the interaction between the processes of QMS
NOTE: The above applies to all requirements of TS
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4. Quality Management
System
4.2.3 Control of Documents
Establish a procedure defining the controls
4.2.3.1 Engineering Standards/Specifications & Changes
Assure timely review (max. Two Weeks), Distribution & Implementation
Maintain a record of the date each change is implemented in
production
Note1: Update record of customer production part approval when the
specifications change (e.g FMEA / Control Plan etc.)
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4. Quality Management
System
4.2.4 Control of Quality Records
Establish a Procedure defining Control of Records.
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5. Management Responsibility
Review Input
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6. Resource Management
6.1 Provision of Resources
Determine and provide resources needed :
Resources means :
Human Resources (i.e. Competent Man-power)
Infra-structure
Work Environment
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6. Resource Management
6.2 Human Resources
6.2.1 General
Personnel to be COMPETENT
on the basis of appropriate education, training, skills and
experience
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6. Resource Management
6.2 Human Resources
6.2.2 Competence, Awareness and Training
The organization to
Determine necessary competence for personnel performing work
affecting product quality,
Provide training or take any other actions to satisfy these needs,
Evaluate effectiveness of the actions taken.
Ensure that its personnel are aware of
relevance and importance of their activities
how they contribute to the achievement of the Quality Objectives
6. Resource Management
6.2.2.1 Product Design Skills
Product Design Responsible personnel be
competent to
achieve design requirements and
identified by organization
6. Resource Management
6.2.2.2 Training
Establish Documented Procedure for
identifying training needs & achieving competence
qualification of personnel with specified assigned tasks
attention be given for satisfying customer specific requirements
Note1:Applies to all employees at all levels
Note2 :Customer specific requirements, for example, digitized mathematically based
data.
6. Resource Management
6.2.2.4 Employee Motivation & Empowerment
For Employee Motivation, have a Process to :
Motivate employees to achieve objectives
Make continual improvements
Create an environment to promote innovation
(Motivation Methods may be Awards, Trophies, Certificates,
Incentives, Appreciation Letters etc.)
6. Resource Management
6.2.2.4 Employee Motivation & Empowerment
For Employee Empowerment, have Process to measure
the extent to :
which personnel are aware of their relevance & importance of their
activities.
how they contribute to the achievement of the quality objectives
(refer 6.2.2 d)
roles and responsibilities in achieving conformance to quality policy
and meeting objectives
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6. Resource Management
6.3 Infrastructure
Determine, provide and maintain infra-structure needed to
achieve the conformity to product requirements
Infra-structure includes, as applicable :
buildings, workspace and associated utilities
process equipment (both hardware and software)
supporting services (such as transport or communication)
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6. Resource Management
6.3.1 Plant, Facility & Equipment Planning
Use Multi-disciplinary approach in developing plans for
Plant, Facilities & Equipment
Plant Layout to optimize Materials Travel & Handling;
Optimize Value added use of Floor Space; Facilitate
Synchronous material flow
6. Resource Management
6.3.2 Contingency Plans
Prepare Contingency Plans to satisfy customer requirements
during emergency conditions; such as :
Contingency
Utility Interruptions
facilities
Labour Shortages
Key Equipment failure
Field Returns
Actions to be taken
e.g. Hiring or availability of spare
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6. Resource Management
6.4 Work Environment
Determine and manage work environment needed to
achieve the conformity to product requirements
Based on Human Factors & Physical Factors
These may include :
safety, rules and guidance, use of PPE
Ergonomics (a science of space requirement)
special facilities for employees
noise, light, temperature, humidity, vibration
hygiene, pollution, cleanliness
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6. Resource Management
6.4.1 Personnel Safety to Achieve Product Quality
Address Product Safety & Means for minimizing
potential risks to employees, especially during
Design & Development Process
Manufacturing Process Activities
7. Product Realization
7.1 Planning of Product Realization
Plan and develop product realization processes
Product realization process must be compatible with QMS
Determine the following as appropriate
Product specific Quality Objective and system requirements;
Product specific processes, documents and resources;
Product specific verification, validation, monitoring, inspection testing
and acceptance criteria;
Records required to demonstrate the compliance of product and
processes to the requirements
Use suitable form(s) for documenting / recording planning output
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7. Product Realization
7.1 Planning of Product Realization
NOTE 1: A document covering QMS process (including product
realization processes & resources required can be referred as
Quality Plan
NOTE 2: Requirements given in 7.3 may be applied for
development of product realization processes
NOTE: Some customers refer to Project Management or APQP for
product realization. APQP emphasizes for defect prevention and
continual improvement instead of defect detection and based on
multi-disciplinary approach
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7. Product Realization
7.1.1 Planning of Product Realization - Supplemental
Include customer requirements and references of its technical
specifications in the product realization as a part of quality plan
7.1.3 Confidentiality
7. Product Realization
7.1.4 Change Control
Establish process to control and react to changes
Define system for assessment, verification and validation of
change.
Perform validation before implementation to the extent possible
For proprietary designs, review the effect of change(s) on fit, form
and function with customer
Ensure the compliance for additional verification / approval
identification requirements
NOTE 1: Any product realization change affecting customer requirements
requires notification to and agreement from the customer
NOTE 2: This applies to product and manufacturing changes
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Maintain the records of review and subsequent action planned and taken
When customer does not provide documented requirements confirm the
requirements before acceptance
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(Contd.)
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7.4 Purchasing
7.4 Purchasing
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7.4 Purchasing
7.4 Purchasing
7.4.1.1 Regulatory Compliance
Ensure all purchased products or materials used in product comply
with applicable regulatory requirements
7.4 Purchasing
7.4.1.3 Customer Approved Sources
Purchase products, materials or services from approved sources when
specified in the contract
Responsibility for ensuring quality of purchased product bought from
customer approved sources lies with the organization
7.4 Purchasing
7.4.3 Verification of Purchased Product
Establish and implement inspection or other similar activity
to ensure the conformance specified purchasing
requirements
When verification is desired at suppliers premises (by the
organization or customer) define in purchase information
The intended verification arrangements
Method of product release
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7.4 Purchasing
7.4.3.1 Incoming Product Quality
Establish a process to assure the quality of purchased
product
Utilize one or more of the following methods
Receipt of and evaluating statistical data
Receiving inspection and testing
Second or third party audits of suppliers site when coupled with the
records of acceptable quality performance
Part evaluation by a designated laboratory
Any other method agreed with the customer
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7.4 Purchasing
7.4.3.2 Supplier Monitoring
Monitor the performance of supplier using
Delivered part quality performance;
Customer disruption (problems) including field failure;
Delivery schedule performance (including incidents of premium
freight);
Special status - customer notifications related to quality or delivery
issues
Promote suppliers own monitoring of their manufacturing
processes
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job change
Ensure availability of work instructions for setup
personnel
Use statistical methods of verification where applicable
Note: Last-off comparisons recommended
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Note: This requirement also applies to availability of tools for vehicle service parts
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including statistical
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over-adjustment)
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Internal auditor
Use qualified internal auditor to conduct audit
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