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ISO 9001:2000
TL 9000 Telecom
Quality Management Systems (QMS)
Requirements

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ISO 9000:2000 Core Standards
9000:2000
Provides (QMS) principles and fundamentals
Describes the ISO series
Lists basic definitions of terms
9001:2000
States requirements for quality management
9004:2000
Provides guidance for establishing a (QMS)
States requirements to meet and exceed
customer expectations
TL 9000
Quality Management System Requirements
Handbook
Provides quality management system
requirements
TL 9000
Quality Management System Measurements
Handbook
Provides metrics collection information
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This class was developed to meet the
following instructional needs:

Provide a basic understanding of ISO 9001: 2000,
quality management systems(QMS) requirement
Provide an overview of TL 9000 registration
requirements

Purpose of Course
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Audience:

Management
Quality and Process Engineering
Process Owners in all functions (I.e. Finance, HR,
IT, Materials, etc.)
Audience
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Participants will be able to:

Discuss how ISO 9001 and TL 9000 fits into
Solectrons strategies and policies
Describe the philosophy of the new standards
Define implementation strategies associated with
the standard
Course Objectives
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I Quality Management Systems(QMS) Overview
II Philosophy of New Standard
III Implementation Strategies
Course Outline
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The philosophy of QMS Standards is
based on defining tools, and criteria
necessary to meet customers
expectations.

Criteria:
Satisfy customer requirements
Provide consistency and repeatability
Support company's needs for internal efficiencies

QMS Philosophy
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I Quality Management Systems(QMS) Overview
II Philosophy of New Standard
III Implementation Strategies
Course Outline
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Customer satisfaction is required, not implied
Quality processes required in all sectors, not just
manufacturing
Efficient processes, with known inputs and outputs
Data and nonconformance data used for continuous
improvement
Evolution of
Quality Systems
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The new ISO 9001 Standard is built on 8 principles of
Quality Management Systems:
1. Customer Focused Organization
2. Leadership
3. Involvement of People
4. Process Approach
5. System Approach to Management
6. Continual process Improvement
7. Factual Approach to Decision Making
8. Mutually Beneficial Supplier Relationships

Quality Management
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ISO 9001-2000 and MBNQA
ISO 9001-2000
1. Customer Focused Organization
2. Leadership
3. Involvement of People
4. Process Approach
5. System Approach to Management
6. Continual Process Improvement
7. Factual Approach to Decision Making
8. Mutually Beneficial Supplier
Relationships
MBNQA
3. Customer and Market Focus
1. Leadership
5. Human Resource Development &
Management
6. Process Management
6. Process Management, 2. Strategic Planning
6. Process Management
4. Information and Analysis, 7. Business
Results
6.3 Supplier and Partnering Processes
ISO 9001-2000 and MBNQA have similar
concepts and organization
9000
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Principle 1
Organizations depend on their
customers and therefore
should;
understand current and future
customer needs
meet customer requirements
strive to exceed customer
expectations
Tools that Solectron
uses are the CFTs and
weekly CSI process.
Customer Focused Organization
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Principle 2
Leaders should;
establish unity of purpose and
direction of the organization
create and maintain the internal
environment in which people
can become fully involved in
achieving the organizations
objectives
LEADERSHIP
Tools Solectron uses
are Hoshin planning,
AOP and LRP
processes.
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Principle 3
Involvement of People
People at all levels are the essence of an organization
Employees full involvement enables their abilities to
be used for the organizations progress
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Principle 4
A desired result is
achieved more efficiently
when related resources
and activities are
managed as a process
Process Approach
Tools Solectron uses
are SIPOC, process
mapping and clearly
documented process.
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Principle 5
System Approach to Management
Identifying, understanding and managing a system
of interrelated processes for a given objective
improves the organizations effectiveness and
efficiency
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Principle 6
Continual Improvement
Continual improvement should be a
permanent objective of the
organization
Focus is on the Seven Step
improvement process at Solectron
Corporation.
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Principle 7
Factual Approach to Decision Making
Effective decisions are based on the analysis of data
and information
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Principle 8
Mutually Beneficial Supplier
Relationships
An organization and its suppliers are
interdependent, and a mutually beneficial
relationship enhances the ability of both to create
value
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I Quality Management Systems(QMS) Overview
II Philosophy of New Standard
III Implementation Strategies
Course Outline
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4 Quality Management System
4.1 General requirements
4.2 Documentation requirements
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General
The organization will document, implement and
maintain a QMS and and continually improve its
effectiveness.
The organization shall
Identify processes needed for the QMS
Determine sequence and interaction of
processes
Monitor, measure and analyze these processes
Implement actions necessary to achieve
planned results
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Documentation

Requirements:
Documented statements of a quality policy and
quality objectives
A quality manual
Documents needed by the organization to ensure
the effective planning, operation and control of
its processes
Control of Customer-Supplied Documents and
Data
Maintain records
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Documentation

Control of Documents, including
Customer documents and data:
Approve documents for adequacy prior to issue
Review and update as necessary and re-approve
Ensure that changes and the current revision status
of documents is identified
Ensure that relevant versions of applicable
documents are available
Ensure that documents of external origin are
identified and their distribution controlled
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Documentation

Control of Records:
Records should remain legible
Readily identifiable
Retrievable
A documented procedure should be established to
define the controls needed for the identification,
storage, protection, retrieval, retention time and
disposition of records.
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5. Management Responsibility
5.1 Management Commitment
5.2 Customer Focus
5.3 Quality Policy
5.4 Planning
5.5 Responsibility and Communication
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Management Commitment
Top Management will provide evidence of its
commitment to the development and implementation
of the QMS and continually improve its effectiveness.
The organization shall
Communicate the importance of meeting
customer and regulatory requirements
Establish a quality policy
Conduct management reviews
Ensure the availability of resources

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Customer Focus
Top management shall ensure that customer
requirements are determined and are met with the
aim of enhancing customer satisfaction.
Top management establishes and maintains
customer relationships
Procedures are established for customer
communication and joint reviews


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Quality Policy

Is appropriate to the purpose of the organization
Includes a commitment to comply with requirements
and continually improve the effectiveness of the
quality management system
Provides a framework for establishing and reviewing
quality objectives
Is communicated and understood within the
organization
Reviewed for continuing suitability
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Quality Policy

Solectron is committed to total quality management and
the requirements of its quality management system to
provide product and product-related services that
conform to all established requirements. We are
committed to defining measures that are effective and
drive decisions from factual and current data. Through
the continual improvement of our management systems,
we are committed to achieving total customer
satisfaction, exceed the expectations of our customers,
and provide error-free, competitive products/solutions
on time with customer satisfaction second to none.
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Planning
Quality Objectives
The organization shall
Top management ensures that quality
objectives, including those needed to meet
requirements for product, are established
at relevant functions. This includes TL 9000
metrics.
Quality Management System Planning
Management ensures that that short and
long term planning is implemented and the
integrity of the QMS is maintained
Customer and supplier input is used for
planning
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Management Representative
Top management will appoint a member of
management, who will have the responsibility and
authority that includes:
Establishing QMS processes
Report the performance of QMS and any need for
improvement
Reports results of audits, customer feedback,
process performance, product conformity,
preventive and corrective actions, and changes
that could affect the QMS
This individual is the Quality Manager for California
Site



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6. Resource Management
6.1 Provision of Resources
6.2 Human Resources
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6 Provision of Resources
The organization shall
Implement and maintain the QMS and continually
improve its effectiveness
Enhance customer satisfaction by meeting
customer requirements

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Human Resources
Competence Awareness and Training
The organization shall
Determine the necessary competence for
personnel performing work affecting
product quality and define requirements for
all positions affecting quality
Provide training, including quality
improvement techniques
Evaluate the effectiveness of the training,
including internal course development
Maintain appropriate records of education,
training, skills and experience

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Training
ESD training is required for all
employees handling sensitive
devices
Advanced quality training is available
for all employees that need it
Hazardous material handling training
is required for all employees that
handle hazardous material
Operators are qualified, not just
trained, to do their jobs
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7 Product Realization
7.1 Planning of Product Realization
7.2 Customer-related Processes
7.3 Design and Development
7.4 Purchasing
7.5 Production and Service Provision
7.6 Control of Monitoring and
Measuring Devices

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The organization shall plan and develop the
processes needed for product realization, and will be
consistent with the requirements for other
processes.
The organization shall
Determine quality objectives and
requirements for the product
Establish processes, documents, and
provide resources specific to the product
Verify, validate, monitor, and test activities
specific to the product

Planning of Product Realization
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More Planning Requirements

Life cycle model a set of integrated
guidelines covering the life cycle of the
product
New Product introduction procedure
Disaster recovery plans
End of life planning
Configuration management

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Customer-related Processes
Determination and Review of Requirements Related to
the Product
The organization shall
Determine requirements specified by the
customer
Determine Statutory and regulatory
requirements related to the product
Ensure that product requirements are defined
Implement arrangements for effective
customer communication, including: product
information, contracts, and feedback

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Customer-related Processes
Notification about problems
Problem severity
Problem escalation
Customer feedback
Recall process
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Design and Development
Procedures to control, verify, and validate product
design and supporting software. A design control
process in operation that has adequate resources and
assigned responsibilities.
The organization shall
Determine the design and development
stages
Determine functional and performance
requirements
Meet input requirements, regulations and
statutory law


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Design and Development
The organization shall
Provide output verifications through
Alternative calculations
Qualification tests
Validate the design by
Ensuring that design verification is successful
Confirm that the final product meets user needs
Assess the need for multiple validations


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Design and Development
Project Plan
Requirements traceability
Test Planning
Customer and Supplier Input
Design and development requirements
Content of requirements
Change management process
Informing customers
Problem resolution
Component Changes
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Purchasing
The organization will ensure that purchased product
conforms to specified purchase requirements. Also,
evaluate and select suppliers based on their ability to
supply product.
The organization will
Prepare, review, and approve purchasing
documents
Establish criteria for determining supplier
acceptability
Develop a supplier classification system
Establish a record system


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Production and Service Provision
The organization will plan and carry out production
and service provision under controlled conditions.
Controlled conditions include:
Availability of information that describes the
characteristics of the product
Use of work instructions
The use of suitable equipment
The availability and use of monitoring and
measuring devices


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Production and Service Provision
Validation of processes for production and service
provision
The organization shall
Define criteria for review of processes
Use specific methods and procedures
Revalidate
Approve of equipment and qualification
personnel


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Production and Service Provision
The organization shall identify product by
suitable means throughout product
realization
Product status shall be identified with
respect to monitoring and measurement
requirements
Recall traceability shall be maintained
Design traceability to identifiable dates, lots
or serial numbers
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Production and Service Provision
Customer Property
The organization shall
Exercise care with customer property while it
is under the organizations control or being
used by the organization
Identify and verify, protect and safeguard
customer property provided for use or
incorporation into the product

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Control of Monitoring and
Measuring Devices
A process to ensure that equipment is properly
calibrated and will remain so. The organization
shall:
Verify and calibrate at specific intervals the
measuring equipment, prior to use, based on
standard traceable to national measurement
standards
Adjust or re-adjust equipment as necessary
Identify as to calibration status

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Control of Monitoring and
Measuring Devices
Safeguard from adjustments that would
invalidate the measurement results
Protect equipment from damage and
deterioration during handling, maintenance
and storage
Label equipment that is either inactive or
unsuitable for measurement and remove
from use.
All monitoring and measurement devices
that do not requirement calibration shall be
identified


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8 Measurement, Analysis and
I mprovement
8.1 General
8.2 Monitoring and Measure
8.3 Control of Nonconforming Product
8.4 Analysis of Data
8.5 Improvement

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General

The organization shall
Demonstrate conformity of the product
Ensure conformity of the QMS
Continually improve the effectiveness of the
QMS


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Monitoring and Measurement
An active plan to search out and put to use information
that reflects the degree of satisfaction being
experienced by customers.
The organization shall
Monitor information relating to customer
Conduct internal audits at planned intervals
Demonstrate the ability of the processes to
achieve planned results
Verify that product requirements have been
met


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Monitoring and Measurement
The organization shall
Document with detail inspection and test
requirements
Keep test and inspection records
Perform periodic retesting
Ensure initial and periodic retest is more
extensive than initial testing
Document frequency of testing
Test return and repair appropriately
Establish test documentation



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Control of Nonconforming
product
The organization will
Identify nonconforming product
Evaluate degree and extend of the
nonconformance
Dispose of nonconforming product according
to quality plan or procedures
Notify concerned parties


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Analysis of Data
A process for identifying the need for collecting the
data required for establishing, controlling, and
verifying process capability and product quality. The
organization shall perform trend analysis of the
nonconforming data.
The organization shall analyze data relating to
Customer satisfaction
Conformity to product requirements
Characteristics and trends of processes and
products


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Improvement
A constant search for ways to improve the QMS, and
an investigation and elimination of causes of
nonconforming product, at any point in the process,
distribution, and installation.
The organization shall
Review nonconformities (including customer
complaints)
Determine the causes of nonconformities
Determine and implement action needed
Review corrective actions taken
Implement Quality Improvement Programs


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The End
A good Quality Management System
makes life easier for everyone by
providing an efficient way to run a
business.