TL 9000 Overview March 2013 ASQ Rev 2 Feb 20 2013 PDF

An Overview
of the
TL 9000 Standard
Objectives
To provide an overview of the TL 9000
rev. 5 requirements and to show how
these fit into the ISO 9001 framework.
To provide an understanding of the

terminology and activities associated with
a TL 9000 quality management system.
March 2013 2
QBS Quality Business Solutions Inc.
TL 9000 Background
TL 9000 is a quality management
standard designed by the QuEST Forum
in 1998 to enhance quality
management practices across the
telecommunications section.
It defines a set of performance-based

measurements to evaluate the results
March 2013
of QMS implementation.
QBS Quality Business Solutions Inc. 3
TL 9000 Background
QuEST Forum is a collaboration of
information and communication technologies
(ICT) service providers and suppliers across
the world who are dedicated to improving
operational and supply chain quality and
performance.
It provides benchmarking data to participating

companies against a set of defined
measurements.
March 2013 QBS Quality Business Solutions Inc. 4
Fitting into the ISO 9001
Framework….
ISO 9001 is intended to be compatible
with other internationally recognized
standards:
Currently aligned with ISO 14001 for

Environmental Management,
QuEST Form has made the commitment to keep

pace with the ISO 9001 Standard.

Scope of ISO 9001
The ISO 9001 standard specifies requirements
for a Quality Management system where an
organization needs:
To demonstrate ability to consistently provide product

that meets customer and applicable statutory and
regulatory requirements.
To enhance customer satisfaction through effective

application of the system including processes for
continual improvement and the assurance of
conformity to customer and applicable regulatory
requirements.

TL 9000 Scope
What is different with TL 9000?
TL 9000 encompasses ALL requirements of

ISO 9001 plus:
Add-on requirements applicable to the telecom

industry;
Requirements for collection of metrics and

reporting of metrics to a central repository.

TL 9000 Scope
What is different with TL 9000?
The standard is contained in 2 separate

publications:
The TL 9000 Quality Management System

Requirements Handbook (rev. 5), and
The TL 9000 Quality Management System

Measurements Handbook (rev. 5).

TL 9000 Measurements
Defined by:
Product Category
Measurement Handbook lists Product Categories and
applicable metrics.
The Product Category sets the terms for data collection
and submission.
Application to Hardware, Software and Service.


TL 9000 Scope
Hardware Add-on requirements have an H in the
requirement number.
Software Add-on requirements have an S in the

requirement number.
Service Add-on requirements have a V in the

requirement number.
Common Add-on requirements are denoted by a

C.

Review of the Standard
The following slides will provide an
overview of the requirements of the
ISO 9001 and TL 9000 standards.

4 Quality Management System
Requirements
4.1 General Requirements
4.2 Documentation Requirements

4.1 General requirements
The organization shall:
establish, document, implement, maintain and continuously
improve the QMS
Identify processes needed for QMS
Determine sequence and interaction
Determine criteria and methods for control to ensure the
processes are effective
Ensure resources and supporting information is available
Monitor, measure and analyze processes
Implement action for continual improvement
Ensure and identify control over processes that are
outsourced.

TL 9000 Add-On Requirements
For 4.1 General Requirements
None
March 2013
4.2 Documentation Requirements
4.2.1 General
QMS documentation shall include:

Quality policy and quality objectives
Quality manual
Required documented procedures
Documents needed by the organization
Records required by this standard.

4.2.2 Quality Manual
The organization shall establish and
maintain a manual to include:
Scope of the QMS
Details/justification for any exclusions
Documented procedures or references
Description of the interaction of the QMS
processes.

4.2.3 Control of Documents
QMS documents shall be controlled.
A Procedure needs to be established to control:
Approval prior to issue
Review, update and re-approval
Identification of changes and current revision
Relevant versions available at points of use
Legible and readily identifiable
External documents
Obsolete documents.

For 4.2.3 Control of Documents
4.2.3.C.1 The organization must have a procedure for

the control of customer-supplied documents and data.
March 2013
4.2.4 Control of Records
Records shall be established and maintained as
evidence of conformance to requirements
Records will remain legible, readily identifiable and
retrievable
Documented procedure must be established for:
Identification – storage – retrieval
Protection – retention time – disposition.

5.1 Management commitment
Top management shall provide evidence of
commitment to develop and improve the QMS
effectiveness:
Communicate the importance of meeting
requirements
Establish the quality policy
Ensure quality objectives are established
Conduct management reviews
Ensure availability of resources.

5.2 Customer Focus
Top management shall ensure:
Customer requirements are determined
and met with the aim of enhancing
customer satisfaction.

For 5.2 Customer Focus
5.2.C.1 Top management shall demonstrate active

involvement in establishing and maintaining mutually-
beneficial relationships between the organization and its
customers.
5.2.C.2 The organization shall establish methods for
communicating with selected customers to share
expectations and to ensure product quality
improvement. The outcome of these communications
should generate actions for resolving identified
issues.
March 2013 22
5.3 Quality Policy
Top management shall ensure policy:
Is appropriate to the purpose of the
organization
Includes commitment to comply with
requirements and continually improve the
QMS
Provides a framework for quality objectives
Is communicated and understood internally
Is reviewed for continuing suitability.

5.4 Planning
5.4.1 Quality Objectives
Top management shall ensure quality
objectives are:
Established at relevant functions and levels
Are measurable and consistent with quality
policy
Quality Objectives include those needed to
meet product requirements

For 5.4.1 Quality Objectives
5.4.1.C.1 Quality Objectives must include targets for TL

9000 measurements.
Measurements are defined in the TL 9000 Quality

Management System Measurement Handbook by product
category.
March 2013 25
TL 9000 Common Measurements
The following measurements are applicable to all product
categories:
NPR – number of problem reports

FRT – problem report fix time
OFR – overdue problem report fix responsiveness
OTD – on-time delivery
March 2013 26
Each type of measurement has rules for calculation and
counting:
e.g. NPR (# Problem Reports):
> count # Minor, Major and Critical PRs
> for defined calculation periods
> normalized
> based on NPRs per unit or per network, as
described in measurement tables.
March 2013 27
Critical PR – condition that severely impacts
primary functionality of the product
Major PR – product is usable, but product is

seriously degraded.
Minor PR – all else.
**Customer generally determines severity level.
March 2013 28
TL 9000 Measurements
Other examples:
Service Impact Outage Measurement (SO)
Software Fixed Quality Measurement (SFQ)
Field Replaceable Unit Returns Measurement (FR)
March 2013 29
TL 9000 Measurements - FR
FR breaks down into…
Early Return Index (returns during 1st 6 months)
One-Year Return Index (returns after 6-18 months)
Long-term Return Index (19 or more months)
March 2013 30
5.4.2 Quality Management
System Planning
Top management shall ensure:
Planning is carried out to meet
requirements of 4.1
To meet quality objectives
To maintain integrity of the QMS during
times of change to the QMS.

For 5.4.2 QMS Planning
5.4.2.C.1 - The organization's quality planning activities

shall include long- and short-term plans with goals
for improving quality and customer satisfaction.
5.4.2.C.2 Customer Input - The organization shall

implement methods for soliciting and considering
customer input for quality planning activities.
5.4.2.C.3 Supplier Input - The organization shall

implement methods for soliciting and using supplier
input for quality planning activities.
March 2013 32
5.5.1 Responsibility and
Authority
Top management shall:

Define responsibilities and authorities
Communicate these within the
organization.

5.5.2 Management
Representative
Appointed by top management from the
organization’s management
Has responsibility and authority to:
Ensure processes for QMS are established,
implemented and maintained
Report to top management on performance of
QMS, and any need for improvement
Ensure the promotion of awareness of customer
requirements.

5.5.3 Internal Communication
Top management shall ensure
appropriate communication processes
are established within the organization
and that communication takes place
regarding effectiveness of the QMS

For 5.5.3 Internal Communication
5.3.C.1 Organization Performance Feedback - The

organization shall inform employees of its quality
performance and the level of customer satisfaction,
including the results of quality management system
reviews.
36
March 2013 QBS Quality Business Solutions Inc.
5.6 Management Review
5.6.1 General
Top management shall:
Perform reviews of the QMS
Conduct these reviews at planned intervals
Ensure the QMS is suitable, adequate and
effective
Assess opportunities for improvement and the
need for any system changes
Evaluate changes to policy and objectives.
Records of management reviews are required.

5.6.2 Review Input
Input to Management Review:
Results of audits
Customer feedback
Process performance and product conformity
Status of preventive and corrective actions
Follow-up actions from previous reviews
Planned changes that could affect the QMS
Recommendations for improvement.

5.6.3 Review Output
Review output shall include decisions and
take actions related to:
Improvement of the effectiveness of the
QMS and its processes
Improvement of product related to
customer requirements
Resource needs.

For 5.6 Management Review
None

6.1 Provision of Resources
The organization shall determine and
provide resources needed to:
Implement and maintain the QMS
Continually improve its effectiveness
Enhance customer satisfaction.

6.2 Human Resources
6.2.1 General
The organization shall select and assign
competent personnel for positions doing work
affecting product quality.
Competence is based on:

Appropriate education
Training
Skills
Experience

6.2.2 Competence, awareness
and training
Identify competency needs
Provide training or take other actions to satisfy
these needs
Evaluate effectiveness of actions taken
Inform employees of the importance of their work
Ensure they understand how they contribute to
the quality objectives.
Records of education, training, skills and

experience are required.

For 6.2.2 Competence, Training and Awareness
6.2.2.C.1 The organization shall ensure consistency in course
planning, development, and delivery for internally developed
courses.
6.2.2.C.2 Those employees who have a direct impact

on the quality of the product, including top management, shall
be trained in and apply the fundamental concepts of continual
improvement, problem solving, and customer satisfaction.
6.2.2.C.3 The organization shall ensure employees are enabled

to participate in product quality training.

March 2013
For 6.2.2 Competence, Training and Awareness CONT.
6.2.2.C.4 All employees with functions that involve handling,

storage, packaging, preservation, or delivery of ESD-sensitive
products shall receive training in ESD protection prior to
performing their jobs.
6.2.2.C.5 The organization shall offer appropriate levels of

advanced quality training.
6.2.2.C.6 Where applicable, staff shall receive training on

Hazardous Conditions.

For 6.2.2 Competence, Training and Awareness CONT.
6.2.2.HV.1 Where applicable, criteria shall be established for

qualification and re-qualification of personnel.
6.2.2.HV.1-NOTE Examples of processes which may require

personnel qualification and re-qualification include wire
wrapping, soldering, welding, and laboratory processes.

6.3 Infrastructure
The organization needs to determine, provide
and maintain the infrastructure needed to
achieve product conformity including:
Buildings, workspace and associated facilities

Process equipment (hardware and software)
Supporting services (transport or
communication)

For 6.3 Infrastructure
6.3.C.1 The organization shall identify critical areas of the

infrastructure and provide for the security needed to
protect these areas.
> this can be done for example on a coded security

map, with personnel keys linked to specific code zones.

6.4 Work Environment
The organization needs to:
Identify work environment factors that affect product

conformity to requirements
Manage these factors as needed to achieve product

conformity.

For 6.4 Work Environment
6.4.C.1 Areas used for handling, storage, and packaging

of products shall be clean, safe, and organized to ensure
that they do not adversely affect product quality or
personnel performance.

7.1 Planning of Product
Realization
Processes need to be planned and
developed consistent with QMS
requirements.
Determine as appropriate:
Quality objectives and requirements
Necessary processes and product resources
Monitoring, inspection/test, verification and
validation activities and criteria for acceptability
Records for evidence of conformity.

For 7.1 Planning of Product Realization
7.1.C.1 The organization shall establish and maintain a life

cycle model(s) for its products.
7.1.C.2 The organization shall establish and maintain

documented plans for disaster recovery and security
restoration.
7.1.C.3 The organization shall establish and maintain a

documented procedure for the discontinuance of
manufacturing and/or support of a product.
March 2013
More on the Disaster Recovery Plan 7.1.C.2…
DR Plan shall enable “ability to recreate and service the

product throughout its life cycle”.
DR Plan shall include crisis management, business

continuity and information management.
DR Plan shall be periodically evaluated for effectiveness.

March 2013
For 7.1 Planning of Product Realization
7 .1.C.4 Tools Management - The organization shall

ensure that internally developed software and/or tools
used in the product life cycle are controlled.
7.1.HS.1 The organization shall establish and maintain a

configuration management plan.
7.1.V.1 Service Delivery Plan - The delivery or

implementation of a service shall comply with the Project
Plan and Risk Management requirements (7.3.1.C.1,
7.3.1.C.4).
7.2 Customer-related Processes
7.2.1 Determination of requirements related
to the product
The organization shall determine:

Requirements specified by the customer
including delivery and post-delivery activity
Requirements not stated by the customer
but necessary for specific or intended use
Statutory or regulatory requirements
Any additional requirements determined by
the organization.

7.2.2 Review of Requirements
related to Product
The organization shall review requirements before
committing to supply a product to a customer and
shall:
Ensure requirements are defined
Resolve any differences from initial order
Ensure you has ability to meet requirements
Confirm requirements when not documented by the
customer
Amend documents to reflect any changes
Maintain Records of reviews and follow up actions.
For 7.2 Review of Requirements Related to Product
7.2.2.C.1 Closure Tracking - All actions resulting from

requirements reviews shall be tracked to closure.
7.2.2.C.2 Contract Review - The organization shall

establish and maintain a contract review process that
should include……….
next slide
March 2013
More on Contract Review 7.2.2.C.2…
Contract review process should include:

product acceptance criteria,
methods of handling problems after contract award,
plans for correction of NCRs after warranty,
risks, contingencies,
protection of proprietary information,
customer’s responsibilities and facilities/tools to be
provided,
Referenced standards and procedures.
March 2013
7.2.3 Customer Communication
The organization shall determine and
implement effective arrangements for
communicating with customers relative to:
Product information
Inquiries, contracts, order handling, and
amendments
Customer feedback, including complaints.

For 7.2.3 Customer Communication
7.2.3.C.1 The organization shall establish and maintain a

documented procedure to notify all customers who may
be affected by a Critical Problem Report.
7.2.3.C.2 The organization shall assign severity levels to

customer-reported problems based on the impact to the
customer: critical, major, and minor problems.
The severity level shall be used in determining the

timeliness of the organization's response.

For 7.2.3 Customer Communication
7.2.3.C.3 Problem Escalation -The organization shall
establish and maintain a documented escalation
procedure to resolve customer-reported problems.
7.2.3.C.4 Problem Report Feedback – The organization

shall provide the customer with feedback on their problem
reports in a timely and systematic manner.
7.2.3.HS.1 Product Replacement – The organization shall

establish and maintain a documented procedure for
identifying and replacing products that are unfit to remain
in service.
More on providing timely feedback on reported PRs…
The standard common metric FRT “Problem Report Fixed

Response Time” explains what timely means in specific
terms.
For product categories 1 through 5..
>major problems due within 30 days
>minor problems due within 180 days
> critical problems require “non-stop immediate
corrective action regardless of time of day or day of the
week”

For 7.2.3 Customer Communication CONT.
7.2.3.HS.2 On customer request, the organization shall

report on a set of jointly agreed design/development
process measures.

7.3 Design and development
7.3.1 Design and development planning

Plan and control product design/development
Determine stages of design/development
Set review, verification, validation activities
Establish responsibility and authority
Manage interfaces between involved groups
Ensure effective communication and roles
Update plan output as design progresses.

For 7.3.1 Design and Development Planning
7.3.1.C.1 The organization's project planning activities shall be based on

the defined product life cycle model. The project plan should
include:
a) project organizational structure,

b) roles, responsibilities, and accountabilities of the project team,
c) roles, responsibilities, and accountabilities of related teams or individuals, within and
outside the organization, and interfaces between them and the project team,
d) means for scheduling, tracking, issue resolution, and management reporting,
e) budgets, staffing, and schedules associated with project activities,
f) identification of method(s), standards, documented procedure(s), and tools to be
used (If such items are clearly defined as part of the product life cycle model, a
reference to that life cycle model is sufficient.),
g) references to related plans (e.g., risk management, development, testing,
configuration management, and quality), ……………..
March 2013
For 7.3.1 Design and Development Planning CONT.
h) project-specific development or service delivery environment and physical resource
considerations (e.g., resources to address development, user documentation, testing,
operation, required development tools, secure computing environment, lab space,
workstations, etc.),
i) customer, user, and supplier involvement during the product life cycle (e.g., joint
reviews, informal meetings, and approvals),
j) management of project quality, including appropriate quality measures,
k) design for 'x' plans as appropriate to the product life cycle (Plan examples include, but
are not limited to, Manufacturability, Reliability, Regulatory, Serviceability, Safety,
Sustainability, and Testability.),
I) lessons learned from previous post-project analyses,
m) project-specific training requirements,
n) required certifications (e.g., product certifications or employee technical certifications),
0) proprietary, usage, ownership, warranty, licensing rights, and
p) post-project analysis and improvement activities, including root cause analysis of
project lessons learned, and corrective actions to be taken to preclude repetition in future
projects.
7.3.1.C.2 Requirements Traceability - The organization
shall establish and maintain a method to trace documented
requirements through design and test.
7 .3.1.C.3 Test plans shall be documented and should

include…
a) through l)
7.3.1.C.4 The organization shall develop and document a

risk management plan which should include…
next slide
More on Risk Management Plan 7.3.1.C.4…
The Risk Management Plan should be done through all

phases of development and include:
Determination of risk categories, probability vs severity ratings

Identification of critical failure modes
Means of managing risks
Inputs from other disciplines
Mechanism for capturing lessons learned.

7.3.1.C.5 Integration Planning - The organization shall develop
and document a plan to integrate the hardware, software,
and/or service components into the product to ensure they
interact as designed.
7.3.1.C.6 Estimation - The organization shall establish and

maintain a method for estimating and tracking project factors
against the project plan throughout the project life cycle.
7.3.1.HS.1 Migration Planning - The organization shall develop

and document a migration plan when a system, hardware or
software product is planned to be migrated from an old to a new
operational environment.
7.3.1.HS.2 During the design and development planning

phase, the organization shall establish and maintain a
method for selecting and reporting appropriate design and
development process quality measures for the project.
7.3.1.S.1 Computer Resources - The organization shall

establish and maintain methods for estimating and tracking
critical computer resources for the target computer, the
computer on which the software is intended to operate.

7.3.1.S.2 Regression Test Planning - If regression testing

is to be performed, test plans shall specify which tests are
regression and what features and functions are covered by
these regression tests.

7.3.2 Design/Development Inputs
Design/development inputs shall include:
Functional and performance requirements
Applicable regulatory and statutory requirements
Applicable information derived from similar designs
Other essential requirements
Inputs reviewed for adequacy
Complete, unambiguous, not in conflict
Records of design inputs required.

For 7.3.2 Design and Development Inputs
7.3.2.C.1 Customer and Supplier Input - The organization shall establish

and maintain methods for soliciting and using customer and supplier
input during the development of new or revised product requirements.
7.3.2.C.2 Design and development requirements shall be defined and

documented, and should include (note these are C requirements!):
a) quality and reliability requirements,
b) functions and capabilities of the product,
c) business, organizational, and user requirements,
d) safety, environmental, sustainability and security requirements,
e) manufacturability, installability, usability, interoperability, and maintainability requirements,
f) design constraints,
g) testing requirements,
h) computer resources for the target computer, and
i) lessons learned from previous projects.
For 7.3.2 Design and Development Inputs CONT.
7.3.2.C.3 Requirements Allocation - The organization shall document

the allocation of the product requirements to the product architecture.
7.3.2.H.1 Content of Requirements - The product requirements shall

include, but are not limited to
a) nominal values and tolerances,
b) maintainability needs, and
c) end-item packaging requirements.
7.3.2.S.1 Identification of Software Requirements - The organization

shall determine, analyze, and document the software component
requirements of the system.

7.3.3 Design/Development Outputs
Provide outputs to enable verification
Approved prior to release
Outputs must:
Meet input requirements
Provide information for purchasing, production
and service
Contain or reference product acceptance criteria
Specify characteristics for safe and proper use.

For 7.3.3 Design and Development Outputs
7.3.3.HS.1 Design and development outputs should include, but are not
limited to:
a) system architecture,
b) system detailed design,
c) source code, and
d) user documentation.
7.3.3.V.1 The required output from the services design and
development shall contain a complete and precise statement of the
service to be provided as well as:
a) service delivery procedures,
b) resource and skill requirements,
c) reliance on suppliers,
d) service characteristics subject to customer evaluation, and
e) standards of acceptability for each service characteristic.
7.3.4 Design/Development Review
Systematic reviews of design shall be performed
at suitable stages, in order to:
Evaluate ability to fulfill requirements
Identify problems and propose necessary actions
Reviews must include representatives from

concerned groups.
Records of results of reviews and any necessary

actions must be maintained.

For 7.3.4 Design/Development Review
None

7.3.5 Design/Development
Verification
Design Verification shall be performed, in
accordance with planned arrangements
Verification shall ensure outputs have met

input requirements
Records of the results of verification and

necessary actions required shall be
maintained.

For 7.3.5 Design/Development Verification
7.3.5.C.1 Verification of Documentation - The organization shall verify

the customer and/or user documentation prior to product delivery.
7.3.5.HS.1 Stress Testing - The organization shall test the product under
stress conditions, including, but not limited to, out-of-boundary and
invalid input conditions, high volume and peak load simulations, and
operational errors.

For 7.3.5 Design/Development Verification CONT.
7.3.5.HS.2 Abnormal Conditions - The organization shall test the product

under abnormal conditions, which shall include, as appropriate
a) hardware errors,
b) software errors,
c) operations, administration, maintenance and provisioning errors,
d) overload traffic,
e) invalid user input, and
f) system recovery from an outage.
7.3.5.S.1 System Testing - Each software release shall be subjected to

a system test in accordance with a documented system test plan.

7.3.6 Design/Development
Validation
Design/development validation shall:
Be performed in accordance with a plan;
Ensure product meets requirements for the

specified application;
Be complete before delivery or
implementation when practical.
Records of results of validation and necessary

actions must be maintained.

For 7.3.6 Design/Development Validation
7.3.6.S.1 Release Management - The organization shall establish

and maintain a method to ensure that the release and delivery of
software products and related documentation are carried out under
controlled conditions. Methods should provide for the delivery to
the customer of:
a) release planning information in advance of the release,

b) product introduction and release schedules,
c) detailed descriptions of product features delivered, including any
changes incorporated in new software products or releases, and
d) advisories regarding current or planned changes to contractual
terms.

7.3.7 Control of
Design/Development Changes
Identify and keep records of design/development
changes;
Evaluate effect on constituent parts and product
already delivered;
Review, verify and validate changes as appropriate;
Approve changes before implementation;
Keep Records of results of review and necessary
actions.

For 7.3.7 Control of Design/Development Changes
7.3.7.C.1 The organization shall establish and maintain a documented

procedure to ensure that all requirements and design changes, which
may arise at any time during the product life cycle, are managed and
tracked in a systematic and timely manner appropriate to the life
cycle stage.
7.3.7.C.2 Informing Customers - The organization shall establish

and maintain a documented procedure to ensure that customers are
informed when design changes affect contractual commitments.

For 7.3.7 Control of Design/Development Changes CONT.
7.3.7.C.3 Problem Resolution Configuration Management -

The organization shall ensure that its configuration management
system tracks fixes to problems and incorporates those fixes in
future revisions.
7.3.7.H.1 Component Changes - The organization shall have a

documented procedure in place to ensure that material or
component substitutions or changes do not adversely affect
conformity to product requirements or performance. Note sub
requirements a) through e).

7.4 Purchasing
7.4.1 Purchasing process
The organization shall control the purchasing
process to ensure purchased product conforms
to requirements.
Base type and extent of control upon effect on the
realization processes and output
Evaluate and select suppliers based on their ability
to supply product to requirements
Establish criteria for selection, evaluation and re-
evaluation
Record results of supplier evaluations and
necessary actions.

For 7.4.1 Purchasing Process

documented purchasing procedure.
7 .4.1.C.2 The organization shall plan and perform supplier

performance management so that:
a) suppliers are qualified to established criteria,
b) evaluation results are considered during supplier selection activities,
c) suppliers are periodically re-evaluated using established criteria,
d) supplier quality performance is tracked and feedback is provided to
suppliers to drive continual improvement, and
e) for identified key suppliers, alignment toward conformity to TL 9000
requirements occurs.

7.4.2 Purchasing Information
Information must describe the product to be
purchased.
As appropriate, include the qualification or approval

requirements for:
Products, procedures, processes and equipment
Qualification of personnel
QMS requirements
Ensure adequacy before communicating to the supplier.

7.4.3 Verification of purchased
product/services
Identify and implement inspection or other
activities to ensure purchased product meets
requirements.
For verification at supplier premises by the

customer, or by the organization, the
organization shall specify the terms in a
contract or other purchasing document.

7.5 Production and Service Provision
7.5.1 Control of Production and Service
Provision
The organization shall plan and carry out activities

under controlled conditions, including as
applicable:
Availability of product characteristics (e.g. drawings)
Availability of work instructions, as necessary
Use of suitable equipment
Use of measuring and monitoring devices
Implementation of monitoring and measurement
Implementation of defined processes for release,
delivery, and post-delivery activities.
For 7.5.1 Control of Production and Servicing
7.5.1.C.1 Service Resources - The organization shall provide

customer contact employees with appropriate tools, training, and
resources necessary to provide effective and timely customer
service.
7.5.1.C.2 Product Delivery - The organization shall establish and

maintain methods to minimize interference with the customer's
normal site operation and service during product delivery and
installation.

For 7.5.1 Control of Production and Servicing CONT.
7.5.1.HS.1 Emergency Service - The organization shall ensure
that services and resources are available to support recovery from
emergency failures of product in the field throughout its expected
life.
7.5.1.HS.2 The organization shall establish and maintain a

documented installation plan. The installation plan shall identify the
resources, the information required, the sequence of events and
any necessary records.
7.5.1.HV.1 Operational Changes - Each time a significant change is

made in the established operation (e.g., a new operator, new
machine, or new technique), a critical examination shall be made of
the first unit(s)/service(s) processed after the change.
7.5.1.S.1 The organization shall establish and maintain a

documented software patching procedure.
7.5.1.S.2 Patch Documentation - The organization shall establish

and maintain methods to ensure that all documentation required to
describe, test, install, and apply a patch has been verified and
delivered with the patch.
7.5.1.S.3 Replication - The organization shall establish and maintain

a documented procedure for replication.

7.5.1.V.1 Software Used in Service Delivery - The organization shall

establish and maintain a documented procedure for the
maintenance and control of software used in service delivery to
ensure continued process capability and integrity (e.g.
debugging/diagnostics tools, test scripts, etc.).
7.5.1.V.2 Tool Changes - The organization shall establish and

maintain a documented procedure to ensure that substitutions or
changes to tools used in performing the service do not adversely
affect the quality of the service.

7.5.2 Validation of Processes
The organization needs to validate processes when
outputs of processes cannot be verified. That is,
processes where deficiencies become apparent only
after product is in use.
Validation process should include:

Defined criteria for approval of process
Approval of equipment and qualification of personnel
Use of specific methods and procedures
Records of validation and re-validation required.

7.5.3 Identification & Traceability
The organization shall identify the product by
suitable means throughout production and
service operations. This includes:
Identifying status of product with respect to
monitoring and measurement
Control unique identification, when a
requirement (e.g. S/N).

For 7.5.3 Identification and Traceability
7.5.3.H.1 Traceability for Recall - Field Replaceable Units (FRU)

shall be traceable throughout the product life cycle in a way that
helps organizations and their customers to identify products being
recalled, needing to be replaced, or modified.
7.5.3.H.2 Traceability of Design Changes - The organization shall

define and implement methods necessary to provide traceability of
design changes to identifiable manufacturing dates, lots, or serial
numbers.
7.5.3.HS.1 Product Identification - The organization shall establish

and maintain a process for the identification of each product and
the level of required control.
7.5.4 Customer Property
Exercise care with customer property
Identify, verify, protect and safeguard
Report to the customer any lost,
damaged, or unsuitable property

Records of loss, damage or unsuitability
are required.

7.5.5 Preservation of product
The organization shall preserve the product
during internal processing and during delivery
to intended destination.
This includes identification, handling,

packaging, storage and protection.
Preservation also applies to constituent parts.

For 7.5.5 Preservation of Product
7.5.5.C.1 Protection from Electrostatic Discharge (ESD)

Damage - Where applicable, ESD protection shall be employed for
components and products susceptible to ESD damage.
7.5.5.HS.1 Packaging and Labeling Verification - The

organization shall establish and maintain methods to ensure that
the packaging and labeling of products and components conform to
specified requirements.
NOTE Packaging and labeling verification is normally performed

on products ready to ship and may include marking and labeling
(e.g., hazardous material marking, ESD sensitivity, barcoding
etc.)

For 7.5.5 Preservation of Product CONT.
7.5.5. HV.1 Deterioration - Where the possibility of deterioration

exists, the organization shall establish and maintain methods to
determine when materials that may impact product quality have
deteriorated or exceeded their expiration dates, and assess any
required subsequent action.
7.5.5.S.1 Software Virus Protection - The organization shall

establish and maintain methods for software virus prevention,
detection, and removal from the deliverable product.

7.6 Control of Monitoring and
Measuring Devices
The organization shall identify devices required to
measure/monitor the product .
Measuring equipment:
Shall be calibrated at specified intervals;
Be adjusted/re-adjusted as necessary;
Be identified as to its calibration status;
Be safeguarded from adjustments that would

invalidate measurements.
Measurement standards must be traceable to

international standards.
For 7.6 Control of Monitoring and Measuring Equipment
7.6.C.1 Equipment Identification - Monitoring and

measuring equipment that is either inactive or unsuitable for use
shall be visibly identified and not used. All monitoring and
measuring equipment that does not require calibration shall be
identified.

8.1 General
The organization shall plan and implement the
monitoring, measurement, analysis and
improvement processes in order to:
Demonstrate conformity of product
Ensure conformity of the QMS
To continually improve the effectiveness of the
QMS.
Determine the need for, and use of, applicable
methods, including statistical techniques

8.2 Measurement and Monitoring
8.2.1 Customer satisfaction
The organization shall monitor customer
perception as to whether customer
requirements have been met.

For 8.2.1 Customer Satisfaction
8.2.1.C.1 Customer Satisfaction Data - The organization shall

establish and maintain a method to collect data directly from
customers concerning their satisfaction with provided products.
The organization shall also collect customer data on how well the
organization meets commitments and its responsiveness to
customer feedback and needs. This data shall be analyzed and
trended.

8.2.2 Internal Audit
The organization shall conduct internal audits at
planned intervals to determine if:
QMS conforms to requirements
QMS is effectively implemented and maintained.
Planning of the audit program should:
Consider status and importance of areas
Consider results of previous audits
Define audit scope, criteria, frequency, methods
Select auditors and conduct audits to ensure
objectivity and impartiality.

8.2.2 Internal Audit (cont.)
There needs to be a documented procedure to

address:
Responsibility and audit requirements
Planning and conduct of audit
Recording Results and maintaining records.
Take corrective action without undue delay
Verify corrective action
Report verification results
Records of internal audits are required.
8.2.3 Monitoring and
Measurement of processes
The organization shall apply suitable methods of
monitoring, and where applicable, measurement
of QMS processes to confirm the ability of
processes to achieve planned results.
Where planned results are not achieved, take

correction and corrective action, as appropriate.

For 8.2.3 Monitoring and Measurement of Processes
8.2.3.C.1 Process measurements shall be identified,

documented, and monitored at appropriate points to ensure
continued suitability and promote increased effectiveness of
processes. This includes the establishment of appropriate
design process measurements.
Key process measurements that impact conformity to product

requirements should have specific performance targets or
control limits established.

measurement of product
The organization shall monitor and measure product
characteristics to verify that requirements for
product are met. This includes:
Carrying out inspection/tests at appropriate stages of

realization in accordance with plans;
Maintaining evidence that test criteria have been met;
Successfully completing all activities before release and
delivery.

measurement of product
In addition, records of inspection and
testing must:
indicate the name of the tester/inspector.

For 8.2.4 Monitoring and Measurement of Product
8.2.4.H.1 Periodic Retesting - The organization shall establish

and maintain a documented procedure that ensures products are
periodically retested to assess the product's ability to continue to
meet design requirements.
8.2.4.H.2 Content of Testing - The initial test and periodic retest

shall be more extensive than the routine quality tests.
8.2.4.H.3 Frequency of Testing - The organization shall establish

and document the frequency for test and periodic retest.

For 8.2.4 Monitoring and Measurement of Product CONT.
8.2.4.H.4 Testing of Repair and Return Products - Repair and

return products shall be subjected to the appropriate evaluation(s)
and/or test(s) to ensure functionality to product specification.
8.2.4.HV.1 Inspection and Test Documentation - Each

inspection or testing activity throughout the product life cycle shall
have detailed documentation. Details should include …. a) through h).

8.2.4.HV.2 Inspection and Test Records - Inspection or test

records shall include
a) product identification,
b) quantity of product,
c) documented procedure(s) followed,
d) person(s) performing the test or inspection,
e) calibrated equipment used,
f) date performed, and
g) number, type, and severity of defects found.

8.2.4.S.1 Test Documentation - Software tests shall be

conducted per the test plan according to a
documented procedure(s). Records of testing shall include
a) test results,
b) analysis of test results,
c) conformity to expected results, and
d) problem reporting for nonconforming items.

8.3 Control of Nonconforming
Product
The organization shall identify and control
nonconforming product to prevent its unintended use or
delivery. There needs to be a documented procedure for
controls and responsibilities.
Records of nonconforming product are required
Corrected product needs to be re-verified before release.

8.4 Analysis of Data
The organization needs to collect and analyze
data on its quality system in order to:
• Demonstrate suitability and effectiveness of QMS
• Evaluate areas for continual improvement.
Analysis of data should provide information on:

Customer satisfaction
Conformity to product requirements
Characteristics and trends of product, processes,
and opportunities for preventive action
Suppliers.

For 8.4 Analysis of Data
8.4.C.1 Trend Analysis of Nonconforming Product - Trend analysis

of discrepancies found in nonconforming product shall be
performed on a defined, regular basis and results utilized as input
for corrective and preventive action.
8.4.HS.1 Field Performance Data - The quality management

system shall include the collection and analysis of field
performance data which can be used to help identify the cause
and frequency of product failure.
8.4.V.1 Service Performance Data - The quality management

system shall include the collection and analysis of service
performance data, which can be used to identify the cause and
frequency of service failure.
8.5 Improvement
8.5.1 Continual Improvement
The organization shall continually improve
the effectiveness of the QMS through the
use of:
Quality policy
Quality objectives
Audit results
Analysis of data
Corrective and preventive action
Management review
For 8.5.1 Continual Improvement

continual improvement program that includes a focus to
improve:
customer satisfaction,
quality and reliability of the product, and
other processes/products/services used within the organization.
8.5.1.C.2 Employee Participation - The organization shall implement

methods for encouraging employee participation in the continual
improvement program.
March 2013
8.5.2 Corrective Action
The organization shall eliminate causes of
nonconformity and prevent recurrence.
A documented procedure defining how to:

Review nonconformity, including customer complaints
Determine the root cause
Evaluate the need for action
Determine and implement needed action
Retain Records of results of action taken
Review the effectiveness of action taken.

For 8.5.2 Corrective Action
8.5.2.S.1 The organization shall establish and maintain

a documented procedure to initiate corrective action
once a reported trouble is diagnosed as a problem.
The documented procedure should provide guidelines
for distinguishing among potential solutions such as:
patching,
immediate source code corrections,
deferring solutions to a planned release, and
providing documented "work-around" operational procedure
and resolution within a designated timeframe based on the
severity of the issue.
March 2013
8.5.3 Preventive Action
The organization shall eliminate the cause of
potential nonconformity and prevent
occurrence.
Documented procedure defining how to:

– Determine potential nonconformities and
their cause(s)
– Evaluate the need for action
– Determine and implement needed action
– Retain Records of results of action taken
– Review effectiveness of preventive action taken.

Questions??

TL 9000 Overview March 2013 ASQ Rev 2 Feb 20 2013 PDF

Uploaded by

Copyright:

Available Formats

TL 9000 Overview March 2013 ASQ Rev 2 Feb 20 2013 PDF

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

TL 9000 Overview March 2013 ASQ Rev 2 Feb 20 2013 PDF

Uploaded by

Copyright:

Available Formats

An Overview

To provide an understanding of the

It defines a set of performance-based

It provides benchmarking data to participating

Currently aligned with ISO 14001 for

QuEST Form has made the commitment to keep

March 2013 QBS Quality Business Solutions Inc. 5

To demonstrate ability to consistently provide product

To enhance customer satisfaction through effective

March 2013 QBS Quality Business Solutions Inc. 6

TL 9000 encompasses ALL requirements of

Add-on requirements applicable to the telecom

Requirements for collection of metrics and

March 2013 QBS Quality Business Solutions Inc. 7

The standard is contained in 2 separate

The TL 9000 Quality Management System

The TL 9000 Quality Management System

March 2013 QBS Quality Business Solutions Inc. 8

Application to Hardware, Software and Service.

March 2013 QBS Quality Business Solutions Inc. 9

Software Add-on requirements have an S in the

Service Add-on requirements have a V in the

Common Add-on requirements are denoted by a

March 2013 QBS Quality Business Solutions Inc. 10

March 2013 QBS Quality Business Solutions Inc. 11

March 2013 QBS Quality Business Solutions Inc. 12

March 2013 QBS Quality Business Solutions Inc. 13

QMS documentation shall include:

March 2013 QBS Quality Business Solutions Inc. 15

March 2013 QBS Quality Business Solutions Inc. 16

Review, update and re-approval

Identification of changes and current revision

Relevant versions available at points of use

Legible and readily identifiable

March 2013 QBS Quality Business Solutions Inc. 17

4.2.3.C.1 The organization must have a procedure for

Protection – retention time – disposition.

March 2013 QBS Quality Business Solutions Inc. 19

March 2013 QBS Quality Business Solutions Inc. 20

March 2013 QBS Quality Business Solutions Inc. 21

5.2.C.1 Top management shall demonstrate active

March 2013 QBS Quality Business Solutions Inc. 23

March 2013 QBS Quality Business Solutions Inc. 24

5.4.1.C.1 Quality Objectives must include targets for TL

Measurements are defined in the TL 9000 Quality

NPR – number of problem reports

Major PR – product is usable, but product is

Minor PR – all else.

**Customer generally determines severity level.

Service Impact Outage Measurement (SO)

Software Fixed Quality Measurement (SFQ)

Field Replaceable Unit Returns Measurement (FR)

Early Return Index (returns during 1st 6 months)

One-Year Return Index (returns after 6-18 months)

Long-term Return Index (19 or more months)

March 2013 QBS Quality Business Solutions Inc. 31

5.4.2.C.1 - The organization's quality planning activities

5.4.2.C.2 Customer Input - The organization shall

5.4.2.C.3 Supplier Input - The organization shall