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ISO/TS16949:2002ISO/TS16949:2002AWARENESSAWARENESS
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Quality Management SystemQuality Management SystemSection 4Section 4
General Requirements (4.1) Establish, document, implement,
maintain, and continually improve a
QMS
Identify the processes needed for
QMS
Determine sequence and interaction
of processes
Determine criteria and methods to
ensure operation and control ofprocesses
Ensure availability of information to
support operation and monitoring of
processes
Measure, monitor, analyze and
implement action to achieve results
and continual improvement
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Quality Management SystemQuality Management SystemSection 4Section 4
General Documentation Requirements (4.2) QMS shall include
Documented Procedures* required by
the standard
Documents required by us to ensurethe effective operation and control of
processes
*Requires the procedure to be established,
documented, implemented andmaintained
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Management ResponsibilityManagement ResponsibilitySection 5Section 5
Management Commitment (5.1) Top management shall provide evidence
of its commitment to the development
and improvement of the QMS by:
Communicating importance of
meeting customer, regulatory and
legal requirements
Establishing quality policy and quality
objectives
Conducting management reviews Ensuring availability of resources
Customer Focus (5.2)
Top management shall ensure thatcustomer needs and expectations are
determined, converted into requirements
and fulfilled with the aim of achieving
customer satisfaction.
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Management ResponsibilityManagement ResponsibilitySection 5Section 5
Quality Policy (5.3) Top management ensures that the quality
policy:
is appropriate to the organizations
purpose
includes a commitment to meeting
requirements and continual
improvement
provides a framework for establishing
and reviewing quality objectives is communicated and understood in
the organization
is reviewed for continuing suitability
The quality policy shall be controlled
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Management ResponsibilityManagement ResponsibilitySection 5Section 5
Planning (5.4) Quality Objectives (5.4.1)
Top management ensures quality
objectives are established at relevant
functions and levels within the
organization.
Quality objectives shall be measurable
and consistent with the quality policy
including the commitment to continual
improvement. Quality objectives shall include those
need to meet requirements for product
Quality Planning (5.4.2)
Top management ensures that
resources needed to achieve quality
objectives are identified and planned
Out put of the planning shall be
documented)
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Management ResponsibilityManagement ResponsibilitySection 5Section 5
Planning (5.4) Quality Planning (5.4.2)
Top management ensures that
resources needed to achieve quality
objectives are identified and planned
Out put of the planning shall be
documented
Quality planning includes:
Processes of the QMS, considering
permissible exclusions
The resources needed
Continual improvement of the QMS
Planning ensures that change is
conducted in a controlled manner andthe integrity of the QMS is maintained
during change.
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Management ResponsibilityManagement ResponsibilitySection 5Section 5
Administration (5.5) Responsibility and authority (5.5.2)
Functions and interrelations within the
organization, including responsibilities
and authorities, shall be defined and
communicated to facilitate effective
quality managment
Management representative (5.5.3)
Top management appoints member(s)
of the management who haveresponsibility and authority that
includes:
Ensuring that processes of the QMS
are established and maintained
Reporting to top management on the
performance of the QMS, including
needs for improvement
Promoting awareness of customer
requirements throughout theorganization
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Management ResponsibilityManagement ResponsibilitySection 5Section 5
Administration (5.5) Management representative (5.5.3)
Top management appoints member(s)
of the management who have
responsibility and authority that
includes:
Ensuring that processes of the
QMS are established and
maintained
Reporting to top management onthe performance of the QMS,
including needs for improvement
Promoting awareness of customer
requirements throughout the
organization
May include liaison with external
parties on matters relating to the
QMS
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Management ResponsibilityManagement ResponsibilitySection 5Section 5
Administration (5.5) Internal communication (5.5.4)
The organization ensures
communication between its various
levels and functions regarding the
processes of the QMS and their
effectiveness.
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Management ResponsibilityManagement ResponsibilitySection 5Section 5
Administration (5.5) Quality Manual (5.5.5)
A quality manual must be established
and maintained that includes:
scope of the QMS documented procedures or
reference to them
description of the sequence and
interaction of the processes in the
QMS
The quality manual must be controlled
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Management ResponsibilityManagement ResponsibilitySection 5Section 5
Administration (5.5) Control of documents (5.5.6)
Documents required for the QMS must
be controlled. A documented
procedure must be established to:
approve documents for adequacy prior to
issue
review, update and re-approve documents
identify current revision of documents
ensure relevant versions of documents are
available at points of use
ensure documents remain legible,
identifiable and retrievable
ensure externally originated documents are
identified and controlled
prevent unintended use of obsoletedocuments and apply identification if they
are retained for any purpose
Documents defined as quality records
must be controlled
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Management ResponsibilityManagement ResponsibilitySection 5Section 5
Administration (5.5) Control of quality records (5.5.7)
Required records for the QMS must be
controlled
Records must be maintained toprovide evidence of conformance to
requirements and of effective
operation of the QMS
Documented procedure must be
established for the identification,storage, retrieval, protection, retention
time and disposition of quality records
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Management ResponsibilityManagement ResponsibilitySection 5Section 5
Management review (5.6) General (5.6.1)
Top management must review the
QMS at planned intervals to ensure
continuing suitability, adequacy, and
effectiveness
Review must evaluate need for
changes to the QMS, including quality
policy and quality objectives
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Management ResponsibilityManagement ResponsibilitySection 5Section 5
Management review (5.6) Review input (5.6.2)
Inputs to management review must
include current performance and
improvement opportunities related to:
Results of audits
Customer feedback
Process performance and product
conformance
Status of preventive and corrective
actions
Follow-up actions from earlier
management reviews
Changes that could affect the QMS
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Management ResponsibilityManagement ResponsibilitySection 5Section 5
Management review (5.6) Review Output (5.6.3)
Output from the management review
must include actions related to:
Improvement of the QMS and itsprocesses
Improvement of product related to
customer requirements
Resource needs
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Resource ManagementResource ManagementSection 6Section 6
Provision of resources (6.1) The organization must determine and
provide, in a timely manner, the
resources needed to:
Implement and improve the processes
of the QMS
Address customer satisfaction
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Resource ManagementResource ManagementSection 6Section 6
Human resources (6.2) Assignment of personnel (6.2.1)
Personnel assigned responsibilities
defined in the QMS must be
competent on the basis of applicable
education, training, skills and
experience
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Resource ManagementResource ManagementSection 6Section 6
Human resources (6.2) Training, awareness and competency
(6.2.2)
The organization must:
Identify competency needs forpersonnel performing activities
affecting quality
Provide training to satisfy these
needs
Evaluate the effectiveness of thetraining provided
Ensure employees are aware of
relevance and importance of their
activities and how they contribute
to achievement of quality objectives
Maintain records of education,
experience, training and
qualifications
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Resource ManagementResource ManagementSection 6Section 6
Facilities (6.3) The organization must identify, provide
and maintain the facilities needed to
achieve product conformity including:
Workspace and associated facilities
Equipment, hardware and software
Supporting services
Work environment (6.4)
The organization must identify and
manage the human and physical factors
of the work environment needed to
achieve product conformity
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Product RealizationProduct RealizationSection 7Section 7
Planning of realization processes (7.1) Sequence of processes required to
achieve product
Consistent with other requirements of
QMS
Documented
Planning must determine, as appropriate:
Quality objectives for the product,
project or contract
Need to establish processes and
documentation, provide resources,
facilities specific to the product
Verification and validation and criteria
for acceptability Records necessary to provide
confidence of conformity of the
processes and resulting product
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Product RealizationProduct RealizationSection 7Section 7
Customer-related processes (7.2) Identification of customer requirements
(7.2.1)
The organization must determine
customer requirements including
Customer specified product
requirements including availability,
delivery and support
Requirements not specified but
necessary for intended or specifieduse
Product obligations including
regulatory and legal requirements
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Product RealizationProduct RealizationSection 7Section 7
Customer-related processes (7.2) Review of product requirements (7.2.2)
Organization must review customer
and other determined requirements
The review must be prior tocommitment to supply a product to the
customer and ensure that:
Product requirements are defined
In the absence of customer
provided requirements, customerrequirements are confirmed
Differences from requirements
previously expressed are resolved
Organization has the ability to meetrequirements
Results must be recorded
Changes must be documented and
communicated
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Product RealizationProduct RealizationSection 7Section 7
Design and/or development (7.3) Design and/or development planning
(7.3.1)
Plan and control design/development
of product
Planning must determine:
Stages of design/development
processes
Review, verification, and validation
activities appropriate to each stage
Responsibilities and authorities for
design/development activities
Interfaces between involved groups
must be managed to ensure effectivecommunication and clarity of
responsibilities
Planning output must be updated as
design/development progresses
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Product RealizationProduct RealizationSection 7Section 7
Design and/or development (7.3) Design and/or development inputs (7.3.2)
Inputs relating to product requirements
must be defined and documented,
including:
Functional and performance
requirements
Regulatory and legal requirements
Information derived from previous
similar designs
Other requirements essential for
design/development
Inputs must be reviewed for adequacy
Incomplete, ambiguous or conflictingrequirements must be resolved
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Product RealizationProduct RealizationSection 7Section 7
Design and/or development (7.3) Design and/or development outputs
(7.3.3)
Outputs must be documented in a
manner that enables verification
against the inputs
Output must:
Meet the input requirements
Provide information for production
and service operations
Contain or reference acceptance
criteria
Define the characteristics of the
product essential to its safe andproper use
Output documents must be approved
prior to release
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Product RealizationProduct RealizationSection 7Section 7
Design and/or development (7.3) Design and/or development review
(7.3.4)
At suitable stages, systematic reviews
must be conducted to:
Evaluate the ability to fulfill
requirements
Identify problems and propose
follow-up actions
Participants in reviews must includerepresentatives of functions concerned
with design/development stages
reviewed
Results of reviews and subsequent
follow-up actions must be recorded
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Product RealizationProduct RealizationSection 7Section 7
Design and/or development (7.3) Design and/or development verification
(7.3.5)
Must be performed to ensure output
meets inputs
Results of verification and follow-up
actions must be recorded (see 5.5.7)
ISO 10007 for guidance
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Product RealizationProduct RealizationSection 7Section 7
Design and/or development (7.3) Design and/or development validation
(7.3.6)
Must be performed to confirm that
product is capable of meeting
requirements for intended use.
Must be completed prior to delivery or
implementation of product
If full validation is impractical, partial
validation must be performed to theextent applicable
Results of the validation and follow-up
actions must be recorded (see 5.5.7)
ISO 10007 for guidance
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Product RealizationProduct RealizationSection 7Section 7
Design and/or development (7.3) Design and/or development changes
(7.3.7)
Must be identified, documented and
controlled.
Includes evaluation of effect of
changes on constituent parts and
delivered products
Must be verified and validated, as
appropriate Approved before implementation
Results of review of changes and
follow-up actions must be documented
(see 5.5.7)
ISO 10007 for guidance
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Product RealizationProduct RealizationSection 7Section 7
Purchasing (7.4) Purchasing Control (7.4.1)
Must control purchasing processes to
ensure purchased product conforms to
requirements
Type and extent dependent on
realization processes and their output
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Product RealizationProduct RealizationSection 7Section 7
Purchasing (7.4) Purchasing Information (7.4.2)
Purchasing documents must contain
information describing the product to
be purchased including, where
appropriate:
Requirements for approval or
qualification of
Product
Procedures
Processes
Equipment
Personnel
QMS requirements Must ensure adequacy of specified
requirements contained in purchasing
documents prior to release
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Product RealizationProduct RealizationSection 7Section 7
Purchasing (7.4) Verification of purchased product (7.4.3)
Must identify and implement activities
necessary for verification of purchased
product
If organization or customer proposes
to perform verification at supplier,
organization must specify intended
verification arrangements and method
of product release in purchasinginformation
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Product RealizationProduct RealizationSection 7Section 7
Production and service operations (7.5) Operations Control (7.5.1)
Must control production and service
operations through:
Availability of information specifyingcharacteristics of product
Availability of work instructions
(where necessary)
Use and maintenance of suitable
equipment for production andservice operations
Availability and use of measuring
and monitoring devices
Implementation of monitoringdevices
Implementation of defined
processes for release, delivery, and
applicable post-delivery activities
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Product RealizationProduct RealizationSection 7Section 7
Production and service operations (7.5) Identification and traceability (7.5.2)
Must identify, where appropriate,
product by suitable means throughout
production and service operations
Must identify status of product with
respect to measurement and
monitoring activities
Must control and record unique
identification of product, wheretraceability is a requirement (see
5.5.7)
Customer property (7.5.3)
Preservation of product (7.5.4)
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Product RealizationProduct RealizationSection 7Section 7
Production and service operations (7.5) Customer property (7.5.3)
Must exercise care with customer
property while under organizations
control or being used by organization
Must identify, verify, protect and
maintain customer property provided
for use or incorporation into product
Customer property lost, damaged, or
otherwise unsuitable must be recordedand reported to customer
Preservation of product (7.5.4)
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Product RealizationProduct RealizationSection 7Section 7
Production and service operations (7.5) Preservation of product (7.5.4)
Must preserve conformity of product
with customer requirements during
internal processing and delivery to
intended destination
Must include identification, handling,
packaging, storage, and protection
Also applies to constituent parts of a
product
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Product RealizationProduct RealizationSection 7Section 7
Control of measurement and monitoringdevices (7.6) (See ISO 10012)
Must identify measurements to be made
and measuring and monitoring devices
required to assure conformity of product
to requirements
Devices must be used and controlled to
ensure measurement capability is
consistent with measurement
requirements Devices must (where applicable)
Be calibrated
Be safeguarded from adjustments
Be protected from damage
Have calibration results recorded (see
5.5.7)
Have validity of previous results
assessed if found out of calibration
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Measurement, Analysis andMeasurement, Analysis and
ImprovementImprovementSection 8Section 8
Planning (8.1)
Must define, plan and implement
measurement and monitoring activities to
assure conformity and achieve
improvement Includes determination of need for, and
use of, statistical techniques
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Measurement, Analysis andMeasurement, Analysis and
ImprovementImprovementSection 8Section 8
Measurement and monitoring (8.2)
Customer satisfaction (8.2.1)
Must monitor information on customer
satisfaction as measurement of
performance of QMS Must determine methods for obtaining
an using this information
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Measurement, Analysis andMeasurement, Analysis and
ImprovementImprovementSection 8Section 8
Measurement and monitoring (8.2) Internal audit (8.2.2)
Must conduct internal audits to determine
whether QMS:
conforms to ISO
has been effectively implemented and
maintained
Must plan audit program considering
Status and importance of activities and areas
Results of previous audits
Must define scope, frequency and methodologies Documented procedure must include
responsibilities and requirements for conducting
audits, ensuring independence, recording results,
and reporting to management
Management must take corrective action on
deficiencies
Follow up actions must include verification of
implementation of corrective action, and reporting
of verification results
See ISO 10011
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Measurement, Analysis andMeasurement, Analysis and
ImprovementImprovementSection 8Section 8
Measurement and monitoring (8.2)
Measurement and monitoring of
processes (8.2.3)
Must apply methods of M&M of
processes necessary to meetcustomer requirements
Must confirm continuing ability of
process to satisfy its intended purpose
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Measurement, Analysis andMeasurement, Analysis and
ImprovementImprovementSection 8Section 8
Measurement and monitoring (8.2)
Measurement and monitoring of product
(8.2.4)
Must M & M characteristics of product
to verify that requirements are met Must be carried out at appropriate
stages of realization process
Evidence of conformity must be
documented. Records must indicate authority
responsible for release of product (see
5.5.7)
Product release and service delivery
must not proceed until all activitieshave been completed, unless
approved by customer
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Measurement, Analysis andMeasurement, Analysis and
ImprovementImprovementSection 8Section 8
Control of nonconformity (8.3)
Must ensure that nonconforming product
is identified and controlled to prevent
unintended use or delivery
Activities must be defined in documentedprocedure
When nonconforming product is detected
after delivery or use, must take action
regarding consequences
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Measurement, Analysis andMeasurement, Analysis and
ImprovementImprovementSection 8Section 8
Analysis of data (8.4)
Must collect and analyze data to
determine the suitability and
effectiveness of QMS and to identify
improvement opportunities Includes data generated by measuring
and monitoring activities and other
relevant sources
Must analyze data to provide information
on:
Customer satisfaction and/or
dissatisfaction
Conformance to customer
requirements Characteristics or processes, product,
and trends
Suppliers
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Measurement, Analysis andMeasurement, Analysis and
ImprovementImprovementSection 8Section 8
Improvement (8.5)
Planning for continual improvement
(8.5.1)
Must plan and manage processes
necessary for the continualimprovement of QMS
Must facilitate the continual
improvement of QMS through quality
policy, objectives, audit results,
analysis of data, corrective and
preventive action and management
review
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Measurement, Analysis andMeasurement, Analysis and
ImprovementImprovementSection 8Section 8
Improvement (8.5)
Corrective action (8.5.2)
Must take corrective action to eliminate the
cause of nonconformities to prevent
recurrence.
Must be appropriate to impact of problems
encountered
Documented procedure must define
requirements for:
Identifying nonconformities
Identifying customer complaints
Determining causes of nonconformity
Evaluating need for action to prevent
recurrence of nonconformity
Determining and implementing correctiveaction
Recording results of actions taken
Reviewing corrective action taken
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Measurement, Analysis andMeasurement, Analysis and
ImprovementImprovementSection 8Section 8
Improvement (8.5)
Preventive action (8.5.3)
Must identify preventive action to
eliminate causes of potential
nonconformities to prevent occurrence Must be appropriate to impact of
potential problems
Documented procedure must define
requirements for:
Identifying potential
nonconformities and their causes
Determining and ensuring
implementation of preventive action
Recording results of action taken Reviewing preventive action taken
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