ISO/TS16949:2002

AWARENESS
Quality Management System
Section 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 of
processes
• Ensure availability of information to
support operation and monitoring of
processes
• Measure, monitor, analyze and
implement action to achieve results
and continual improvement
 Quality Management System
Section 4
General Documentation Requirements (4.2)
• QMS shall include
• Documented Procedures* required by
the standard
• Documents required by us to ensure
the effective operation and control of
processes

*Requires the procedure to be established,

documented, implemented and
maintained
 Management Responsibility
Section 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 that
customer needs and expectations are
determined, converted into requirements
and fulfilled with the aim of achieving
customer satisfaction.
 Management Responsibility
Section 5
Quality Policy (5.3)
• Top management ensures that the quality
policy:
• is appropriate to the organization’s
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
 Management Responsibility
Section 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)
 Management Responsibility
Section 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 and
the integrity of the QMS is maintained
during change.
 Management Responsibility
Section 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 have
responsibility 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 the
organization
 Management Responsibility
Section 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 on
the 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
 Management Responsibility
Section 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.
 Management Responsibility
Section 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
 Management Responsibility
Section 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 obsolete
documents and apply identification if they
are retained for any purpose
• Documents defined as quality records
must be controlled
 Management Responsibility
Section 5
Administration (5.5)
• Control of quality records (5.5.7)
• Required records for the QMS must be
controlled
• Records must be maintained to
provide 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
 Management Responsibility
Section 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
 Management Responsibility
Section 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
 Management Responsibility
Section 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 its
processes
• Improvement of product related to
customer requirements
• Resource needs
 Resource Management
Section 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
 Resource Management
Section 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
 Resource Management
Section 6
Human resources (6.2)
• Training, awareness and competency
(6.2.2)
• The organization must:
• Identify competency needs for
personnel performing activities
affecting quality
• Provide training to satisfy these
needs
• Evaluate the effectiveness of the
training 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
 Resource Management
Section 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
 Product Realization
Section 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
 Product Realization
Section 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 specified
use
• Product obligations including
regulatory and legal requirements
 Product Realization
Section 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 to
commitment to supply a product to the
customer and ensure that:
• Product requirements are defined
• In the absence of customer
provided requirements, customer
requirements are confirmed
• Differences from requirements
previously expressed are resolved
• Organization has the ability to meet
requirements
• Results must be recorded
• Changes must be documented and
communicated
 Product Realization
Section 7
Customer-related processes (7.2)
• Customer communication (7.2.3)
• Organization must identify and
implement arrangements for
communication with customers
relating to:
• Product information
• Enquiries, contracts or order
handling including amendments
• Customer feedback, including
customer complaints
 Product Realization
Section 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 effective
communication and clarity of
responsibilities
• Planning output must be updated as
design/development progresses
 Product Realization
Section 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 conflicting
requirements must be resolved
 Product Realization
Section 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 and
proper use
• Output documents must be approved
prior to release
 Product Realization
Section 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 include
representatives of functions concerned
with design/development stages
reviewed
• Results of reviews and subsequent
follow-up actions must be recorded
 Product Realization
Section 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

 Product Realization
Section 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 the
extent applicable
• Results of the validation and follow-up
actions must be recorded (see 5.5.7)

ISO 10007 for guidance

 Product Realization
Section 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

 Product Realization
Section 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
 Product Realization
Section 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
 Product Realization
Section 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 purchasing
information
 Product Realization
Section 7
Production and service operations (7.5)
• Operations Control (7.5.1)
• Must control production and service
operations through:
• Availability of information specifying
characteristics of product
• Availability of work instructions
(where necessary)
• Use and maintenance of suitable
equipment for production and
service operations
• Availability and use of measuring
and monitoring devices
• Implementation of monitoring
devices
• Implementation of defined
processes for release, delivery, and
applicable post-delivery activities
 Product Realization
Section 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, where
traceability is a requirement (see
5.5.7)
• Customer property (7.5.3)

• Preservation of product (7.5.4)

 Product Realization
Section 7
Production and service operations (7.5)
• Customer property (7.5.3)
• Must exercise care with customer
property while under organization’s
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 recorded
and reported to customer

• Preservation of product (7.5.4)

 Product Realization
Section 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
 Product Realization
Section 7
Production and service operations (7.5)
• Validation of processes (7.5.5)
• Must validate any production and
service processes where the resulting
output cannot be verified by
measurement or monitoring
• Includes processes where deficiencies
may become apparent only after product
is in use or service delivered
• Must define arrangements for validation
that must include, as applicable:
• Qualification of processes
• Qualification of equipment or
personnel
• Use of defined methodologies and
procedures
• Requirements for records
• Re-validation
 Product Realization
Section 7
Control of measurement and monitoring
devices (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
 Measurement, Analysis and
Improvement
Section 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
 Measurement, Analysis and
Improvement
Section 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
 Measurement, Analysis and
Improvement
Section 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
 Measurement, Analysis and
Improvement
Section 8
Measurement and monitoring (8.2)
• Measurement and monitoring of
processes (8.2.3)
• Must apply methods of M&M of
processes necessary to meet
customer requirements
• Must confirm continuing ability of
process to satisfy its intended purpose
 Measurement, Analysis and
Improvement
Section 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 activities
have been completed, unless
approved by customer
 Measurement, Analysis and
Improvement
Section 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 documented
procedure
• When nonconforming product is detected
after delivery or use, must take action
regarding consequences
 Measurement, Analysis and
Improvement
Section 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
 Measurement, Analysis and
Improvement
Section 8
Improvement (8.5)
• Planning for continual improvement
(8.5.1)
• Must plan and manage processes
necessary for the continual
improvement 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
 Measurement, Analysis and
Improvement
Section 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 corrective
action
• Recording results of actions taken
• Reviewing corrective action taken
 Measurement, Analysis and
Improvement
Section 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