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ELEMENT 4 - Quality management system

4.1 General Requirements
4.1.1 Has the organization established and documented Quality manual according to ISO/TS
a quality management system in accordance with 16949:2002 or one with a conversion
the requirements of ISO/TS 16949:2002? (4.1) matrix.
4.1.2 Has the organization implemented and maintained Key personnel interview.
its established quality management system in Examples of effective
accordance with the requirements of ISO/TS implementation.
16949:2002? (4.1)
4.1.3 Is the organization continually improving the Examples and status of quality
effectiveness of its quality management system in management system continuous
accordance with the requirements of ISO/TS improvement projects, not corrective
16949:2002? (4.1.1.1) actions.
Management review results.
4.1.4 Does the organization's quality management Quality manual according to ISO/TS
system: a) identify the processes needed for the 16949:2002 or one with a conversion
quality management system and their application matrix.
throughout the organization? b) determine the
sequence and interaction of these processes? c)
determine criteria and methods needed to ensure
that both the operation and control of these
processes are effective? (4.1.a,b,c)

4.1.5 Does the organization's quality management Review of all the elements of the
system: a) ensure the availability of resources quality management system to insure its
and information necessary to support the operation continuing suitability and effectiveness.
and monitoring of the processes needed for its Review of quality cost indicators
quality management system? b) monitor, measure Management review meeting
and analyze the processes needed for its quality minutes, attendance and adequate
management system? c) implement actions frequency.
necessary to achieve planned results and continual Action plans and follow-up.
improvement of the processes needed for its quality
management system? (4.1.d,e,f)

4.1.6 Does the organization manage the processes

needed for its quality management system in
accordance with the requirement of ISO/TS
16949:2002? (4.1)
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4.1.7 Does the organization ensure control over

outsourced processes that affects product
conformity with requirements? (4.1)
4.1.8 Is the control of the organization's outsourced Quality manual according to ISO/TS
processes that affects product conformity with 16949:2002 or one with a conversion
requirements identified within the quality matrix.
management system? (4.1)
ELEMENT 4.2 Documentation requirements
4.2.1 General
4.2.1 Does the quality management system Quality manual according to ISO/TS
documentation include the following: a) 16949:2002 or one with a conversion
documented statements of a quality policy and matrix.
quality objectives? b) a quality manual? c) Adequacy of the procedures to the
documented procedures required by ISO/TS complexity of the organization.
16949:2002? d) documents needed by the Quality management system
organization to ensure the effective planning, procedures.
operation and control of its processes? e) records Quality records.
required by ISO/TS 16949:2002 (see element
4.2.4)? (4.2.1)

4.2.2 Quality Manual

4.2.2 Has the organization established and maintained a Quality manual according to ISO/TS
quality manual that includes: a) the scope of the 16949:2002 or one with a conversion
quality management system, including details of matrix.
and justification for any exclusions (see section 1.2
of ISO/TS 16949:2002)? b) the documented
procedures established for the quality management
system, or reference to them? c) a description of
the interaction between the processes of the quality
management system? (4.2.2)

4.2.3 Control of documents

4.2.3 Does the organization control the documents Quality manual according to ISO/TS
required by the quality management system? 16949:2002 or one with a conversion
(4.2.3) matrix.
Document control master list or
equivalent.
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4.2.4 Has the organization established a documented Document approval authority.

procedure to define controls needed: a) to Document approval records.
approve documents for adequacy prior to issue? b) Availability of documents in various
to review and update as necessary and re- locations.
approve documents? c) to ensure that changes Knowledge of document location.
and the current revision status of documents are Document accessibility.
identified? d) to ensure that relevant versions of Storage and disposal of obsolete
applicable documents are available at points of documents.
use? e) to ensure that documents remain legible Process for notification/distribution of
and readily identifiable? f) to ensure that documents from internal and external
documents of external origin are identified and their origins.
distribution controlled? g) to prevent the Review and approval of revised
unintended use of obsolete documents, and to documents.
apply suitable identification to them if they are
retained for any purpose? (4.2.3)

4.2.3.1 Engineering specifications

4.2.5 Does the organization have a process to assure the Process for notification/distribution of
timely review, distribution and implementation of all customer engineering standards
customer engineering standards/specifications and changes.
changes (including the updating of appropriate Process for implementation of
documents) based on customer required schedule? customer initiated changes.
(4.2-3-1) Document changes triggered by
engineering changes.

4.2.6 Does the organization maintain a record of the date Records of engineering changes
on which each change is implemented in implemented.
production? (4.2.3,1)
4.2.4 Control of records
4.2.7 Has the organization established and maintained Quality management system records.
records to provide evidence of conformity to Records maintenance system,
requirements and of the effective operation of the including disposal of records.
quality management system? (4.2.4)
4.2.8 Are records legible, readily identifiable and Quality management system records
retrievable? (4.2.4) legibility.
Identification of quality
management system records.
Environment and storage
conditions must be compatible with the
file storage medium (ex: hard copy, floppy
disk, etc.).
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4.2.9 Has the organization established a documented Quality manual according to ISO/TS
procedure to define the controls needed for the 16949:2002.
identification, storage, protection, retrieval, Defined record retention time
retention time and disposition of records? (4.2.4) compared to customer/regulatory
requirements.
Record disposal after retention period
expires.
Including identification of
obsolescence documents.
Identification of invalid/obsolete
documents.

4.2.10 Does the organization treat quality records as a Evidence of quality records being
special type of document and control them maintained and controlled per quality
according to the requirements given in questions manual.
4.2.7 and 4.2.8? (4.2.4)
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Internal Audit Date Internal Auditor 1: Internal Auditor 2:

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No. Question What to look for NC / IO Comments / Evidence

5 - Management responsibility
5.1 Management commitment
5.1.1 Does top management have evidence of providing Documented policy statement with
commitment to the development and clearly defined and measurable quality
implementation of its quality management system? objectives approved by CEO.
(5.1)
5.1.2 Does the organization's top management have Customer defined objectives
evidence of providing commitment to continually (Customer specifications) and company
improving its quality management system goals stated in the business plan and
effectiveness by a) communicating to the their alignment with the quality policy
organization the importance of meeting customer statement.
as well as statutory and regula Quality manual according to 1SO/TS
16949:2002.
Management reviews meeting
minutes,

5.1.1 Process Efficiency

5.1.3 Does organization's top management monitor the Review of product realization and
product realization processes and the support support processes by top management.
processes to assure their effectiveness and Indicators and records.
efficiency? (5.1.1) Reporting process.
5.2 Customer Focus
5.2.1 Does top management ensure that customer Description of an objective process.
requirements are determined and fulfilled with the Methodology used for surveys.
aim of enhancing customer satisfaction? (5.2) Original Customer data and scope
such as customer satisfaction feedback
(surveys, scorecards, awards, etc.).
5.3 Quality policy
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5.3.1 Does top management ensure that the quality Documented policy statement with
policy: a) is appropriate to the purpose of the clearly defined and measurable quality
organization? b) includes a commitment to objectives approved by CEO.
comply with requirements and continually improve Records of improvement.
the effectiveness of the quality management Quality objectives included/linked to
system? c) provides the business plan.
Scope of the Quality objectives.
Direct inte

5.4 Quality objectives

5.4.1 Does the organization's top management ensure
that quality objectives, including those needed to
meet requirements for product (see section 7.1 of
the ISO/TS 16949:2002 technical specification) are
established at relevant functions and levels within
the o
5.4.2 Are the organization's quality objectives Quality cost indicators and quality
measurable and consistent with the quality policy? indices.
(5.4.1) Quality objectives included/linked to
the business plan.
5.4.3 Did top management define any quality objectives Quality objectives included/linked to
and measurements? (5.4.1.1) the business plan.
Scope of the Quality objectives
5.4.4 Are the organization 's quality objectives and Quality objectives included/linked to
measurements included in the business plan and the business plan.
used by top management to deploy the Management review meeting
organization's quality policy? (5.4.1.1) minutes, attendance and adequate
frequency.
5.4.2 Quality management system planning
5.4.5 Does top management of the organization ensure Internal audit results.
that a) the planning of the quality management
system is carried out in order to meet the general
quality management system requirements stated in
section 4.1 oflSO/TS 16949:2002, as well as the
quality ob
5.5 Responsibility, authority and communication
5.5.1 Responsibility and authority
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5.5.1 Does the organization's top management ensure Responsibilities and authority as
that the responsibilities and authorities are defined defined in job descriptions,
and communicated within the organization? (5.5.1) responsibilities matrices, procedures, and
accountabilities documents.
5.5.1.1 Quality responsibility
5.5.2 Is management with responsibility and authority for Select examples of non-compliance
corrective action promptly informed of products or from suitable sources such as internal or
processes that do not conform to requirements? external concerns/complaints, etc.
(5.5.1.1) Communication channels and
timeliness.
5.5.3 Does the organization 's personnel responsible for Who is responsible for quality in the
quality have the authority to stop production to production process?
correct quality problems? (5.5.1.1) How the authority is defined.
Recent examples.
5.5.4 Are the organization's production operations staffed Quality Assurance responsible
with personnel that ensure product quality across personnel in all shifts.
all shifts? (5.5.1.1)
5.5.2 Management representative
5.5.5 Did the organization's top management appoint a Who is the person in charge of this
member of management who, irrespective of other responsibility?
responsibilities, shall have responsibility and Evidence of activities performed
authority that includes a) ensuring that processes including empowerment for all applicable
needed for the quality management system are system elements including design, sales,
established, manufacturing, delivery, etc.
Management review minutes.

5.5.2.1 Customer representative

5.5.6 Did the organization 's top management designate Quality function representative in
individual(s) to represent the needs of the customer project teams.
to address quality requirements, such as selection Quality function participation in
of special characteristics, setting quality objectives milestones decision points {Production
and related training, corrective and preventive release, Engineering release, ...).
Responsibilities and job description
of the customer representative (ex Quali

5.5.3 Internal Comunication

5.5.7 Does top management ensure that appropriate Communication channels and
communication processes are established within timeliness.
the organization? (5.5.3)
5.5.8 Does top management ensure that communication Communication channels and
takes place within the organization regarding the timeliness.
effectiveness of the quality management system?
(5.5.3)
5.6 Management review .
5.6.1 General
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5.6.1 Does the organization's top management review its Review of all the elements of the
quality management system, at planned intervals, quality system to insure its continuing
to ensure its continuing suitability, adequacy and suitability and effectiveness.
effectiveness? (5.6.1) Review of quality cost indicators.
Management review meeting
minutes, attendance and adequate
frequency.
Action plans and foll

5.6.2 Do the organization's management reviews include Evidence of continuous improvement

assessing opportunities for improvement and the projects initiated from management
need for changes to the quality management reviews.
system, including the quality policy and quality
objectives? (5.6.1)
5.6.3 Are the organization's records from management Retention of management reviews
reviews maintained? (5.6.1) meeting minutes.
5.6.1.1 Quality management system performance
5.6.4 Do the management reviews include all elements of Review of all the elements of the
the quality management system and its quality system to insure its continuing
performance trends as an essential part of the suitability and effectiveness.
continual improvement process? (5.6.1.1) Trends in metrics (business and
customer satisfaction).
Basis for continuous improvement
projects.

5.6.5 Do the management reviews include monitoring of Policy, business plan and customer
quality objectives, and the regular reporting and satisfaction metrics reports.
evaluation of the cost of poor quality (see elements Product results (quality, cost, time)
8.4-1 and 8.5.1 of ISO/TS16949:2002(E)) ? against quality policy goals and customer
(5.6.1.1) specified targets.
5.6.6 Are the results of the management reviews Trends in metrics (business and
recorded to provide, as a minimum, evidence of the customer satisfaction).
achievement of: objectives specified in the quality Basis for continuous improvement
policy? objectives specified in the business plan? projects.
customer satisfaction with product supplied? Management review meeting
(5.6.1.1) minutes.
Action plans and follow-up.

5.6.2 Review input

5.6.7 Does the organization's input to its management Reports prepared for management
review include information on: a) results of reviews.
audits? b) customer feedback? c) process Management review meeting
performance and product conformity? d) status of minutes.
preventive and corrective actions? e) follow-up Action plans and follow-up.
actions fr Content of management review
meeting agenda.

5.6.2.1 Review input ~ Supplemental

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5.6.8 Do management reviews include an analysis of Content of management review

actual and potential field- failures and their impact meeting agenda.
on quality-, safety, or the environment? (5.6.2.1)
5.6.3 Review output
5.6.9 Does the output from the organization's Examples of continuous improvement
management review include any decisions and projects initiated from management
actions related to: a) improvement of the reviews.
effectiveness of the quality management system Examples of product improvements
and its processes? b) improvement of product initiated from management reviews.
related to customer requirement
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No. Question What to look for NC / IO Comments / Evidence

6 Resource management
6.1 Provision of resources
6.1.1 Does the organization determine and provide the Job descriptions.
resources needed a) to implement and maintain Training records.
the quality management system and continually Quality Plans.
improve its effectiveness? b) to enhance customer Shift staffing/supervision.
satisfaction by meeting customer requirements? Personnel workload.
(6.1)
6.2 Human resources
6.2.1 General
6.2.2 Are the personnel performing work affecting Training records complementing the
product quality competent on the basis of type of work that the personnel perform
appropriate education, training, skills and on the product.
experience? (6.2.1) Personnel records.
Interviews with design personnel.
6.2.2 Competences, awareness & training
6.2.3 Does the organization a) determine the Job description.
necessary competence for personnel performing Qualification for each position.
work affecting product quality? b) provide training Training plan.
or take other actions to satisfy these needs? c) Training records.
evaluate the effectiveness of the actions taken? d)
ensure
6.2.2.1 Product desing skills
6.2.4 Does the organization ensure that personnel with Training records complementing the
product design responsibility are qualified to type of design activity.
achieve design requirements and are skilled in Personnel records.
applicable tools and techniques? (6.2.2.1) Interviews with design personnel.
6.2.5 Has the organization identified applicable tools and Listing of tools needed for product
techniques needed for product design? (6.2.2.1) design.
Personnel training on product design
techniques needed.
PO(s) on tools needed.
6.2.2.2 Training
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6.2.6 Has the organization established and maintained Quality manual according to ISO/TS
documented procedures fur identifying training 16949:2002
needs and achieving competence of all personnel
performing activities affecting product quality.
(6.2.2.2)
6.2.7 Are the personnel performing specific assigned Training records complementing the
tasks qualified on the basis of education, training, type of tasks assigned to personnel.
skills and/or experience, as required? (6.2.2.2) Personnel records.
Interviews with personnel.
6.2.8 Has the organization given attention to training that Evidence of personnel training
satisfies customer specific requirements? (6.2.2.2) that satisfies customer specific
requirements.
6.2.2.3
6.2.9 Does the organization provide on the job training Training records for personnel in new
for personnel in any new or modified job affecting assignments.
product quality including contract or agency Training records for contract
personnel? (6.2.2.3) personnel.
6.2.10 Are the personnel affecting quality, informed about Training contents.
the consequences to the customer of
nonconformity to quality requirements? (6.2.2.3)
6.2.2.4 Employee motivation and empowerment
6.2.11 Does the organization have a process for Incentive systems used.
motivation of employees to achieve quality
objectives, to make continual improvements, and
create an environment to promote innovation ?
(6.2.2.4)
6.2.12 Does the organization 's employee motivation Scope of employee motivation.
process include promotion of quality and
technological awareness through the whole
organization? (6.2.2.4)
6.2.13 Does the organization have a process for Measurement of employee
measurement to ensure that its personnel are satisfaction.
aware of the relevance and importance of their
activities and how they contribute to the
achievement of the quality objectives? (6.2.2.4)
6.3 Infrastructure
6.3.1 Does the organization determine, provide and Quality manual according to ISO/TS
maintain the infrastructure needed to achieve 16949:2002.
conformity to product requirements? (6.3) Product results - internal and external
product failure rate.
6:3.1 Plant, facility and equipment planning
6.3.2 Does the organization use a multidisciplinary Team composition has to be cross-
approach for developing plant, facility and functional.
equipment plans? (6.3.1)
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6.3.3 Is the organization's plant layouts optimized for Process flow analysis.
material travel, handling and value-added use of Plant layout (current and planned).
floor space and shall facilitate synchronous material
flow? (6.3.1)
6.3.4 Has the organization developed and implemented Metrics for ergonomics, automation,
methods to evaluate and monitor the effectiveness line balance, inventory levels.
of existing operations? (6.3.1)
6.3.2 Contingency plans
6.3.5 Has the organization prepare contingency plans to Contingency plans.
satisfy the customer requirements in the event of Identification of Key Equipment.
an emergency such as utility interruptions, labour
shortages, key equipment failure, and field returns?
(6.3.2)
6.4 Work environment
6.4.1 Does the organization determine and manage the . Quality manual according to ISO/TS
work environment needed to achieve conformity to 16949:2002.
product requirements? (6.4)
6.4.1 Personnel safety
6.4.2 Does the organization 's quality policy and practices Preventive activities in design and
address product safety and means to minimize process control.
potential risks to employees, especially in design Knowledge and application of
and development process and in the manufacturing legislation.
process activities? (6.4.1) Risk analysis such as FMEA.
Results of internal/external audits
including: - System certifications, -
Corrective actions.
Reco

6.4.2 Cleanliness of premises

6.4.3 Does the organization maintain its premises in a Tour of plant.
state of order cleanliness and repair consistent with
the product? (6.4.2)
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No. Question What to look for NC / IO Comments / Evidence

7 Product realization
7.1 Planning of product realization
7.1.1 Has the organization planned and developed the Quality Planning process.
processes needed for product realization? (7.1) Project Planning process.
Quality plans for new products.
7.1.2 Is the organization's planning of product realization Development of Quality plan(s).
consistent with the requirements of the other
processes of the quality management system?
(7.1)
7.1.3 In planning product realization, does the Quality plan and Design Record,
organization determine the following, as Control Plan, Operator Instructions,
appropriate: a) quality objectives and Product Approval records,
requirements for the product? b) the need to resources/facilities and any plans to
establish processes, documents, and provide enhance them.
resources specific to the product? c) Design validation at the various
stages of the design.
Link between process changes and
up

7.1.4 Is the organization's planning of product realization Product realization output format &
output in a form suitable for the organization's content.
method of operations? (7.1)
7.1.1 Planning of product realization - supplemental
7.1.5 Are the customer requirements and references to Quality plans.
its technical specifications included in the planning Customer specifications.
of product realization as a quality plan? (7-1-1) Technical specifications.
7.1.2 Acceptance criteria
7.1.6 Did the organization define acceptance criteria for Test specification.
the product being developed and where required, Product validation test plan with
approved by the customer? (7.1.2) defined acceptance criteria.
7.1.7 Is the organization 's acceptance criteria for Acceptance criteria in test plan and
attribute data sampling zero defects? (7.1.2) test specifications.
7.1.3 Confidentiality
7.1.8 Does the organization ensure the confidentiality of Information access security.
customer contracted products and projects under Security for product development
development, and related product information?
(7.1.3)
7.1.4 Change control
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7.1.9 Does the organization have a process to control Engineering change request process.
and react to changes that impact product Change records.
realization including those initiated by the supplier?
(7.1.4)
7.1.10 Does organization assess the effects of changes? Impact study including proprietary
(7.1.4) design.
Change management process.
7.1.11 Has the organization defined the verification and Test specification.
validation activities for changes, to ensure Product validation test plan with
compliance with customer requirements? (7.1.4) defined acceptance criteria.
7.1.12 Does the organization validate changes before Evidence of design and production
implementation? (7.1.4) validation tests conducted for product
changes.
7.1.13 Does the organization review proprietary designs, Impact study including proprietary
impact on form, fit, function, (including design.
performance, and/or durability) with the customer Change management process.
so that all effects'can be properly evaluated (7.1.4)

7.1.14 Does the organization meet additional Design and production validation test
verification/identification requirements such as report.
those required for new product introduction when
required by the customer? (7.1.4)
7.2 Customer-related processes
7.2.1 Determination of requirements related to the product
7.2.1 Does the organization determine: Process for government, safety and
a) requirements specified by the customer, eviromental regulations compliance.
including requirements for delivery & post-delivery Organization's Internal products
activities? specifications
b) requirements not stated by customer but
necesarry for specified or intended use, where
known?
c) statutory and r

7.2.1.1 Customer designated special characteristics

7.2.2 Can the organization demonstrate conformity to Designation and control of special
customer requirements for designation, characteristics.
documentation and control of special Quality documents: control plan,
characteristics? (7.2.1.1) specifications, drawings, etc shall report
the special characteristics designation.
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7.2.2 Review of requirements related to the product

7.2.3 Does the organization review the requirements Feasibility studies.
related to a product prior to the organization's
commitment to supply to the customer? (7.2.2)
7.2.4 Does the organization ensure that a) product Customer contract review.
requirements are defined? b) contract or order Product specification review.
requirements differing from those previously Resolution of differences.
expressed are resolved? c) the organization has Feasibility assessments.
the ability to meet the defined requirements? (7.2.2)

7.2.5 Does the organization maintain records of the Records of contract review.
results of the review and actions arising from the
review? (7.2.2)
7.2.6 Where the customer provides no documented Sign off design validation and
statement of requirement, does the organization production validation test plan with
confirm the customer requirements before acceptance criteria.
acceptance? (7.2.2)
7.2.2.1 Organization manufacturing feasibility
7.2.7 Does the organization investigate, confirm and Feasibility studies.
document the manufacturing feasibility of the Risk analysis.
proposed products in the contract review process
including risk analysis? (7.2.2.1)
7.2.3 Customer communication
7.2.8 Has the organization determined and implemented Common language at the interface
effective arrangements for communicating with level.
customers in relation to: a) product information?
b) enquiries, contracts or order handling,
including amendments? c) customer feedback,
including custo
7.2.3.1 Customer communication - supplemental
7.2.9 Does the organization have the ability to Common language at the interface
communicate necessary information including data level.
in a customer specified language and format? Common language for technical
(7.2.3.1) specifications and important documents.
Customer/ supplier EDI system
requirements and supplier capabilities.
7.3 Design and development
7.3.1 Design and development planning
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7.3.1 Does the organization plan and control the design The organization taking lead in
and development of product? (7.3.1) product design and development
activities.
The organization managing the
product design and development
processes.
Project records such as milestones
decision points are controlled and
approved by the org

7.3.2 During the design and development planning, does Product design and development
the organization determine: a) the design and process.
development stages? b) the review, verification Product design review; verification
and validation that is appropriate to each design and validation process.
and development stage? c) the responsibilities Job description for product design
and au and development personnel.
7.3.3 Does the organization manage the interfaces Internal audit results.
between different groups involved in design and Review of organizational interfaces
development to ensure effective communication with roles and communication processes.
and clear assignment of responsibility? (7.3.1.)
7.3.4 Is the organization's product design and Evidence of product design and
development planning output updated, as development planning output updated as
appropriate, as the design and development design and development progresses.
progresses? (7.3.1.)

7.3.1.1 Multidisciplinary approach

7.3.5 Does the organization use a multidisciplinary Functions represented in product
approach to prepare for product realization, development teams.
including: development/finalization and monitoring Personnel involved in definition of
of special characteristics? development, and review special characteristics, FMEA, and
ofFMEAs including actions to reduce potential Control Plan.
risks? developm

7.3.2 Design and development inputs

7.3.6 Does the organization determine inputs relating to Design input records & documents.
product requirements and maintain the related
records? (7.3.2)
7.3.7 Does the organization's inputs relating to product Customer specification.
requirements include: a) functional and Statutory and regulatory
performance requirements? b) applicable requirements.
statutory and regulatory requirements? c) where Previous / existing product design
applicable, information derived from previous information.
similar designs? d) Product benchmarking.
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7.3.8 Does organization review its inputs relating to Customer specification analysis.
product requirements for adequacy? (7.3.2) Feasibility contract review.
7.3.9 Are the inputs relating to product requirements Customer specification analysis.
complete, unambiguous and not in conflict with Feasibility contract review minutes.
each other? (7.3.2)
7.3.2.1 Product Desing Input
7.3.10 Does the organization identify, document and Customer specification analysis.
review the product design inputs requirements Feasibility contract review minutes.
including: customer requirements (contract
review)? use of information (the organization shall
have a process to deploy information gained)?
targets for product qua
7.3.2.2 Manufacturing process design input
7.3.1.1 Does the organization identify, document and Design FMEA.
review the manufacturing process design input Productivity, process capability, costs
requirements, including: product design output targets.
data? targets for productivity, process capability Regulations.
and cost? customers requirements if any? Customer requirements, if any.
experience from previous Experience from previous
development.

7.3.2.2 Special characteristics

7.3.12 Does the organization identify special Process to establish special
characteristics and: include all special characteristics.
characteristics in the control plan? comply with Design Record.
customer specified definitions and symbols? Review customer requirements for
identify process control documents including special characteristics, definitions and
drawings, FMEAs, control plans, and o symbol identification.
Control plans.
Product drawings.
Operator instructions.

7.3.3 I Design and development outputs

7.3.13 Does the organization provide outputs of design Design output records matching
and development in a form that enables verification criteria established in design input
against the design and development input and requirements.
approved prior to release? (7.3.3)
7.3.14 Do the organization's design and development DV test reports that show test results;
outputs a) meet the input requirements for design acceptance criteria.
and development? b) provide appropriate Engineering drawings.
information for purchasing, production and for
service provision? c) contain or reference product
acceptance cri
7.3.3.1 Product design outputs - Supplemental
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7.3.15 Is the organization 's product design output Design output records matching
expressed in terms that can be verified and criteria established in design input
validated against product design input requirements.
requirements? (7.3.3.1)
7.3.16 Does the organization's product design output Availability of all applicable product
include: design FMEA, reliability results? product design output documents.
special characteristics, specifications? product
error-proofing, as appropriate? product definition
including drawings? product design reviews
results? diagno
7.3.3.2 Manufacturing process design output
7.3.17 Is the organization's manufacturingprocess design Process specifications and drawings.
output expressed in terms that can be verified Process FMEA's.
against manufacturing process design input Job instructions.
requirements and validated? (73.3.2) Process approval acceptance criteria.
Quality, reliability, maintainability data.
Mistake-proofing activities results.
Nonconformity detectio

7.3.18 Does the organization's manufacturing process Availability of all applicable process
design output include: specifications and drawings? design output documents.
manufacturing process flow chart / layout?
manufacturing process FMEAs? control plan? work
instructions? process approval acceptance criteria?
data for quali

7.3.4 Design and development review

7.3.19 Does the organization perform systematic reviews Design review planning and records.
of design and development at suitable stages in Design review extended to all
accordance with planned arrangements: a) to functions affected by it.
evaluate the ability of the results of design and Product design and development
development to fulfill requirements? b) to identify status reviews.
any pr Link of corrective action to status
reviews.
 Internal Audit Report Company Data

7.3.20 Do the participants in the systematic reviews of Link of corrective action to

design and development identify any problems and status/design reviews.
propose necessary actions? (7.3.4)

7.3.21 Are the records of the results of the reviews and Design review planning and records
any necessary actions maintained by the maintained.
organization? (7.3.4)

7.3.4.1
7.3.22 Does the organization define and analyze Project reviews at different phases of
measurements at specified stages of design and product realization process for all active
development and reported with summary results as projects.
an input to management review? (73.4.1) Policy deployment summary results.
7.3.5 Design and development verification
7.3.23 Does the organization perform design and Design verification done in according
development verification in accordance with to the planning.
planned arrangements to ensure that the design Comparison between outputs and
and development outputs have satisfied the design design requirements.
and development input requirements? (7.3.5) Corrective actions based on results.
7.3.24 Does the organization maintain records of the Design verification reports.
results of the verification and any necessary
actions? (7.3.5)
7.3.6 Design and development validation
7.3.25 Does the organization perform design and Design validation against user
development validation, accordance with planned requirements / needs.
arrangements (see element 7.3.lof ISO/TS Comparison between customer plan
16949:2002) to ensure that the resulting product is and internal development plans.
capable of meeting the requirements for the Design validation records.
specified application or inte Documented failure.
7.3.26 Wherever practicable, does the organization Completion of product validation
complete design and development validation prior testing prior to start of production.
to the delivery or implementation of the product?
(7.3.6)
7.3.27 Does the organization maintain records of the Product validation test report.
results of validation and any necessary actions? Corrective action process for the
(7.3.6) design activity.
Corrective Action Records.
7.3.6.1 Design and development validation - suppler)
 Internal Audit Report Company Data

7.3.28 Does the organization perform design and Design validation against user
development validation in accordance with requirements / needs.
customer requirements including program timing? Comparison between customer plan
(7.3.6,1) and internal development plans.
Design validation records.
Documented failure.
7.3.6.2 Prototype program
7.3.29 When required by the customer, does the Prototype facilities.
organization have a prototype program and control Prototype records.
plan? (73-6.2) Prototype control plan.
7.3.30 Wherever possible, does the organization use the Design / prototype /production tooling.
same suppliers, tooling and manufacturing Prototype realization and test
processes as will be used in production? (7.3.6.2) conditions must be known and controlled.

7.3.31 Does the organization monitor all performance Test records.

testing activities for timely completion and
conformance to requirements? (7.3.6.2)
7.3.32 Is the organization responsible for the Sub-contractor management as
subcontracted services, including technical appropriate.
leadership? (7.3.6.2)
7.3.6.3 Product approval process
7.3.33 Does the organization conform to a product and Compliance with customer
process approval procedure recognized by the requirements regarding product approval
customer? (7.3.6.3) process.
7.3.34 Does the organization apply a product and process Product approval process
approval procedure recognized by the customer to documentation and records for suppliers.
its suppliers? (7.3,63)
7.3.7 Control of design and development changes
7.3.35 Does the organization identify design and Change records.
development changes and maintain records
relevant to those changes? (7.3.7)
7.3.36 Does the organization review, verify and validate Design change approval process
design and development changes, as appropriate,
and approved before implementation? (7.3.7)
7.3.37 Does the organization's review of design and Impact study including proprietary
development changes include evaluation of the design.
effect of the changes on constituent parts and Change management process.
already delivered product? (7.3.7)
7.3.38 Does the organization maintain records of the Change records.
results for the review of design and development
changes and any necessary actions? (7.3.7)
7.4 Purchasing
7.4.1 Purchasing process
 Internal Audit Report Company Data

7.4.1 Does the organization ensure that purchased Organization's incoming inspection.
product conforms to specified purchase Source inspection.
requirements? (7.4.1) Process audit at supplier's site.

7.4.2 Does the organization's type and extent of control Control methods determined by effect
applied to the supplier and the purchased product of the purchased product on subsequent
depend upon the effect of the purchased product product realization or final product.
on subsequent product realization or the final
product? (7.4.1)
7.4.3 Does the organization evaluate and select suppliers Selection system.
based on their ability to supply products in Performance rating system.
accordance with the organization's requirements? Organization's supplier manual.
(7.4.1)
7.4.4 Has the organization established criteria for Selection system.
selection, evaluation, and re-evaluation of its Performance rating system.
suppliers? (7.4.1)
7.4.5 Does the organization maintain records of the Suppliers' 2nd party audit results
results of supplier evaluations and any necessary conducted by the organization.
actions arising from the supplier evaluation? (7.4.1) Approved supplier records.

7.4.1.1 Regulatory compliance

7.4.6 Do all purchase products or materials used in the Audit results from government and
organization 's product satisfy applicable regulatory environment organizations.
requirements? (7.4. 1.1) Supplier Internal Audits.
Warrants or certificates of
compliance.
Audits of suppliers.
7.4.1.2 Supplier quality management system development
7.4.7 Are the organization's suppliers registered to ISO Copies of suppliers' ISO 9001:2000
9001: 2000 by a third party? (7.4.1.2) certificates.
7.4.8 Does the organization perform quality management Supplier development process.
system development with the goal of supplier Evidence of subcontractor
compliance to 1SO/TS 16949:2002(E)? (7.4.1.2) development.

7..4.1.3 Customer-approved sources

7.4.9 Where specified by the contract, does the Approved suppliers list if applicable.
organization purchase products, materials or How are these lists used?
services from approved sources? (7.4.1.3)
7.4.10 Is the organization responsible for ensuring the Scope of organization's incoming
quality of purchased products supplied by inspection includes purchased products
customer-designated sources, including tool/gage supplier by customer- designated
suppliers? (7.4.1.3) sources.
Scope of organization's supplier
management process includes customer-
designated sources.
 Internal Audit Report Company Data

7.4.2 Purchasing information

7.4.11 Does the organization's purchasing information Purchase order / release.
describe the product to be purchased, including Commercial contract.
where appropriate: a) requirements for approval
of product, procedures, processes and equipment?
b) requirements for qualification of personnel? c)
qua
7.4.12 Does the organization ensure the adequacy of Review of contract/purchase order
specified purchase requirements prior to their extends to suppliers.
communication to the supplier? (7.4.2)
7.4.3 Verification of purchased product
7.4.13 Does the organization establish and implement the Incoming inspection plans.
inspection or other activities necessary for ensuring
that purchased product meets specified purchase
requirements? (7.4.3)
7.4.14 Where the organization or its customer intends to Supplier and subcontractors.
perform verification at the supplier's premises, does Purchase order and contract.
the organization state the intended verification
arrangements and method of product release in the
purchasing information? (7.4.3)
7.4.3.1 Incoming product quality
7.4.15 Does the organization have a process to ensure the Incoming inspection.
quality of purchased product utilizing one or more Source inspection.
of the following methods: receipt of, and evaluation 2nd or 3rd party audits of supplier sites.
of, statistical data by the organization? receiving Independent evaluation of
inspection and/or testing such as sampling based acceptability of product by a designated 3r
party.

7.4.3.2 Supplier monitoring

7.4.16 Does the organization monitor supplier Subcontractor performance records.
performance through the following indicators: Subcontractor corrective action.
Delivered part quality performance? Customer
disruptions including field returns? Delivery
schedule performance (including incidents of
premium freight)? (7.4.3.2)

7.4.17 Does the organization promote supplier monitoring Evidence of continuous

of their manufacturing processes' performance? improvements implemented by the
(7.43.2) suppliers through review of their own
monitoring of manufacturing
processes performance.

7.5 Preproduction and service provision

 Internal Audit Report Company Data

7.5.1 Control of production and service provision

7.5.1 Does the organization plan and carry out production Tour of plant and facilities.
and service provision under the following controlled Master part or correct level assembly
conditions, as applicable: a) the availability of drawings.
information that describes the characteristics of the Work instructions at work stations.
product? b) the availability of work inst

7.5.1.1 Control plan

7.5.2 Does the organization: develop control plans at the Control plans for different product
system, subsystem, component and/or material levels.
level, for the product supplied, including those for DFMEA and PFMEA were used as
bulk materials produced by the organization and all inputs to the control plans.
purchased products and materials? have a control
plan

7.5.3 Does the organization 's control plan: list the Review of control plans.
controls used for the manufacturing process Control Plans for applicable stages.
control? includes methods for monitoring and Control Plan framework with data.
recording results of control exercised over special
characteristics (see 7.3.2.3 of ISO/1SO/TS
16949:2002:2002 (E)) de

7.5.4 Does the organization review and update control Matching between product/process
plans when any change occurs affecting product, changes, instability/ non-capability
manufacturing process, measurement, logistics, process results, and control plans
supply sources or FMEA (see 7.1.4 ofSO/TS updating.
16949:2002 (E))? (7.5.1.1)

7.5.1.2 Work instructions

7.5.5 Has the organization prepare documented work Availability of job instructions at the
instructions for all employees having workstation.
responsibilities for the operation of processes?
(7.5.1.2)
 Internal Audit Report Company Data

7.5.6 Are the organization's work instructions accessible Availability of job instructions at the
for use at the workstation? (7.5.1.2) workstation.
7.5.7 Are the organization 's work instructions derived Link between job instructions and
from sources such as the quality plan, the control source documents, e.g. Control Plan,
plan and the product realization process? (7.5.1.2) Design Record, FMEA.
7.5.1.3 Verification of job set-ups
7.5.8 Does the organization verify job set-ups whenever Job set-up records and approval.
performed? (7.5A3)
7.5.9 Are the organization's work instructions available Set-up instructions.
for set-up personnel? (7.5.1.3)
7.5.10 Does the organization use statistical methods of Job set-up records.
verification of job set-ups where applicable?
(7.5.1.3)
7.5.1.4 Preventive and predictive maintenance
7.5.11 Does the organization identify key process Existence of preventive maintenance.
equipment and provide resources for
machine/equipment maintenance and develop an
effective planned total preventive maintenance
system? (7.5.1.4)
7.5.12 Does the organization 's preventive maintenance System effectiveness demonstrated
system minimally include the following: planned by specifics measurement indicator.
maintenance activities? packaging and Key equipment list.
preservation of equipment, tooling and gauging? Maintenance records.
availability of replacement parts for key Predictive maintenance examples.
manufacturing equipment? docume Plant tour.
7.5.13 Does the organization utilize predictive Predictive maintenance examples.
maintenance methods to continually improve the
effectiveness of its preventive system? (7.5.1.4)
7.5.1.5 Tooling management
7.5.14 Does the organization provide resources for tool Tool/gage design staffing and
and gauge design, fabrication and verification qualification.
activities? (7.5.1.5)
7.5.15 Does the organization establish and implement a Tool management process.
system for tooling management including:
maintenance and repair facilities and personnel?
storage and recovery? set-up? tool-change
programmes for perishable tools? tool design
modification documentation, in
7.5.16 Has the organization implemented a system to Sub-contractor management system
monitor its tooling management activities if any (choice, evaluation and control).
work is outsourced? (7.5.1.5)
7.5.1.6 Production scheduling
 Internal Audit Report Company Data

7.5.17 Is the organization's production scheduled in order Process for production scheduling.
to meet customer requirements? (7.5.1.6) The scheduling system should be
based on a "pull" and not on a "push"
system.
7.5.1.7 Feedback of information from service
7.5.18 Has the organization established and maintained a Meeting reports, follow up and
process for communication of information on corrective actions/responsibility/dates.
service concerns to manufacturing, engineering Product service data.
and design activities? (7.5.1.7)
7.5.1.8 Servicing agreement with customer
7.5.19 When there is a servicing agreement with the Planning of periodical audits.
customer, does the organization verify the Reports and follow up.
effectiveness of: any organization service centers?
special purpose tools or measurement equipment?
training of servicing personnel? (7.5.1.8)

7.5.2 Validation of processes for production and service provision

7.5.20 Does the organization validate any processes for all Process validation/capability studies
its production and service provision where the results.
resulting output cannot be verified by subsequent Process parameters monitoring and
monitoring or measurement? (7.5.2) control evidence.
7.5.21 Does the organization's validation of processes for Process validation/capability studies
all its production and service provision demonstrate results.
the ability of these processes to achieve planned
results? (7.5.2)
7.5,22 Has the organization establish arrangements for all Requirement specification for
its processes for production and service provision operations, equipment and personnel.
including, as applicable: a) defined criteria for Related records of qualification.
review and approval of the processes? b) Frequency and conditions of
approval of equipment and qualification of revalidation.
personnel? c)
7.5.3 Identification and traceability
7.5.23 Does the organization identify the product by Check for positive recall.
suitable means throughout product realization? Suitable product identification
(7.5,3) throughout the facility.
Traceability from raw materials to
delivered product.
7.5.24 Does the organization identify the product status Clear identification of work in-
with respect to monitoring and measurement process; finished goods and rejected
requirements? (7.5.3) goods and/or components.
Inspection records.
7.5.25 Where traceability is a requirement, does the Traceability system.
organization control and record the unique
identification of the product (see element 4.2.4 of
ISO/TS 16949:2002? (7-5.3)
 Internal Audit Report Company Data

7.5.4 Customer property

7.5.26 Does the organization exercise care with customer Handling procedure of customer
property while it is under the organization's control property.
or being used by the organization? (7.5.4)

7.5.27 Does the organization identify, verify, protect and Product identification.
safeguard customer property provided for use or Storage environment.
incorporation into the product? (7.5.4)
7.5.28 Does the organization report to the customer and Damage to customer supplied
maintain records for customer property that is lost, product reports.
damaged or otherwise found to be unsuitable for What happened to customer owned
use? (7.5.4) returnable packaging? How was it
accounted for?
7.5.4.1 Customer owned tooling
7.5.29 Are the customer-owned tools, manufacturing, test, Permanent identification of tooling
inspection tooling and equipment permanently and equipment ownership.
marked so thai the ownership of each item is
visible, and can be determined? (7.5.4.1)

7.5.5 Preservation of product

7.5.30 Does the organization preserve the conformity of Procedure development and
product during internal processing and delivery to documentation.
the intended destination? (7.5.5) Plant tour.
7.5.31 Does the organization's preservation of product Product preservation procedures.
include identification, handling, packaging, storage Plant tour.
and protection? (7.5.5)
7.5.32 Does the organization's preservation of production Scope product preservation
apply to the constituent parts of a product? (7.5.5) procedures.
Plant tour.
7.5.5.1 Storage and inventory
7.5.33 Does the organization assess the condition of Storage product specifications.
product in stock at appropriate planned intervals to Inspection records.
detect deterioration? (7.5.5,1) Plant tour.
7.5.34 Does the organization use an inventory Inventory management system.
management system to optimize inventory turns Evidence of FIFO.
over time and assure stock rotation? (7.5.5.1) Control of obsolete product.
7.5.35 Does the organization control obsolete product in a Obsolete products stored in
similar manner to nonconforming product? (7.5.5J) quarantine area.

7.6 Control of monitoring and measuring devices

7.6.1 Has the organization determined the monitoring Test equipment accuracy and
and measurement to be undertaken and the precision capability related to the required
monitoring and measuring devices needed to measurement.
provide evidence of conformity of product to
determined requirements? (7-6)
 Internal Audit Report Company Data

7.6.2 Has the organization established processes to Monitoring and measurement trials
ensure that monitoring and measurement can be during prototype builds.
carried out and are carried out in a manner that is Procedure address in organization's
consistent with the monitoring and measurement quality manual in accordance to ISO/TS
requirements? (7.6) 16949:2002(E).
7.6.3 Where necessary to ensure valid results, are the Test equipment inventory.
organization's measuring equipment: a) Certifications for calibration masters
calibrated or verified at specified intervals, or prior and their traceability to international
to use, against measurement standards traceable national recognized standard.
to international or national measurement Calibration results records.
standards? b) adj Method of control of calibration
settings.
Calibration status

7.6.4 Does the organization assess and record the Records of re-inspected product.
validity of the previous measuring results when the
equipment is found not to conform to
requirements? (7.6)
7.6.5 Does the organization take appropriate action on Actions taken on the equipment that
the equipment that is found not conforming to are found not conforming to requirements
requirements and any product affected it? (7.6) and any product that was affected by it.

7.6.6 Does the organization maintain records of the Gage studies records.
results of calibration and verification (see element
4.2.4 of ISO/TS 16949:2002)? (7.6)
7.6.7 When the equipment is used in the monitoring and Product labeling system.
measurement of specified requirements, has the Customer requirements.
organization confirm the ability of computer Labeling audit.
software to satisfy the intended application? (7.6)
7.6.8 Has the organization undertaken the confirmation Test software / comparative
of computer software satisfying an intended references verification.
application prior to initial use and reconfirmed as
necessary? (7.6)
7.6.1 Measurement system analysis
7.6.9 Does organization conduct statistical studies to Measurement system analysis
analyze the variation present in the results of each studies including Gage Repeatability &
type of measuring and test equipment system? Reproducability.
(7.6.1)
7.6.10 Does the organization conduct measurement Measurement system analysis
system analysis for measurement systems results.
referenced in the control plan? (7.6.1)
7.6.11 Does the organization use measurement system Check methods against customer
analytical methods and acceptance criteria that measurement system analysis
conform to those in customer reference manuals on requirements.
measurement systems analysis? (7.6.1) Customer approval records, for other
analytical methods used.
7.6.2 Calibration Records
 Internal Audit Report Company Data

7.6.12 Does the organization 's records of the calibration Measurement equipment records.
activity for all gauges, measuring and test Original specification of measurement
equipment, including employee- and customer- equipment.
owned gauges, include: a) equipment
identification including the measurement standard
against which the equipmen
7.6.3 Laboratory requirements
7.6.3.1 Internal laboratory
7.6.13 Does the organization 's internal laboratory facility Laboratory Scope.
have a defined scope that includes capability to
perform the required inspection, test or calibration
services? (7.6.3,1)
7.6.14 Is the organization 's lab scope included in the Organization's quality manual per
quality management system and comply with ISO/TS 16949:2002(E).
technical requirements including: adequacy of the
laboratory procedures? qualifications of the
laboratory personnel conducting tests? testing of
the commodity? perf
7.6.3.2 External laboratory
7.6.15 Do the external / commercial/ independent Commercial Laboratory Accreditation
laboratory facilities used for inspection, test or records.
calibration services by the organization have a
defined laboratory scope that includes capability to
perform the required inspection, test or calibration,
and: -
 Internal Audit Report Company Data

Internal Audit Date Internal Auditor 1: Internal Auditor 2:

COP audited Responsible of Area / COP Resposible of area signature

No. Question What to look for NC / IO Comments / Evidence

8 Measurement, analysis and improvement

8.1 General
8.1.1 Has the organization planned and implemented the Internal audit results.
monitoring, measurement, analysis and Product conformance data.
improvement processes needed a) to
demonstrate conformity of the product? b) to
ensure conformity of the quality management
system? c) to continually improve th
8.1.2 Has the organization determined the applicable Methods used for organization's
methods and the extent of their use for its monitoring, measurement, analysis and
monitoring, measurement, analysis and improvement processes.
improvement processes? (8.1)
8.1.1 Identification of statistical tools
8.1.3 Does the organization determine the appropriate Review of control plan.
statistical tools for each process during advance Review of quality plan.
quality planning and included in the control plan? Plant tour.
(8.1.1)
8.1.2 Knowledge of basic statistical concepts
8.1.4 Does the organization understand basic statistical Interview with personnel including
concepts, such as variation, control (stability), management demonstrating the
process capability and over-adjustment? (8.1.2) knowledge of major statistical concepts
like variation and distribution, process
control, cause and effect relationship,
common and special causes.
Statistical techniques training

8.1.5 Does the organization utilize basic statistical Basic statistical study reports.
concepts throughout its establishment? (8.1.2)
8.2.1 Customer satisfaction
8.2.1 Does the organization monitor information relating Review of information relating to
to customer perception as to whether the customer satisfaction routinely/set
organization has met customer requirements as interval.
one of the performance of the quality management Customer satisfaction performance
system? (8.2.1) indicators.
8.2.2 Has the organization determine the methods for Methods for obtaining information
obtaining information relating to customer relating to customer perception as to
perception as to whether the organization has met whether the organization has met
customer requirements? (8.2.1) customer requirements.
 Internal Audit Report Company Data

8.2.1.1 Customer satisfaction - Supplemental

8.2.3 Does the organization monitor customer Continual evaluation of performance
satisfaction through continual evaluation of of realization processes.
performance of the realization processes? (8.21.I)
8.2.4 Are the organization 's performance indicators for Review of performance indicators
customer satisfaction based on objective data and for customer satisfaction.
include, but not be limited to: delivered part quality
performance? customer disruptions including field
returns? delivery schedule performance (including

8.2.5 Does the organization monitor manufacturing Measurement of manufacturing

processes performance to demonstrate compliance processes against compliance to
with customer requirements for product quality and customer requirements.
efficiency of the process? (8.2.1.1)

8.2.2 Internal audit

8.2.6 Does the organization conduct internal audits at Audit schedule.
planned intervals to determine whether the quality Records of performed audits.
management system: a) conforms to the planned
arrangements (see 7.1), to the requirements
ISO/TS 16949:2002 and to the quality management
system require
8.2.7 Has the organization planned for an audit program Appropriate prioritization.
that takes into consideration the status and
importance of the processes and areas to be
audited, as well as the results of previous audits?
(8.2.2)
8.2.8 Has the organization define the internal audit Audit schedule.
criteria, scope, frequency and methods? (8.2.2) Internal audit procedure stated in
quality manual.
8.2.9 Does the organization ensure objectivity and Organization charts.
impartiality of the audit process in the selection of Auditors only conduct audits in areas
auditors and conduct of internal audits? (8.2.2) that are independent of the their job
functions.
8.2.10 Has the organization define the responsibilities and Department or individual responsible
requirements for planning and conducting audits, for internal audit activities and also the
and for reporting results and maintaining records in reporting of audit results to upper
a documented procedure? (8.2.2) management.
8.2.11 Does the management responsible for the area Closure time for audit findings.
being audited ensure that actions are taken without
undue delay to eliminate detected non-conformities
and their causes? (8.2.2)
8.2.12 Does the organization's internal audit follow-up Records of verification.
activities include the verification of the actions
taken and the reporting of verification results (see
element 8.5.2 of lSO/TS 16949:2002)?
 Internal Audit Report Company Data

8.2.2.1 Quality management system audit

8.2,13 Does the organization audit its quality management Audit plans and schedule.
system to verify compliance with ISO/TS Interview with the different area
16949:2002 and any additional quality managers.
management system requirements? (8.2.2.1) Audit reports.
8.2.2.2 Manufacturing process audit
8.2.14 Does the organization audit each manufacturing Audit plans.
process to determine its effectiveness? (8.2.2.2) Audit reports.
8.2.2.3 Product audit
8.2.15 Does the organization audit products at appropriate Audit plan, process flow chart and
stages of production and delivery to verify schedule.
conformance to all specified requirements at a Product audit procedure and reports.
defined frequency? (8.2.2.3)
8.2.2.4 Internal audit plans
8.2.16 Does the organization's internal audits cover all Audit plan.
quality management related processes, activities Audit schedule.
and shifts, and scheduled according to an annual
plan? (8-2-2-4)
8.2.17 Does the organization increase its audit frequency Audit schedule.
appropriately when internal/external non- Appropriate prioritization.
conformities or customer complaints occur?
(8.2.2.4)
8.2.2.5 Internal auditor qualification
8.2.18 Are the organization 's internal auditors qualified to Compliance to customer
audit the requirements of ISO/TS 16949:2002 (see requirements.
element 6.2.2.2)? (8.2.2.5)
8.2.3 Monitoring and measurement of processes
8.2.19 Does the organization apply suitable methods for Methods of
monitoring and, where applicable, measurement of monitoring/measuring quality
the quality management system processes? (8.2.3) management system processes.

8.2.20 Does the organization's methods for monitoring and Monitoring and measurement
measurement of processes demonstrate the ability results.
of the processes to achieve planned results?
(8.2.3)
8.2.21 When planned results are not achieved by the Planned/executed corrective
organization's processes, does the organization actions.
take correction and corrective action to ensure
conformity of the product? (8.2.3)
8:2.3.1 Monitoring and measurement of manufacturing processes
8.2.22 Does the organization perform process studies on Preliminary process capability results.
all new manufacturing processes to verify process Production control plan.
capability and to provide additional input for
process control? (8.2.3,1)
 Internal Audit Report Company Data

8.2.23 Does the organization document the results of Process study reports.
process studies with specifications where Plan/executed actions from process
applicable for means of production, measurement study results.
and test, and maintenance instructions? (8-2.3.1)
8.2.24 Does the organization 's documents for monitoring Monitoring & measurement of
and measurement of manufacturing processes manufacturing processes documents.
include objectives for manufacturing process
capability, reliability, maintainability and availability,
as well as acceptance criteria? (8.2.3.1)

8.2.25 Does the organization maintain manufacturing Current Cpk/Ppk versus customer
process capability or performance as specified by approved Cpk/Ppk.
the customer part approval process requirements? Existing reaction plan.
(8.2.3.1) Verifying the accuracy of Cpk/Ppk
calculations.
8.2.26 Does the organization ensure that the control plan Review of production line to process
and process flow diagram are implemented, flow diagram and control plan.
including adherence to the specified: measurement
techniques? sampling plans ? acceptance criteria?
reaction plans when acceptance criteria are not
met? (8.2.3.1)
8.2.27 Does the organization note significant process Review of control charts.
events on the control charts? (8.2.3.1)
8.2.28 Does the organization initiate the appropriate Records of reaction taken.
reaction plan from the control plan for
characteristics that are either unstable or non-
capable? (8.2.3.1)
8.2.29 Does the organization's reaction plans for Contents of reaction plan for unstable
characteristics that are either unstable or non- and non- capable processes.
capable include containment of product and 100% Records.
inspection as appropriate? . (8.2.3.1)
8.2.30 Does the organization establish a corrective action Corrective action reports.
following the initiation of reaction plans, indicating
specific timing and assigned responsibilities to
assure that the process becomes stable and
capable? (8.2.3.1)
8.2.31 Are the organization's corrective action plans Corrective action approval process.
reviewed with and approved by the customer when Corrective action reports.
so required? (8.2.3.1)
8.2.32 Does the organization maintain records of effective Records of process change dates.
dates of process changes? (8.2.3.1)
8.2.4 Monitoring and measurement of product
8.2.33 Does the organization monitor and measure the Control plans.
characteristics of the product to verify that product Inspection instructions.
requirements have been met? (8.2.4) Records.
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8.2.34 Does the organization monitor and measure the Control plans.
characteristics of the product at appropriate stages Inspection instructions.
of the product realization process in accordance Records.
with the planned arrangements (see element 7.1 of
ISO/TS 16949:2002)? (8.2.4)
8.2.35 Does the organization maintain evidence of product Inspection records that include
conformity with the acceptance criteria? (8.2.4) acceptance criteria, inspector performing
the test, test status and, testing date.
8.2.36 Does the organization's records on monitoring and Inspection records that indicate the
measurement of product indicate the person(s) person(s) authorizing release of product.
authorizing release of product (see element 4.2.4 of
ISO/ISO/TS 16949:2002:2002 (E))? (8,2.4)
8.2.37 Are the organization's product release and service Release of product and service
delivery proceed only after all the planned delivery after all planned arrangement is
arrangements (see element 7.1 of ISO/TS satisfactorily completed.
16949:2002) have been satisfactorily completed,
unless otherwise approved by a relevant authority,
and where applicable
8.2.4.1 Layout inspection and functional testing
8.2.38 Does the organization perform a layout inspection Layout inspection reports.
and a functional verification to applicable customer Control plan.
engineering material and performance standards
for all products at a sufficient frequency as
specified in the control plan? (8.2.4 A)
8.2.39 Does the organization have layout inspection and Inspection records that include
functional testing results available for customer acceptance criteria, inspector performing
review? (8.2.4.1) the test, test status and, testing date.
8.2.4.2 Appearance items
8.2.40 For organizations manufacturing parts designated Maintenance/Control and storage
by the customer as "appearance items", does the conditions of masters.
organization provide: appropriate resources Visual aids.
including lighting for evaluation? masters for color, Personnel qualification / training
grain, gloss, metallic brilliance, texture, distinctness records.
of Tour of facility.
8.3 Control of nonconforming product
8.3.1 Does the organization ensure that product which Follow one or more nonconforming
does not conform to product requirements is case and verify the flow (identification,
identified and controlled to prevent its unintended segregation, etc.).
use or delivery? (8.3) Obsolete products.
8.3.2 Does the organization define the controls and Procedure address in quality manual.
related responsibilities and authorities for dealing
with nonconforming product a documented
procedure? (8.3)
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8.3.3 Does the organization deal with nonconforming Follow one or more non-conforming
product by one or more of the following ways: a) case and verify the visual identification
by taking action to eliminate the detected and segregation area.
nonconformity? b) by authorizing its use, release Records of concession.
or acceptance under concession by a relevant
authority and, wh
8.3.4 Does the organization maintain records of the Records.
nature of nonconformities and any subsequent
actions taken, including concessions obtained (see
element 4.2.4 of ISO/TS16949:2002(E))? (8.2.3)

8.3.5 When nonconforming product is corrected, does Instruction for re-qualifying

the organization re-verify to demonstrate conformity corrected nonconforming product.
to the requirements? (8.2.3)
8.3.6 When nonconforming product is detected after Follow one or more
delivery or use has started, does the organization nonconforming case and verify the
take action appropriate to the effects, or potential flow (identification, segregation,
effects, of the nonconformity? (8.2.3) etc.).
8.3.1 Control of nonconforming product - supplemental
8.3.7 Does the organization classify unidentified or Follow one or more
suspect status product as nonconforming product nonconforming case and verify the
(see element 7.5.3 of lSO/TS 16949:2002)? (8.3.1) flow (identification, segregation,
etc.).
8.3.2 Control of reworked product
8.3.8 Are the organization's instructions for rework, Rework instructions.
including re-inspection requirements accessible
and utilized by the appropriate personnel? (8.3.2)
8.3.3 Customer information
8.3.9 Does the organization inform the customers Follow one or more nonconforming
promptly in the event that nonconforming product case and verify the flow (identification,
has been shipped? (8.3.3) segregation, etc.).
Procedure stated in quality manual.
8.3.4 Customer waiver
8.3.10 Does the organization obtain customer concession Follow one or more nonconforming
or deviation permit prior to further processing case and verify the flow (identification,
whenever the product or manufacturing process is segregation, etc.).
different from that which is currently approved?
(8.3.4)
8.3.11 Does the organization maintain a record of the Record of concession with expiration
expiration date or quantity authorized by customer date.
concession or deviation permit? (8.3.4)
8.3.12 Does the organization ensure compliance with the Inspection results.
original or superseding specifications and
requirements when the authorization for deviation
expires? (8.3.4)
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8.3.13 Does the organization properly identify on each Proper label/identification for material
shipping container material shipped on an shipped on authorization.
authorization? (8.3.4)
8.3.14 Does the organization apply the customer waiver Process define in quality manual.
requirements for production product to purchased
product as well? (8.3.4)
8.3.15 Does the organization agree with any product Process define in quality manual.
concession requests from suppliers before
submission to the customer? (8.3.4)
8.4 Analysis of data
8.4.1 Does the organization determine, collect and Internal performance data such as:
analyze appropriate data to demonstrate the Poor quality cost indicators, Effectiveness
suitability and effectiveness of the quality and efficiency of production processes,
management system and to evaluate where Test results, Process capability data,
continual improvement of the effectiveness of the Quality audits, Results of product
quality management system can b inspections, Internal and external quality
data, Subcont

8.4.2 Does the organization's data analysis include data Data analysis report.
generated as a result of monitoring and
measurement and from other relevant sources?
(8.4)
8.4.3 Does the organization's analysis of data provide Data analysis report.
information relating to: a) customer satisfaction
(see element 8.2.1 of ISO/TS 16949:2002)? b)
conformance to product requirements (see element
7.2.1 of ISO/TS 16949:2002)? c) characteristics
and tr
8.4.1 Analysis and use of data
8.4.4 Does the organization compare trends in quality Customer problem resolution.
and operational performance compared with Comparison of trends to objectives
progress toward objectives and lead to action to (goals).
support the following: development of priorities for Specific actions to trend analysis.
prompt solutions to customer-related problems? Prioritization of action.
determination of
8.5 Improvement
8.5.1 Continual improvement
8.5.1 Does the organization continually improve the Examples of continuous projects
effectiveness of the quality management system initiated from quality policy, quality
through the use of the quality policy, quality objectives, audit results, analysis of data,
objectives, audit results, analysis of data, corrective corrective and preventive actions and
and preventive actions and management review? management review.
(8.5.1)
8.5.1.1 Organization continual improvement
8.5.2 Has the organization define a process for continual Procedure as stated in quality
improvement? (8.5.1.1) manual.
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8.5.1.2 Manufacturing process improvement

8.5.3 Does the organization 's continual improvement Records showing improvement in
focus upon control and reduction of variation in special characteristics.
products of characteristics and manufacturing Reduction in process parameter
process parameters? (8.5.1.2) variation.
8.5.2 Corrective action
8.5.4 Does the organization take action to eliminate the Examples.
cause of non-conformities in order to prevent
recurrence? (8.5.2)
8.5.5 Are the organization's corrective actions Review examples.
appropriate to the effects of the non- conformities
encountered? (8.5.2)
8.5.6 Has the organization established a documented List of customer complaints. Root
procedure to define requirements for: a) Cause Analysis and records.
reviewing non-conformities (including customer Determination of corrective action
complaints)? b) evaluating the need for action to needed.
ensure that non-conformities do not recur? c) Corrective action taken.
determining and Corrective action effectiveness.
8.5.2.1 Problem solving
8.5.7 Does the organization have a defined process for Problem solving process used by
problem solving leading to root cause identification organization.
and elimination? (8.5.2.1)
8.5.8 If a customer-prescribed problem solving format Responses to customer complaints.
exists, does the organization use the prescribed Customer formats.
format? (8.5.2.1)
8.5.2.2 Error-proofing
8.5.9 Does the organization use error-proofing methods Examples.
in their corrective action process? (8.5.2.2)
8.5.2.3 Corrective action impact
8.5.10 Does the organization apply the corrective action, Review of documents related to
and controls implemented, to eliminate the cause of similar products and processes.
a nonconformity to other similar processes and
products? (8.5.2.3)
8.5.2.4 Rejected product test/analysis
8.5.11 Does the organization analyze parts rejected by the List of returned parts.
customer's manufacturing plants, engineering Records of analysis.
facilities, and dealerships? (8.5.2.4) Minimalization of cycle time.
8.5.12 Does the organization minimize the cycle time of its Review product test/analysis process.
rejected product test/analysis process? (8.5.2.4)

8.5.13 Does the organization keep records of its rejected Records.

product test/analyses and make available upon
request? (8.5.2.4)
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8.5.14 Does the organization perform analysis and, initiate Examples.

corrective action to prevent recurrence? (8.5.2-4)

8.5.3 Preventive action

8.5.15 Does the organization determine action to eliminate Examples.
the causes of potential non-conformities in order to
prevent their occurrence? (8.5.3)
8.5.16 Are the organization's preventive actions Examples.
appropriate to the effects of the potential problems?
(8.5.3)
8.5.17 Has the organization establish a documented Sources of information used for
procedure to define requirements for: a) preventive action.
determining potential non- conformities and their Root cause determination (FMEA,
causes? b) evaluating the need for action to FTA, etc).
prevent occurrence of non-conformities? c) Records and result analysis.
determining and impleme