ISO TS 16949 2009 Audit Checklist
ISO TS 16949 2009 Audit Checklist
ISO TS 16949 2009 Audit Checklist
SCORING LEGEND:
C – Complies, O – Observation, N – Nonconformity, N/A – Not Applicable,
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ISO TS 16949:2009 Audit Checklist
QUESTIONNAIRES EVIDENCE TO CHECK FINDINGS SCORE
4 QUALITY MANAGEMENT SYSTEM
4.1 General Requirements
4.1q1 Has the organization established, Evidences of this question can be demonstrated
documented, implemented and throughout the audit.
maintained a QMS and continually
improved its effectiveness in
accordance with ISO/TS 16949:2009?
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ISO TS 16949:2009 Audit Checklist
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T4.1.1q1 Does the organization have adequate
control over outsourced processes to
ensure conformity to all customer
requirements?
(See 7.4)
4.2.1q1b Does Organization have a Review the Quality Manual, and note the doc.
quality manual? ISO/TS and rev.
16949:2009, Art 4.2.1(b)
4.2.1q1c Does the organization have the a) Review the procedure master list and confirm
documented procedures required by that all mandatory procedures are included.
ISO 9001:2008? b) Take a photo of the master list.
ISO/TS 16949:2009, Art 4.2.1(c)
4.2.2q1b Does the quality manual (QM) contain Check if doc numbers of procedures are written
or reference the documented at relevant section of the QM to indicate
procedures established for the QMS? appropriate procedure applied.
ISO/TS 16949:2009, Art 4.2.2(b)
4.2.2q1c Does the quality manual include a a) Check if there a document in annex of QM or
description of the interaction out of the QM, as document describing
between the processes of the QMS? interaction between processes.
ISO/TS 16949:2009, Art 4.2.2(c) b) Take photo of the map.
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4.2.3q2a Is there a documented procedure that a) Ask for the procedure of document control,
defines the controls needed for and note its doc. #. and current revision in the
approve INTERNAL documents for report.
adequacy prior to issue? b) Check if this procedure contain clear
ISO/TS 16949:2009, Art 4.2.3 requirements need for: -
Ensuring the legibility and identification
- Authorities for approve prior to issue -
Ensure that only latest rev. at workplace
- Ensure the identification of changes
4.2.3q2f Is there a documented procedure that a) Ask if there is a master list containing all
defines the controls needed for documents for QMS, with doc title, doc. #..
ensure that documents of EXTERNAL Current revision. And distribution record / name
origin are identified and their of users.
distribution controlled? b) Select few docs from the master list, and
ISO/TS 16949:2009, Art 4.2.3 cross check on site (User hands) if these docs
have same doc. #., rev. #., and accurate #. of
copy distributed.
4.2.3q2g Is there a documented procedure that a) Ask the responsible to explain how to prevent
defines the controls needed for the use of obsolete documents. b) Check
prevent the unintended use of if there is a documented procedure for:
obsolete documents, and to apply - Identification of obsolete doc.
suitable identification to them if they - Retention period and location c)
are retained for any purpose? Note the doc #.. and current rev. in this report.
ISO/TS 16949:2009, Art 4.2.3
T4.2.3.1q2 Does the review occur in two weeks Check if the company includes time spent to
or less? implement.
ISO/TS 16949:2009, Art 4.2.3.1
T4.2.3.1q3 What records do you have showing a) Check if the company maintains a record of
implementation dates of changes? Is changes in engineering specifications from
there evidence showing that customers or regulatory or industry documents?
documents are updated? ISO/TS b) Randomly select two cases from the list, and
16949:2009, Art 4.2.3.1 ask them to show you record of implementation
of such changes in others documents (ie
FMEA, Control Plans...etc).
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ISO TS 16949:2009 Audit Checklist
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4.2.4 Control of Records
4.2.4q1 What records exist that provide a) Check if the company has a master list that
evidence of conformity to with all quality records with detail of:
requirements and of the effective - Name / template #..
operation of the QMS? (Should be - Creation method (handwriting / elec)
reviewed throughout the audit) - Resp. for initiate and approve.
ISO/TS 16949:2009, Art 4.2.4 - Retention period / location
- Saving form (in paper or electronic)
- Disposal method after expiration.
b) Take photo of the master list
4.2.4q2 Are records legible, readily Should be reviewed throughout the audit.
identifiable and retrievable?
ISO/TS 16949:2009, Art 4.2.4
4.2.4q3 Does Organization have a Review the procedure and note its doc. #. and
documented procedure defining the current revision.
controls needed for the identification,
storage, protection, retrieval,
retention time and disposition of
records?
ISO/TS 16949:2009, Art 4.2.4
T4.2.4.1q1 Have the record requirements been Should be reviewed throughout the audit.
reviewed to ensure conformance with Review few records at every process to see if
regulatory and customer there is signature / name of the operator and for
requirements? the reviewer and approver.
ISO/TS 16949:2009, Art 4.2.4.1
5 MANAGEMENT RESPONSIBILITY
5.1 Management Commitment
5.1q1a Does top management communicate a) Review records (with attendance) of meeting
the importance of meeting customer held by top management. b)
and statutory and regulatory Review records of meeting related to any new
requirements to the organization? project.
5.1q1b Has a company quality policy (QP) a) Check if there QP documented, hand signed
been established? (See 5.3) by top management.
b) Check if QP is posted in public board for all
employees to view. And, eventually take a
photo of it.
5.1q1c Has company established a) Check if the quality objectives are hand
quality objectives and signed by all managers and published.
communicated all members? b) Ask them to explain and demonstrate that
(See 5.4.1) quality objectives are aligned to fit with policy.
5.1q1e Does top management ensure the a) Manpower list at each position
availability of resources to support b) Machine and facility
and continually improve the QMS?
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5.2 Customer Focus
5.2q1 Has top management ensured that a) Check if there is any responsible person or
customer requirements are group dedicated for identification of customer
determined and met with the aim of requirements.
enhancing customer satisfaction? b) Check if there any records showing a list of
identified requirements per customer, and
related procedures or method applied to fit
them.
5.3q1b Does the quality policy include a Read the quality policy.
commitment to comply with
requirements and continually
improve QMS effectiveness?
5.3q1c Are the contents of the quality policy Read the quality policy and ask them to explain
relevant to the organization and how the company measures them.
measurable?
5.3q1d Is the quality policy communicated a) Check if there is QP documented and hand
and understood within the signed by top management.
organization? b) Check if QP is posted in public board for all
employees to view.
5.4 Planning
5.4.1 Quality Objectives
5.4.1q1 Has top management established Check if the quality objectives are hand signed
quality objectives (including those by all managers and published.
needed to meet requirements for
product) at relevant functions and
levels within the organization?
5.4.1q2 Are the quality objectives consistent a) Ask them to explain how quality objectives
with the quality policy? What are the are aligned to fit with quality policy.
measurements? b) Review record of measurement of last year,
and for this year.
c) Check if the result are published and take a
photo of quality objectives.
T5.4.1.1q1 Are quality objectives and Check if the quality objectives are hand signed
metrics included in the by all managers and published.
business plan?
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ISO TS 16949:2009 Audit Checklist
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5.4.2q1b How do you ensure that the integrity a) Check if there is a document as guideline to
of the QMS is maintained when handle any changes that could potentially
changes to the QMS are planned and happen, note doc. #. / rev.
implemented? b) Check if the company has a reaction plan
with responsible for implementing changes.
T5.5.1.1q1 Are managers responsible for a) Check if there a document that describes the
corrective action informed of flow for the communication of quality issues,
nonconforming products or and note the doc. #. / rev.
processes? b) Check if a record of internal / external
Are they informed in a timely manner? complaints are maintained.
T5.5.1.1q2 Do personnel responsible for product Review JD for Quality Manager / Supervisor
quality have the authority to stop and check if this is included.
production to correct quality
problems?
T5.5.1.1q3 What personnel on each shift have Check if there is a representative of the Quality
responsibility for ensuring product Department in charge of quality for the whole
quality? company. Note his/her name.
5.5.2q1a Does the MR have responsibility and Review JD for MR and check if this is included.
authority to ensure that processes
needed for the QMS are established,
implemented and maintained?
5.5.2q1b Does the MR have the responsibility a) Review the organization chart and the
to report to top management on the position of MR, including report line.
performance of the QMS and any need b) Review his last report submitted to top
for improvement? management (Is this signed by the MR?)
5.5.2q1c Does the MR have the responsibility Review JD for MR, and check if this is included.
to ensure the promotion of awareness
of customer requirements throughout
the organization?
T5.5.2.1q1 Has top management designated as Check if there is nomination letter, take photo of
Customer Representative to ensure that letter.
that customer requirements are
addressed?
T5.5.2.1q2 Does their responsibility and authority Review JD for customer representative and
include selection of special check if this is included.
characteristics, setting quality
objectives and related training,
corrective and preventive actions,
product design and development?
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5.5.3 Internal Communication
5.5.3q1 How is information regarding the a) Check if the company has defined clear
effectiveness of the QMS methods (email, fax, telephone, meeting, paper
communicated within the record) for communication of information.
organization? b) Check if the implementation of these are
effective and their efficiency monitored (On time
delivery, accuracy).
5.6.1q2 What kinds of information are Check the scope of management review -
reviewed in management reviews? suitability, adequacy and effectiveness of QMS;
(Must include suitability, adequacy improvement; & changes to the QMS, quality
and effectiveness of QMS; policy and objectives.
improvement; & changes to the QMS,
quality policy and objectives)
5.6.1q3 Can you show me records from recent Check records of last two management reviews
management reviews? and compare status of improvement between
both.
T5.6.1.1q1 Do management reviews include all Verify records of last two management reviews.
requirements of the quality
management system and performance
trends? (Verify records)
T5.6.1.1q2 Can you show management review Verify records of last two management review.
records including monitoring of
quality objectives, and cost of poor
quality metrics? (Verify records)
T5.6.1.1q3 Can you show records providing Verify records performance of each objectives
evidence of achievement of the and take photo.
quality objectives specified in the
business plan, and customer
satisfaction with product supplied?
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ISO TS 16949:2009 Audit Checklist
QUESTIONNAIRES EVIDENCE TO CHECK FINDINGS SCORE
6 RESOURCE MANAGEMENT
6.2 Provision of Resources
6.1q1a What resources has the organization Review factory profile.
provided to implement and maintain
the QMS and continually improve its
effectiveness?
6.1q1b What resources has the organization Evidence on question (See 6.2, 6.3, 6.4) will be
provided to ensure that customer acceptable.
requirements are met?
(See 6.2, 6.3, 6.4)
6.2.2q1b What training or other actions do you a) Verify if a periodical (annual) training plan is
provide to satisfy the needs of documented.
personnel? b) Take a photo of the training program.
6.2.2q1c When you provide training or other a) Verify if there is method for evaluating
actions to satisfy competence needs, effectiveness of training provided, and name of
how do you evaluate the effectiveness examiner.
of those actions? (records) b) Verify of the trainer is the same person
that conduct evaluation.
6.2.2q1e Where do you maintain records Select three training topics from the training
of education, training, skills program, and verify if related training records
and experience? are available and fit with the program.
T6.2.2.1q1 What tools and techniques has the a) Verify if Autocad, Pro/E…ERP system or any
organization identified as necessary similar system is applied for design personnel.
for product design personnel? b) Note revision number of those design tools.
T6.2.2.1q2 What records do you have showing Verify design personal skill matrix and related
that product design personnel are certificate / training record.
competent to design and are skilled in
the identified tools and techniques?
T6.2.2.2q1 Can you show me documented Check the existence of the procedure, and note
procedures for identifying training doc. #. / rev.
needs and achieving competence of
all personnel performing activities
affecting product quality?
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T6.2.2.2q2 What records do you have that a) Verify record of training / certificate of
personnel performing specific personnel performing key process (for
assigned tasks are qualified - example).
especially to meet customer b) Verify record of training / certificate of
requirements? (See 6.2.2e) personnel for specific client requirement, note
the specific client is possible.
T6.2.2.3q2 How do you inform personnel about Select a few workers at the manufacturing area,
the consequences to the customer of and ask them to show the defect part and
nonconformity to quality explain the consequence of this defective part.
requirements? (Sample throughout
organization)
T6.2.2.4q3 What process has been established to a) Is there any questionnaire test for employee
measure the extent to which to evaluate their knowledge?
personnel are aware of the relevance
and importance of their activities and
how they contribute to the
achievement of the quality
objectives?
(See 6.2.2d)
6.3 Infrastructure
6.3q1a Are the buildings, workspace and a) Visit the facility, specially the condition of how
utilities provided appropriate to product / material are stored.
achieve conformity to product b) Verify if the factory has a maintenance
requirements? program.
How are they maintained?
6.3q1b What kind of process equipment Listed in the factory profile, take photos.
(both hardware and software) is
necessary to conform to product
requirements? How is the equipment
maintained?
6.3q1c What supporting services (such as Listed in the factory profile and take photos.
transport or communication) are
needed to ensure that product meets
requirements? How are they
maintained?
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T6.3.1q2 Can you show that plant layouts a) Is the pathways visible defined for material
optimize material travel, handling storage, machines position and peoples
and floor space use, and facilitate rotation? Take photo.
synchronous material flow? b) Is the direction of moving clearly marked?
T6.3.1q3 What methods are used to evaluate Record of periodical evaluation of time used to
and monitor the effectiveness of move material from this location to another
existing operations? place, a long a certain pathway.
7 PRODUCT REALIZATION
7.1 Planning of Product Realization
7.1q1 Are the processes needed for product Verify if there a process map or flow chart for
realization identified? product realization and note doc #. / rev.
7.1q2 Is the planning of product realization Check the relation between this process with
consistent with the requirements of others process. Define where it gets input and
the other processes of the QMS? where its output goes.
Verify there are no inconsistencies or
conflicts between quality system
procedures.
7.1q3a Where in the product realization a) Verify if the step for the identification of product
process do you determine the quality requirements are planned.
objectives and requirements for b) Check if there a record as example of any
products? product.
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7.1q3c How do you determine verification, a) Verify if there is planning defining method for
validation, monitoring, inspection and verification, validation…etc.
test activities specific to the product, b) Check if there a record as example of any
and the criteria for product product.
acceptance?
7.1q3d What records exist showing that both Check if there a record as example of any
the realization processes and the product.
product meet requirements?
7.1q4 What are the outputs of product Verify if there a documented planning.
realization planning? Are they in a
form suitable for the organization?
T7.1.2q2 When attribute data sampling, is the Check the inspection criteria.
acceptance level zero defects?
7.1.3 Confidentiality
T7.1.3q1 How does the organization ensure
the confidentiality of customer-
contracted products, projects under
development, and related product
information?
7.1.4 Change Control
T7.1.4q1 What process is there to control
and react to changes that impact
product realization?
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7.2.1q1d Does the organization determine any
additional requirements determined
by the organization.
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7.3.1q3 How does the organization ensure
effective communication and clear
assignment of responsibility
between different groups involved
in design and development?
7.3.2q3 How does the organization ensure NOTE: Special characteristics (see 7.2.1.1) are
that requirements are complete, included in this requirement.
unambiguous and don’t conflict with
each other?
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7.3.3 Design and Development Outputs
7.3.3q1 How can design and development
outputs be verified against the
inputs? (see 7.3.5q1) Are these
outputs approved prior to release?
T7.3.3.1q1 Can you show that the manufacturing The manufacturing process design output shall be
process design outputs include expressed in terms that can be verified against
- specifications and drawings, manufacturing process design input requirements
- manufacturing process flow chart/ layout,
and validated.
- manufacturing process FMEAs,
- control plans,
- work instructions,
- process approval acceptance criteria,
- data for quality, reliability, maintainability
and measurability
- results of error-proofing activities, as
appropriate, and
- methods of rapid detection and feedback of
product/manufacturing process
nonconformities.
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T7.3.6.1q1 Is design and development validation
performed in accordance with
customer requirements, including
program timing?
7.4 PURCHASING
7.4.1 Purchasing Process
7.4.1q1 How do you ensure that purchased
product conforms to specified
purchase requirements?
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T7.4.1.3q1 Do your customer(s) specify
supplier(s) in contracts/ purchase
orders?
This includes products, materials,
services, tooling, & gages, etc.
If so, can you show that the
customer- designated sources are
being used as required?
T7.4.3.1q1 What processes are in place to Must include one or more of following:
assure the quality of purchased - evaluation of supplier statistical data
product? - receiving inspection and/or testing
- second- or third-party audits of suppliers, along
with records of acceptable quality
- laboratory part evaluation
- another method agreed with the customer
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7.5.1q1d When carrying out production (or
service) are appropriate gages, etc.
used in production (or service)?
(See 7.6)
7.5.1q1e When carrying out production (or
service) are appropriate kinds of
monitoring and measurement
done? (See 8.2.4)
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T7.5.1.4q2 What predictive maintenance
methods do you use? Can you
demonstrate that predictive
maintenance has resulted in
continual improvement of the
effectiveness and efficiency of
production equipment?
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7.5.4 Customer Property
7.5.4q1 Do you use any customer-owned
property, such as product,
packaging, drawings, tooling,
gages, etc
If so, ask questions below.
7.5.4q2 How do you ensure that customer-
owned property is identified, verified,
protected, and safeguarded?
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7.6q7 Do you use computer software for
monitoring and measurement? If so,
is its ability to perform that function
confirmed prior to initial use and
reconfirmed as necessary?
T7.6.1q1 Can you show me R&R studies for Is there other statistical studies analyzing the
each type of measuring and test variation in measurement & test results?
equipment system referenced in the
control plan?
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8 MEASUREMENT, ANALYSIS AND IMPROVEMENT
8.1 General
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8.2.2q5 Can you show me your internal audit
procedure? Can you show me the
records of internal QMS audits?
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T8.2.3.1q4 Do records show that manufacturing
process capability or original
customer- approved performance is
being maintained?
8.2.4q5 How do you ensure that product is not NOTE: When selecting product parameters to
released until the all requirements monitor compliance to specified internal and
have been met? If product must be external requirements, the organization
released prior to this, how is it determines the types of product characteristics,
approved? leading to
- the types of measurement
- suitable measurement means, and
- the capability and skills required
T8.2.4.1q1 Can you show me layout inspection NOTE: Layout inspection is the complete
and functional verification results? measurement of all product dimensions shown on
Do they address applicable customer the design records.
specifications and correlate with the
control plan requirements?
Are results available for customer
review?
T8.2.4.2q1 Do you provide parts designated by If so can you show that you have:
customer(s) as appearance items? If - appropriate resources including lighting for
so, what support to you have? evaluation
- masters for color, grain, gloss, metallic brilliance,
texture, distinctness of image (DOI), as
appropriate
- maintenance and control of appearance masters
and evaluation equipment, and
- verification that personnel making appearance
evaluations are competent and qualified to do so
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8.3q2 Can you show me your documented
procedure defining the controls for
dealing with nonconforming
product? Does it include related
responsibilities and authorities?
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8.5 Improvement
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8.5.3 Preventive Action
8.5.3q1 How do you determine potential
nonconformities to take action one?
Do preventive action records identify
and address root cause(s)?
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