IATF 16949:2016 QMS AUDIT CHECKLIST

Audit Area : Audit Date :

Auditee : Auditor :

IATF Clause No :

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Clause Requirements Item Audited / Questions Remarks
Yes No (If any)
7 SUPPORT
7.1 Resources
7.1.1 General
The organization shall determine and provide the 1) Demonstrate how resources are determined for
resources needed for the establishment, the establishment, implementation, maintenance
implementation, maintenance and continual and continual improvement of the QMS?
improvement of the quality management system.
The organization shall consider: 2) Show me how the capabilities and constraints on
internal resources are considered?
a) the capabilities of, and constraints on, existing
internal resources; 3) Show me how needs from external providers are
b) what needs to be obtained from external considered?
providers.

7.1.2 People
The organization shall determine and provide the How do you provide persons necessary to
persons necessary for the effective implementation consistently meet customer, applicable statutory and
of its quality management system and for the regulatory requirements for the QMS including the
operation and control of its processes. necessary processes?

7.1.3 The organization shall determine, provide and How do you determine, provide and maintain the
maintain the infrastructure necessary for the infrastructure for the operation of processes to
operation of its processes and to achieve conformity achieve products and service conformity?
of products and services.
a) buildings and associated utilities;
b) equipment, including hardware and software;
c) transportation resources;
d) information and communication technology.

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Clause Requirements Item Audited / Questions Remarks
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7.1.3.1 Plant, facility, and equipment planning
The organization shall use a multidisciplinary
approach including risk identification and risk
mitigation methods for developing and improving
plant, facility, and equipment plans. In designing
plant layouts, the organization shall:

a) optimize material flow, material handling, and

value added use of floor space including control of
nonconforming product; and
b) facilitate synchronous material flow, as applicable;
and
c) implement cyber protection of equipment and
systems supporting manufacturing

Methods shall be developed and implemented to

evaluate manufacturing feasability for new product
or new operations. Manufacturing feasability
assessments shall include capacity planning. These
methods shall also be applicable for evaluating
proposed changes to existing operations.

The organization shall maintain process

effectiveness, including periodic re-evaluation
relative to risk, to incorporate any changes made
during process approval, control plan maintenance
(see Section 8.5.1.1), and verification of job set-ups
(see Section 8.5.1.3)

Assessment of manufacturing feasibility and

evaluation of capacity planning shall be inputs to
management reviews (see ISO 9001, Section 9.3)

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7.1.4 Environment for the operation of processes
The organization shall determine, provide and How do you determine, provide and maintain the
maintain the environment necessary for the environment for the operation of processes to
operation of its processes and to achieve conformity achieve products and service conformity?
of products and services.

a) social (e.g. non-discriminatory, calm, non-

confrontational);
b) psychological (e.g. stress-reducing, burnout
prevention, emotionally protective);
c) physical (e.g. temperature, heat, humidity, light,
airflow, hygiene, noise).

These factors can differ substantially depending on

the products and services provided.

7.1.4.1 Environment for the operation of processes -

supplemental
The organization shall maintain its premises in a state How do you maintain this premises in a state of
of order, cleanliness, and repair that is consistent order, cleanliness, and repair?
with the product and manufacturing process needs

7.1.5 Monitoring and measuring resources

7.1.5.1 General
The organization shall determine and provide the 1) How are the resources determined for ensuring
resources needed to ensure valid and reliable results valid and reliable monitoring and measuring results,
when monitoring or measuring is used to verify the where used?
conformity of products and services to requirements.
2) How do you ensure that resources provided are
The organization shall ensure that the resources suitable for the specific monitoring and
provided: measurement activities and are maintained to ensure
continued fitness for purpose?
a) are suitable for the specific type of monitoring and
measurement activities being undertaken; 3) Show me the documented information which is
b) are maintained to ensure their continuing fitness evidence of fitness for purpose of monitoring and
for their purpose. measurement resources?

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The organization shall retain appropriate
documented information as evidence of fitness for
purpose of the monitoring and measurement
resources.

7.1.5.1 Measurement system analysis

.1 Statistical studies shall be conducted to analyse the 1) Do you have MSA record?
variation present in the results of each type of
inspection, measurement, and test equipment 2) Is there any customer approval on alternative
system identifieed in the control plan. The analystical methods use? Do retain the record?
methods and acceptance criteria used shall conform
to those in reference manuals on measurement 3) Do you analyze variation in measurement in
system analysis. Other analytical methods and inspection equipment?
acceptance criteria may be used if approved by the
customer.

Records of customer acceptance of alternative

methods shall be retained along with results from
alternative measurement system analysis (see
Section 9.1.1.1)

7.1.5.2 Measurement traceability

When measurement traceability is a requirement, or 1) Where applicable, show me how measurement
is considered by the organization to be an essential instruments are:
part of providing confidence in the validity of
measurement results, measuring equipment shall be: a) Verified or calibrated at specified intervals against
national or international measurement standards.
a) calibrated or verified, or both, at specified b) If there are no standards, show me the
intervals, or prior to use, against measurement documented information which is used as the basis
standards traceable to international or national used for calibration or verification.
measurement standards; when no such standards
exist, the basis used for calibration or verification 2) Show me how measurement instruments are
shall be retained as documented information; identified to determine their calibration status.
b) identified in order to determine their status;
c) safeguarded from adjustments, damage or 3) Show me how they are safeguarded from
deterioration that would invalidate the calibration adjustments.
status and subsequent measurement results.

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The organization shall determine if the validity of 4) Show me how they are safeguarded from damage
previous measurement results has been adversely and deterioration.
affected when measuring equipment is found to be
unfit for its intended purpose, and shall take 5) How do you determine the validity of previous
appropriate action as necessary. measurements if you find an instrument to be
defective during verification or calibration?

6) What appropriate actions can you take?

7.1.5.2 Calibration / verification records

.1 The organization shall heav a documented processs 1) Do you have documented information of
for managing calibration / verification records. calibration/verification in order to provide evidence
Records of the calibration / verification activitity for of conformity, includes any on site supplier owned
all gauges and measuring and test equipment equipment?
(including employee-owned equipment relevant for
measuring, customer-owned equipment, or on-site 2) Do you consider applicable internal, customer,
supplier-owned equipment) needed to provide legislative, and regulatory requirements in order to
evidence of conformity to internal requirements, establish approval criteria for inspection,
legislative and regulatory requirements, and measurement, and test equipment
customer-defined requirements shall be retained. calibration/verification activities?

The organization shall ensure that calibration /

verification activities and records shall include the
following details:

a) revisions following engineering changes that

impact measurement systems
b) any out-of-specification readings as received for
calibration / verification
c) an asssessment of the risk of the intended use of
the product caused by the out-of-specification
condition
d) when a piece of inspection measurement and test
equipment is found to be out of calibration or
defective during its planned verification or calibration
or during its use, documented

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information on the validity of previous measurement
results obtained with this piece of inspection
measurement and test equipment shall be retained,
including the associated standard's last calibration
date and the next due date on the calibration report
e) notification to the customer if suspect product or
material has been shipped
f) statements of conformity to specification after
calibration / verification
g) verification that the software version used for
product and process control is specified
h) record of the calibration and maintenance
activities for all gauging (including employee-owned
equipment, customer-owned equipment, or on-site
supplier-owned equipment)
i) production-related software verification used for
product and process control (including software
installed on employee-owned equipment, customer-
owned equipment, or on-site supplier-owned
equipment)

7.1.5.3 Laboratory requirements

7.1.5.3 Internal laboratory
.1 An organization’s internal laboratory facility shall 1) Do you have lab procedures?
have a defined scope that includes its capability to
perform the required inspection, test, or calibration 2) Is the lab personnel undergo training?
services. This laboratory scope shall be included in
the quality management system documentation. The 3) Do you follow national or international guidelines?
laboratory shall specify and implement, as a
minimum, requirements for:

a) adequacy of the laboratory technical procedures;

b) competency of the laboratory personnel;
c) testing of the product;
d) capability to perform these services correctly,
traceable to the relevant process standard (such as

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ASTM, EN, etc.); when no national or international
standard(s) is available, the organization shall define
and implement a methodology to verify
measurement system capability;
e) customer requirements, if any;
f) review of the related records.

7.1.5.3 External laboratory

.2 External/commercial/independent laboratory 1) Are the external laboratory accredited to
facilities used for inspection, test, or calibration a) Accredited by Standards Malaysia(SM) or national
services by the organization shall have a defined equivalent accreditation which is a member of ILAC
laboratory scope that includes the capability to MRA (International Laboratory Accreditation Forum
perform the required inspection, test, or calibration, Mutual Recognition Arrangement), or
and either: b) ISO/IEC 17025 accreditation (internal
accreditation) or
a) the laboratory shall be accredited to ISO/IEC c) Scope of calibration (eg: SAMM) or
17025 or its national equivalent and include the d) CNAS CL01 in China
relevant inspection, test, or calibration service in the
scope of the accreditation (certificate); the certificate 2) If not, is the equipment is produced by OEM
of calibration or test report shall include the mark of member? Show me their internal calibration
a national accreditation body; or procedure.
b) there shall be evidence that the external
laboratory is acceptable to the customer

Calibration services may be performed by the

equipment manufacturer when a qualified laboratory
is not available for a given piece of equipment. In
such cases, the organization shall ensure that the
requirements listed in Section 7.1.5.3.1 have been
met.

Use of calibration services, other than by qualified (or

customer accepted) laboratories, may be subject to
government regulatory confirmation, if required.

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Clause Requirements Item Audited / Questions Remarks
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7.1.6 Organizational knowledge
The organization shall determine the knowledge 1) How do you determine necessary knowledge for
necessary for the operation of its processes and to the operation of processes?
achieve conformity of products and services.
This knowledge shall be maintained and be made 2) How do you determine necessary knowledge to
available to the extent necessary. achieve conformity of products and services?

When addressing changing needs and trends, the 3) How do you maintain this knowledge and how do
organization shall consider its current knowledge and you make it available to the extent necessary?
determine how to acquire or access any necessary
additional knowledge and required updates. 4) How do you consider current knowledge and how
do you acquire additional knowledge when
addressing changing needs and trends?

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