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ISO 9001:2015 Audit Checklist

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Audit Title

Location

Client / Site

Conducted on 24 oct. 2023 23:52 WAT

Prepared by amira zouaoua

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1.4Contextoftheorganization-0/25(0%)
4 Context of the organization 0 / 25 (0%)
1.1.Introduction
Introduction
Please complete all sections starting immediately below. This internal self-assessment will evaluate
the compliance of your Quality Management System with ISO 9001:2015. Remember to attach
evidence to items where required, and to sign off and complete this assessment in the final
section.
1.2.4.1Understandingtheorganizationanditscontext-0/3(0%)
4.1 Understanding the organization and its 0 / 3 (0%)
context

Verify how the organization has determined external and

internal issues relevant to its purpose and strategic direction.

Verify how these issues affect the ability to achieve the

intended result of the QMS.

Verify how the organization monitors and reviews

information about these internal and external issues.
1.3.4.2Understandingtheneedsandexpectationsofinterestedparties-0/4(0%)
4.2 Understanding the needs and 0 / 4 (0%)
expectations of interested parties

Verify how organization determined relevant interested

parties to QMS.

Verify how the organization has determined the relevant

needs and expectations of interested parties.

Verify how the organization has determined the impact or

potential impact of the interested parties.

Verify how the organization monitors and reviews

information about interested parties and their relevant
requirements.
1.4.4.3Determiningthescopeofthequalitymanagementsystem-0/8(0%)
4.3 Determining the scope of the quality 0 / 8 (0%)
management system

Verify the QMS scope considers the following:

External and internal issues. ☐

The requirements of relevant interested parties. ☐

The products and services of the organization. ☐

Verify how the organization has determined how the ISO

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9001:2015 standard is applied within the organization.

If the organization has determined any of the requirements of

the ISO 9001:2015 standard not to be applicable, show me how
conformity of products and services are not affected by this.

Verify QMS scope is documented.

Verify scope states what products and services are covered by

the QMS and how it justifies instances where requirements
cannot be applied.
1.5.4.4Qualitymanagementsystemanditsprocesses-0/10(0%)
4.4 Quality management system and its 0 / 10 (0%)
processes

Show me how the processes have been determined and how

they interact.

Verify how the processes for the QMS were determine. Verify
the inputs and outputs to the processes.

Verify the sequence and interaction of of the processes.

Verify the criteria, methods, measurement and related

performance indicators needed to operate and control the
processes.

Verify how resources are determined and allocated.

Verify how responsibilities and authorities are determined.

Verify how risks and opportunities are considered and what

actions are taken to address them.

Verify what methods are used to monitor, measure and

evaluate processes. Verify changes, if needed, are
implemented to achieve intended results.

Verify how opportunities for improvement for the QMS and its
processes are determined.

Reviewed documented information created to support the

operation of its processes.
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2.5Leadership-0/31(0%)
5 Leadership 0 / 31 (0%)
2.1.5.1Leadershipandcommitment-0/16(0%)
5.1 Leadership and commitment 0 / 16 (0%)

Top management is identified

Verify top management demonstrates leadership and

commitment by

Taking accountability for QMS effectiveness ☐

Ensuring the QMS policy and objectives are established and

are compatible with strategic direction and context of ☐
organization

Ensuring the QMS is integrated into organization's business

processes
☐

Promoting the use of the process approach and risk-based

thinking
☐

Ensuring resources are available ☐

Communicating the importance of effective QMS and of

conforming to its requirements
☐

Ensuring intended outcomes ☐

Engaging, directing and supporting persons to contribute to

the effectiveness of the QMS
☐

Promoting continuous improvement ☐

Supporting other relevant management roles to demonstrate

their leadership as it applies to their areas of respsonsibility
☐

Verify how top management demonstrates leadership and

commitment with respect to customer focus by ensuring that

customer and applicable statutory and regulatory

requirements are determined, understood and consistently ☐
met.

the risks and opportunities that affect product and service

conformity and the ability to enhance customer satisfaction ☐
are determined and addressed.

the focus of enhancing customer satisfaction is maintained. ☐

2.2.5.2Policy-0/8(0%)
5.2 Policy 0 / 8 (0%)
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Verify the quality policy ...

is appropriate to the purpose and context of the organization

and supports its strategic direction.
☐

provides a framework for setting quality objectives. ☐

includes a commitment to satisfy applicable requirements. ☐

includes a commitment to continual improvement of the QMS. ☐

Verify QMS Policy is maintained as documented information.

Verify QMS Policy is communicated, understood and applied

within the organization.

Verify QMS Policy is available to relevant interested parties.

2.3.5.3Organizationalroles,responsibilitiesandauthorities-0/7(0%)
5.3 Organizational roles, responsibilities 0 / 7 (0%)
and authorities

Verify responsibilities and authorities for relevant roles are

assigned and communicated within the organization

Verify top management assigns responsibility and authority

for..

ensuring the QMS conforms to the ISO 9001:2015 standard. ☐

ensuring that processes are delivering their intended outputs. ☐

reporting on the performance of the QMS and on

opportunities for improvement, in particular to top ☐
management.

ensuring the promotion of customer focus throughout the

organization.
☐

ensuring the integrity of the QMS is maintained when

changes to the QMS are planned and implemented.
☐
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3.6Planning-0/22(0%)
6 Planning 0 / 22 (0%)
3.1.6.1Actionstoaddressrisksandopportunities-0/6(0%)
6.1 Actions to address risks and 0 / 6 (0%)
opportunities

Verify how the internal and external issues and interested

parties are considered when planning for the QMS?

Verify how risks and opportunities are determined and

addressed so the QMS can achieve its intended results,
prevent and reduce undesired effects and achieve continual
improvement

Verify how actions are planned to address risks and

opportunities.

Verify how actions are integrated and implemented into the

QMS processes.

Verify how the organization evaluates the effectiveness of the

actions.

Verify how actions are taken to address risks and

opportunities determined as being appropriate to the
potential impact on the conformity of products and services.
3.2.6.2Qualityobjectivesandplanningtoachievethem-0/11(0%)
6.2 Quality objectives and planning to 0 / 11 (0%)
achieve them

Verify quality objectives are established at relevant functions,

levels and processes.

Verify the quality objectives are..

consistent with the quality policy. ☐

measurable. ☐

taking into account applicable requirements. ☐

relevant to the conformity of products and services and to the

enhancement of customer satisfaction.
☐

moinitored. ☐

communicated. ☐

updated as appropriate. ☐

Verify objectives are documented.

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Verify how the organization determines what will be done,

with what resources, when completed and how the results
will be evaluated for quality objectives.
3.3.6.3Planningofchanges-0/5(0%)
6.3 Planning of changes 0 / 5 (0%)

Verify how QMS changes are planned systematically.

Verify how the organization demonstrates the purpose and

potential consequences of changes.

Verify how the organization considers the integrity of the

QMS.

Verify how resources are made available.

Verify how responsibility and authority is allocated and

reallocated.
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4.7Support-0/33(0%)
7 Support 0 / 33 (0%)
4.1.7.1Resources-0/16(0%)
7.1 Resources 0 / 16 (0%)

Verify how resources are determined for the organization.

Show me how the capabilities and constraints on internal

resources are considered.

Show me how needs from external providers are considered.

Verify how the organization provides persons necessary to

consistently meet customer, applicable statutory and
regulatory requirements for the QMS including the necessary
processes.

Verify how the organization determines, provides and

maintains the infrastructure for the operation of processes to
achieve products and services conformity.

Verify how the organization determines, provides and

maintains the environment for the operation of processes to
achieve products and service conformity.

Verify how resources are determined to ensure valid and

reliable monitoring and measuring results.

Verify how the organization ensures that the resources

provided are suitable for the specific type of monitoring and
measurement activities being undertaken and that they are
maintained to ensure continued fitness of purpose.

Verify documented information that shows evidence of fitness

for purpose of monitoring and measurement resources.

Show me how measurement instruments are verified or

calibrated at specific intervals against national or
international standards. If no standards, show me
documented information which is used as the basis for
calibration or verification.

Show me how measurement instruments are identified.

Show me how measurement instruments are safeguarded

from adjustments, damage and deterioration.

Verify how the organization determines the validity of

previous measurements if you find an instrument to be
defective during verification or calibration. Verify any actions
taken.

Verify how the organization determines the necessary

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knowledge for the operation of processes and achieves

conformity of products and services.

Verify how knowledge is maintained and made available to

the extent necessary.

Verify how the organization determines current knowledge

and how its acquires additional knowledge when addressing
changing needs and trends.
4.2.7.2Competence-0/4(0%)
7.2 Competence 0 / 4 (0%)

Show me how you determine the necessary competence of

people doing work under your control that affects quality
performance.

Show me how you determine competence on the basis of

appropriate education, training or experience.

Show me how you take actions to acquire necessary

competence where applicable and how do you evaluate the
effectiveness of those actions.

Verify documented information as evidence of competence

where appropriate.
4.3.7.3Awareness-0/5(0%)
7.3 Awareness 0 / 5 (0%)

Verify people doing work under the organization's control are

aware of

the quality policy. ☐

the relevant quality objectives. ☐

their contribution to the effectiveness of the QMS, including

the benefits of improved performance.
☐

the implications of not conforming with the QMS

requirements.
☐
4.4.7.4Communication-0/1(0%)
7.4 Communication 0 / 1 (0%)

Verify internal and external communication process (what,

when, with whom and how to communicate).
4.5.7.5Documentedinformation-0/7(0%)
7.5 Documented information 0 / 7 (0%)

Verify documented information required by the ISO 9001:2015

standard.
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Verify documented information that shows the effectiveness

of the QMS.

Show me that your documented information contains

appropriate identification, format (language, software
version, graphics, ...) and media (paper, electronic, ...).

Show me how the documented information is reviewed and

approved for suitability and adequacy.

Show me how you control documented information and make

it available and suitable for use. Tell me how you protect your
documented information.

Verify how the organization controls the distribution, access,

retrieval, use, storage, preservation, legibility, control of
changes, retention and disposition of documented
information.

Verify documented information of external origin is identified,

as appropriate, and controlled.
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5.8Operation-0/103(0%)
8 Operation 0 / 103 (0%)
5.1.8.1Operationalplanningandcontrol-0/9(0%)
8.1 Operational planning and control 0 / 9 (0%)

Verify how the organization has planned, implemented and

controlled processes needed to meet the requirements of
products and services.

Verify how requirements for products and services are

determined.

Verify how criteria for processes and acceptance for products

and services are determined.

Verify how resources are determined.

Verify how process control is implemented.

Show me documented information that demonstrates

processes have been carried out as planned and can
demonstrate conformity of products and services.

Determine how output from the planning process is suitable

for operations.

Verify how planned changes are controlled. Verify how

unintended changes are reviewed and what actions are taken
to mitigate any adverse effects, as necessary.

Verify how outsourced processes are controlled.

5.2.8.2Determinationofrequirementsforproductsandservices-0/13(0%)
8.2 Determination of requirements for 0 / 13 (0%)
products and services

Verify processes created for communicating with customers

on information relating to products, services, enquiries,
contracts, order handling, customer views, perceptions and
complaints, handling or treatment of customer property and
specific requirements for contingency actions.

Verify process to determine the requirements for products

and services to be offered to potential customers and how the
process is established, implemented and maintained.

Verify how product and service requirements including

statutory and regulatory requirements are defined. Verify
that the organization has the ability to meet the defined
requirements and substantiate any claims for its products and
services.

Verify how the organization reviews..

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customer requirements for delivery and post-delivery. ☐

requirements necessary for customer's specified or intended

use, where known.
☐

statutory and regulatory requirements applicable to the

products and services.
☐

other contract or order requirements. ☐

Show me that the review is conducted prior to the

organization's commitment to supply products and services to
the customer.

Verify how the organization resolves differences in the

contract or order requirements from those previously defined.

Verify how the organization confirms customer requirements

where the customer doesn't provide a documented
statement.

Verify documented information of reviews describing new or

changed requirements to products and services.

Verify documented information of amended reviews and how

relevant personnel are made aware of those changes.
5.3.8.3Designanddevelopmentofproductsandservices-0/32(0%)
8.3 Design and development of products 0 / 32 (0%)
and services

Verify how the design and development process is

established, implemented and maintained.

In determining the stages and control for design and

development, verify the organization considers..

the nature, duration and complexity of the activities. ☐

the requirements that specify particular process stages

including applicable reviews.
☐

required verification and validation. ☐

responsibilities and authorities. ☐

how interfaces are controlled between individuals and

parties.
☐

the need for involvement of customer and user groups. ☐

Verify documented information that confirms design and

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development requirements have been met.

In determining requirements essential for the type of

products and services being designed and developed, the
organization shall consider..

functional and performance requirements. ☐

information derived from previous similar design and

development activities.
☐

statutory and regulatory requirements. ☐

standard or codes of practice that the organization has

committed to implement.
☐

potential consequences of failure due to the nature of the

products and services.
☐

Verify that the inputs are complete and unambiguous.

Verify documented information on design and development

inputs are retained.

Verify the organization applies controls to the design and

development process to ensure that..

the results to be achieved are defined. ☐

reviews are conducted to evaluate the ability of the results of

design and development to meet requirements.
☐

verification activities are conducted to ensure that the

resulting products and services meet the requirements for the ☐
specified application or intended use.

validation activities are conducted to ensure that the

resulting products and services meet the requirements of the ☐
specified application or intended use.

any necessary actions are taken on problems determined

during the reviews, or verification and validation activities.
☐

Verify documented information of these activities are

retained.

Verify the organization ensures the design and development

outputs..

meet the input requirements. ☐

are adequate for the subsequent processes for the provision ☐

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of products and services.

include or reference monitoring and measuring requirements,

as appropriate , and acceptance criteria.
☐

specify the characteristics of the products and services that

are essential for their intended purpose and their safe and ☐
proper provision.

Verify documented information on design and development

outputs are retained.

Verify the organization identifies, reviews and controls

changes made during, or subsequent to, the design and
development of products and services, to the extent
necessary to ensure that there is no adverse impact on
conformity to requirements.

Verify documented information on design and development

changes, the result of reviews, the authorization of changes
and the actions taken to prevent adverse impacts are
retained.
5.4.8.4Controlofexternallyprovidedprocesses,productsandservices-0/15(0%)
8.4 Control of externally provided 0 / 15 (0%)
processes, products and services

Verify how the organization ensures externally provided

processes, products and services conform to specified
requirements.

Verify controls applied to externally provided processes,

products and services when products and services are
intended for incorporation into the organization's own
products and services, products and services are provided
directly to the customer or a process, or part of a process, is
provided by an external provider as a result of a decision by
the organization.

Verify how the organization determines and applies criteria

for the evaluation, selection, monitoring of performance and
re-evaluation of external providers.

Verify documented information of activities and actions

arising from the evaluations.

Verify how the organization determines controls applied to

the external provision of processes, products and services and
the resulting output.

Verify how the organization considers the potential impact of

the external provided processes, products and services on its
ability to meet customer and applicable statutory and
regulatory requirements.
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Verify the effectiveness of the controls applied by the external

provider.

Verify how the organization determines the verification, or

other activities, necessary to ensure the externally provided
processes, products and services meet requirements.

Verify the organization communicates to external providers

its requirements for..

the processes, products and services to be provided. ☐

the approval of product and services; methods, processes and

equipment; and the release of products and services.
☐

competence, including any required qualification of persons. ☐

the external providers' interactions with the organization. ☐

control and monitoring of the external providers'

performance to be applied by the organization.
☐

verification or validation activities that the organization, or

its customer, intends to perform at the external providers' ☐
premises.
5.5.8.5Productionandserviceprovision-0/23(0%)
8.5 Production and service provision 0 / 23 (0%)

Verify the organization has documented information that

defines the characteristics of the products to be produced, the
services to be provided or the activities to be performed and
the results to be achieved.

Verify the availability and use of suitable monitoring and

measuring resources.

Verify the implementation of monitoring and measuring

activities at appropriate stages to verify that criteria for
control of processes or outputs, and acceptance criteria for
products and services, have been met.

Verify the use of suitable infrastructure and environment for

the operation of processes.

Verify the appointment of competent persons, including any

required qualification.

Verify the validation, and periodic revalidation, of the ability

to achieve planned results of the processes for production and
service provision, where the resulting output cannot be
verified by subsequent monitoring or measurement.
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Verify the implementation of actions to prevent human error

(i.e. poke yoke, visual locations, checklist, emergency stops,
templates, document control, ...)

Verify the implementation of release, delivery and

post-delivery activities.

Verify how organization identifies outputs from the process to

ensure conformity.

How does the organization identify the status of process

outputs.

Verify how the organization controls the unique identification

of process outputs when traceability is required. Verify
documented information of traceability, where required.

What care is provided to customers' or external providers'

property?

Verify how the organization identifies, verifies, protects and

safeguards customers' or external providers' property which
is provided for use or incorporation into the organization's
products or services.

Verify retained documented information for property that is

damaged or otherwise found to be unsuitable for use.

Verify how the organization ensures preservation of the

process outputs to ensure conformity to requirements.

Verify the organization considers the following to meet

post-delivery activities.

statutory and regulatory requirements ☐

potential undesired consequences associated with its

products and services
☐

the nature, use and intended lifetime of its products and

services
☐

customer requirements ☐

customer feedback ☐

Verify how the organization reviews and controls changes for

production or service provision.

Verify retained documented information describing the

results of the review of changes, the person(s) authorizing the
change and any necessary actions arising from the review.
5.6.8.6Releaseofproductsandservices-0/3(0%)
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8.6 Release of products and services 0 / 3 (0%)

Verify at appropriate stages product and service requirements

have been met.

Verify products and services are not released to the customer

until the planned arrangements have been satisfactorily
completed, unless otherwise approved by relevant authority
and, as applicable, by the customer.

Verify retained documented information that shows evidence

of conformity with acceptance criteria and traceability to
person(s) authorizing the release.
5.7.8.7Controlofnonconformingoutputs-0/8(0%)
8.7 Control of nonconforming outputs 0 / 8 (0%)

Verify that outputs that do not conform to requirements are

identified and controlled.

Verify appropriate action is taken for nonconforming products

and services (also include after delivery of product or
during/after the provision of services).

Correction ☐

Segregation, containment, return or suspension of provision

of products and services
☐

Informing the customer ☐

Obtaining authorization for acceptance under concession ☐

Verify conformity to the requirements when nonconforming

outputs are corrected.

Verify retained documented information that describes the

nonconformity, describes actions taken, describes any
concessions obtained and identifies the authority deciding the
action in respect of the nonconformity.
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6.9Performanceevaluation-0/39(0%)
9 Performance evaluation 0 / 39 (0%)
6.1.9.1Monitoring,measurement,analysisandevaluation-0/12(0%)
9.1 Monitoring, measurement, analysis and 0 / 12 (0%)
evaluation

Verify the organization has determined what needs to be

monitored and measured, the methods to be used, when it
will be performed, analyzed and evaluated.

Verify the organization evaluates the performance and

effectiveness of its QMS.

Review retained appropriate documented information

Verify the organization monitors customers' perceptions of

the degree to which their needs and expectations have been
fulfilled.

Verify the organization analyzes and evaluates:

conformity of products and services. ☐

the degree of customer satisfaction. ☐

the performance and effectiveness of the QMS. ☐

if planning has been implemented effectively. ☐

the effectiveness of actions taken to address risks and

opportunities.
☐

the performance of external providers. ☐

the need for improvements the the QMS. ☐

6.2.9.2Internalaudit-0/8(0%)
9.2 Internal audit 0 / 8 (0%)

Verify audits are conducted at planned intervals

Verify organization has established, implemented, and

maintains an internal audit program

Verify the importance of the process, changes affecting the

organization and the results of previous audits are considered

Verify audit criteria and scope are created for each audit

Auditors are objective and impartial

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Audit results reported to relevant management

Verify appropriate correction and corrective actions are taken

without delay

Review retained documented information

6.3.9.3Managementreview-0/19(0%)
9.3 Management review 0 / 19 (0%)

Verify management reviews QMS at planned intervals

Verify inputs to management review includes:

status of actions from previous management reviews ☐

changes in external and internal issues relevant to the QMS ☐

customer satisfaction and feedback from relevant interested

parties
☐

the extent to which quality objectives have been met ☐

process performance and conformity of products and services ☐

nonconformities and corrective actions ☐

monitoring and measurement results ☐

audit results ☐

the performance of external providers ☐

adequacy of resources ☐

effectiveness of actions taken to address risks and

opportunities
☐

opportunities for improvement ☐

Verify outputs to management review includes:

opportunities for improvement ☐

any need for changes to the QMS ☐

resource needs ☐

Verify retained documented information

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7.10Improvement-0/9(0%)
10 Improvement 0 / 9 (0%)
7.1.10.1General-0/1(0%)
10.1 General 0 / 1 (0%)

Verify the organization determines and selects opportunities

for improvement to improve products and services, corrects,
prevents or reduces undesired effects and improves the
performance and effectiveness of the QMS.
7.2.10.2Nonconformityandcorrectiveaction-0/7(0%)
10.2 Nonconformity and corrective action 0 / 7 (0%)

Verify how organization reacts to nonconformity, including

complaints, by evaluating how its takes action to control and
correct it and how it deals with the consequences.

Verify how the organization evaluates the need for action to

eliminate the cause(s) of the nonconformity, in order that it
does not recur or occur elsewhere.

Verify how organization implements necessary actions.

Verify how organization evaluates the effectiveness of actions

taken.

Verify the organization updates risks and opportunities

determined during planning, if necessary.

Verify any changes made to the QMS, if necessary.

Verify retained documented information that provides

evidence of the nature of the nonconformity and any
subsequent actions taken and the results of any corrective
actions
7.3.10.3Continualimprovement-0/1(0%)
10.3 Continual improvement 0 / 1 (0%)

Verify how the organization continually improves. Does it

consider the results of analysis and evaluation and the
outputs from management review to determine if there are
needs or opportunities that shall be addressed as part of
continual improvement?
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8.SignOff
Sign Off
8.1.SignOff
Sign Off
I, the undersigned, have completed this audit in an accurate manner. I have attached evidence as
required and declare this assessment complete.

Full name and signature of auditor