Document Code:

QMS Internal Audit Checklist

Date of Effectivity:

This form is to be used during the actual interview with the auditee to note down the objective evidence that supports or
contradicts the established criteria. The final and official statements necessary to establish conformity or nonconformity
must be recorded on the Audit Findings Report.

Process: Payment of Claims Process Owner: Accounting Section

Date &Time Start:
9:15 AM
Auditees: M Dalengga Date &Time End:
9:30 AM

Criteria to be Checked Audit Questions Observed Evidence Audit Findings

(what must be happening) (what is actually (C or NC)
Define the planned results and planned
activities to be fulfilled, including actions to
happening) Record the result of the
evaluation of the observed
Describe your observations on the
address risks and opportunities, and the evidence against the
extent of achievement of the
relevant requirements that must be sampled criteria. Identify
planned results and realization of
satisfied. (i.e. customer, regulatory, opportunity for
planned activities, including
product, service, process, international improvement if the audit
actions to address risks and
standard) finding warrants it. If there
opportunities, and conformance
is any, describe good
with the relevant requirements
practices worth noting.
Note down risks that might
lead to potential problems.
6 Planning for the quality
management system
6.1 Actions to address risks
and opportunities
6.1.1
When planning for the quality
management system, the
organization shall consider the issues
referred to in 4.1 and the
requirements referred to in 4.2 and
determine the risks and opportunities Is there a master list of
that processes and interested
need to be addressed to: parties that the section
a) give assurance that the quality keeps?
management system can achieve its
intended result(s);
b) prevent, or reduce, undesired
effects;
c) achieve continual improvement.
6.1.2
The organization shall plan:
a) actions to address these risks and
opportunities;
b) how to:
1) integrate and implement the Is there a risk assessment
actions into its quality management and management process in
system processes (see 4.4); the section?
2) evaluate the effectiveness of these
actions
Actions taken to address risks and
opportunities shall be proportionate to
the potential impact on the conformity
of products and services
 Document Code:
QMS Internal Audit Checklist
Date of Effectivity:

6.2 Quality objectives and

planning to achieve them
6.2.1
The organization shall establish
Where is the documented
quality objectives at relevant
information on the quality
functions, levels and processes.
objectives?
The quality objectives shall:
- Citizens’ Charter
a) be consistent with the quality
- IPCRs
policy,
b) be measurable;
c) take into account applicable
requirements;
d) be relevant to conformity of
products and services and the
enhancement of customer
satisfaction;
e) be monitored;
f) be communicated;
g) be updated as appropriate.
The organization shall retain
documented information on the
quality objectives.
6.2.2
When planning how to achieve its
How does the organization
quality objectives, the organization
determine what will be done,
shall determine:
with what resources, when
a) what will be done;
completed and how will
b) what resources will be required;
results be evaluated for
c) who will be responsible;
quality objectives?
d) when it will be completed;
e) how the results will be evaluated
6.3 Planning of changes How do you handle
Where the organization determines changes?
the need for change to the quality
management system (see 4.4) the In terms of:
change shall be carried out in a
planned and systematic manner. 1. New staff
The organization shall consider: 2. New forms to use
a) the purpose of the change and any 3. Changes to policies
of its potential consequences; and directives
b) the integrity of the quality
management system;
c) the availability of resources;
d) the allocation or reallocation of
responsibilities and authorities.
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7 Support
7.1 Resources
7.1.1 General
The organization shall determine and Demonstrate how resources
provide the resources needed for the are determined for the
establishment, implementation, establishment,
maintenance and continual implementation, maintenance
improvement of the quality and continual improvement
management system. of the QMS.
The organization shall consider: Show me how the
a) the capabilities of, and constraints capabilities and constraints
on, existing internal resources; on internal resources are
b) what needs to be obtained from considered.
external providers. Show me how needs from
external providers are
considered.

7.1.2 People
To ensure that the organization can How do you provide persons
consistently meet customer and necessary to consistently
applicable statutory and regulatory
meet customer, applicable
requirements, the organization shall
statutory and regulatory
provide the persons necessary for the
effective requirements for the QMS
operation of the quality management including the necessary
system, including the processes processes?
needed.
7.1.3 Infrastructure
The organization shall determine, How do you determine,
provide and maintain the provide and maintain the
infrastructure for the operation of its infrastructure for the
processes to achieve conformity of operation of processes to
products and services achieve products and service
conformity?

7.1.4 Environment for the

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

7.1.6 Organizational knowledge How do you determine

The organization shall determine the necessary knowledge for the
knowledge necessary for the operation of processes? How
operation of its processes and to do you determine necessary
achieve conformity of products and knowledge to achieve
services conformity of products and
This knowledge shall be maintained services?
and made available to the extent How do you maintain this
necessary. knowledge and how do you
When addressing changing needs make it available to the
and trends, the organization shall extent necessary?
consider its current knowledge and How do you consider current
determine how to acquire or access knowledge and how do you
the necessary additional knowledge. acquire additional knowledge
when addressing changing
needs and trends?
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7.2 Competence
The organization shall: Show me how:
a) determine the necessary You determine the necessary
competence of person(s) doing work competence of people doing
under its control that affects its quality work under your control that
performance; affects quality performance;
b) ensure that these persons are How do you determine
competent on the basis of competence on the basis of
appropriate education, training, or appropriate education,
experience; training or experience?
c) where applicable, take actions to How do you take actions to
acquire the necessary competence, acquire necessary
and evaluate the effectiveness of the competence where
actions taken; applicable and how do you
d) retain appropriate documented evaluate the effectiveness of
those actions?
information as evidence of
Show me documented
competence.
information where
appropriate of competence.

7.3 Awareness
Persons doing work under the
organization’s How are people aware of:
control shall be aware of: The quality policy?
a) the quality policy; Relevant quality objectives?
b) relevant quality objectives; Their contribution to the
c) their contribution to the effectiveness of the QMS?
effectiveness of the quality The benefits of improved
performance?
management system, including the
The implications of not
benefits of improved quality
conforming with the QMS
performance;
requirements?
d) the implications of not conforming
with the quality management system
requirements
7.4 Communication
The organization shall determine the
How do you determine
internal and external communications internal and external
relevant to the quality management communications relevant to
system including: the QMS?
a) on what it will communicate; How do you determine:
b) when to communicate; What?
c) with whom to communicate; When?
d) how to communicate. With Whom?
How?

7.5 Documented information

7.5.1 General
The organization’s quality What documented
management system shall include: information do you have as
a) documented information required required by this standard?
by this International Standard; What documented
b) documented information information do you have as
determined by the organization as being necessary for the
being necessary for the effectiveness effectiveness of your QMS?
of the quality management system.
7.5.2 Creating and updating
When creating and updating Show me that your
documented information the documented information
organization shall ensure appropriate: contains:
a) identification and description (e.g. Identification;
a title, date, author, or reference Description;
number); In what media format?
b) format (e.g. language, software Show me how the
version, graphics) and media (e.g. documented information is
paper, electronic); reviewed and approved for
c) review and approval for suitability suitability and adequacy.
and adequacy.
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7.5.3 Control of documented

information
7.5.3.1
Documented information required by
the quality management system and Show me how you control
by this International Standard shall be documented information.
controlled to ensure: Show me how you make it
a) it is available and suitable for use, available and suitable for
where and when it is needed; use.
b) it is adequately protected (e.g. How do you protect your
from loss of confidentiality, improper documented information?
use, or loss of integrity) When controlling
7.5.3.2 documented information,
how do you address:
For the control of documented
Distribution;
information, the organization shall
Access;
address the following
Retrieval;
activities, as applicable:
Use;
a) distribution, access, retrieval and
Storage and preservation;
use;
Legibility;
b) storage and preservation, including
Control of changes;
preservation of legibility;
Retention and disposition.
c) control of changes (e.g. version
How do you identify as
control);
appropriate and control
d) retention and disposition.
documented information of
Documented information of external
external origin which you
origin determined by the organization
have determined as
to be necessary for the planning and
necessary for the QMS
operation of the quality management
system shall be identified as
appropriate, and controlled.

8 Operation How are processes needed

to meet requirements for
8.1 Operational planning provision of products and
and control services planned,
The organization shall plan, implemented and controlled?
implement and control the processes, How are requirements for
as outlined in 4.4, needed to meet products and services
requirements for the provision of determined?
products and services and to How is criteria for processes
implement the actions determined in and acceptance for products
6.1, by: and services determined?
a) determining requirements for the How are resources
product and services; determined?
b) establishing criteria for the How is process control
processes and for the acceptance of implemented?
products and services; Show me the documented
c) determining the resources needed information that shows
to achieve conformity to product and confidence in that the
service requirements; processes have been carried
d) implementing control of the out as planned and can
processes in accordance with the demonstrate conformity of
criteria; products and services.
e) retaining documented information How have you determined
to the extent necessary to have that the output from the
confidence that the processes have planning process is suitable
been carried out as planned and to for your operations?
demonstrate conformity of products How do you control planned
and services to requirements. changes? How do you review
The output of this planning shall be the consequences of
suitable for the organization’s unintended changes? What
operations. action is taken to mitigate
any adverse effects?
How do you control
outsourced processes?
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The organization shall control

planned changes and review the
consequences of unintended
changes, taking action to mitigate any
adverse effects, as necessary.
The organization shall ensure that
outsourced processes are controlled
in accordance with 8.4.

8.2 Determination of
requirements for products
and services
8.2.1 Customer communication
The organization shall establish the What are your processes for
processes for communicating with communicating with
customers in relation to: customers? How do you
a) information relating to products communicate information
and services; relating to:
b) enquiries, contracts or order Products;
handling, including changes; Services;
c) obtaining customer views and Enquiries;
perceptions, including customer Contracts;
complaints; Order handling;
d) the handling or treatment of Customer views, perceptions
customer property, if applicable; and complaints;
e) specific requirements for Handling or treatment of
contingency actions, when relevant. customer property;
Specific requirements for
contingency actions?
8.2.2 Determination of
requirements related to
products and services
The organization shall establish,
implement and maintain a process to
determine the requirements for the What is your process to
products and services to be offered to determine the requirements
potential customers. for products and services to
The organization shall ensure that: be offered to potential
a) product and service requirements customers? How do you
(including those considered establish, implement and
necessary by the organization), and maintain this process?
applicable statutory and regulatory
requirements, are defined;
b) it has the ability to meet the
defined requirements and
substantiate the claims for the
products and services it offers.
8.2.3 Review of requirements How do you review:
related to products and Customer requirements for
services delivery and post-delivery?
The organization shall review, as Requirements necessary for
applicable: customers’ specified or
a) requirements specified by the intended use, where known;
customer, including the requirements Additional statutory and
for delivery and post-delivery regulatory requirements
activities; applicable to products and
b) requirements not stated by the services;
customer, but necessary for the Any other contract or order
customers’ specified or intended use, requirements.
when known; Show me that the review is
c) additional statutory and regulatory conducted prior to your
requirements applicable to the commitment to supply
products and services; products and services to your
d) contract or order requirements customers. How do you
differing from those previously resolve contract or order
expressed
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This review shall be conducted prior requirements which differ

to the organization’s commitment to from those previously
supply products and services to the defined?
customer and shall ensure contract or How do you confirm
order requirements differing from customer requirements
those previously defined are where the customer does not
resolved. provide a documented
Where the customer does not provide statement?
a documented statement of their Show me where you retain
requirements, the customer documented information
requirements shall be confirmed by which describes results of
the organization before acceptance. the review including any new
Documented information describing or changed requirements.
the results of the review, including Show me the documented
any new or changed requirements for information containing
the products and services, shall be changes to products and
retained. services. How do you ensure
Where requirements for products and that relevant personnel are
services are changed, the made aware of those
organization shall ensure that changes?
relevant documented information is
amended and that relevant personnel
are made aware of the changed
requirements.

8.4 Control of externally How do you ensure

provided products and externally provided
processes, products and
services services conform to specified
8.4.1 General requirements?
The organization shall ensure that Show me how you apply
externally provided processes, specified requirements for
products, and services conform to the control of externally
specified requirements. provided products and
The organization shall apply the services when:
specified requirements for the control Products and services are
of externally provided products and provided by external
services when: providers for incorporation
a) products and services are provided into your own products and
by external providers for services;
incorporation into the organization’s You provide products and
own products and services; services directly to
b) products and services are provided customers by external
directly to the customer(s) by external providers on your behalf;
providers on behalf of the A process or part-process is
organization; provided by an external
c) a process or part of a process is provider as a result of a
provided by an external provider as a decision to outsource a
result of a decision by the process or function.
organization to outsource a process Show me how you establish
or function. and apply criteria for
evaluation, selection,
The organization shall establish and
monitoring of performance
apply criteria for the evaluation,
and re-evaluation of external
selection, monitoring of performance
providers. How do you
and re-evaluation of external
assess their ability to provide
providers based on their ability to
processes or products and
provide processes or products and
services in accordance with
services in accordance with specified
specified requirements?
requirements.
What documented
The organization shall retain
information do you have of
appropriate documented information
the results of evaluations,
of the results of the evaluations,
monitoring of performance
monitoring of the performance and
and re-evaluations of
re-evaluations of the external
external providers?
providers.
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8.4.2 Type and extent of control

of external provision
In determining the type and extent of How do you determine the
controls to be applied to the external controls applied to the
provision of processes, products and external provision of
services, the organization shall take processes, products and
into consideration: services and take into
a) the potential impact of the consideration:
externally provided processes, a) The potential impact of the
products and services on the externally provided
organization’s ability to consistently processes, products and
meet customer and applicable services on the ability to
statutory and regulatory consistently meet customer
requirements; and applicable statutory and
b) the perceived effectiveness of the regulatory requirements?
controls applied by the external b) The perceived
provider effectiveness of the controls
The organization shall establish and applied by the external
implement verification or other provider?
activities necessary to ensure the What verification or other
externally provided processes, activities do you have to
products and services do not ensure externally provided
adversely affect the organization’s processes, products and
ability to consistently deliver services do not adversely
conforming products and services to affect your ability to
its customers. consistently deliver
Processes or functions of the conforming products and
organization which have been services to your customers?
outsourced to an external provider When processes or functions
remain within the scope of the have been outsourced to
organization’s quality management external providers, how do
system; accordingly, the organization you consider a) and b) in
shall consider a) and b) above and 8.4.1 and how do you define
define both the controls it intends to the controls intended to be
apply to the external provider and applied to the external
those it intends to apply to the provider and to the resulting
resulting process output. process output?

8.4.3 Information for external Show me how you

providers communicate to external
The organization shall communicate providers, applicable
to external providers applicable requirements for:
requirements for the following: Products and services to be
a) the products and services to be provided or the processes to
provided or the processes to be be performed on behalf of
performed on behalf of the the organization;
organization; Approval or release of
b) approval or release of products products and services,
and services, methods, processes or methods, processes or
equipment; equipment;
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c) competence of personnel, Competence of personnel,

including necessary qualification; including necessary
d) their interactions with the qualification;
organization’s quality management Their interactions with the
system; organization’s quality
e) the control and monitoring of the management system;
external provider’s performance to be The control and monitoring of
applied by the the external provider’s
organization; performance to be applied by
f) verification activities that the the
organization, or its customer, intends organization;
to perform at the external provider’s Verification activities that the
premises. organization, or its customer,
The organization shall ensure the intends to perform at the
adequacy of specified requirements external provider’s premises.
prior to their communication to the Before you communicate
external provider. with external providers, how
do you ensure the adequacy
of specified requirements?

8.5 Production and service What controlled conditions

provision do you have for production
and service provision,
8.5.1 Control of production and including delivery and post-
service provision delivery activities?
The organization shall implement Can you show me controlled
controlled conditions for production conditions for:
and service provision, including a) the availability of
delivery and post-delivery activities. documented information
Controlled conditions shall include, as defining the characteristics of
applicable: the products and services;
a) the availability of documented b) the availability of
information that defines the documented information
characteristics of the products and defining the activities to be
services; performed and the results to
b) the availability of documented be achieved;
information that defines the activities c) monitoring and
to be performed and the results to be measurement activities at
achieved; appropriate stages to verify
c) monitoring and measurement that criteria for control of
activities at appropriate stages to processes and process
verify that criteria for control of outputs, and acceptance
processes and process outputs, and criteria for products and
acceptance criteria for products and services, have been met
services, have been met. d) the use, and control of
d) the use, and control of suitable suitable infrastructure and
infrastructure and process process environment;
environment; e) the availability and use of
e) the availability and use of suitable suitable monitoring and
monitoring and measuring resources; measuring resources;
f) the competence and, where f) the competence and,
applicable, required qualification of where applicable, required
persons; qualification of persons;
g) the validation, and periodic g) the validation, and periodic
revalidation, of the ability to achieve revalidation, of the ability to
planned results of any process for achieve planned results of
production and service provision any process for production
where the resulting output cannot be and service provision where
verified by subsequent monitoring or the resulting output cannot
measurement; be verified by subsequent
h) the implementation of products monitoring or measurement;
and services release, delivery and h) the implementation of
post-delivery activities products and services
release, delivery and post-
delivery activities.
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8.5.2 Identification and

traceability
Where necessary to ensure What means do you use to
conformity of products and services, identify process outputs to
the organization shall use suitable ensure conformity of
means to identify process outputs products and services?
The organization shall identify the How do you identify the
status of process outputs with respect status of process outputs?
to monitoring and measurement How do you control the
requirements throughout production unique identification of
and service provision. process outputs, where
Where traceability is a requirement, applicable? What
the organization shall control the documented information
unique identification of the process do you retain?
outputs, and retain any documented
information necessary to maintain
traceability.
8.5.3 Property belonging to
customers or external
providers
The organization shall exercise care What care do you provide for
with property belonging to the customer or external
customer or external providers while provider’s property while
it is under the organization’s control under your control?
or being used by the organization. How do you identify, verify,
The organization shall identify, verify, protect and safeguard that
protect and safeguard the customer’s property which is provided for
or external provider’s property use or incorporation into your
provided for use or incorporation into products or services?
the products and services. What means do you use to
When property of the customer or report to the customer or
external provider is incorrectly used, external provider if their
lost, damaged or otherwise found to property is incorrectly used,
be unsuitable for use, the lost, damaged or found to be
organization shall report this to the unsuitable for use?
customer or external provider.
8.5.4 Preservation
The organization shall ensure How do you ensure
preservation of process outputs preservation of process
during production and service outputs during production
provision, to the extent necessary to and service provision to
maintain conformity to requirements. maintain conformity to
product requirements?

8.5.5 Post-delivery activities

As applicable, the organization shall How do you meet
meet requirements for post-delivery requirements for post-
activities associated with the products delivery activities associated
and services. with products and services?
In determining the extent of post- How do you determine:
delivery activities that are required, Risk;
the organization shall consider: Nature, use and intended
a) the risks associated with the lifetime;
products and services; Customer feedback;
b) the nature, use and intended Statutory and Regulatory
lifetime of the products and services; requirements, when
c) customer feedback; determining the extent of
d) statutory and regulatory post-delivery activities
requirements required with products and
services?
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8.5.6 Control of changes How do you review and

The organization shall review and
control unplanned changes
control unplanned changes essential
to ensure continuing
for production or service provision to
conformity with specified
the extent necessary to ensure
requirements?
continuing conformity with specified
What documented
requirements.
information can you show
The organization shall retain
me which describes the
documented information describing
results of reviews of
the results of the review of changes,
changes, the personnel
the personnel authorizing the change,
authorizing change and any
and any necessary actions.
necessary actions?

8.6 Release of products and

services
Show me how planned
The organization shall implement the
arrangement have been
planned arrangements at appropriate
implemented at appropriate
stages to verify that product and
stages to verify product and
service requirements have been met.
service requirements have
Evidence of conformity with the
been met. Show me what
acceptance criteria shall be retained.
evidence you retain.
The release of products and services
Show me how the release of
to the customer shall not proceed
products and services is held
until the planned arrangements for
until planned arrangements
verification of conformity have been
for verification of conformity
satisfactorily completed, unless
have been satisfactorily
otherwise approved by a relevant
completed, unless approved
authority and, as applicable, by the
by a relevant authority, or the
customer. Documented information
customer if applicable. Show
shall provide traceability to the
me documented
person(s) authorizing release of
information which shows
products and services for delivery to
traceability to the person
the customer.
authorizing release of
products and services
.
8.7 Control of non-
conforming process
outputs, products and
services
The organization shall ensure How do you identify and
process outputs, products and control process outputs,
services that do not conform to products and services that do
requirements are identified and not conform to requirements
controlled to prevent their unintended and prevent their unintended
use or delivery. use or delivery?
The organization shall take What appropriate corrective
appropriate corrective action based actions are taken based on
on the nature of the nonconformity the nature of the
and its impact on the conformity of nonconformity and its impact
products and services. This applies on the conformity of products
also to nonconforming products and and services? How do you
services detected after delivery of the apply this to nonconformity
products or during the provision of detected after delivery?
the service How you deal with
As applicable, the organization shall nonconforming process
deal with nonconforming process outputs, products and
outputs, products and services in one services in terms of:
or more of the following ways: Correction;
a) correction; Segregation, containment,
b) segregation, containment, return or return or suspension of
suspension of provision of products
provision of products and
and services;
c) informing the customer; services?
d) obtaining authorization for: Informing the customer?
- use “as-is’; Obtaining authorization for
use as-is?
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- release, continuation or re-provision Release, continuation or re-

of the products and services; provision of the products and
- acceptance under concession. service?
Where nonconforming process Acceptance under
outputs, products and services are concession?
corrected, conformity to the How do you verify
requirements shall be verified. conformance where process
The organization shall retain outputs, products and
documented information of actions services are corrected
taken on nonconforming process following nonconformance?
outputs, products and services, What documented
including on any concessions information do you keep
obtained and on the person or following actions taken to
authority that made the decision
address nonconformities,
regarding dealing with the
including any concessions
nonconformity.
obtained and on the person
or authority that made the
decision regarding dealing
with the nonconformance.

9 Performance evaluation
9.1 Monitoring,
measurement, analysis and
evaluation
9.1.1 General Show me how you
The organization shall determine: determine:
a) what needs to be monitored and What needs to be monitored
measured; and measured?
b) the methods for monitoring, Methods for monitoring,
measurement, analysis and measurement, analysis and
evaluation, as applicable, to ensure evaluation to ensure valid
valid results; results?
c) when the monitoring and When to perform monitoring
measuring shall be performed; and measuring?
d) when the results from monitoring When results shall be
and measurement shall be analyzed analyzed and evaluated?
and evaluated. What documented
The organization shall ensure that information can you show me
monitoring and measurement that monitoring and
activities are implemented in measurement activities have
accordance with the determined been implemented in
requirements and shall retain accordance with determined
appropriate documented information requirements?
as Show me how you evaluate
evidence of the results. the quality performance and
The organization shall evaluate the the effectiveness of the
quality performance and the QMS.
effectiveness of the quality
management system.
9.1.2 Customer satisfaction
The organization shall monitor How do you monitor
customer perceptions of the degree customer perception of the
to which requirements have been degree to which
met. requirements have been
The organization shall obtain met?
information relating to customer How do you obtain
views and opinions of the information relating to
organization and its products and customer views and opinions
services. of your products and
The methods for obtaining and using services?
this information shall be determined. What methods for obtaining
and using this information do
you have?
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9.1.3 Analysis and evaluation

The organization shall analyze and Show me how you analyze
evaluate appropriate data and and evaluate data and
information arising from monitoring, information arising from
measurement and other sources. monitoring, measurement
The output of analysis and evaluation and other sources.
shall be used to: Show me how the output of
a) demonstrate conformity of analysis and evaluation is
products and services to used to:
requirements; Demonstrate conformity of
b) assess and enhance customer products and services to
satisfaction; requirements?
c) ensure conformity and Assess and enhance
effectiveness of the quality customer satisfaction?
management system; Ensure conformity and
d) demonstrate that planning has effectiveness of the QMS?
been successfully implemented; Demonstrate that planning
e) assess the performance of has been successfully
processes; implemented?
f) assess the performance of external Assess process
provider(s); performance?
g) determine the need or Assess performance of
opportunities for improvements within external providers?
the quality management system. Determine the need or
The results of analysis and evaluation opportunities for
shall also be used to provide inputs to improvements within the
management review. QMS?
How me where the results of
analysis and evaluation are
used to provide inputs to
management review.

10 Improvement
10.1 General
The organization shall determine and
How do you determine and
select opportunities for improvement
select opportunities for
and implement necessary actions to
improvement? What
meet customer requirements and
necessary actions have you
enhance customer satisfaction.
implemented so that you
This shall include, as appropriate:
a) improving processes to prevent have met customer
nonconformities; requirements and enhanced
b) improving products and services to customer satisfaction?
meet known and predicted Show me how you have:
requirements; Improved processes to
c) improving quality management prevent nonconformities;
system results. Improved products and
services to meet known and
predicted requirements;
Improved QMS results.
 Document Code:
QMS Internal Audit Checklist
Date of Effectivity:

10.2 Nonconformity and

corrective action
10.2.1
When a nonconformity occurs, When nonconformities occur,
including those arising from show me how;
complaints, the organization shall: You react;
a) react to the nonconformity, and as Take action to control and
applicable: correct it;
1) take action to control and correct it; Deal with the consequences;
2) deal with the consequences; Evaluate the need for action
b) evaluate the need for action to to eliminate the cause so that
eliminate the cause(s) of the it does not recur or occur
nonconformity, in order that it does elsewhere by:
not recur or occur elsewhere, by: Reviewing the
1) reviewing the nonconformity; nonconformity;
2) determining the causes of the Determining the cause of the
nonconformity; nonconformity;
3) determining if similar Determining if similar
nonconformities exist, or could nonconformities exist or
potentially occur; could potentially occur;
c) implement any action needed; Actions needed are
d) review the effectiveness of any implemented;
corrective action taken; Review the effectiveness of
e) make changes to the quality corrective actions taken, if
management system, if necessary. any;
Corrective actions shall be Make necessary changes to
appropriate to the effects of the the QMS.
nonconformities encountered. Show me how correction
actions were appropriate to
the effects of the
nonconformities
encountered.

10.2.2
The organization shall retain What documented
documented information as evidence information can you show
of: me as evidence of:
a) the nature of the nonconformities The nature of the
and any subsequent actions taken; nonconformities and
b) the results of any corrective action. subsequent actions taken;
The results of any corrective
action.

10.3 Continual improvement

The organization shall continually Demonstrate that you
improve the suitability, adequacy, and continually improve the
effectiveness of the quality suitability, adequacy and
management system. effectiveness of the QMS.
The organization shall consider the Demonstrate that outputs of
outputs of analysis and evaluation, analysis and evaluation and
the outputs from
and the outputs from management management review are
review, to confirm if there are areas considered to
of underperformance or opportunities
that shall be addressed as part of confirm if there are areas of
continual improvement. underperformance or
Where applicable, the organization opportunities that shall be
shall select and utilize applicable addressed as part of
tools and methodologies for continual improvement.
investigation of the causes of What applicable tools and .
underperformance and for supporting methodologies for
continual improvement. investigation of the causes of
underperformance and to
support continual
improvement are selected?

Audited by: Acknowledged by:

 Document Code:
QMS Internal Audit Checklist
Date of Effectivity:

Date: Date: