Office of The Director, Quality Assurance Management Center

Form ID DGAM-OTUP-ODQA-F031-000C
Issue Date 16-11-20 Issue Status 3

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Reviewed & Authorized ODQA Approved by OTUP
by
Office of the Director, Quality Assurance Management Center
QA-F039
Audit Checklist: ISO 9001:2015

Clause Requirement Result Objective Evidence
Scope Compliant? Interview Observation Documented REMARKS
1, 4.3
YES NO Information
1, 4.3
Is the scope of the QMS found as a documented information? Are
there any declared areas of the standard that is considered not
applicable? If yes, what is the justification provided? Is it deemed
justifiable?
2 Normative References
Are all normative references cited including industry specific
normative reference available? Record specific normative
references and availability.
4.1 Understanding the organization and it’s context
Record evidence that external and internal issues are monitored,
reviewed and considered to determine the scope of the QMS.
4.2 Understanding the needs and expectations of interested

parties
Record evidence that interested parties relevant to the
organization are identified and their requirements determined,
monitored, reviewed and considered in determining the scope of
the QMS.
4.4 Quality Management System and Its Processes
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QA-F039

1, 4.3
YES NO Information
Is the QMS established, implemented, maintained with a provision
for continual improvement?
Are the necessary processes including its inputs, sequence,

outputs and risks and opportunities identified with supporting
documented information for the operation of processes?
5.1.1 Leadership: General Requirements
Record how top management demonstrates leadership and
commitment with respect to the QMS. Does top management
demonstrate leadership in the 10 areas required by the standard?
5.1.2 Customer Focus
Record how top management demonstrates leadership and
commitment with respect to customer focus.
5.2 Quality Policy
Record who has approved the quality policy (name and title). Is it
appropriate for purpose and context of organization? Does it
specify commitments to satisfy applicable requirements and
ensuring continual improvements?
5.2.2 Communicating Quality Policy

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QA-F039

1, 4.3
YES NO Information
Record how quality policy is communicated, made understood to
staff and made available to interested parties. Check how it is
kept as a documented information.
5.3 Organizational Roles, Responsibilities & Authorities
Record how the responsibilities and authorities have been INFO
assigned, communicated and made understood within the RMAT
organisation. ION
AND
CASH
IER
NO
JD
SAYS
6.1 1 Actions to Address Risks and Opportunities
Are the external and internal issues as well as expectations of
interested parties considered in planning the QMS and
determining the risks and opportunities that needs to be
addressed to ensure achievement of intended results, promote
desirable effects, prevent or reduce negative effects and ensure
improvement?
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QA-F039

1, 4.3
YES NO Information
Record how this is demonstrated.
6.1.2 Planning of actions to address risks and opportunities
Record how the organization plan to address risk and
opportunities identified. Is it proportionate to the potential impact
in case of nonconformity?
6.2 Quality Objectives and Planning to Achieve Them

Record a sample of quality objectives and the achieved results. Infor
How is it monitored, communicated and updated? matio
Is it relevant, measurable and consistent with the quality policy? n and
How is it documented? Cashi
er
Is there clear planning to meet documented objectives? Must Unit:
indicate action, person responsible, target time for achievement Objec
and method for evaluation. tive:
1.
T
2.
T
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QA-F039

1, 4.3
YES NO Information
6.3 Planning of Changes
Record how planning for changes in the QMS is carried out
7.1.1 Resources: General

Record how the company ensure there are resources available to
implement, maintain, and continually improve the Quality
Management System and ensure customer satisfaction.
7.1.2 People
Record how the company has determined the persons necessary
for the effective implementation of the QMS and operation and
control of processes.
7.1.3 Infrastructure
Record how the company has determined, provided and Back-
maintained the infrastructure to ensure conformity. up
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QA-F039

1, 4.3
YES NO Information
syste
m
7.1.4 Environment for the Operation of Processes
Record how the client has determined, provided and maintained
the environment necessary for the operation of its processes to
achieve conformity. Is the environment suitable considering both
human physical factors?
7.1.5 Monitoring and Measuring Resources
Record how the organization provides resources needed to ensure
valid and reliable result when monitoring and measuring is used
to verify conformity to requirements.
7.1.5.2 Measurement Traceability
Record details of the type of equipment used for monitoring and Manu
measuring purposes, how identified and safeguarded. Is there al
documented information showing test and/or calibration. check
s
Record the action to be taken in the event of equipment that fails
test/calibration.
7.1.6 Organizational Knowledge

Record how the organization determines and maintains
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QA-F039

1, 4.3
YES NO Information
knowledge necessary for operation of its processes towards
achievement of conformity. How is this made available? Is there
provision for acquisition or access to updates or additional
knowledge specific to the operation of its processes?
7.2 Competence
Record how the organization determines the necessary
competence, ensures persons are competent and provides for
acquisition of necessary competence. Has the necessary
competence been achieved? Record documented information.
7.3 Awareness
Sample the staff. Record if they are able to relay awareness with
regards to the 4 aspects required by the standard..
7.4 Communication
Has the organization determined the internal and external Call,
communications relevant to the QMS? Does it specify the what, email
when, with whom, who and how of the communication process? ,
meeti
ng/m
em
7.5.1 Documented Information: General
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QA-F039

1, 4.3
YES NO Information
Are the documented information being necessary to the
organization identified? Record specified documented information
available.
7.5.2 Creating and Updating
Record how the organization creates and updates documented
information. Are all documented information updated? Are all
documented information reviewed and approved by the
appropriate authority?
7.5.3 Control of documented information
Record how the organization controls documented information
including access, retrieval, use, storage, preservation, retention,
disposal as well as control of changes. Are all documented
information appropriately controlled?
8.1 Operational Planning and Control
Given the processes involved in operation, is it adequately
planned and controlled? Record how changes to the operational
plan is being controlled. Is a review of the consequences of
unintended changes being done? Are outsourced processes
controlled?
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QA-F039

1, 4.3
YES NO Information
8.2.1 Customer Communication

Record what the effective arrangements are for communications Call
with customers and record some examples. or
email
8.2.2 Determining the Requirements for Products & Services
Record how the organisation determines customer requirements Packa
and sample of this working. ge
nad
Pims
(com
puter
)
8.2.3 Review of the Requirements for Products & Services
Record how the organisation reviews customer requirements prior PIMS
to acceptance of order/contract/tender and record samples to AND
show this is effective. Is necessary documented information ROUT
available ING
SLIP
8.2.4 Changes to Requirements for Products & Services
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QA-F039

1, 4.3
YES NO Information
Are the relevant documented information amended and relevant
information is made aware for any changes to the customer
requirements?
8.3.1 Design and Development of Products & Services: General

Has the organization established, implemented and maintained a NA
design and development process appropriate to ensure
subsequent provision of products or services?
8.3.2 Design & Development Planning
Record how the organisation plans and controls design activities.
Did it consider all 10 aspects required by the standard?
8.3.3 Design & Development Input

Record examples to demonstrate design input is effective. Did it
consider all 5 aspects stated in the standard?
8.3.4 Design & Development Controls

Record the controls established by the organization in the design
and development process. Is it effective to ensure results are
achieved? Are the documented information retained for
verification and validation?
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QA-F039

1, 4.3
YES NO Information
8.3.5 Design & Development Output
Record how the company makes sure the design output are
adequate and has met input requirements and record samples. Is
appropriate documented information available?
8.3.6 Design & Development Changes
Record how the organisation reviews, verifies and validates
changes. Samples taken to be recorded.
8.4 Control of Externally Provided Processes, products &
services
Record how the organisation selects, evaluates, monitors and re-
evaluates external providers of processes, products and services.
Samples taken to be recorded. Is documented information
available?
8.4.2 Type and Extent of Control
Record how the organisation determines the type and extent of
control to externally provided processes, products and services to
ensure that they meet the requirements.
8.4.3 Information of External Providers
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QA-F039

1, 4.3
YES NO Information
Record how the organisation ensures that information is adequate
prior to communications with the external providers as specified
in the standard. Record samples taken.
8.5.1 Control of Production and Service Provision

Record the controlled conditions implemented to ensure
conformity. Are the controls implemented in the production and
service provision adequate?
8.5.2 Identification and Traceability

Record the system for identification and traceability of required Requ
outputs and record samples taken. est
for
valid
ID;
numb
ering
syste
m;
CODI
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QA-F039

1, 4.3
YES NO Information
NG
SYST
EM
DAIL
Y
BACK
TO 1,
ACCE
SSIO
N
8.5.3 Property belonging to customers or external providers
Record whether and how customer or external provider property

is held, controlled as well as reported to customer or external
provider in incidents of lost, damage, or unsuitability for use.
8.5.4 Preservation
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QA-F039

1, 4.3
YES NO Information
Record how outputs are preserved until they reach the customer
or to their intended use. As applicable record how it is identified,
handled, prevented from contamination, packaged, stored,
transmitted/transported and protected at all times.
8.5.5 Post Delivery Activities

Is the organization able to meet requirements for post delivery
activities according to the extent agreed upon with customer?
8.5.6 Control of Changes

Record how the organization reviews and controls changes to
production and service provision? Is there available documented
information showing review of changes, person authorizing
changes and the actions taken?
8.6 Release of Products and Services

What are the planned arrangement to verify that product and
service requirements are met? Is it done during appropriate
stages? Is it adequately done prior to release of products and
services?
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QA-F039

1, 4.3
YES NO Information
8.7 Control of Non-Conforming Outputs
Record how non-conforming outputs are controlled and samples
taken. Is documented information available?
9.1 Monitoring, measurement, analysis and evaluation

Has the organization identified what needs to be mionitored and
measured, how, when and when the results are to be analysed
and evaluated?
9.1.2 Customer Satisfaction

Is there a mechanism to obtain, monitor and evaluate degree to
which needs and expectations of customers are met? What is the
actual result?
9.1.3 Analysis and Evaluation
Record evidence of organisation’s analysis and evaluation of
appropriate data. Is analysis used to evaluate 7 key points
required in the standard?
9.2 Internal Audit

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QA-F039

1, 4.3
YES NO Information
Record what the planning of audits is, who has conducted internal
audits and what the competence is. Record samples taken for
audit documented information.
9.3.1 Management Review: General

Record date(s) of last Management Reviews, the frequency and
next planned date(s).Is there documented information of the
conducted MR?
9.3.2 Review Input
Record the input to the management review. Does it cover all 6
main inputs and 7 trends specified in the standard?
9.3.3 Review Output

Record the output of the management review. Is it adequate as
per input?
10.1 Improvement: General
Is the organisation able to determine and select opportunities for
improvement? Record actions for improvement that has been
implemented.
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QA-F039

1, 4.3
YES NO Information
10.2 Non-Conformity and Corrective Action

In the event of a non-conformity, record the system for
reviewing, determining cause, evaluating, implementing action
and reviewing effectiveness to prevent recurrence and record
samples taken. Is documented information available?
10.3 Continual Improvement

Record evidence of continual improvement. Has the organization
considered results of analysis and evaluation as well as
management review output to pursue continual improvement?

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Form ID DGAM-OTUP-ODQA-F031-000C

Issue Date 16-11-20 Issue Status 3

Audit Checklist: ISO 9001:2015

4.2 Understanding the needs and expectations of interested

Audit Checklist: ISO 9001:2015

Are the necessary processes including its inputs, sequence,

5.2.2 Communicating Quality Policy

Audit Checklist: ISO 9001:2015

Audit Checklist: ISO 9001:2015

6.2 Quality Objectives and Planning to Achieve Them

Audit Checklist: ISO 9001:2015

7.1.1 Resources: General

Audit Checklist: ISO 9001:2015

7.1.6 Organizational Knowledge

Audit Checklist: ISO 9001:2015

Audit Checklist: ISO 9001:2015

Audit Checklist: ISO 9001:2015

8.2.1 Customer Communication

Audit Checklist: ISO 9001:2015

8.3.1 Design and Development of Products & Services: General

8.3.3 Design & Development Input

8.3.4 Design & Development Controls

Audit Checklist: ISO 9001:2015

Audit Checklist: ISO 9001:2015

8.5.1 Control of Production and Service Provision

8.5.2 Identification and Traceability

Audit Checklist: ISO 9001:2015

Record whether and how customer or external provider property

Audit Checklist: ISO 9001:2015

8.5.5 Post Delivery Activities

8.5.6 Control of Changes

8.6 Release of Products and Services

Audit Checklist: ISO 9001:2015

9.1 Monitoring, measurement, analysis and evaluation

9.1.2 Customer Satisfaction

9.2 Internal Audit

Audit Checklist: ISO 9001:2015

9.3.1 Management Review: General

9.3.3 Review Output

Audit Checklist: ISO 9001:2015

10.2 Non-Conformity and Corrective Action

10.3 Continual Improvement

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