ISO 9001:2015 Audit Checklist

(Quality Control)
Audit Scoring Criteria
A risk-based internal audit approach allows the internal audit to concentrate on reviewing the major risks to the organization. The audit’s role is to provide
assurance that key risks to the organization’s objectives are being well controlled.
The audit findings ‘traffic lights’ are intended to visually communicate the risk posed by the audit finding of any system or processes being audited. The rating
system is stratified from ‘compliant’ to ‘major non-conformance’ to convey a concise and consistent method for scoring each audit finding. At the end of the
audit, the findings can be transferred into an Excel spreadsheet to create charts, summary tables and trend data to paste into the audit report or management
review documentation.
This methodology should be uniformly applied for every internal quality audit that Oxychem Corporation will undertake.

Finding Definition/Impact Action/Mitigation

Compliant means adherence with the requirements of the ISO standard and the QMS. The
COMPLIANT Continue to monitor trends/indicators.
process is implemented and documented and records exist to verify this.

OFI means observation or an opportunity for improvement, a low risk issue that offers an
Review and implement immediate actions to improve the
opportunity to improve current practice. Processes may be cumbersome or overly complex
OFI process(s). Monitor trends/indicators to determine if
but meet their targets and objectives. Unresolved OFIs may degrade over time to become
improvement was achieved.
non-compliant.

A medium risk, minor non-conformance resulting in deviation of one requirement of an ISO Investigate root cause(s) and implement corrective action.
MINOR N/C clause or standard. This does not likely result in the failure of the management system or Conduct follow-up audit to verify implementation and
process but may worsen to become a major nonconformance over time. effectiveness.

A high risk, major non-conformance resulting in deviation of a whole clause of the ISO
Investigate root cause(s) and implement corrective action.
standard. This nonconformance directly impacts customer requirements, is likely to result
MAJOR N/C Conduct follow-up audit to verify implementation and
in the customer receiving nonconforming products or services, or which may reduce the
effectiveness.
effectiveness of the QMS.

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 ISO 9001:2015 Audit Checklist
(Quality Control)

Guide for Auditor Audit Evidence

Claus
Requirement Audit Question
e
Guide what to ask per requirement Provide reference to documented information to
and what evidence to look for justify the finding

4.0 Context of the organization (4.4)

4.4 QMS and its
Are processes and their
processes interactions, needed for the QMS
and their application established,
implemented and maintained for
the continual improvement of its
QMS, in accordance with the
requirements of ISO 9001:2015
Look for Business Process model for
the interactions of each processes
--discuss the sequence and interaction
of QC processes
-Ask for list of SOPs available

Are required INPUT and expected
OUTPUT of every processes are
identified and documented?
Has the organization determined
the criteria and methods needed to
ensure the implementation and
effectiveness of the processes?
Are criteria and methods
monitored, measured and reviewed
through performance indicators?
Are they documented?
Are resources needed to obtain the
expected outputs available and
documented in the process?
For every process, what is the input
and expected output? Is it identified in
the procedure and documented?
How do you ensure the effectiveness of
your operation and control on the
above processes?
Are they monitored, measured and
reviewed? (Clause 9.1))
Are they documented? (ask for copy of
report per area)
Are the resources needed defined in
the procedure? (Clause 7.1.5)

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 ISO 9001:2015 Audit Checklist
(Quality Control)

Guide for Auditor Audit Evidence

Claus
Requirement Audit Question
e
Guide what to ask per requirement Provide reference to documented information to
and what evidence to look for justify the finding

Is there a documented assignation Are the assigned person or process

of responsibilities and authorities to
ensure compliance of these
processes?
Has the organization identified risk
and opportunities for each process
in which possible events will impact
the achievement of Quality
objectives?
Are there documented results to
evaluate the effectiveness of these
processes and reviewed in a timely
manner by the management?
Are changes or actions applied for
the improvement of the processes
and its QMS monitored and
documented?
5.0 Leadership (5.2)
5.2.2 Communicating the Is the quality policy documented
Quality Policy and posted with the organization?
Do employees understand the
Quality Policy?
6.0 Planning (6.1 , 6.2, 6.3)
6.1 Actions to address risk What are the method/techniques
used to identify risks and
and opportunities
opportunities?
Are risks and opportunities
owner identified on each process?
(Clause 5.3)
Have you identified any risk and
opportunities for every process in the
laboratory? (Clause 6.1.1)
How will you address it? (Clause 6.1.2)
Have you conduct evaluation on the
documented results and review the
effectiveness of those processes?
(Clause 9.1.3)
How frequent?
Is this documented?
After evaluation, do you implement
changes for the improvement of the
processes?(Clause 10.3)
Is it monitored and documented?
Do you have list of identified risk and
opportunities that need to be addressed
on your area?
What are the method used?

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 ISO 9001:2015 Audit Checklist
(Quality Control)

Guide for Auditor Audit Evidence

Claus
Requirement Audit Question
e
Guide what to ask per requirement Provide reference to documented information to
and what evidence to look for justify the finding
categorized per their severity of Did you considered risk and
their impact? opportunities from internal and external
Has the organization consider risks issues and from IP?
Are they categorized based on their
and opportunities from internal and impact or severity?
external issues and from
requirements of interested parties?
Is there an established
plan/method detailing the actions
to be taken to address risks and
opportunities?
Is there an evidence that Is the changes brought by risk and
consideration of risk and opportunities integrated with the QMS?
opportunities from internal and
Is there an evidence?
external issues has been
integrated in the QMS?
Are the actions effective or
adequate?
6.2 Quality objectives and Is there an established Quality
planning to achieve goals and objectives? Is it
them documented?
Are quality objectives measurable
and consistent with the quality
policy?

Are quality objectives

communicated in any sort of
media/form?
Has the organization defined a Can you explain the Quality objectives of
plan or strategy on how to meet the your department?

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 ISO 9001:2015 Audit Checklist
(Quality Control)

Guide for Auditor Audit Evidence

Claus
Requirement Audit Question
e
Guide what to ask per requirement Provide reference to documented information to
and what evidence to look for justify the finding
set quality objectives?
What is your plan or strategy on how you
will meet the set objectives?
Are quality objectives monitored
and reviewed at reasonable
interval?
6.3 Planning of Changes Has the organization identified and Have you identified potential changes
documented potential changes? on manufacturing processes?
Is the purpose of changes defined? What is the purpose of changes?
Are potential consequences Are potential consequences reviewed
documented and analysed prior prior implementing the changes?
implementing the changes?
Is there a plan of how to implement How does the changes implemented -
changes to ensure integrity of the integrate with the QMS?
QMS?
Are resources are available to
implement the changes?
Are changes communicated to Are involved personnel aware on the
relevant people? Changed changes?
responsibilities?
7.0 Support ( 7.1, 7.3, 7.4, 7.5)
7.1.4 Environment for the Has the organization determined, How do you maintained the
provided and maintained the environment necessary for the
operation of processes
environment necessary for the operation of processes and achieve
conformity of products?
operation of its processes and to
-when it comes to physical
achieve conformity of products and environment?
services? -is there recreation activities for the
employees? c/o HR
7.1.5.1 Monitoring and Has the organization determined Do you have list of monitoring and .

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 ISO 9001:2015 Audit Checklist
(Quality Control)

Guide for Auditor Audit Evidence

Claus
Requirement Audit Question
e
Guide what to ask per requirement Provide reference to documented information to
and what evidence to look for justify the finding

measurement and provided resources for measuring resources used in testing

monitoring and measuring of
resources
conformity of products and
services?
Has the organization ensure that
the resources provided are suitable
and maintained to ensure their
continuing fitness for their
purpose?
Is there an evidence of fitness for
purpose of the monitoring and
measurement resources?
7.3 Awareness Does employee training include the
quality policy and the methods
established to comply with it?
Are employees aware of quality
objectives and issues that may
affect the ability to meet them?
Are employees informed about
their contribution to the
effectiveness of the QMS and the
benefits of meeting the quality
objectives?
Are employees aware of the
impact/implications of non-
conformance with QMS?
7.4 Communication Is relevant information to the QMS
identified to be shared internally?
products?
Do you have calibration and maintenance
program for the monitoring and measuring
resources?
Is there an evidence of equipment
calibration and maintenance?
Discuss on 5.2.2 Communicating the
quality policy
Ask employees if they aware on the
quality objectives set by the department
and their contributions to achieve it?
Are they aware of the benefits obtained
of meeting the objectives?
Are they aware of the impact to the
organization if they are not complying
with the QMS?
Does the performance of the
department communicated to the
employees?

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 ISO 9001:2015 Audit Checklist
(Quality Control)

Guide for Auditor Audit Evidence

Claus
Requirement Audit Question
e
Guide what to ask per requirement Provide reference to documented information to
and what evidence to look for justify the finding
Is relevant information to the QMS N/A – to be asked with the Top
identified to be shared externally? Management
Is information communicated in a When this was communicated to the
timely manner? employees?
Does the organization identified all N/A – to be asked with the Top
the internal and external interested Management
parties to whom information will
communicated to?
Is there an established method to What method was used in
communicate information relevant communicating information?
to QMS?
Has the organization nominated a Who was in-charge on communicating
person/department in charge of information to the employees?
communicating information
internally and externally?
7.5.1 Documented
Information
7.5.2 Creating and updating Are quality system procedures, Are forms, procedures, work
work instructions and other instructions used are uniquely
procedures related to QMS are identified?
documented and identified?
Is any form of media (paper,
electronic file) used as a method to
document procedures and work
instructions?
Is there a documented procedure Is the procedure in-place was approved
in place that describes approval, to be used and distributed by
distribution and change control for designated person?
internal documents?

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 ISO 9001:2015 Audit Checklist
(Quality Control)

Guide for Auditor Audit Evidence

Claus
Requirement Audit Question
e
Guide what to ask per requirement Provide reference to documented information to
and what evidence to look for justify the finding
Is there an evidence that approval,
distribution and change of
documents are properly followed
as described in the procedures?
8.0 Operation (8.1, 8.5, 8.7)
8.1 Operational planning Has the organization planned
and control process for operation?
Has the organization implemented What are the process controls
and controlled the processes to implemented in the laboratory to meet
meet the requirements on the requirements in delivering
products?
delivering quality products?
Has the organization determined Are resources needed for laboratory
the requirements and the operations provided?
resources needed for the
products?
Has the organization established Are there criteria established for the
criteria for the processes and processes and acceptance of the
acceptance of products? products?
Has the organization maintained
and retained documented
information to have confidence that
the processes have been carried
out as planned? To demonstrate
the conformity of the products to
their requirements?
Has the organization identifies Is there identified risks and
risks and opportunities on opportunities on operational
operational processes? processes? Is there a plan to mitigate
the risks?

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 ISO 9001:2015 Audit Checklist
(Quality Control)

Guide for Auditor Audit Evidence

Claus
Requirement Audit Question
e
Guide what to ask per requirement Provide reference to documented information to
and what evidence to look for justify the finding
Has the organization ensure that Is there process done by third party?
outsourced processes are How this process controlled?
controlled?
8.5 Production and
Service Provision
8.5.1 Control of production Does the organization identify,
and service provision document and control all operation
processes?
Is there a documented information
(WI/SOP/Guideline) that defines
the characteristic of products
produced or the activities to be
performed that readily available to
the operator?
Are the monitoring and measuring
resources available and suitable
for the control of production and
service provision?
Does the organization ensured use
of suitable infrastructure and good
working environment for the
operation of processes?
Has the organization ensured that
employees are competent,
qualified and well trained in the
industry?
Is there a validation or revalidation
of the ability to achieved planned
results of the processes for

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 ISO 9001:2015 Audit Checklist
(Quality Control)

Guide for Auditor Audit Evidence

Claus
Requirement Audit Question
e
Guide what to ask per requirement Provide reference to documented information to
and what evidence to look for justify the finding
production provision, where the
resulting output cannot be verified
by subsequent monitoring or
measurement?
Has the organization established a Is there a procedure implemented to
procedure for actions to be taken prevent human error that affecting the
to prevent human error from quality of products?
affecting the quality system?
8.5.2 Identification and Are there procedures that define
Traceability the identification of products and
materials at various places and is
there evidence of compliance)
Is there a procedure/system that Is there a system for easy tracking of
describes how product tracking products? Is there an evidence of
data is to be captured and is there compliance?
evidence of compliance?
8.5.6 Control of changes Does the organization document, How does changes in laboratory
control and maintain records of documented?
changes for production provision to
ensure continuing conformity with
requirements?
Are changes reviewed and Are the changes reviewed and
authorized by competent approved prior implementation?
personnel?
8.6 Release of products Does the organization identify,
and services monitor and measure product
characteristics to verify conformity
to requirements?
Are all personnel, performing

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 ISO 9001:2015 Audit Checklist
(Quality Control)

Guide for Auditor Audit Evidence

Claus
Requirement Audit Question
e
Guide what to ask per requirement Provide reference to documented information to
and what evidence to look for justify the finding
monitoring and measurement,
trained and competent?
Has the organization retained
documented information on the
release of products?
Can authorization records for
release of products or service be
traced back to a person(s)?
8.7 Control of Has the organization ensured that How does on-hold, rejected, and for
outputs that do not conforms are disposal samples treated? Are they
nonconforming outputs
identified and controlled to prevent properly identified and prevent from
intended use?
their untended use or delivery?
Is there a procedure? Evidence?
Is there a procedure define the
marking, identification or
segregation of non-conforming
products during subsequent
storage and processing? Is there
an evidence of compliance?
Is there a procedure that requires How does nonconforming products
evaluation of non-conforming evaluated, including investigation?
products, including investigation Is there an evidence?
made? Is there an evidence of
compliance?
Is there a procedure that defines How are dispositions given?
disposition options and conditions
of non-conforming products? Is
there an evidence of compliance?
Is there a procedure that describes
how re-work will be accomplished

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 ISO 9001:2015 Audit Checklist
(Quality Control)

Guide for Auditor Audit Evidence

Claus
Requirement Audit Question
e
Guide what to ask per requirement Provide reference to documented information to
and what evidence to look for justify the finding
and documented? Is there an
evidence of compliance?
Is there a procedure that describes How products from returns handled?
handling nonconformity detected
after delivery of products to the
customer? Is there an evidence of
compliance?
9.0 Performance Evaluation (9.1)
9.1.1 Monitoring, Does the organization determined What areas/process are need to be
what needs to be monitored and monitored and measured?
measurement,
analysis and measured?
evaluation Have methods for monitoring, How they are monitored and
measuring, analysing and measured?
evaluating validity of results been
defined and identified?
Are methods describe how, when Is the procedures describes the
and who to monitor and measure? process on how to monitor and
measure it?
Does the organization evaluated How do you evaluate the performance
the performance and the and the effectiveness of the QMS?
effectiveness of the QMS?
Are there evidence of
implementation?
9.1.3 Analysis of evaluation Is there a procedure to evaluate How do you evaluate the result of
result of analysis for the conformity analysis for performance objectives?
of products? Objective goals? Performance of the
products?
Has the organization evaluated the How do you evaluate the performance
performance and effectiveness of and the effectiveness of the QMS?
the QMS?

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 ISO 9001:2015 Audit Checklist
(Quality Control)

Guide for Auditor Audit Evidence

Claus
Requirement Audit Question
e
Guide what to ask per requirement Provide reference to documented information to
and what evidence to look for justify the finding
Is there a procedure to evaluate Is there a procedure to check the
the effectiveness of actions taken effectiveness of actions taken to
to address risks and opportunities? address risk and opportunities?
Has the organization identified a Is there an instances that
need for improvements to the improvements to the QMS were
QMS? identified?
10 Improvement (10.1, 10.3)
10.1 Improvement Is there a system or procedure as
a guideline for identification of
opportunities for improvement of
products, performance and
effectiveness of QMS?
Is there a responsible person in
charge to conduct this
identification?
Is there an evidence of identifying Is there an instances that opportunities
opportunities of improvement? for improvements were identified?
10.3 Continual Is there a system or procedure as
Improvement a guideline for continuous
improvement of QMS?
Does the organization consider
results of KPIS and evaluate them
to determine necessity of
improvement?

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