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Checklist For QMSC

This document is an internal audit checklist for Tekhaf Trading PLC's quality management system. It reviews the company's compliance with ISO 9001:2015 requirements across key clauses, including understanding the organization and context, leadership, planning, support, operation, performance evaluation, and improvement. The checklist examines whether the company has properly documented processes and ensures requirements are met for communication, documented information, actions to address risks and objectives, and management of changes. It is used to assess conformance and identify opportunities for enhancement of the quality management system.

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Alayou Tefera
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0% found this document useful (0 votes)
64 views7 pages

Checklist For QMSC

This document is an internal audit checklist for Tekhaf Trading PLC's quality management system. It reviews the company's compliance with ISO 9001:2015 requirements across key clauses, including understanding the organization and context, leadership, planning, support, operation, performance evaluation, and improvement. The checklist examines whether the company has properly documented processes and ensures requirements are met for communication, documented information, actions to address risks and objectives, and management of changes. It is used to assess conformance and identify opportunities for enhancement of the quality management system.

Uploaded by

Alayou Tefera
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
You are on page 1/ 7

Company Name: Document number:

TEKHAF TRADING PLC OF/TH/043


Page No.: Page 1 of 7
TITLE: INTERNAL AUDIT CHECKLIST

Date

Auditors

1.

2.

ISO9001:2015 Quality Management System Documented Auditor’s Notes and


Clause # Requirements Information Evidence
Reference

4 Context of the organization


4.1 Understanding the organization and its context
Has the organization identified all external and
4.1 internal issues relevant to its purpose and
direction?
What is the process for monitoring and review of
4.1 the external and internal issues?

4.2 Understanding the needs and expectations of interested parties


Has the organization identified all relevant
4.2 interested party requirements that are relevant to
the quality management system? How is the
information monitored?

4.3 Determining the scope of the Quality Management System


4.3 Is the scope of the quality management system,
including products and services provided and
justification for any exclusion, defined?

4.3 Is the scope of the quality management system


maintained as documented information?
4.3 Are the following considered when determining
the scope?
• External and Internal Issues
• Requirements of relevant interested
parties
• The products and services provided.
Company Name: Document number:
TEKHAF TRADING PLC OF/TH/043
Page No.: Page 2 of 7
TITLE: INTERNAL AUDIT CHECKLIST

ISO9001:2015 Quality Management System Documented Auditor’s Notes and


Clause # Requirements Information Evidence
Reference
4.3 Is there assurance that all requirements of the
standard that can be applied, have been applied
by the organization and those determined non-
applicable do not affect the organization’s ability
or responsibility to ensure conformity?

4.4 Quality Management System and its processes


Have the processes of the organization been
4.4 identified?
• Inputs and Outputs
• Sequence and interaction
• Criteria, method and performance
indicators
• Resources needed
• Defined responsibility and authority for all
personnel.
• Risks and Opportunities
• Method for monitoring and change to
ensure intended results
• Opportunities for improvement of the
processes
Has the organization defined
4.4 • Needed documented information to
support the operation of its processes?
• Documented information to be retained as
evidence that the processes are being
carried out as planned?

6 Planning for the Quality Management System


Has the organization considered risks and
6.1.1 opportunities noted in 4.1 and 4.2 and have
assurances that QMS
• Can achieve its intended results?
• Mitigate Risk by prevention or reduction
of undesired effects?
• Enhance desirable effects?
• Achieve improvements?
Company Name: Document number:
TEKHAF TRADING PLC OF/TH/043
Page No.: Page 3 of 7
TITLE: INTERNAL AUDIT CHECKLIST

ISO9001:2015 Quality Management System Documented Auditor’s Notes and


Clause # Requirements Information Evidence
Reference
Does the organization plan
6.1.2 • Actions needed to address risks and
opportunities?
• Integrate actions into its QMS processes?
• Evaluate the effectiveness of actions?

Has the organization established Quality objectives


6.2.1 that are:
• Consistent with the Quality Policy?
• Are measurable?
• Considered applicable requirements?
• Relevant?
• Monitored?
• Communicated?
• Updated?
Has the organization planned how to achieve its
6.2.2 quality objectives by
• Identifying what has to be done?
• Identifying the needed resources?
• Identifying the responsibility for
achievement?
• Due date for achievement?
• Evaluation of the results?

For changes to the QMS, has the organization


6.3 proceeded in a planned and systemic manner by
• Identifying the changes and their
consequence?
• The integrity of the QMS?
• Availability of resources?
• Allocation or reallocation of responsibilities
and authorities?
Company Name: Document number:
TEKHAF TRADING PLC OF/TH/043
Page No.: Page 4 of 7
TITLE: INTERNAL AUDIT CHECKLIST

ISO9001:2015 Quality Management System Documented Auditor’s Notes and


Clause # Requirements Information Evidence
Reference

7.4 Communication
Have the following been addressed for all
7.4 internal and external communication
channels?
• Subject of Communication?
• When to communicate?
• With whom?
• How?
• Who?

7.4 Is Leadership able to demonstrate how they


ensure that appropriate communication
processes are established within the
organization, and that communication takes
place regarding the effectiveness of the
quality management system?

7.5 Documented Information


Does the organization’s quality management
7.5.1 system include
• Documented information required by
ISO9001:2015?
• Documented information determined by
the organization to be necessary for the
effectiveness of the quality management
system?

Are all documented information


7.5.2 • Properly identified (e.g. title, date, author
or reference)?
• In defined format – language, software
version, graphics, and media?
• Reviewed and approved for adequacy?
Company Name: Document number:
TEKHAF TRADING PLC OF/TH/043
Page No.: Page 5 of 7
TITLE: INTERNAL AUDIT CHECKLIST

ISO9001:2015 Quality Management System Documented Auditor’s Notes and


Clause # Requirements Information Evidence
Reference
Are all documented information controlled to
7.5.3.1 ensure
• Its suitability and availability?
• Adequately protected from use or
improper use?
Have the following issues addressed for control of
7.5.3.2 Documented Information;
•Distribution, control, access, retrieval and use?
•Storage and preservation, including legibility?
• Control of changes (version control)?
• Retention and disposition?
• Identification and control of documents of
external origin?

9.2 Internal Audits


Does the internal quality audit activity determine
9.2.1 whether the quality management system:
• Conforms to planned arrangements?
• Conforms to ISO 9001:2015?
• Conforms to quality management system
requirements established by the organization?
• Is effectively implemented and maintained?

Is evidence available to confirm that internal


9.2.2 audits are conducted at planned intervals based
upon:
• The status and importance of the processes
and areas to be audited?
• The results of previous audits?
• Customer feedback?
• Changes impacting the organization?

Have audit criteria, scope, frequency and methods


9.2.2 been defined?
Company Name: Document number:
TEKHAF TRADING PLC OF/TH/043
Page No.: Page 6 of 7
TITLE: INTERNAL AUDIT CHECKLIST

ISO9001:2015 Quality Management System Documented Auditor’s Notes and


Information Evidence
Clause # Requirements Reference

Is evidence available to confirm that internal


9.2.2 auditors do not audit their own work, and are
objective and impartial of the audit process?
Does the management responsible for the area
9.2.2 being audited ensure that any necessary
corrections and corrective actions are taken
without undue delay to eliminate detected
nonconformities and their causes?
Are documented information maintained as
9.2.2 evidence of the implementation of the audit
program and the audit results?

10.1 Improvement
Is the organization selecting opportunities for
10.1 improvement and implementing necessary actions
to meet customer requirements?
Is the organization taking actions to prevent
10.1 nonconformities, improve products and services,
and improve the overall quality management
system results?

10.2 Nonconformity and corrective action


In the presence of a nonconformity, does the
10.2 organization
• React to the nonconformity by taking
actions to control and correct it, and
dealing with its consequences?
• Evaluate the need for action to eliminate
the cause?
• Implement any action needed?
• Review the effective of any corrective
action?
• Make change to the quality management
system?
In the presence of a nonconformity, does the
10.2 organization react to the nonconformity by taking
actions to control and correct it, and dealing with
its consequences?

PLEASE MAKE SURE THAT THIS IS THE CORRECT ISSUE BEFORE USE
Company Name: Document number:
TEKHAF TRADING PLC OF/TH/043
Page No.: Page 7 of 7
TITLE: INTERNAL AUDIT CHECKLIST

ISO9001:2015 Quality Management System Documented Auditor’s Notes


Clause # Requirements Information and
Reference Evid
Are actions taken appropriate to the effects, or ence
10.2 potential effects of the nonconformity?

Are corrective actions taken appropriate to the


10.2 effects of the nonconformities encountered?
10.2 Is action taken to eliminate the causes of
nonconformities in order to prevent recurrence?
Is documented information maintained to show
10.2 the nature of the nonconformity and any
subsequent actions taken, and the results of any
corrective action taken?

10.3 Continual Improvement


Is the organization continually improving the
10.3 suitability, adequacy and effectiveness of the
quality management system?
Are the outputs of analysis and evaluation, and
10.3 the outputs from the management review process
used to identify the areas of underperformances?
Are specialized tools and methodologies used for
10.3 investigation of the causes of underperformance?
10.3 How is it demonstrated that the effectiveness of
the quality management system is being
continually improved?

PLEASE MAKE SURE THAT THIS IS THE CORRECT ISSUE BEFORE USE

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