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ISO 9001 2015 Transition Gap Analysis Checklist
ISO 9001 2015 Transition Gap Analysis Checklist
2016
ISO 9001:2015 Quality Management System Audit Checklist
Disclaimer
This audit is intended for use within one organization. The audit may be customized to suit your needs and preferences.
THE AUDIT IS DISTRIBUTED ON AN "AS IS" BASIS WITHOUT WARRANTIES OF ANY KIND, EITHER EXPRESSED OR
IMPLIED.
Copyright
This tool is created and copyrighted by PRO QC INTERNATIONAL & ART OF QUALITY CONSULTING
Copyrights of all the questions used in this presentation are held by their respective owners.
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ISO 9001:2015 Quality Management System Audit Checklist
AUDIT PLAN
Name of our organization audited:
Audit Number:
Functional Area covered: All ISO 9001:2015 QMS related process areas
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ISO 9001:2015 Quality Management System Audit Checklist
GAP ANALYSIS EVALUATION Affected QMS Gap Analysis Results Responsibility Due Date
Process Opportunity for Improvement (Who?) (Until
Audit Result Summary (OFI) Recommendation when?)
(Clausewise)
Name the Clause Name the affected (Write all justification artifacts like... Who will take care of Calculate due
QMS Process Levels of current implementation at organization, that particular QMS dates for the
(Existing/New) Nonconformity to ISO 9001:2015 facts, Easy to upgrade? Implementation
implement or accomplish, potential remedy or Project Plan
solution to become compliant, etc...
Date: Date: ..
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ISO 9001:2015 Quality Management System Audit Checklist
11 Has our organization determined the external and internal issues that are relevant to its
1
purpose and its strategic direction and
that affect our ability to achieve the intended result(s) of our quality management system?
(Are documents available like Business Plans, SWOT Analysis, Stakeholder Analysis, etc)
2 2 Is our organization monitoring and reviewing information about these external and internal
issues? How is it done?
1 Due to their effect or potential effect on our organizations ability to consistently provide
products and services that meet our customer and applicable statutory and regulatory
requirements, has our organization determined in documented format ...
a) the interested parties that are relevant to our quality management system?
b) the requirements of these interested parties that are relevant to our quality management
system? (Any documentation available as evidence for that?)
2 Whether and how our organization monitors and reviews information about these interested
parties and their relevant requirements?
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ISO 9001:2015 Quality Management System Audit Checklist
1 Has our organization determined the boundaries and applicability of our quality
management system to establish its scope? (Scope Statement available?)
3 Did our organization apply all the requirements of the ISO 9001:2015 standard if they
were applicable within the determined scope of our QMS?
4 Is the scope of our organizations quality management system visually available and
maintained as documented information somewhere?
5 Does the scope state the types of our products and services covered, and provide
justification for any requirement of the ISO 9001:2015 standard that our organization
determines as not applicable to the scope of our quality management system?
6 Are we aware that conformity to the ISO 9001:2015 standard may only be claimed if the
requirements determined as not applicable do not affect our organizations ability or
responsibility to ensure the conformity of our products and services and the enhancement
of customer satisfaction?
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ISO 9001:2015 Quality Management System Audit Checklist
(4.4.1)
2 Has our organization ...
a) determined the inputs required and the outputs expected from these processes?
b) determined the sequence and interaction of these processes? (Flow charts?)
c) determined and applied the criteria and methods (including monitoring, measurements
and related performance indicators) needed to ensure the effective operation and
control of these processes?
d) determined the resources needed for these processes and ensured their availability?
e) assigned the responsibilities and authorities for these processes?
f) addressed the risks and opportunities as determined in accordance with the
requirements of 6.1 (planning)?
g) evaluated these processes and implemented any changes needed to ensure that
these processes achieve their intended results?
h) tried to improve these processes and also our entire quality management system?
(4.4.2)
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ISO 9001:2015 Quality Management System Audit Checklist
Clause 5: LEADERSHIP
5.1 Leadership and commitment
Sl. # Audit Question Audit Result Describe the Gap
1 (5.1.1 - General)
In order to demonstrate its leadership and commitment with respect to our quality
management system, is our top management Hands on...
a) taking accountability for the effectiveness of our quality management system? Please
cite some examples.
b) ensuring that our quality policy and quality objectives are established for our quality
management system and are compatible with the context and strategic direction of our
organization? Please cite some examples (Quality Policy signed, etc?).
c) ensuring the integration of our quality management system requirements into our
organizations business processes? Please cite some examples.
d) promoting the use of the process approach and risk-based thinking? Please cite some
examples. (Quality training, E-newsletter, any other documented evidence, etc)
e) ensuring that the resources needed for our quality management system are available?
Please cite some examples. Is there are Employee Handbook available?
f) communicating the importance of effective quality management and of conforming to
our quality management system requirements? Please cite some examples.
g) ensuring that our quality management system achieves its intended results? Please
cite some examples. Is there a List of Authorities/Responsibilities, Org-Chart available?
h) engaging, directing and supporting persons to contribute to the effectiveness of our
quality management system? Please cite some examples.
i) promoting improvement? Please cite some examples. Improvement plans, etc
j) supporting other relevant management roles to demonstrate their leadership as it
applies to their areas of responsibility? Please cite some examples. QMS Process
owner plan, Master-list of approved SOPs, Records, Job descriptions, advanced
quality training evidence records (Lean, Six Sigma, etc)
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ISO 9001:2015 Quality Management System Audit Checklist
In order to demonstrate its leadership and commitment with respect to customer focus, is
our top management ensuring that ...
NOTES:
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ISO 9001:2015 Quality Management System Audit Checklist
5.2 Policy
1 Has our top management established, implemented and maintaining a quality policy that ...
a) is appropriate to the purpose and context of our organization and supports its strategic
direction?
b) provides a framework for setting our quality objectives?
c) includes a commitment to satisfy applicable requirements?
d) includes a commitment to continual improvement of the quality management system?
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ISO 9001:2015 Quality Management System Audit Checklist
1 Does our top management ensure that the responsibilities and authorities for relevant QMS
related process roles are assigned, communicated and understood within our organization?
(Responsibility Charts, Org-Chart, etc)
2 Has our top management assigned the responsibility and authority for ...
a) ensuring that our quality management system conforms to the requirements of the ISO
9001:2015 standard?
b) ensuring that all QMS related processes are delivering their intended outputs?
c) reporting on the performance of our quality management system and on opportunities for
improvement, in particular to our top management?
d) ensuring the promotion of customer focus throughout our organization?
e) ensuring that the integrity of our quality management system is maintained when changes
to our quality management system are planned and implemented?
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ISO 9001:2015 Quality Management System Audit Checklist
Clause 6: PLANNING
1 When planning for our quality management system, did our organization consider the
issues referred to in 4.1 and the requirements referred to in 4.2 and determine all
risks and relevant new opportunities that need to be addressed to:
a) give assurance that our quality management system can achieve its intended
result(s)? Global Risk plan if needed? Inclusive Supplier risk evaluation?
b) enhance desirable effects?
c) prevent, or reduce, undesired effects? (FMEA, or any other Risk planning tool?)
d) achieve improvement?
(6.1.2)
(6.1.2)
3 Whether the actions taken to address risks and opportunities shall be proportionate
to the potential impact on the conformity of products and services? Global and local?
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ISO 9001:2015 Quality Management System Audit Checklist
(6.1.2)
4 Do the options to address all to our organization relevant risks include avoiding risk,
taking risk in order to pursue an opportunity, eliminating the risk source, changing the
likelihood or consequences, sharing the risk, or retaining risk by informed decision?
(6.1.2)
5 Has any opportunity led to the adoption of new practices, launching new products,
opening new markets, addressing new customers, building partnerships, using new
technology and other desirable and viable possibilities to address our organizations
or its customers needs? Please cite some instances.
NOTES:
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ISO 9001:2015 Quality Management System Audit Checklist
3 Does our organization maintain documented information on the QMS quality objectives?
(6.2.2)
4 When planning how to achieve our quality objectives, does our organization determine ...
a) what will be done? Do we collect and track monthly KPI Records for status update?
b) what resources will be required?
c) who will be responsible? Process owners responsible for tracking process interruptions?
d) when it will be completed? Quarterly, Monthly, weekly?
e) how the results will be evaluated? Is the Quality team tracking/analyzing KPI trends?
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ISO 9001:2015 Quality Management System Audit Checklist
1 When our organization determines the need for changes to our quality
management system, are the changes carried out in a planned manner?
Any SOP for that available?
NOTES:
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ISO 9001:2015 Quality Management System Audit Checklist
Clause 7: SUPPORT
7.1 Resources
1 Has our organization determined and is providing the resources needed for the
establishment, implementation, maintenance and continual improvement of our quality
management system? Is that a constant item line of our QMS Management Reviews?
(7.1.2 - People)
2 Does our organization determine and provide the persons necessary for the effective
implementation of our quality management system and for the operation and control of its
relevant processes? Job Skill Matrix? Annual Training plan in place? etc...
(7.1.3 - Infrastructure)
3 Does our organization determine, provide and maintain the infrastructure necessary for
the operation of its processes and to achieve conformity of products & services?
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ISO 9001:2015 Quality Management System Audit Checklist
4 Has our organization determined, provided and is maintaining the environment necessary
for the operation of its processes and to achieve conformity of our products and services?
What is the status of the following environmental factors (if relevant) ...
5 Has our organization determined and is providing the resources needed to ensure valid
and reliable results when monitoring or measuring is used to verify the conformity of
products and services to requirements with focus on non-conformities? Who is doing
Legal Watch and Statutory/Regulatory Watch in our organization?
6 Whether and how does our organization ensure that the resources provided ...
a) are suitable for the specific type of monitoring and measurement activities being
undertaken?
b) are maintained to ensure their continuing fitness for their purpose?
9 Does our organization determine if the validity of previous measurement results has been
adversely affected when measuring equipment is found to be unfit for its intended
purpose, and take appropriate action as necessary?
(7.1.6 - Organizational knowledge)
10 Has our organization determined the knowledge necessary for the operation of its QMS
processes and to achieve conformity of products and services?
11 Whether this knowledge is maintained within documented information and made available
to the extent necessary?
(7.1.6 - Organizational knowledge)
12 When addressing changing needs and trends, does our organization consider its current
knowledge and determine how to acquire or access any necessary additional knowledge
and required updates?
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ISO 9001:2015 Quality Management System Audit Checklist
a) internal sources (e.g. intellectual property; knowledge gained from experience; lessons
learned from failures and successful projects; capturing and sharing undocumented
knowledge and experience; the results of improvements in processes, products and
services)?
b) external sources ( e.g. standards; academia; conferences; gathering knowledge from
customers or external providers)?
7.2 Competence
a) determine the necessary competence of person(s) doing work under its control that
affects the performance and effectiveness of our quality management system?
b) ensure that these persons are competent on the basis of appropriate education,
training, or experience? Job Skill matrix, HR Competency plan for growth, etc
c) where applicable, take actions (for example, the provision of training to, the mentoring
of, or the reassignment of currently employed persons; or the hiring or contracting of
competent persons) to acquire the necessary competence, and evaluate the
effectiveness of the actions taken?
d) retain appropriate documented information as evidence of competence?
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ISO 9001:2015 Quality Management System Audit Checklist
7.3 Awareness
1 Whether and how does our organization ensure that persons doing work
under our organizations control are aware of:
7.4 Communication
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ISO 9001:2015 Quality Management System Audit Checklist
7.5.1 General
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ISO 9001:2015 Quality Management System Audit Checklist
(7.5.3.2)
(7.5.3.2)
(7.5.3.2)
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ISO 9001:2015 Quality Management System Audit Checklist
Clause 8: OPERATION
1 Has our organization planned, implemented and controlling the processes needed to meet
the requirements for the provision of products and services, and to implement the actions
determined in Clause 6 (Planning)?
a) determining the requirements for our products and services? Which SOP?
b) establishing criteria for the processes and the acceptance of products and services?
c) determining the resources needed to achieve conformity to the product and service
requirements? (Supplier evaluations, Annual evaluation of all Third Party vendors?)
d) implementing control of the processes in accordance with the criteria?
e) determining, maintaining and retaining documented information to the extent necessary
to have confidence that the processes have been carried out as planned, and, to
demonstrate the conformity of products and services to their requirements?
3 Is the output of this planning suitable for our organizations operations? Can we defend that
with some examples from recent past?
4 Whether and how our organization is controlling planned changes and reviewing the
consequences of unintended changes, taking action to mitigate any adverse effects, as
necessary?
5 How does our organization ensure that outsourced processes are controlled?
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ISO 9001:2015 Quality Management System Audit Checklist
a) the requirements for our products and services are defined, including any
applicable statutory and regulatory requirements, and, those considered
necessary by our organization?
b) our organization can meet the claims we make for our products and
services we offer? Sales terms/Purchase order terms recent version?
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ISO 9001:2015 Quality Management System Audit Checklist
(8.2.3.1)
(8.2.3.1)
(8.2.3.1)
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ISO 9001:2015 Quality Management System Audit Checklist
(8.2.3.1)
(8.2.3.1)
(8.2.3.2)
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ISO 9001:2015 Quality Management System Audit Checklist
8.3.1 General
1 In determining the stages and controls for design and development, does our
organization consider ...
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ISO 9001:2015 Quality Management System Audit Checklist
NOTES:
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ISO 9001:2015 Quality Management System Audit Checklist
1 Does our organization determine the requirements essential for the specific
types of our products and services to be designed and developed?
3 How do you make sure that the inputs are adequate for design and
development purposes, complete and unambiguous? And who approves this?
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ISO 9001:2015 Quality Management System Audit Checklist
1 Does our organization apply controls to our design and development process to
ensure that ...
1 Does our organization ensure that all design and development outputs ...
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ISO 9001:2015 Quality Management System Audit Checklist
2 Does our organization retain documented information on all design and development
outputs?
1 Does our organization identify, review and control all changes made during, or
subsequent to, the design and development of our products and services, to the extent
necessary to ensure that there is no adverse impact on conformity to requirements?
2 Whether and what documented information does our organization retaining on ...
Do we have Flow Charts/Routing for customer complaints for our internal routing?
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ISO 9001:2015 Quality Management System Audit Checklist
8.4.1 General
1 How does our organization ensure that externally provided processes, products and
services conform to the proposed product and service requirements?
Non-conformity Register in place?
a) products and services from external providers are intended for incorporation into
our organizations own products and services?
b) products and services are provided directly to the customer(s) by external
providers on behalf of our organization?
c) a process, or part of a process, is provided by an external provider as a result of
a decision by our organization?
3 Whether and how does our organization determine and apply criteria for the
evaluation, selection, monitoring of performance, and re-evaluation of external
providers? Is it based on their ability to provide processes or products and services in
accordance with requirements?
4 What documented information does our organization retain for these activities and
any necessary actions arising from these evaluations?
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ISO 9001:2015 Quality Management System Audit Checklist
1 How does our organization ensure that externally provided processes, products and
services do not adversely affect our organizations ability to consistently deliver
conforming products and services to our customers?
a) ensure that externally provided processes remain within the control of our quality
management system?
b) define both the controls that it intends to apply to an external provider and those it
intends to apply to the resulting output?
c) take into consideration:
1) the potential impact of the externally provided processes, products and
services on our organizations ability to consistently meet customer and
applicable statutory and regulatory requirements?
2) the effectiveness of the controls applied by the external provider?
NOTES:
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ISO 9001:2015 Quality Management System Audit Checklist
1 How does our organization ensure the adequacy of requirements prior to their
communication to the external provider?
2 Does our organization communicate to external providers its requirements for ...
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ISO 9001:2015 Quality Management System Audit Checklist
1 Has our organization implemented production and service provision under controlled
conditions?
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ISO 9001:2015 Quality Management System Audit Checklist
1 Does our organization use suitable means to identify all outputs when it is necessary to
ensure the conformity of our products and services?
2 How does our organization identify the status of all outputs with respect to monitoring and
measurement requirements throughout production and service provision?
3 How does our organization control the unique identification of the outputs when traceability
is a requirement, and shall retain the documented information necessary to enable
traceability?
1 Does our organization exercise care with property belonging to customers or external
providers while it is under our organizations control or being used by our organization?
2 Does our organization identify, verify, protect and safeguard customers or external
providers property provided for use or incorporation into our products and services?
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ISO 9001:2015 Quality Management System Audit Checklist
3 When the property of a customer or external provider is lost, damaged or otherwise found
to be unsuitable for use, does our organization report this to the customer or external
provider and retain documented information on what has occurred?
4 Does your definition (and coverage) of customers or external providers property include
materials, components, tools and equipment, premises, intellectual property and personal
data?
8.5.4 Preservation
1 How does our organization preserve the outputs during production and service provision, at
least to the extent necessary to ensure conformity to requirements?
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ISO 9001:2015 Quality Management System Audit Checklist
1 How does our organization meet requirements for post-delivery activities associated
with our products and services?
2 In determining the extent of post-delivery activities that are required, does our
organization consider ...
3 Does our definition (and coverage) of post-delivery activities include actions under
warranty provisions, contractual obligations such as maintenance services, and
supplementary services such as recycling or final disposal?
1 Does our organization review and control changes for production or service provision, to
the extent necessary to ensure continuing conformity with all requirements?
2 Does our organization retain documented information describing the results of the
review of any changes, the person(s) authorizing the change, and any necessary
actions arising from the review?
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ISO 9001:2015 Quality Management System Audit Checklist
2 How do we ensure that the release of our products and services to the customer do not
proceed until the planned arrangements have been satisfactorily completed, unless
otherwise approved by a relevant authority and, as applicable, by our customer?
3 Does our organization retain documented information on the release of our products and
services? Are the records up-to-date? Please show some samples.
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ISO 9001:2015 Quality Management System Audit Checklist
1 How does our organization ensure that outputs that do not conform to their requirements
are identified and controlled to prevent their unintended use or delivery?
(8.7.1)
2 Does our organization take appropriate action based on the nature of the nonconformity
and its effect on the conformity of our products and services?
(8.7.1)
3 Does this also apply to nonconforming products and services detected after delivery of
products, during or after the provision of services?
(8.7.1)
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ISO 9001:2015 Quality Management System Audit Checklist
(8.7.1)
5 Is the new conformity to the requirements verified when nonconforming outputs are
corrected (i.e., re-inspection)?
(8.7.2)
NOTES:
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ISO 9001:2015 Quality Management System Audit Checklist
9.1.1 General
2 Whether and how does our organization evaluate the performance of our QMS and the
effectiveness of our quality management system?
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ISO 9001:2015 Quality Management System Audit Checklist
2 Has our organization determined the methods for obtaining, monitoring and reviewing
this information? Do we evaluate also Internal Customer satisfaction? How?
3 Does our organization use any statistical techniques to analyze our QMS related data?
Are our people trained on using statistical techniques for QMS related data analysis?
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ISO 9001:2015 Quality Management System Audit Checklist
4 Are our internal auditors aware of / trained on the audit standard (i.e., ISO19011:2011)?
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ISO 9001:2015 Quality Management System Audit Checklist
9.3.1 General
1 Does our top management review our organizations quality management system
at planned intervals, to ensure its continuing suitability, adequacy, effectiveness
and alignment with the strategic direction of our organization?
1 Is the QMS management review planned/carried out taking into consideration ...
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ISO 9001:2015 Quality Management System Audit Checklist
1 Do the outputs of our last QMS management review include top management
decisions and concise actions with responsibilities and due date for accomplishment
related to ...
NOTES:
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ISO 9001:2015 Quality Management System Audit Checklist
Clause10: IMPROVEMENT
10.1 General
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ISO 9001:2015 Quality Management System Audit Checklist
1 When a nonconformity (NC) occurs, including any nonconformity arising from complaints,
whether internal or external complaint nature, does our organization ...
b) evaluate the need for action to eliminate the cause(s) of the nonconformity, in order
that it does not recur or occur elsewhere, by:
1) reviewing and analyzing the nonconformity?
2) determining the causes of the nonconformity?
3) determining if similar non-conformities exist, or could potentially occur?
2 How does our organization make sure that all corrective actions are appropriate to the
effects of the non-conformities encountered? Any follow-up done to check whether the
corrective actions were effective?
(10.2.2)
1 How does our organization continually improve the suitability, adequacy and
effectiveness of our quality management system?
2 Does our organization consider the results of analysis and evaluation, and the outputs
from our QMS management reviews, to determine if there are needs or opportunities
that shall be addressed as part of continual improvement?
3 Can our organization show any trend charts / graphs to prove that our organization is
showing efforts for continual improvement on critical parameters of our QMS (such as
material rejections management, field-failures management, warranty claims-, repairs-,
reworks-, customer complaints management, and service response time management,
etc.)?
Date: ..
Date: ..
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