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Abstract

ISO 9001:2015 Clause 9.2 Internal Audit The purpose of an internal audit is to systematic and independent assess the effectiveness of any organization’s quality management system and its overall performance Internal audit demonstrate the compliance with a planned arrangements’, e.g. the QMS and how its processes are implemented and maintained.
Internal Quality Management System Audit Checklist (ISO 9001:2015)
Q# ISO 9001:2015 Clause Audit Question Audit Evidence
4 Context of the Organization
4.1 Understanding the organization and its context
4.1q1 The organization shall determine external and
internal issues that are relevant to its purpose and
its strategic direction and that affect its ability to
achieve the intended result(s) of its quality
management system.
How has the organization determined
external and internal issues relevant to its
purpose and strategic direction?
How do these affect the ability to achieve
the intended result of the QMS?
4.1q2 The organization shall monitor and review the
information about these external and internal
issues.
How do you monitor and review information
about these internal and external issues?
NOTE 1 Understanding the external context can be facilitated by considering issues arising from legal,
technological, competitive, market, cultural, social, and economic environments, whether international,
national, regional or local.
NOTE 2 Understanding the internal context can be facilitated by considering issues related to values, culture
knowledge and performance of the organization.
4.2 Understanding the needs and expectations of interested parties
4.2q1 Due to their impact or potential impact on the
organization’s ability to consistently provide
products and services that meet customer and
applicable statutory and regulatory requirements,
the organization shall determine:
a) the interested parties that are relevant to the
quality management system;
b) the requirements of these interested parties
that are relevant to the quality management
system.
How have you determined what interested
parties are relevant to the QMS?
How have you determined what
requirements those parties have that are
relevant to the QMS?
How has impact or potential impact been
determined?
4.2q2 The organization shall monitor and review the
information about these interested parties and their
relevant requirements.
How do you monitor and review the
information about interested parties and
their relevant requirements?
4.3 Determining the scope of the quality management system
4.3q1 The organization shall determine the boundaries
and applicability of the quality management system
to establish its scope.
How have the boundaries and applicability
of the QMS been used to establish the
scope of the organization?
4.3q2 When determining this scope, the organization
shall consider:
a) the external and internal issues referred to in
4.1;
b) the requirements of relevant interested parties
referred to in 4.2;
c) the products and services of the organization.
How have:
The external and internal issues;
The requirements of relevant interested
parties and;
The products and services of the
organization been considered when
determining the scope of the organization?
4.3q3 Where a requirement of this International Standard
within the determined scope can be applied, then it
shall be applied by the organization.
How has the application of the International
Standard within the scope been determined,
and how has it been applied by the
organization?
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Q# ISO 9001:2015 Clause Audit Question Audit Evidence
4.3q4 If any requirement(s) of this International Standard
cannot be applied, this shall not affect the
organization’s ability or responsibility to ensure
conformity of products and services.
How have any requirements of the
International Standard been determined as
not applicable? Show me how conformity of
products and services are not affected by
this.
4.3q5 The scope shall be available and be maintained as
documented information stating the:
- products and services covered by the
quality management system;
- justification for any instance where a
requirement of this International Standard
cannot be applied.
Where is the scope available? Where is it
maintained as documented information?
Does it state what products and services
are covered by the QMS?
Does it justify how instances of
requirements of the QMS cannot be
applied?
Scope required as documented information.
4.4 Quality management system and its processes
4.4q1 The organization shall establish, implement,
maintain and continually improve a quality
management system, including the processes
needed and their interactions, in accordance with
the requirements of this International Standard.
How has the QMS been established? Show
me how this is implemented. How is it
maintained and continually improved? How
have the processes been determined and
how do they interact?
4.4q2 The organization shall determine the processes
needed for the quality management system and
their application throughout the organization and
shall determine:
a) the inputs required and the outputs expected
from these processes;
b) the sequence and interaction of these
processes;
c) the criteria, methods, including measurements
and related performance indicators needed to
ensure the effective operation, and control of these
processes;
d) the resources needed and ensure their
availability;
e) the assignment of the responsibilities and
authorities for these processes;
f) the risks and opportunities in accordance with the
requirements of 6.1, and plan and implement the
appropriate actions to address them;
g) the methods for monitoring, measuring, as
appropriate, and evaluation of processes and, if
needed, the changes to processes to ensure that
they achieve intended results;
h) opportunities for improvement of the processes
and the quality management system.
How have the processes been determined
for the QMS?
What are the inputs and outputs for those
processes?
What is the sequence and interaction of the
processes?
What are the criteria, methods,
measurement and related performance
indicators needed to operate and control
those processes?
What resources are needed and how are
these made available?
How are responsibilities and authorities
assigned for those processes?
How are risks and opportunities considered
and what plans are made to implement
actions to address them?
What methods are used to monitor,
measure and evaluate processes and, if
needed, what changes are made to achieve
intended results?
How are opportunities to improve the
processes and the QMS determined?
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Q# ISO 9001:2015 Clause Audit Question Audit Evidence
4.4q3 The organization shall maintain documented
information to the extent necessary to support the
operation of processes and retain documented
information to the extent necessary to have
confidence that the processes are being carried out
as planned.
What documented information exists to
support the operation of processes? How is
this documented information retained? How
is confidence that the processes are being
carried out as planned determined?
Documented information to support the operation of
processes.
5 Leadership
5.1 Leadership and commitment
5.1.1 Leadership and commitment for the quality management system
5.1.1q1 Top management shall demonstrate leadership and
commitment with respect to the quality
management system by:
a) taking accountability of the effectiveness of the
quality management system;
b) ensuring that the quality policy and quality
objectives are established for the quality
management system and are compatible with the
strategic direction and the context of the
organization;
c) ensuring that the quality policy is communicated,
understood and applied within the organization;
d) ensuring the integration of the quality
management system requirements into the
organization’s business processes;
e) promoting awareness of the process approach;
f) ensuring that the resources needed for the
quality management system are available;
g) communicating the importance of effective
quality management and of conforming to the
quality management system requirements;
h) ensuring that the quality management system
achieves its intended results;
i) engaging, directing and supporting persons to
contribute to the effectiveness of the quality
management system;
j) promoting continual improvement;
k) supporting other relevant management roles to
demonstrate their leadership as it applies to their
areas of responsibility.
Show me how top management
demonstrates leadership and commitment
w.r.t. the QMS by taking accountability of
the effectiveness of the QMS.
How is the quality policy and objectives
established for the QMS and how are they
compatible with the strategic direction and
the organizational context?
How is the quality policy communicated
within the organization? Show me how this
is understood and applied.
How are the requirements of the QMS
integrated into the business processes?
How do you promote awareness of the
process approach?
How do you ensure that resources needed
for the QMS area available?
How do you communicate the importance of
effective quality management?
How do you communicate the importance of
conforming to the QMS requirements?
How do you ensure that the QMS achieves
its intended results?
How do you engage, direct and support
people to contribute to the effectiveness of
the QMS?
How do you promote continual
improvement?
How do you support other relevant
management roles to demonstrate
leadership in their areas of responsibility?
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NOTE Reference to “business” in this International Standard can be interpreted broadly to mean those
activities that are core to the purposes of the organization’s existence; whether the organization is public,
private, for profit or not for profit.
5.1.2 Customer focus
5.1.2q1 Top management shall demonstrate leadership and
commitment with respect to customer focus by
ensuring that:
a) customer requirements and applicable statutory
and regulatory requirements are determined and
met;
b) the risks and opportunities that can affect
conformity of products and services and the ability
to enhance customer satisfaction are determined
and addressed;
c) the focus on consistently providing products and
services that meet customer and applicable
statutory and regulatory requirements is
maintained;
d) the focus on enhancing customer satisfaction is
maintained.
Show me how top management
demonstrates leadership and commitment
w.r.t. customer focus ensuring requirements
and applicable statutory and regulatory
requirements are determined and met.
How are risks and opportunities that can
affect conformity of products and services
determined?
How is the ability to enhance customer
satisfaction determined and addressed?
How is the focus on consistently providing
products and services that meet customer
and applicable statutory and regulatory
requirements maintained?
How is customer satisfaction maintained?
5.2 Quality policy
5.2.1
5.2.1q1 Top management shall establish, review and maintain
a quality policy that:
a) is appropriate to the purpose and context of the
organization;
b) provides a framework for setting and reviewing
quality objectives;
c) includes a commitment to satisfy applicable
requirements;
d) includes a commitment to continual improvement
of the quality management system.
How does top management establish,
review and maintain a quality policy?
How is it determined to be appropriate to
the purpose and context of the
organization?
Does it provide a framework for setting and
reviewing quality objectives?
Does it contain a commitment to satisfy
applicable requirements?
Does it include a commitment to continual
improvement of the QMS?
5.2.2
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5.2.2q1 The quality policy shall:
a) be available as documented information;
b) be communicated, understood and applied
within the organization;
c) be available to relevant interested parties, as
appropriate.
Where is the quality policy available as
documented information?
How is it communicated?
Show me how it is understood and applied
within the organization.
How have you made it available to relevant
interested parties?
Quality Policy as document information
5.3 Organizational roles, responsibility and authorities
5.3q1 Top management shall ensure that the
responsibilities and authorities for relevant roles
are assigned, communicated and understood
within the organization.
How does top management ensure that
responsibilities and authorities for relevant
roles are assigned, communicated and
understood within the organization?
5.3q2 Top management shall assign the responsibility
and authority for:
a) ensuring that the quality management system
conforms to the requirements of this International
Standard;
b) ensuring that the processes are delivering their
intended outputs;
c) reporting on the performance of the quality
management system, on opportunities for
improvement and on the need for change or
innovation, and especially for reporting to top
management;
d) ensuring the promotion of customer focus
throughout the organization;
e) ensuring that the integrity of the quality
management system is maintained when changes
to the quality management system are planned and
implemented.
How does top management assign the
responsibility and authority for:
Ensuring that the QMS conforms to the
International standard?
Ensuring processes are delivering their
intended outputs?
How is the performance of the QMS,
opportunities for improvement and the need
for change or innovation reported to top
management?
How is customer focus promoted within the
organization?
How is the integrity of the QMS maintained
when changes to the QMS are planned and
implemented?
6 Planning for the quality management system
6.1 Actions to address risks and opportunities
6.1.1
6.1.1q1 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 that
need to be addressed to:
a) give assurance that the quality management
system can achieve its intended result(s);
b) prevent, or reduce, undesired effects;
c) achieve continual improvement.
How are the internal and external issues
and interested parties considered when
planning for the QMS?
How are risks and opportunities determined
and addressed so that the QMS can::
a) achieve its intended results;
b) Prevent or reduce undesired effects;
c) Achieve continual improvement?
6.1.2
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6.1.2q1 The organization shall plan:
a) actions to address these risks and opportunities;
b) how to:
1) integrate and implement the actions into its
quality management system processes (see 4.4);
2) evaluate the effectiveness of these actions.
How are actions planned to address risks
and opportunities?
How are actions integrated and
implemented into the QMS processes?
How do you evaluate the effectiveness of
the actions?
6.1.2q2 Actions taken to address risks and opportunities
shall be proportionate to the potential impact on the
conformity of products and services.
How are actions taken to address risks and
opportunities determined as being
appropriate to the potential impact on the
conformity of products and services?
6.2.2.1 Product design skills
6.2.2.1q
1
The organization shall ensure that personnel with
product design responsibility are competent to
achieve design requirements and are skilled in
applicable tools and techniques.
Applicable tools and techniques shall be identified
by the organization.
How do you determine that personnel with
product design responsibility are competent
to achieve design requirements? How do
you determine skills required in applicable
tools and techniques? How do you identify
applicable tools and techniques?
NOTE Options to address risks and opportunities can 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.
6.2 Quality objectives and planning to achieve them
6.2.1
6.2.1q1 The organization shall establish quality objectives
at relevant functions, levels and processes.
The quality objectives shall:
a) be consistent with the quality 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.
Where are the quality objectives and are
these at all relevant functions, levels and
processes?
Are they consistent with the quality policy?
Are they measureable?
Do they consider applicable requirements?
Are they relevant to the conformity of
products and services and do they enhance
customer satisfaction?
Are they monitored? How? How often?
How are they communicated?
How are they updated?
Where is the documented information on
the quality objectives?
Documented information on quality objectives
6.2.2
6.2.2q1 When planning how to achieve its quality
objectives, the organization shall determine:
a) what will be done;
b) what resources will be required;
c) who will be responsible;
d) when it will be completed;
e) how the results will be evaluated.
How does the organization determine what
will be done, with what resources, when
completed and how will results be evaluated
for quality objectives?
6.3 Planning of changes
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6.3q1 Where the organization determines the need for
change to the quality management system (see
4.4) the change shall be carried out in a planned
and systematic manner.
The organization shall consider:
a) the purpose of the change and any of its
potential consequences;
b) the integrity of the quality management system;
c) the availability of resources;
d) the allocation or reallocation of responsibilities
and authorities.
How are changes to the QMS planned
systematically?
Demonstrate the purpose and potential
consequences of changes;
Demonstrate the integrity of the QMS;
Demonstrate how resources are made
available?
Demonstrate how responsibility and
authority is allocated or reallocated.
7 Support
7.1 Resources
7.1.1 General
7.1.1q1 The organization shall determine and provide the
resources needed for the establishment,
implementation, maintenance and continual
improvement of the quality management system.
The organization shall consider:
a) the capabilities of, and constraints on, existing
internal resources;
b) what needs to be obtained from external
providers.
Demonstrate how resources are determined
for the establishment, implementation,
maintenance and continual improvement of
the QMS.
Show me how the capabilities and
constraints on internal resources are
considered.
Show me how needs from external
providers are considered.
7.1.2 People
7.1.2q1 To ensure that the organization can consistently
meet customer and applicable statutory and
regulatory requirements, the organization shall
provide the persons necessary for the effective
operation of the quality management system,
including the processes needed.
How do you provide persons necessary to
consistently meet customer, applicable
statutory and regulatory requirements for
the QMS including the necessary
processes?
7.1.3 Infrastructure
7.1.3q1 The organization shall determine, provide and
maintain the infrastructure for the operation of its
processes to achieve conformity of products and
services.
How do you determine, provide and
maintain the infrastructure for the operation
of processes to achieve products and
service conformity?
NOTE 1 Any product realization change affecting customer requirements requires notification to, and
agreement from, the customer.
7.1.4 Environment for the operation of processes
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7.1.4q1 The organization shall determine, provide and
maintain the environment necessary for the
operation of its processes and to achieve
conformity of products and services.
How do you determine, provide and
maintain the environment for the operation
of processes to achieve products and
service conformity?
NOTE Environment for the operation of processes can include physical, social, psychological, environmental
and other factors (such as temperature, humidity, ergonomics and cleanliness).
7.1.5 Monitoring and measuring resources
7.1.5q1 Where monitoring or measuring is used for
evidence of conformity of products and services to
specified requirements the organization shall
determine the resources needed to ensure valid
and reliable monitoring and measuring results.
How are the resources determined for
ensuring valid and reliable monitoring and
measuring results, where used?
7.1.5q2 The organization shall 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 continued fitness
for their purpose.
How do you ensure that resources provided
are suitable for the specific monitoring and
measurement activities and are maintained
to ensure continued fitness for purpose?
7.1.5q3 The organization shall retain appropriate
documented information as evidence of fitness for
purpose of monitoring and measurement
resources.
Show me the documented information
which is evidence of fitness for purpose of
monitoring and measurement resources.
Documented information of fitness for purpose of monitoring
& measurement resources.
7.1.5q4 Where measurement traceability is: a statutory or
regulatory requirement; a customer or relevant
interested party expectation; or considered by the
organization to be an essential part of providing
confidence in the validity of measurement results;
measuring instruments shall be:
-verified or calibrated at specified intervals or prior
to use against measurement standards traceable to
international or national measurement standards.
Where no such standards exist, the basis used for
calibration or verification shall be retained as
documented information;
-identified in order to determine their calibration
status;
-safeguarded from adjustments, damage or
deterioration that would invalidate the calibration
status and subsequent measurement results.
Where applicable, show me how
measurement instruments are:
Verified or calibrated at specified intervals
against national or international
measurement standards;
If there are no standards, show me the
documented information which is used as
the basis used for calibration or verification.
Show me how measurement instruments
are identified to determine their calibration
status.
Show me how they are safeguarded from
adjustments.
Show me how they are safeguarded from
damage and deterioration.
Documented information for the basis of calibration or
verification where no standards exist.
7.1.5q5 The organization shall determine if the validity of
previous measurement results has been adversely
affected when an instrument is found to be
defective during its planned verification or
calibration, or during its use, and take appropriate
corrective action as necessary.
How do you determine the validity of
previous measurements if you find an
instrument to be defective during verification
or calibration?
What appropriate actions can you take?
7.1.6 Organizational knowledge
7.1.6q1 The organization shall determine the knowledge
necessary for the operation of its processes and to
achieve conformity of products and services.
How do you determine necessary
knowledge for the operation of processes?
How do you determine necessary
knowledge to achieve conformity of
products and services?
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Q# ISO 9001:2015 Clause Audit Question Audit Evidence
7.1.6q2 This knowledge shall be maintained, and made
available to the extent necessary.
How do you maintain this knowledge and
how do you make it available to the extent
necessary?
7.1.6q3 When addressing changing needs and trends, the
organization shall consider its current knowledge
and determine how to acquire or access the
necessary additional knowledge.
How do you consider current knowledge
and how do you acquire additional
knowledge when addressing changing
needs and trends?
NOTE 1 Organizational knowledge can include information such as intellectual property and lessons learned.
NOTE 2 To obtain the knowledge required, the organization can consider:
a) internal sources (e.g. learning from failures and successful projects, capturing undocumented knowledge
and experience of topical experts within the organization);
b) external sources (e.g. standards, academia, conferences, gathering knowledge with customers or
providers).
7.2 Competence
7..2q1 The organization shall:
a) determine the necessary competence of
person(s) doing work under its control that affects
its quality performance;
b) ensure that these persons are competent on the
basis of appropriate education, training, or
experience;
c) where applicable, take actions to acquire the
necessary competence, and evaluate the
effectiveness of the actions taken;
d) retain appropriate documented information as
evidence of competence.
Show me how:
You determine the necessary competence
of people doing work under your control that
affects quality performance;
How do you determine competence on the
basis of appropriate education, training or
experience?
How do you take actions to acquire
necessary competence where applicable
and how do you evaluate the effectiveness
of those actions?
Show me documented information where
appropriate of competence.
Documented information as evidence of competence where
appropriate.
NOTE Applicable actions can include, for example, the provision of training to, the mentoring of, or the re-
assignment of currently employed persons; or the hiring or contracting of competent persons.
7.3 Awareness
7.3q1 Persons doing work under the organization’s
control shall be aware of:
a) the quality policy;
b) relevant quality objectives;
c) their contribution to the effectiveness of the
quality management system, including the benefits
of improved quality performance;
d) the implications of not conforming with the
quality management system requirements.
How are people aware of:
The quality policy?
Relevant quality objectives?
Their contribution to the effectiveness of the
QMS?
The benefits of improved performance?
The implications of not conforming with the
QMS requirements?
7.4 Communication
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7.4q1 The organization shall determine the internal and
external communications relevant to the quality
management system including:
a) on what it will communicate;
b) when to communicate;
c) with whom to communicate;
d) how to communicate.
How do you determine internal and external
communications relevant to the QMS?
How do you determine:
What?
When?
With Whom?
How?
7.5 Documented information
7.5.1 General
7.5.1q1 The organization’s quality management system
shall include:
a) documented information required by this
International Standard;
b) documented information determined by the
organization as being necessary for the
effectiveness of the quality management system.
What documented information do you
have as required by this standard?
What documented information do you
have as being necessary for the
effectiveness of your QMS?
Documented information required by this standard.
Documented information necessary for the effectiveness of
the QMS.
NOTE The extent of documented information for a quality management system can differ from one
organization to another due to:
a) the size of organization and its type of activities, processes, products and services;
b) the complexity of processes and their interactions;
c) the competence of persons.
7.5.2 Creating and updating
7.5.2q1 When creating and updating documented
information the organization shall ensure
appropriate:
a) identification and description (e.g. a title, date,
author, or reference number);
b) format (e.g. language, software version,
graphics) and media (e.g. paper, electronic);
c) review and approval for suitability and adequacy.
Show me that your documented
information contains:
Identification;
Description;
In what media format?
Show me how the documented information
is reviewed and approved for suitability and
adequacy.
Documented information (in various media) needs
identification, description.
Review / approval process?
7.5.3 Control of documented information
7.5.3.1
7.5.3.1q
1
Documented information required by the quality
management system and by this International
Standard shall be controlled to ensure:
a) it is available and suitable for use, where and
when it is needed;
b) it is adequately protected (e.g. from loss of
confidentiality, improper use, or loss of integrity).
Show me how you control documented
information.
Show me how you make it available and
suitable for use.
How do you protect your documented
information?
Control of documented information.
Suitability and availability for use.
How is it protected?
7.5.3.2
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7.5.3.2q
1
For the control of documented information, the
organization shall address the following
activities, as applicable:
a) distribution, access, retrieval and use;
b) storage and preservation, including preservation
of legibility;
c) control of changes (e.g. version control);
d) retention and disposition.
When controlling documented information,
how do you address:
Distribution;
Access;
Retrieval;
Use;
Storage and preservation;
Legibility;
Control of changes;
Retention and disposition.
Control of documented information.
Change control, distribution, access, retrieval, use, storage,
preservation, legibility, retention and disposition.
7.5.3.2q
2
Documented information of external origin
determined by the organization to be necessary for
the planning and operation of the quality
management system shall be identified as
appropriate, and controlled.
How do you identify as appropriate and
control documented information of
external origin which you have determined
as necessary for the QMS
Control of external documented information.
NOTE Access can imply a decision regarding the permission to view the documented information only, or the
permission and authority to view and change the documented information.
8 Operation
8.1 Operational planning and control
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8.1q1 The organization shall plan, implement and control
the processes, as outlined in 4.4, needed to meet
requirements for the provision of products and
services and to implement the actions determined
in 6.1, by:
a) determining requirements for the product and
services;
b) establishing criteria for the processes and for the
acceptance of products and services;
c) determining the resources needed to achieve
conformity to product and service requirements;
d) implementing control of the processes in
accordance with the criteria;
e) retaining documented information to the extent
necessary to have confidence that the processes
have been carried out as planned and to
demonstrate conformity of products and services to
requirements.
How are processes needed to meet
requirements for provision of products and
services planned, implemented and
controlled?
How are requirements for products and
services determined?
How is criteria for processes and
acceptance for products and services
determined?
How are resources determined?
How is process control implemented?
Show me the documented information
that shows confidence in that the processes
have been carried out as planned and can
demonstrate conformity of products and
services.
Documented information to show processes have been
carried out as planned and can demonstrate conformity of
products and services.
8.1q2 The output of this planning shall be suitable for the
organization's operations.
How have you determined that the output
from the planning process is suitable for
your operations?
8.1q3 The organization shall control planned changes
and review the consequences of unintended
changes, taking action to mitigate any adverse
effects, as necessary.
How do you control planned changes? How
do you review the consequences of
unintended changes? What action is taken
to mitigate any adverse effects?
8.1q4 The organization shall ensure that outsourced
processes are controlled in accordance with 8.4.
How do you control outsourced processes?
8.2 Determination of requirements for products and services
8.2.1 Customer communication
8.2.1q1 The organization shall establish the processes for
communicating with customers in relation to:
a) information relating to products and services;
b) enquiries, contracts or order handling, including
changes;
c) obtaining customer views and perceptions,
including customer complaints;
d) the handling or treatment of customer property, if
applicable;
e) specific requirements for contingency actions,
when relevant.
What are your processes for communicating
with customers? How do you communicate
information relating to:
Products;
Services;
Enquiries;
Contracts;
Order handling;
Customer views, perceptions and
complaints;
Handling or treatment of customer property;
Specific requirements for contingency
actions?
8.2.2 Determination of requirements related to products and services
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8.2.2q1 The organization shall establish, implement and
maintain a process to determine the requirements
for the products and services to be offered to
potential customers.
What is your process to determine the
requirements for products and services to
be offered to potential customers? How do
you establish, implement and maintain this
process?
8.2.2q2 The organization shall ensure that:
a) product and service requirements (including
those considered necessary by the organization),
and 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.
How do you define product and service
requirements including statutory and
regulatory requirements?
How do you ensure that you have the ability
to meet the defined requirements and
substantiate any claims for your products
and services?
8.2.3 Review of requirements related to products and services
8.2.3q1 The organization shall review, as applicable:
a) requirements specified by the customer,
including the requirements for delivery and post-
delivery activities;
b) requirements not stated by the customer, but
necessary for the customers' specified or intended
use, when known;
c) additional statutory and regulatory requirements
applicable to the products and services;
d) contract or order requirements differing from
those previously expressed.
How do you review:
Customer requirements for delivery and
post-delivery?
Requirements necessary for customers’
specified or intended use, where known;
Additional statutory and regulatory
requirements applicable to products and
services;
Any other contract or order requirements.
NOTE Requirements can also include those arising from relevant interested parties.
8.2.3q2 This review shall be conducted prior to the
organization’s commitment to supply products and
services to the customer and shall ensure contract
or order requirements differing from those
previously defined are resolved.
Show me that the review is conducted prior
to your commitment to supply products and
services to your customers. How do you
resolve contract or order requirements
which differ from those previously defined?
8.2.3q3 Where the customer does not provide a
documented statement of their requirements, the
customer requirements shall be confirmed by the
organization before acceptance.
How do you confirm customer requirements
where the customer does not provide a
documented statement?
8.2.3q4 Documented information describing the results of
the review, including any new or changed
requirements for the products and services, shall
be retained.
Show me where you retain documented
information which describes results of the
review including any new or changed
requirements.
Documented information of reviews describing new or
changed requirements to products and services.
8.2.3q5 Where requirements for products and services are
changed, the organization shall ensure that
relevant documented information is amended and
that relevant personnel are made aware of the
changed requirements.
Show me the documented information
containing changes to products and
services. How do you ensure that relevant
personnel are made aware of those
changes?
Documented information of amended reviews and how
relevant personnel are made aware of those changes.
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8.3 Design and development of products and services
8.3.1 General
8.3.1q1 Where the detailed requirements of the
organization’s products and services are not
already established or not defined by the customer
or by other interested parties, such that they are
adequate for subsequent production or service
provision, the organization shall establish,
implement and maintain a design and development
process.
How do you establish, implement and
maintain a design and development process
(where detailed requirements of your
products and services are not already
established or defined by the customer or
other parties).
NOTE 1 The organization can also apply the requirements given in 8.5 to the development of processes for
production and services provision.
NOTE 2 For services, design and development planning can address the whole service delivery process. The
organization can therefore choose to consider the requirements of clauses 8.3 and 8.5 together.
8.3.2 Design and development planning
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8.3.2q1 In determining the stages and controls for design
and development, the organization shall consider:
a) the nature, duration and complexity of the
design and development activities;
b) requirements that specify particular process
stages, including applicable design and
development reviews;
c) the required design and development verification
and validation;
d) the responsibilities and authorities involved in
the design and development process;
e) the need to control interfaces between
individuals and parties involved in the design and
development process;
f) the need for involvement of customer and user
groups in the design and development process;
g) the necessary documented information to
confirm that design and development requirements
have been met.
When determining the stages and control
for design and development, show me how
you consider:
The nature, duration and complexity of the
activities;
Requirements that specify particular
process stages including applicable
reviews;
Required verification and validation;
Responsibilities and authorities;
How interfaces are controlled between
individuals and parties;
The need for involvement of customer and
user groups.
Show me documented information that
confirms design and development
requirements have been met.
Documented information that confirms design & development
requirements have been met.
8.3.3 Design and development inputs
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8.3.3q1 The organization shall determine:
a) requirements essential for the specific type of
products and services being designed and
developed, including, as applicable, functional and
performance requirements;
b) applicable statutory and regulatory
requirements;
c) standards or codes of practice that the
organization has committed to implement;
d) internal and external resource needs for the
design and development of products and services;
e) the potential consequences of failure due to the
nature of the products and services;
f) the level of control expected of the design and
development process by customers and other
relevant interested parties.
Can you show me how you determine:
Requirements essential for the type of
products and services being designed and
developed, including as applicable:
Functional & performance requirements;
Statutory and regulatory requirements;
Standards or codes of practice where there
is a commitment to implement;
Internal and external resources needed for
the design and development of products
and services;
Potential consequences of failure;
Level of control expected of the design and
development process by customers and
other relevant parties.
8.3.3q2 Inputs shall be adequate for design and
development purposes, complete, and
unambiguous. Conflicts among inputs shall be
resolved.
How do you determine that inputs are
adequate, complete and unambiguous for
design and development? How do you
resolve conflicts among inputs?
8.3.4 Design and development controls
8.3.4q1 The controls applied to the design and
development process shall ensure that:
a) the results to be achieved by the design and
development activities are clearly defined;
b) design and development reviews are conducted
as planned;
c) verification is conducted to ensure that the
design and development outputs have met the
design and development input requirements;
d) validation is conducted to ensure that the
resulting products and services are capable of
meeting the requirements for the specified
application or intended use (when known).
How do controls that are applied to the
design and development process ensure:
Results achieved by design and
development activities are clearly defined?
Design and development reviews are
conducted as planned?
Outputs meet the input requirements by
verification/
Validation is conducted to ensure that the
resulting products and services are capable
of meeting the requirements for the
specified application or intended use (when
known)?
8.3.5 Design and development outputs
8.3.5q1 The organization shall ensure that design and
development outputs:
a) meet the input requirements for design and
development;
b) are adequate for the subsequent processes for
the provision of products and services;
c) include or reference monitoring and measuring
requirements, and acceptance criteria, as
applicable;
d) ensure products to be produced, or services to
be provided, are fit for intended purpose and their
safe and proper use.
How do you ensure that design and
development outputs:
Meet the input requirements for design and
development?
Are adequate for the subsequent processes
for the provision of products and services?
Include or reference monitoring and
measuring requirements, and acceptance
criteria, as applicable?
Ensure products to be produced, or services
to be provided, are fit for intended purpose
and their safe and proper use?
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8.3.5q2 The organization shall retain the documented
information resulting from the design and
development process.
Show me the documented information
which results from the design and
development process.
Documented information from the design and development
process.
8.3.6 Design and development changes
8.3.6q1 The organization shall review, control and identify
changes made to design inputs and design outputs
during the design and development of products
and services or subsequently, to the extent that
there is no adverse impact on conformity to
requirements.
How do you review, control and identify
changes made to the design inputs and
outputs during design and development of
products and services ensuring no impact
on conformity to requirements?
8.3.6q2 Documented information on design and
development changes shall be retained.
Show me the documented information for
design and development changes.
Documented information for design and development
changes.
8.4 Control of externally provided products and services
8.4.1 General
8.4.1q1 The organization shall ensure that externally
provided processes, products, and services
conform to specified requirements.
How do you ensure externally provided
processes, products and services conform
to specified requirements?
8.4.1q2 The organization shall apply the specified
requirements for the control of externally provided
products and services when:
a) products and services are provided by external
providers for incorporation into the organization’s
own products and services;
b) products and services are provided directly to
the customer(s) by external providers on behalf of
the organization;
c) a process or part of a process is provided by an
external provider as a result of a decision by the
organization to outsource a process or function.
Show me how you apply specified
requirements for the control of externally
provided products and services when:
Products and services are provided by
external providers for incorporation into your
own products and services;
You provide products and services directly
to customers by external providers on your
behalf;
A process or part-process is provided by an
external provider as a result of a decision to
outsource a process or function.
8.4.1q3 The organization shall establish and apply criteria
for the evaluation, selection, monitoring of
performance and re-evaluation of external
providers based on their ability to provide
processes or products and services in accordance
with specified requirements.
Show me how you establish and apply
criteria for evaluation, selection, monitoring
of performance and re-evaluation of
external providers. How do you assess their
ability to provide processes or products and
services in accordance with specified
requirements?
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8.4.1q4 The organization shall retain appropriate
documented information of the results of the
evaluations, monitoring of the performance and re-
evaluations of the external providers.
What documented information do you
have of the results of evaluations,
monitoring of performance and re-
evaluations of external providers?
Documented information of external providers’ performance.
8.4.2 Type and extent of control of external provision
8.4.2q1 In determining the type and extent of controls to be
applied to the external provision of processes,
products and services, the organization shall take
into consideration:
a) the potential impact of the externally provided
processes, products and services on the
organization’s ability to consistently meet customer
and applicable statutory and regulatory
requirements;
b) the perceived effectiveness of the controls
applied by the external provider.
How do you determine the controls applied
to the external provision of processes,
products and services and take into
consideration:
a) The potential impact of the externally
provided processes, products and services
on the ability to consistently meet customer
and applicable statutory and regulatory
requirements?
b) The perceived effectiveness of the
controls applied by the external provider?
8.4.2q2 The organization shall establish and implement
verification or other activities necessary to ensure
the externally provided processes, products and
services do not adversely affect the organization's
ability to consistently deliver conforming products
and services to its customers.
What verification or other activities do you
have to ensure externally provided
processes, products and services do not
adversely affect your ability to consistently
deliver conforming products and services to
your customers?
8.4.2q3 Processes or functions of the organization which
have been outsourced to an external provider
remain within the scope of the organization’s
quality management system; accordingly, the
organization shall consider a) and b) above and
define both the controls it intends to apply to the
external provider and those it intends to apply to
the resulting process output.
When processes or functions have been
outsourced to external providers, how do
you consider a) and b) in 8.4.1 and how do
you define the controls intended to be
applied to the external provider and to the
resulting process output?
8.4.3 Information for external providers
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8.4.3q1 The organization shall communicate to external
providers applicable requirements for the following:
a) the products and services to be provided or the
processes to be performed on behalf of the
organization;
b) approval or release of products and services,
methods, processes or equipment;
c) competence of personnel, including necessary
qualification;
d) their interactions with the organization's quality
management system;
e) the control and monitoring of the external
provider’s performance to be applied by the
organization;
f) verification activities that the organization, or its
customer, intends to perform at the external
provider’s premises.
Show me how you communicate to external
providers, applicable requirements for:
Products and services to be provided or the
processes to be performed on behalf of the
organization;
Approval or release of products and
services, methods, processes or equipment;
Competence of personnel, including
necessary qualification;
Their interactions with the organization's
quality management system;
The control and monitoring of the external
provider’s performance to be applied by the
organization;
Verification activities that the organization,
or its customer, intends to perform at the
external provider’s premises.
8.4.3q2 The organization shall ensure the adequacy of
specified requirements prior to their communication
to the external provider.
Before you communicate with external
providers, how do you ensure the adequacy
of specified requirements?
8.5 Production and service provision
8.5.1 Control of production and service provision
8.5.1q1 The organization shall implement controlled
conditions for production and service provision,
including delivery and post-delivery activities.
What controlled conditions do you have for
production and service provision, including
delivery and post-delivery activities?
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Q# ISO 9001:2015 Clause Audit Question Audit Evidence
8.5.1q2 Controlled conditions shall include, as applicable:
a) the availability of documented information that
defines the characteristics of the products and
services;
b) the availability of documented information that
defines the activities to be performed and the
results to be achieved;
c) monitoring and measurement activities at
appropriate stages to verify that criteria for control
of processes and process outputs, and acceptance
criteria for products and services, have been met.
d) the use, and control of suitable infrastructure
and process environment;
e) the availability and use of suitable monitoring
and measuring resources;
f) the competence and, where applicable, required
qualification of persons;
g) the validation, and periodic revalidation, of the
ability to achieve planned results of any process for
production and service provision where the
resulting output cannot be verified by subsequent
monitoring or measurement;
h) the implementation of products and services
release, delivery and post-delivery activities.
Can you show me controlled conditions for:
a) the availability of documented information
defining the characteristics of the products
and services;
b) the availability of documented
information defining the activities to be
performed and the results to be achieved;
c) monitoring and measurement activities at
appropriate stages to verify that criteria for
control of processes and process outputs,
and acceptance criteria for products and
services, have been met.
d) the use, and control of suitable
infrastructure and process environment;
e) the availability and use of suitable
monitoring and measuring resources;
f) the competence and, where applicable,
required qualification of persons;
g) the validation, and periodic revalidation,
of the ability to achieve planned results of
any process for production and service
provision where the resulting output cannot
be verified by subsequent monitoring or
measurement;
h) the implementation of products and
services release, delivery and post-delivery
activities.
Documented information defining characteristics of the
products and services
8.5.2 Identification and traceability
8.5.2q1 Where necessary to ensure conformity of products
and services, the organization shall use suitable
means to identify process outputs.
What means do you use to identify process
outputs to ensure conformity of products
and services?
8.5.2q2 The organization shall identify the status of process
outputs with respect to monitoring and
measurement requirements throughout production
and service provision.
How do you identify the status of process
outputs?
8.5.2q3 Where traceability is a requirement, the
organization shall control the unique identification
of the process outputs, and retain any documented
information necessary to maintain traceability.
How do you control the unique identification
of process outputs, where applicable? What
documented information do you retain?
Documented information of traceability, where required.
NOTE Process outputs are the results of any activities which are ready for delivery to the organization’s
customer or to an internal customer (e.g. receiver of the inputs to the next process); they can include
products, services, intermediate parts, components, etc.
8.5.3 Property belonging to customers or external providers
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8.5.3q1 The organization shall exercise care with property
belonging to the customer or external providers
while it is under the organization's control or being
used by the organization. The organization shall
identify, verify, protect and safeguard the
customer’s or external provider’s property provided
for use or incorporation into the products and
services.
What care do you provide for customer or
external provider’s property while under
your control?
How do you identify, verify, protect and
safeguard that property which is provided
for use or incorporation into your products
or services?
8.5.3q2 When property of the customer or external provider
is incorrectly used, lost, damaged or otherwise
found to be unsuitable for use, the organization
shall report this to the customer or external
provider.
What means do you use to report to the
customer or external provider if their
property is incorrectly used, lost, damaged
or found to be unsuitable for use?
NOTE Customer property can include material, components, tools and equipment, customer premises,
intellectual property and personal data.
8.5.4 Preservation
8.5.4q1 The organization shall ensure preservation of
process outputs during production and service
provision, to the extent necessary to maintain
conformity to requirements.
How do you ensure preservation of process
outputs during production and service
provision to maintain conformity to product
requirements?
NOTE Preservation can include identification, handling, packaging, storage, transmission or transportation,
and protection.
8.5.5 Post-delivery activities
8.5.5q1 As applicable, the organization shall meet
requirements for post-delivery activities associated
with the products and services.
How do you meet requirements for post-
delivery activities associated with products
and services?
8.5.5q2 In determining the extent of post-delivery activities
that are required, the organization shall consider:
a) the risks associated with the products and
services;
b) the nature, use and intended lifetime of the
products and services;
c) customer feedback;
d) statutory and regulatory requirements.
How do you determine:
Risk;
Nature, use and intended lifetime;
Customer feedback;
Statutory and Regulatory requirements,
when determining the extent of post-delivery
activities required with products and
services?
NOTE Post-delivery activities can include actions under warranty provisions, contractual obligations such as
maintenance services, and supplementary services such as recycling or final disposal.
8.5.6 Control of changes
8.5.6q1 The organization shall review and control
unplanned changes essential for production or
service provision to the extent necessary to ensure
continuing conformity with specified requirements.
How do you review and control unplanned
changes to ensure continuing conformity
with specified requirements?
8.5.6q2 The organization shall retain documented
information describing the results of the review of
changes, the personnel authorizing the change,
and any necessary actions.
What documented information can you
show me which describes the results of
reviews of changes, the personnel
authorizing change and any necessary
actions?
Documented information describing results of review of
changes, personnel and actions.
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8.6 Release of products and services
8.6q1 The organization shall implement the planned
arrangements at appropriate stages to verify that
product and service requirements have been met.
Evidence of conformity with the acceptance criteria
shall be retained.
Show me how planned arrangement have
been implemented at appropriate stages to
verify product and service requirements
have been met. Show me what evidence
you retain.
8.6q2 The release of products and services to the
customer shall not proceed until the planned
arrangements for verification of conformity have
been satisfactorily completed, unless otherwise
approved by a relevant authority and, as
applicable, by the customer. Documented
information shall provide traceability to the
person(s) authorizing release of products and
services for delivery to the customer.
Show me how the release of products and
services is held until planned arrangements
for verification of conformity have been
satisfactorily completed, unless approved by
a relevant authority, or the customer if
applicable. Show me documented
information which shows traceability to the
person authorizing release of products and
services.
Documented information providing traceability, authorizing
release of products and services.
8.7 Control of non-conforming process outputs, products and services
8.7q1 The organization shall ensure process outputs,
products and services that do not conform to
requirements are identified and controlled to
prevent their unintended use or delivery.
How do you identify and control process
outputs, products and services that do not
conform to requirements and prevent their
unintended use or delivery?
8.7q2 The organization shall take appropriate corrective
action based on the nature of the nonconformity
and its impact on the conformity of products and
services. This applies also to nonconforming
products and services detected after delivery of the
products or during the provision of the service.
What appropriate corrective actions are
taken based on the nature of the
nonconformity and its impact on the
conformity of products and services? How
do you apply this to nonconformity detected
after delivery?
8.7q3 As applicable, the organization shall deal with
nonconforming process outputs, products and
services in one or more of the following ways:
a) correction;
b) segregation, containment, return or suspension
of provision of products and services;
c) informing the customer;
d) obtaining authorization for:
- use “as-is’;
- release, continuation or re-provision of the
products and services;
- acceptance under concession.
How you deal with nonconforming process
outputs, products and services in terms of:
Correction;
Segregation, containment, return or
suspension of provision of products and
services?
Informing the customer?
Obtaining authorization for use as-is?
Release, continuation or re-provision of the
products and service?
Acceptance under concession?
8.7q4 Where nonconforming process outputs, products
and services are corrected, conformity to the
requirements shall be verified.
How do you verify conformance where
process outputs, products and services are
corrected following nonconformance?
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8.7q5 The organization shall retain documented
information of actions taken on nonconforming
process outputs, products and services, including
on any concessions obtained and on the person or
authority that made the decision regarding dealing
with the nonconformity.
What documented information do you
keep following actions taken to address
nonconformities, including any concessions
obtained and on the person or authority that
made the decision regarding dealing with
the nonconformance.
Documented information for actions taken following
nonconformance, including concessions and authority
granted.
9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
9.1.1q1 The organization shall determine:
a) what needs to be monitored and measured;
b) the methods for monitoring, measurement,
analysis and evaluation, as applicable, to ensure
valid results;
c) when the monitoring and measuring shall be
performed;
d) when the results from monitoring and
measurement shall be analysed and evaluated.
Show me how you determine:
What needs to be monitored and
measured?
Methods for monitoring, measurement,
analysis and evaluation to ensure valid
results?
When to perform monitoring and
measuring?
When results shall be analysed and
evaluated?
9.1.1q2 The organization shall ensure that monitoring and
measurement activities are implemented in
accordance with the determined requirements and
shall retain appropriate documented information as
evidence of the results.
What documented information can you
show me that monitoring and measurement
activities have been implemented in
accordance with determined requirements?
Documented information of monitoring and measurement
activities in accordance with determined requirements.
9.1.1q3 The organization shall evaluate the quality
performance and the effectiveness of the quality
management system.
Show me how you evaluate the quality
performance and the effectiveness of the
QMS.
9.1.2 Customer satisfaction
9.1.2q1 The organization shall monitor customer
perceptions of the degree to which requirements
have been met.
How do you monitor customer perception of
the degree to which requirements have
been met?
9.1.2q2 The organization shall obtain information relating to
customer views and opinions of the organization
and its products and services.
How do you obtain information relating to
customer views and opinions of your
products and services?
9.1.2q3 The methods for obtaining and using this
information shall be determined.
What methods for obtaining and using this
information do you have?
NOTE Information related to customer views can include customer satisfaction or opinion surveys, customer
data on delivered products or services quality, market-share analysis, compliments, warranty claims and
dealer reports.
9.1.3 Analysis and evaluation
9.1.3q1 The organization shall analyse and evaluate
appropriate data and information arising from
monitoring, measurement and other sources.
So me how you analyse and evaluate data
and information arising from monitoring,
measurement and other sources.
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9.1.3q2 The output of analysis and evaluation shall be used
to:
a) demonstrate conformity of products and services
to requirements;
b) assess and enhance customer satisfaction;
c) ensure conformity and effectiveness of the
quality management system;
d) demonstrate that planning has been successfully
implemented;
e) assess the performance of processes;
f) assess the performance of external provider(s);
g) determine the need or opportunities for
improvements within the quality management
system.
Show me how the output of analysis and
evaluation is used to:
Demonstrate conformity of products and
services to requirements?
Assess and enhance customer satisfaction?
Ensure conformity and effectiveness of the
QMS?
Demonstrate that planning has been
successfully implemented?
Assess process performance?
Assess performance of external providers?
Determine the need or opportunities for
improvements within the QMS?
9.1.3q3 The results of analysis and evaluation shall also be
used to provide inputs to management review.
Show me where the results of analysis and
evaluation are used to provide inputs to
management review.
9.2 Internal audit
9.2.1
9.2.1q1 The organization shall conduct internal audits at
planned intervals to provide information on whether
the quality management system;
a) conforms to:
1) the organization’s own requirements for
its quality management system;
2) the requirements of this International
Standard;
b) is effectively implemented and maintained.
Are internal audits being conducted at
planned intervals? Do they determine
whether the QMS conforms to the
requirements of ISO 9001 and to the other
requirements established by Organization?
(Review records to demonstrate
conformance)
Do they determine whether the QMS is
effectively implemented and maintained?
(Review records)
9.2.2
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9.2.2q1 The organization shall:
a) plan, establish, implement and maintain an audit
programme(s) including the frequency, methods,
responsibilities, planning requirements and
reporting, which shall take into consideration the
quality objectives, the importance of the processes
concerned, customer feedback, changes
impacting on the organization, and the results of
previous audits;
b) define the audit criteria and scope for each
audit;
c) select auditors and conduct audits to ensure
objectivity and the impartiality of the audit process;
d) ensure that the results of the audits are reported
to relevant management;
e) take necessary correction and corrective actions
without undue delay;
f) retain documented information as evidence of the
implementation of the audit programme and the
audit results.
Can you show me audit programme(s) that
takes into consideration the quality
objectives, importance of the processes,
customer feedback, changes impacting the
organization and the results of previous
audits?
Where are the audit criteria and scope for
each audit?
Can you demonstrate that selection of
auditors and the conduct of audits are
objective and impartial and that auditors
don’t audit their own work?
How are audit results reported to relevant
management?
Can you demonstrate that necessary
correction and corrective actions are taken
without undue delay?
Can you show me documented
information of the audit programme and
the audit results?
Documented information of the audit programme and results
NOTE See ISO 19011 for guidance.
9.3 Management Review
9.3.1
9.3.1q1 Top management shall review the organization's
quality management system, at planned intervals,
to ensure its continuing suitability, adequacy, and
effectiveness.
What is the frequency that top management
reviews the organization's QMS? How is
the QMS deemed suitable, adequate and
effective?
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9.3.1q2 The management review shall be planned and
carried out taking into consideration:
a) the status of actions from previous management
reviews;
b) changes in external and internal issues that are
relevant to the quality management system
including its strategic direction;
c) information on the quality performance, including
trends and indicators for:
1) nonconformities and corrective actions;
2) monitoring and measurement results;
3) audit results;
4) customer satisfaction;
5) issues concerning external providers and other
relevant interested parties;
6) adequacy of resources required for maintaining
an effective quality management system;
7) process performance and conformity of products
and services;
d) the effectiveness of actions taken to address
risks and opportunities (see clause 6.1);
e) new potential opportunities for continual
improvement.
What kinds of information are reviewed in
management reviews? These must include:
actions status of previous reviews;
changes to internal/external issues relevant
to the QMS;
issues that affect strategy;
KPIs for nonconformities and corrective
actions;
monitor and measurement of results;
audit results;
customer satisfaction;
issues concerning external providers;
issues concerning other relevant parties;
adequacy of resources and effectiveness of
QMS;
process performance;
conformity of products and services;
actions taken to address risks and
opportunities and their effectiveness;
new potential opportunities for continual
improvement.
9.3.2
9.3.2q1 The outputs of the management review shall
include decisions and actions related to:
a) continual improvement opportunities;
b) any need for changes to the quality
management system, including resource needs.
Show me that management reviews include
decisions and actions relating to:
Continual improvement opportunities;
The need for changes to the QMS including
resource needs.
9.3.2q2 The organization shall retain documented
information as evidence of the results of
management reviews.
Show me what documented information
you have as evidence of management
reviews.
Documented information of management reviews.
10 Improvement
10.1 General
10.1q1 The organization shall determine and select
opportunities for improvement and implement
necessary actions to meet customer requirements
and enhance customer satisfaction.
How do you determine and select
opportunities for improvement? What
necessary actions have you implemented
so that you have met customer
requirements and enhanced customer
satisfaction?
10.1q2 This shall include, as appropriate:
a) improving processes to prevent nonconformities;
b) improving products and services to meet known
and predicted requirements;
c) improving quality management system results.
Show me how you have:
Improved processes to prevent
nonconformities;
Improved products and services to meet
known and predicted requirements;
Improved QMS results.
NOTE Improvement can be effected reactively (e.g. corrective action), incrementally (e.g. continual
improvement), by step change (e.g. breakthrough), creatively (e.g. innovation) or by re-organization (e.g.
transformation).
10.2 Nonconformity and corrective action
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Q# ISO 9001:2015 Clause Audit Question Audit Evidence
10.2.1
10.2.1q1 When a nonconformity occurs, including those
arising from complaints, the organization shall:
a) react to the nonconformity, and as applicable:
1) take action to control and correct it;
2) deal with the consequences;
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 the nonconformity;
2) determining the causes of the nonconformity;
3) determining if similar nonconformities exist, or
could potentially occur;
c) implement any action needed;
d) review the effectiveness of any corrective action
taken;
e) make changes to the quality management
system, if necessary.
When nonconformities occur, show me how;
You react;
Take action to control and correct it;
Deal with the consequences;
Evaluate the need for action to eliminate the
cause so that it does not recur or occur
elsewhere by:
Reviewing the nonconformity;
Determining the cause of the nonconformity;
Determining if similar nonconformities exist
or could potentially occur;
Actions needed are implemented;
Review the effectiveness of corrective
actions taken, if any;
Make necessary changes to the QMS.
10.2.1q2 Corrective actions shall be appropriate to the
effects of the nonconformities encountered.
Show me how correction actions were
appropriate to the effects of the
nonconformities encountered.
NOTE 1 In some instances, it can be impossible to eliminate the cause of a nonconformity.
NOTE 2 Corrective action can reduce the likelihood of recurrence to an acceptable level.
10.2.2
10.2.2q1 The organization shall retain documented
information as evidence of:
a) the nature of the nonconformities and any
subsequent actions taken;
b) the results of any corrective action.
What documented information can you
show me as evidence of:
The nature of the nonconformities and
subsequent actions taken;
The results of any corrective action.
Documented information of the nature of nonconformities,
subsequent actions and results of corrective action.
10.3 Continual improvement
10.3q1 The organization shall continually improve the
suitability, adequacy, and effectiveness of the
quality management system.
Demonstrate that you continually improve
the suitability, adequacy and effectiveness
of the QMS.
10.3q2 The organization shall consider the outputs of
analysis and evaluation, and the outputs from
management review, to confirm if there are areas
of underperformance or opportunities that shall be
addressed as part of continual improvement.
Demonstrate that outputs of analysis and
evaluation and the outputs from
management review are considered to
confirm if there are areas of
underperformance or opportunities that shall
be addressed as part of continual
improvement.
10.3q3 Where applicable, the organization shall select and
utilise applicable tools and methodologies for
investigation of the causes of underperformance
and for supporting continual improvement.
What applicable tools and methodologies
for investigation of the causes of
underperformance and to support continual
improvement are selected?
Page 27
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