ISO

9001:2015 Requirements of ISO 9001:2015 Guidance Auditing Questions

Clause No.
CLAUSE 4
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. The organization shall
This new concept How has the organization
monitor and review information about these
relates to the factors determined external and
external and internal issues.
and internal issues?
NOTE 1 Issues can include positive and negative
conditions affecting How do you monitor and
factors or conditions for consideration.
organizational review information about
NOTE 2 Understanding the external context can
operation this?
be facilitated by considering issues arising from
E.g. regulation, Are these relevant to
legal, technological, competitive, market, cultural,
governance and purpose and strategic
social and economic environments, whether
stakeholders direction?
international, national, regional or local.
NOTE 3 Understanding the internal context can
be facilitated by considering issues related to
values, culture, knowledge and performance of the
4.1 organization
How have you determined
Due to their effect or potential effect on the what interested parties are
organizations ability to consistently provide Consider who the relevant to the QMS?
products and services that meet interested parties How have you determined
customer and applicable statutory and regulatory might be and what requirements those
requirements, the organization shall determine: what their relevant parties have that are relevant
a) the interested parties that are relevant to the interests might be, e.g. to the QMS?
quality management system; customers, How has impact or potential
b) the requirements of these interested parties that shareholders, board impact been determined?
are relevant to the quality management system. members, Is the organization reviewing
The organization shall monitor and review competitors, and monitoring information
information about these interested parties and regulators. about these interested parties
their relevant requirements and their relevant
4.2 requirements?

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 How have the boundaries and
The organization shall determine the boundaries applicability of the QMS been
and applicability of the quality management system used to establish the scope of
to establish its scope. the organization?
When determining this scope, the organization
How have: The external and
shall consider:
internal issues; the
a) the external and internal issues referred to in
requirements of relevant
4.1;
interested parties and; the
b) the requirements of relevant interested parties
products and services of the
referred to in 4.2;
organization been considered
c) the products and services of the organization.
when determining the scope of
The organization shall apply all the requirements of
the organization?
this International Standard if they are applicable
Where is the scope available?
within the determined
Where is it maintained as
scope of its quality management system. Elements which do not
documented information?
The scope of the organizations quality apply can and should
Does it state what products and
management system shall be available and be be
services are covered by the
maintained as documented justifiedunderClause4.3
QMS?
information. The scope shall state the types of of 9001:2015.
products and services covered, and provide Does it justify how instances of
requirements of the QMS
justification for any requirement
of this International Standard that the organization cannot be applied?
determines is not applicable to the scope of its Can the organization claim
quality management conformity to the ISO
system. 9001:2015 International
Conformity to this International Standard may only Standard by Ensuring that
be claimed if the requirements determined as not requirements determined as
being applicable do not applicable do not affect the
not affect the organizations ability or responsibility organizations ability or
to ensure the conformity of its products and responsibility to ensure the
services and the enhancement of customer conformity of its products,
satisfaction. services and enhancement of
4.3 customer satisfaction?

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 4.4 How has the QMS been
4.4.1 The organization shall establish, implement, established?
maintain and continually improve a quality Show me how this is
management system, including the processes implemented and how is it
needed and their interactions, in accordance with maintained and continually
the requirements of this International Standard. improved?
The organization shall determine the processes How have the processes been
needed for the quality management system and determined and how do they
their application throughout the organization, and interact?
shall: How have the processes been
a) determine the inputs required and the outputs
determined for the QMS?
expected from these processes;
What are the inputs and
b) determine the sequence and interaction of these
outputs for those processes?
processes;
What is the sequence and
c) determine and apply the criteria and methods
interaction of the processes?
(including monitoring, measurements and related
An elevated focus on What are the criteria, methods,
performance indicators) needed to ensure the
processes. Adoption of measurement and related
effective operation and control of these processes;
the performance indicators needed
d) determine the resources needed for these
process approach is to operate and control those
processes and ensure their availability;
now mandatory and processes?
e) assign the responsibilities and authorities for
will What resources are needed and
these processes;
be audited accordingly how are these made available?
f) address the risks and opportunities as
How are responsibilities and
determined in accordance with the requirements of
6.1; authorities assigned for those
g) evaluate these processes and implement any processes?
changes needed to ensure that these processes How are risks and opportunities
achieve their intended results; considered and what plans are
h) improve the processes and the quality made to implement actions to
management system. address them?
4.4.2 To the extent necessary, the organization What methods are used to
shall: monitor, measure and evaluate
a) maintain documented information to support processes and, if needed, what
the operation of its processes; changes are made to achieve
b) retain documented information to have intended results?
confidence that the processes are being carried out How are opportunities to
as planned. improve the processes and the
QMS determined?
CLAUSE 5

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 Show me how top management
demonstrates leadership &
commitment with respect to the
Top management shall demonstrate leadership and QMS by taking accountability of
commitment with respect to the quality the effectiveness of the QMS?
management system by: How is the quality policy &
a) taking accountability for the effectiveness of the objectives established for the
quality management system; QMS and how they are
b) ensuring that the quality policy and quality compatible with the strategic
objectives are established for the quality direction & the organizational
management system and are compatible with the context?
context and strategic direction of the organization; How is the quality policy
c) ensuring the integration of the quality communicated within the
management system requirements into the organization?
organizations business processes; Enhances 5.1, How this is understood and
d) promoting the use of the process approach and Management applied?
risk-based thinking; commitment, from How can the requirements of
e) ensuring that the resources needed for the the 2008 Standard. The the QMS integrated into the
quality management system are available; 2015 repositions business processes?
f) communicating the importance of effective some requirements to How do you promote
quality management and of conforming to the leadership, not awareness of the process
quality management system requirements; management. The approach and how do you ensure
g) ensuring that the quality management system emphasis has shifted that resources needed for the
achieves its intended results; from QMS area available?
h) engaging, directing and supporting persons to ensuring to engaging. How do you communicate the
contribute to the effectiveness of the quality importance of effective quality
management system; management and conforming to
i) promoting improvement; the QMS requirements?
j) supporting other relevant management roles to How do you ensure that the
demonstrate their leadership as it applies to their QMS achieves its intended
areas of responsibility. results?
NOTE Reference to business in this International How to engage, direct and
Standard can be interpreted broadly to mean those support people to contribute to
activities that are core to the purposes of the the effectiveness of the QMS?
organizations existence, whether the organization How do you promote continual
is public, private, for profit or not for profit improvement and support other
relevant management roles to
demonstrate leadership in their
5.1.1 areas of responsibility?

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 How top management
demonstrates leadership and
commitment with respect to
customer focus, ensuring
Top management shall demonstrate leadership and statutory and regulatory
Enhances 5.1,
commitment with respect to customer focus by requirements are determined
Management
ensuring that: and met?
commitment, from
a) customer and applicable statutory and How can risks & opportunities
the 2008 Standard. The
regulatory requirements are determined, that can affect conformity of
2015 repositions
understood and consistently met; products & services determined?
some requirements to
b) the risks and opportunities that can affect How can the ability to enhance
leadership, not
conformity of products and services and the ability customer satisfaction determined
management. The
to enhance customer satisfaction are determined and addressed?
emphasis has shifted
and addressed; How to maintain the focus on
from
c) the focus on enhancing customer satisfaction is consistently providing products
ensuring to engaging.
maintained and services that meet customer
and applicable statutory and
regulatory requirements?
How can customer satisfaction
5.1.2 be maintained?
How top management
Enhanced
establishes, reviews and
Top management shall establish, implement and requirements from the
maintains a quality policy?
maintain a quality policy that: 2008 version: more
How it is determined to be
a) is appropriate to the purpose and context of the attention to be paid to
appropriate for the purpose and
organization and supports its strategic direction; the application of the
context of the organization?
b) provides a framework for setting quality policy across the
If it provides a framework for
objectives; organization. There is a
setting and reviewing quality
c) includes a commitment to satisfy applicable need for documented
objectives?
requirements; information, as
If it contains any commitment
d) includes a commitment to continual opposed to a
to satisfy applicable
improvement of the quality management system. documented
requirements and for continual
statement.
5.2.1 improvement of the QMS?
Whether the quality policy is
The quality policy shall:
available as documented
a) be available and be maintained as documented
information?
information;
How can it be communicated?
b) be communicated, understood and applied
How can it be understood and
within the organization;
applied within the organization
c) be available to relevant interested parties, as
and how is it available to relevant
appropriate.
5.2.2 interested parties?

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 How will top management
ensure that the responsibilities
and authorities for relevant roles
Top management shall ensure that the are communicated, understood
responsibilities and authorities for relevant roles and assigned within the
are assigned, communicated and understood organization?
within the organization. How does top management
The role of the
Top management shall assign the responsibility and assign the responsibility and
Management
authority for: authority for
Representative has
a) ensuring that the quality management system a)Ensuring that the QMS
disappeared; however
conforms to the requirements of this International conforms with the requirements
the requirements of
Standard; of the ISO9001:2015
the 2008 clause 5.5.2
b) ensuring that the processes are delivering their International standard
still need to be met.
intended outputs; b) Ensuring that processes are
There is a new
c) reporting on the performance of the quality delivering their intended
requirement that
management system and on opportunities for outputs?
someone is tasked with
improvement (see 10.1), in particular to top How will the performance of
preserving the integrity
management; the QMS, opportunities for
of the QMS while it is
d) ensuring the promotion of customer focus improvement and the needs for
in the process of
throughout the organization; change or innovation will be
change.
e) ensuring that the integrity of the quality reported to top management?
management system is maintained when changes How will the customer focus be
to the quality management system are planned and promoted within the
implemented. organization?
How will the integrity of the
QMS maintained when changes
5.3 are planned and implemented?
CLAUSE 6
How are the internal & external
issues plus the interested parties
considered while planning for the
When planning for the quality management QMS?
system, the organization shall consider the issues How can the risks and
Organizations must
referred to in 4.1 and the requirements referred to opportunities be determined and
determine its context,
in 4.2 and determine the risks and opportunities addressed so that the QMS can
and the arising risks
that need to be addressed to: a) achieve its intended results;
and opportunities.
a) give assurance that the quality management b) Prevent or reduce undesired
Actions to address risk
system can achieve its intended result(s); effects;
must be proportional
b) enhance desirable effects; c) Achieve continual
to the potential impact.
c) prevent, or reduce, undesired effects; improvement?
d) achieve improvement Has the organization taken into
consideration the issues referred
in 4.1 and the requirements
6.1.1 referred to in 4.2?

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 Whether the organization has
planned actions to address risks
and opportunities?
The organization shall plan: How are they integrated and
a) actions to address these risks and opportunities; implemented into the QMS
b) how to: processes?
1) integrates and implements the actions into its How to evaluate their
quality management system processes (see 4.4); effectiveness?
2) evaluate the effectiveness of these actions. Whether the actions are taken
Actions taken to address risks and opportunities to address risks and
shall be proportionate to the potential impact on opportunities determined as
the conformity of products and services. being appropriate to the
potential impact on the
conformity of products and
6.1.2 services?
Whether the organization has
quality objectives, relevant
functions, levels and processes?
The organization shall establish quality objectives at
Are these consistent with the
relevant functions, levels and processes needed for
Extension of 2008 quality policy?
the quality management system. The quality
clauses, 5.4.1 and Whether they are measureable
objectives shall:
5.4.2. Stronger and consider applicable
a) be consistent with the quality policy;
emphasis on the requirements?
b) be measurable;
importance of Whether they are relevant to
c) take into account applicable requirements;
objectives, which the products and services and
d) be relevant to conformity of products and
should be set for enhance customer satisfaction?
services and to enhancement of customer
processes. The Are they being monitored?
satisfaction;
organization must How? How often?
e) be monitored;
retain documented How will they be
f) be communicated;
information on quality communicated?
g) be updated as appropriate.
objectives. How can they be updated?
The organization shall maintain documented
Whether the documented
information on the quality objectives
information on the quality
objectives is appropriate and
6.2.1 maintained?
While planning how to achieve
When planning how to achieve its quality quality objectives, whether the
objectives, the organization shall determine: organization has determined:
a) what will be done; a) What is to be done?
b) what resources will be required; b) What resources will be used?
c) who will be responsible; c) Who will be responsible?
d) when it will be completed; d) When it will be completed?
e) how the results will be evaluated. e) How will the results be
6.2.2 evaluated?

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 Whether the changes to the
When the organization determines the need for
An extension of the QMS are planned systematically?
changes to the quality management system, the
existing requirement: How to demonstrate the
changes shall be carried out in a planned manner
organizations must purpose and potential
(see 4.4). The organization shall consider:
identify the purpose consequences of these changes
a) the purpose of the changes and their potential
and likely and the integrity of the QMS?
consequences;
consequences of How resources will be made
b) the integrity of the quality management system;
change, and the available?
c) the availability of resources;
necessary resources How responsibility and
d) the allocation or reallocation of responsibilities
and responsibilities. accountability is allocated or
and authorities.
6.3 reallocated?
CLAUSE 7
The organization shall determine and provide the How resources are determined
resources needed for the establishment, for the establishment,
implementation, maintenance and continual implementation, maintenance
Need to evidence
improvement of the quality management system. and continual improvement of
external as well as
The organization shall consider: the QMS?
internal resource
a) the capabilities of, and constraints on, existing How will the capabilities and
requirements.
internal resources; constraints on internal resources
b) what needs to be obtained from external and needs from external
7.1.1 providers. providers are to be considered?
How has the organization
The organization shall determine and provide the determined and provided the
persons necessary for the effective implementation persons necessary for the
No significant change
of its quality management system and for the effective implementation of its
operation and control of its processes. QMS and for the operation and
7.1.2 control of its processes?

The organization shall determine, provide and

maintain the infrastructure necessary for the How has the organization
operation of its processes and to achieve determined, provided and
Enhanced reference to
conformity of products and services. maintained the infrastructure
examples: hardware,
NOTE Infrastructure can include: necessary for the operation of its
software,
a) buildings and associated utilities; processes and for achieving
transportation
b) equipment, including hardware and software; conformity of products and
c) transportation resources; services?
d) information and communication technology.
7.1.3

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 The organization shall determine, provide and
More prescriptive than
maintain the environment necessary for the
before with a
operation of its processes and to achieve
requirement to
conformity of products and services.
determine, provide and How has the organization
NOTE A suitable environment can be a combination
maintain a suitable determined, provided, and
of human and physical factors, such as:
environment. There is a maintained the environment
a) social (e.g. non-discriminatory, calm, non-
note in the new clause necessary for the operation of its
confrontational);
that examples of processes and to achieve
b) psychological (e.g. stress-reducing, burnout
environment for the conformity of products and
prevention, emotionally protective);
operation of services?
c) physical (e.g. temperature, heat, humidity, light,
processes include
airflow, hygiene, noise).
social, psychological
These factors can differ substantially depending on
and environmental
7.1.4 the products and services provided.
How has the organization
determined and provided the
resources needed to ensure valid
and reliable results while
monitoring and measuring is
The organization shall determine and provide the used to verify the conformity of
resources needed to ensure valid and reliable products and services to
results when monitoring or measuring is used to Measuring requirements?
verify the conformity of products and services to equipment becomes Whether the organization has
requirements. The organization shall ensure that measuring ensured that the resources
the resources provided: resource, provided:
a) are suitable for the specific type of monitoring acknowledging that a) Are suitable for the specific
and measurement activities being undertaken; professional type of monitoring and
b) are maintained to ensure their continuing fitness judgment and human measurement activities being
for their purpose. senses may also be a undertaken?
The organization shall retain appropriate measuring resource, b) Are maintained to ensure their
documented information as evidence of fitness for e.g. tea tasting. continuing fitness for their
purpose of the monitoring and measurement purpose?
resources. Whether the organization
retained documented
information as evidence of
fitness for purpose of the
monitoring and measurement
7.1.5.1 resources or not?

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 Whether the organization has
ensured that if measurement
traceability is a requirement for
providing confidence in the
validity of measurement results,
that measuring equipment is:
When measurement traceability is a requirement,
a) Calibrated or verified, or both,
or is considered by the organization to be an
at specified intervals, or prior to
essential part of providing confidence in the validity
use, against measurement
of measurement results, measuring equipment
standards traceable to
shall be:
international or national
a) calibrated or verified, or both, at specified
measurement standards & when
intervals, or prior to use, against measurement
no such standards exist, the basis
standards traceable to international or national
used for calibration or
measurement standards; when no such standards
verification is retained as
exist, the basis used for calibration or verification
documented information?
shall be retained as documented information;
b) Identified in order to
b) identified in order to determine their status;
determine their status or not?
c) safeguarded from adjustments, damage or
c) Safeguarded from
deterioration that would invalidate the calibration
adjustments, damage or
status and subsequent measurement results.
deterioration that would
The organization shall determine if the validity of
invalidate the subsequent
previous measurement results has been adversely
measurement results?
affected when measuring equipment is found to be
How has the organization
unfit for its intended purpose, and shall take
determined if the validity of
appropriate action as necessary.
previous measurement results
has been adversely affected
when measuring equipment is
found to be unfit for its intended
purpose, &takes appropriate
7.1.5.2 action?

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 The organization shall determine the knowledge
necessary for the operation of its processes and to
achieve conformity of products and services. This
knowledge shall be maintained and be made
available to the extent necessary. When addressing How has the organization
changing needs and trends, the organization shall determined necessary knowledge
consider its current knowledge and determine how for the operation of processes?
to acquire or access any necessary additional How to determine necessary
Examples of such
knowledge and required updates. knowledge required for achieving
knowledge could be
NOTE 1 Organizational knowledge is knowledge conformity of products and
intellectual e.g.
specific to the organization; it is gained by services?
designer software and
experience. It is information that is used and shared How will you maintain this
external sources of
to achieve the organizations objectives. knowledge and make it available
knowledge e.g.
NOTE 2 Organizational knowledge can be based on: to the extent necessary?
academia or
a) internal sources (e.g. intellectual property; How to consider current
conferences
knowledge gained from experience; lessons learned knowledge and how to acquire
from failures and successful projects; capturing and additional knowledge when
sharing undocumented knowledge and experience; addressing changing needs and
the results of improvements in processes, products trends?
and services);
b) external sources (e.g. standards; academia;
conferences; gathering knowledge from customers
7.1.6 or external providers).
The organization shall: How do you determine the
a) determine the necessary competence of necessary competence of people
person(s) doing work under its control that affects doing work under your control
the performance and effectiveness of the quality that affects quality performance?
management system; How to determine competence
The requirement has
b) ensure that these persons are competent on the on the basis of appropriate
been extended to
basis of appropriate education, training, or education, training and
include people
experience; experience?
performing work under
c) where applicable, take actions to acquire the How to take actions for
the organizations
necessary competence, and evaluate the acquiring necessary competence
control, i.e. outsourced
effectiveness of the actions taken; where applicable and to evaluate
resource such as
d) retain appropriate documented information as the effectiveness of those
agencies.
evidence of competence. actions?
NOTE Applicable actions can include, for example, Whether the appropriate
the provision of training to, the mentoring of, or documented information as
the reassignment of currently employed persons; evidence of competence is
7.2 or the hiring or contracting of competent persons. retained or not?

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 This is more expansive How are people in the
The organization shall ensure that persons doing and now applies to all organization aware of the quality
work under the organizations control are aware of: persons doing work policy and relevant quality
a) the quality policy; under the objectives?
b) relevant quality objectives; organizations control. What is their contribution to
c) their contribution to the effectiveness of the People must be aware the effectiveness of the QMS?
quality management system, including the benefits of policy, objectives, What will be the benefits of
of improved performance; how they contribute improved performance?
d) the implications of not conforming with the and the implications of What will be the implications of
quality management system requirements not conforming to the not conforming to the QMS
7.3 QMS. requirements?
This is now much more How has the organization
The organization shall determine the internal and
prescriptive and determined internal and external
external communications relevant to the quality
includes external communications relevant to the
management system, including:
communications. QMS?
a) on what it will communicate;
Organizations must How to determine:
b) when to communicate;
now determine what, What to communicate?
c) with whom to communicate;
when, with whom and When to communicate?
d) how to communicate;
how communications With Whom to communicate?
e) who communicates.
7.4 should take place. How to communicate?
The organizations quality management system The Documented
shall include: information must be
a) documented information required by this controlled but there is
International Standard; no longer a Does the organization have the
b) documented information determined by the requirement to have a documented information as
organization as being necessary for the documented procedure required by this standard?
effectiveness of the quality management system. for this process. Whether the documented
NOTE The extent of documented information for a Requirements now information determined by the
quality management system can differ from one extend to access and organization is necessary for the
organization to another due to: the size of usage, recognizing that effectiveness of the quality
organization and its type of activities, processes, electronic information management system?
products and services; the complexity of can be accessed as
processes and their interactions; the read-only, without
competence of persons. authority to change.
7.5.1
When creating and updating documented Whether the documented
information, the organization shall ensure information contains
appropriate: identification, description and
a) identification and description (e.g. a title, date, the appropriate format?
author, or reference number); How the documented
b) format (e.g. language, software version, information is reviewed and
graphics) and media (e.g. paper, electronic); approved for suitability and
c) review and approval for suitability and adequacy adequacy?
7.5.2

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 Documented information required by the quality
management system and by this International How will the documented
Standard shall be controlled to ensure: information be controlled?
a) it is available and suitable for use, where and How to make it available and
when it is needed; suitable for use?
b) it is adequately protected (e.g. from loss of How to protect it?
7.5.3.1 confidentiality, improper use, or loss of integrity).
For the control of documented information, the
organization shall address the following activities,
as applicable:
When controlling documented
a) distribution, access, retrieval and use;
information, how to address
b) storage and preservation, including preservation
distribution, access, retrieval,
of legibility;
use, storage and preservation,
c) control of changes (e.g. version control);
legibility, control of changes, its
d) retention and disposition.
retention and disposition.
Documented information of external origin
How to identify appropriate
determined by the organization to be necessary for
and controlled documented
the planning and operation of the quality
information of external origin
management system shall be identified as
which is necessary for the QMS.
appropriate, and be controlled. Documented
information retained a evidence of conformity shall
7.5.3.2 be protected from unintended alterations.
CLAUSE 8
The organization shall plan, implement and control How processes will meet the
the processes needed to meet the requirements for requirements for provision of
the provision of products and services, and to products and services planned,
implement the actions determined in Clause 6 by: implemented and controlled?
a) determining the requirements for the products How can the requirements for
and services; products and services be
b) establishing criteria for determined?
1) the processes; This is a reworking and What is criteria for processes
2) the acceptance of products and services; reorganizing the 2008 and acceptance for products and
c) determining the resources needed to achieve Clause 7.1 services?
conformity to the product and service requirements. The How can the resources be
requirements; requirement to plan determined?
d) implementing control of the processes in and develop processes How is control process
accordance with the criteria; is not new, but has implemented?
e) determining and keeping documented been extended to Determine the documented
information to the extent necessary: include information that shows that the
1) to have confidence that the processes have implementation and processes have been carried out
been carried out as planned; control. as planned and conforms
2) to demonstrate the conformity of products products and services to the
and services to their requirements. requirements.
NOTE Keeping implies both the maintaining and How can it be determined that
the retaining of documented information. The the output from the planning
output of this planning shall be suitable for the process is suitable for your
organizations operations. The organization shall operations?
8.1 control planned changes and review the How to control planned

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 consequences of unintended changes, taking action changes?
to mitigate any adverse effects, as necessary. The How to review the
organization shall ensure that outsourced consequences of unintended
processes are controlled changes?
Action to be taken to mitigate
any adverse effects?
How to control outsourced
processes?
A subtle change in the
supplier customer
relationship: the
organization has
What is the process for
Communication with customers shall include: already determined the
communicating with customers?
a) providing information relating to products and products and services it
How to communicate
services; intends to offer,
information relating to products;
b) handling enquiries, contracts or orders, including reflecting a more
services; enquiries; contracts;
changes; common business
order handling; customer views,
c) obtaining customer feedback relating to products environment for
perceptions and complaints;
and services, including customer complaints; certification customers.
handling or treatment of
d) handling or controlling customer property; Requirements should
customer property; specific
e) establishing specific requirements for include those from
requirements for contingency
contingency actions, when relevant. interested parties and
actions?
also include statutory
and regulatory
requirements relating
8.2.1 to the product.
What is the process for
determining the requirements for
When determining the requirements for the products and services to be
products and services to be offered to customers, offered to potential customers?
the organization shall ensure that: How to establish, implement
a) the requirements for the products and services and maintain this process?
are defined, including: How to define product and
1) any applicable statutory and regulatory service requirements including
requirements; statutory and regulatory
2) those considered necessary by the requirements?
organization; How to ensure that we have
b) the organization can meet the claims for the the ability to meet the defined
products and services it offers. requirements and substantiate
any claims for our products and
8.2.2 services?

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 How has the organization
determined that it has the ability
to meet the requirements for
products and services offered to
customers?
If the organization has
conducted a review before
committing to supply products
The organization shall ensure that it has the ability
and services to a customer that
to meet the requirements for products and services
includes:
to be offered to customers. The organization shall
a) Requirements specified by the
conduct a review before committing to supply
customer, inclusive of
products and services to a customer, to include:
requirements for delivery and
a) requirements specified by the customer,
post delivery activities?
including the requirements for delivery and post-
b) Requirements not stated, but
delivery activities;
are necessary for the specified or
b) requirements not stated by the customer, but
intended use, when known?
necessary for the specified or intended use, when
c) Requirements specified by the
known;
organization?
c) requirements specified by the organization; d)
d) Statutory and regulatory
statutory and regulatory requirements applicable
requirements applicable to the
to the products and services;
products and services?
e) contract or order requirements differing from
e) Contract or order
those previously expressed. T
requirements different from
he organization shall ensure that contract or order
those previously expressed?
requirements differing from those previously
Whether the organization
defined are resolved. The customers requirements
ensured that contract or order
shall be confirmed by the organization before
requirements differing from
acceptance, when the customer does not provide a
those previously defined are
documented statement of their requirements.
resolved or not?
How has the organization
ensured that customer
requirements are confirmed by
the organization before
acceptance, if the customer does
not provide a documented
8.2.3.1 statement of their requirements?
Whether the organization has
The organization shall retain documented
retained documented
information, as applicable:
information as applicable:
a) on the results of the review;
a) On the reviews results?
b) on any new requirements for the products and
b) On any new requirement for
services.
the products and services?
8.2.3.2
The organization shall ensure that relevant How has the organization
documented information is amended, and that ensured that relevant
relevant persons are made aware of the changed documented information is
requirements, when the requirements for products amended, and that relevant
8.2.4 and services are changed. persons are made aware of it.

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 This new clause
mandates the How to establish, implement
The organization shall establish, implement and
introduction of a and maintain a design and
maintain a design and development process that is
design and development process to ensure
appropriate to ensure the subsequent provision of
development process subsequent provision of products
products and services.
where this activity is and services.
8.3.1 required
In determining the stages and controls for design
and development, the organization shall consider:
a) the nature, duration and complexity of the While determining the stages
design and development activities; and control for design and
b) the required process stages, including applicable development, how to consider
design and development reviews; the nature, duration and
c) the required design and development verification complexity of the activities;
and validation activities; requirements that specify
d) the responsibilities and authorities involved in particular process stages
the design and development process; Builds on existing 2008 including applicable reviews;
e) the internal and external resource needs for the clauses 7.3.1- 7.3.6. required verification and
design and development of products and services; Design and validation; responsibilities and
f) the need to control interfaces between persons development needs to authorities?
involved in the design and development process; be approached as a How are interfaces controlled
g) the need for involvement of customers and users process. between individuals and parties?
in the design and development process; What is the need for
h) the requirements for subsequent provision of involvement of customer and
products and services; user groups?
i) the level of control expected for the design and Has the documented
development process by customers and other information that confirms design
relevant interested parties; and development requirements
j) the documented information needed to have been met, are maintained.
demonstrate that design and development
8.3.2 requirements have been met.

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 How do you determine
requirements essential for the
type of products and services
being designed and developed,
including:
The organization shall determine the requirements
Functional & performance
essential for the specific types of products and
requirements;
services to be designed and developed. The
Statutory and regulatory
organization shall consider:
requirements;
a) functional and performance requirements;
Information from previous similar
b) information derived from previous similar design
development and designed
and development activities; Builds on existing 2008
activities;
c) statutory and regulatory requirements; clauses 7.3.1- 7.3.6.
Standards or codes of practice
d) standards or codes of practice that the Design and
which the organization is a
organization has committed to implement; development needs to
committed to implement;
e) potential consequences of failure due to the be approached as a
Potential consequences of
nature of the products and services. process.
failure;
Inputs shall be adequate for design and
Whether the inputs are
development purposes, complete and
adequate for design and
unambiguous. Conflicting design and development
development purposes, complete
inputs shall be resolved. The organization shall
and unambiguous?
retain documented information on design and
Whether the organization has
development inputs.
resolved conflicting design and
development inputs?
If the documented information
on design and development
8.3.3 inputs has been retained?
How will the controls that are
applied to the design and
The organization shall apply controls to the design development process ensure that
and development process to ensure that: the results achieved by design
a) the results to be achieved are defined; and development activities are
b) reviews are conducted to evaluate the ability of clearly defined?
the results of design and development to meet Whether the design and
requirements; development reviews are
c) verification activities are conducted to ensure Builds on existing 2008 conducted as planned?
that the design and development outputs meet the clauses 7.3.1- 7.3.6. If the outputs meet the input
input requirements; Design and requirements by verifying that
d) validation activities are conducted to ensure that development needs to the resulting products and
the resulting products and services meet the be approached as a services are capable of meeting
requirements for the specified application or process. the requirements for the
intended use; specified application or intended
e) any necessary actions are taken on problems use?
determined during the reviews, or verification and Whether any necessary action
validation activities; has been taken on problems
f) documented information of these activities is determined during the reviews,
retained or verification and validation
activities?
8.3.4 Whether the documented

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 information of the activities is
retained?
How to ensure whether the
design and development outputs
meet the input requirements for
design and development or not?
The organization shall ensure that design and If they are adequate for the
development outputs: subsequent processes for the
a) meet the input requirements; provision of products and
b) are adequate for the subsequent processes for services?
Builds on existing 2008
the provision of products and services; Whether they include or refer
clauses 7.3.1- 7.3.6.
c) include or reference monitoring and measuring monitoring and measuring
Design and
requirements, as appropriate, and acceptance requirements, and acceptance
development needs to
criteria; criteria, as applicable?
be approached as a
d) specify the characteristics of the products and How do they ensure that the
process.
services that are essential for their intended products to be produced, or
purpose and their safe and proper provision. services to be provided, are fit for
The organization shall retain documented intended purpose and are safe
information on design and development outputs. and proper for use?
Whether the documented
information which results from
the design and development
8.3.5 process is maintained?
How to review, control and
identify changes made in the
design inputs and outputs during
The organization shall identify, review and control design and development of
changes made during, or subsequent to, the design products and services, ensuring
and development of products and services, to the there is no impact on conformity
Builds on existing 2008
extent necessary to ensure that there is no adverse to requirements?
clauses 7.3.1- 7.3.6.
impact on conformity to requirements. The How does the organization
Design and
organization shall retain documented information retain documented information
development needs to
on: on:
be approached as a
a) design and development changes; a) The design and development
process.
b) the results of reviews; changes?
c) the authorization of the changes; b) The results of reviews?
d) the actions taken to prevent adverse impacts. c) The authorization of the
changes?
d) The actions taken to prevent
8.3.6 adverse impacts?

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 How to ensure that externally
provided processes, products and
services conform to specified
requirements?
How to apply specified
requirements for the control of
The organization shall ensure that externally externally provided products and
provided processes, products and services conform services when:
to requirements. The organization shall determine Products and services are
the controls to be applied to externally provided provided by external providers
processes, products and services when: Enhanced emphasis on for incorporation in your
a) products and services from external providers external providers and products and services;
are intended for incorporation into the the extent of Products and services are
organizations own products and services; employment of provided directly to customers by
b) products and services are provided directly to contractors in current external providers on your
the customer(s) by external providers on behalf of commercial practice. behalf;
the organization; Extent of controls A process or part-process is
c) a process, or part of a process, is provided by an needs to take account provided by an external provider
external provider as a result of a decision by the of the potential impact as a result of the decision to
organization. on the organizations outsource a process or function.
The organization shall determine and apply criteria ability to consistently How to establish and apply
for the evaluation, selection, monitoring of meet requirements. criteria for evaluation, selection,
performance, and reevaluation of external Risk assessment will be monitoring of performance and
providers, based on their ability to provide applicable here re-evaluation of external
processes or products and services in accordance providers.
with requirements. The organization shall retain How to assess their ability to
documented information of these activities and any provide processes or products
necessary actions arising from the evaluations and services in accordance with
requirements specified?
If the documented information
of the results of evaluations,
monitoring of performance and
reevaluations of external
8.4.1 providers is maintained?

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 How to determine whether the
controls applied to the external
provision of processes, products
and services, take into
consideration:
The organization shall ensure that externally a) The potential impact of the
provided processes, products and services do not externally provided processes,
adversely affect the organizations ability to products and services on the
consistently deliver conforming products and ability to continuously meet
services to its customers. The organization shall: customer and applicable
a) ensure that externally provided processes statutory and regulatory
remain within the control of its quality requirements?
management system; b) The perceived effectiveness of
b) define both the controls that it intends to apply the controls applied by the
to an external provider and those it intends to external provider?
apply to the resulting output; What verification or other
c) take into consideration: activities have to be done to
1) the potential impact of the externally provided ensure externally provided
processes, products and services on the processes, products and services
organizations ability to consistently meet customer do not adversely affect your
and applicable statutory and regulatory ability to deliver conforming
requirements; products and services to your
2) the effectiveness of the controls applied by the customers?
external provider; d) determine the verification, or How does the organization:
other activities, necessary to ensure that the a) Ensure that externally
externally provided processes, products and provided processes remain within
services meet requirements. the control of its QMS?
b) Ensure if it has defined both
the controls it intends to apply to
an external provider and those it
intends to apply to the resulting
8.4.2 output?
The organization shall ensure the adequacy of How to communicate to
requirements prior to their communication to the external providers, the applicable
external provider. The organization shall requirements for products and
communicate to external providers its services to be provided or the
requirements for: processes to be performed on
a) the processes, products and services to be behalf of the organization?
provided; How to communicate approval
b) the approval of: or release of products and
1) products and services; services, methods, processes or
2) methods, processes and equipment; equipment; competence of
3) the release of products and services; personnel, including necessary
c) competence, including any required qualification qualification; their interactions
of persons; with the organization's QMS?
d) the external providers interactions with the How to control and monitor the
organization; external providers performance;
e) control and monitoring of the external providers verification activities that the
8.4.3 performance to be applied by the organization; organization, or its customer,

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 f) verification or validation activities that the intends to perform at the
organization, or its customer, intends to perform at external providers premises?
the external providers premises. How to ensure the adequacy of
specified requirements?
What are the controlled
conditions for production and
service provision, including
delivery and post-delivery
activities?
The organization shall implement production and What are the controlled
service provision under controlled conditions. conditions for:
Controlled conditions shall include, as applicable: a) Documented information
a) the availability of documented information that defining the characteristics of the
defines: products and services?
1) the characteristics of the products to be b) Documented information
produced, the services to be provided, or the defining the activities to be
activities to be performed; performed and the results to be
2) the results to be achieved; achieved?
b) the availability and use of suitable monitoring c) Monitoring and measuring
and measuring resources; activities at appropriate stages to
c) the implementation of monitoring and ensure that criteria for control of
measurement activities at appropriate stages to processes and process outputs,
verify that criteria for control of processes or and acceptance criteria for
outputs, and acceptance criteria for products and No significant changes. products and services, have been
services, have been met; met?
d) the use of suitable infrastructure and d) Use and control of suitable
environment for the operation of processes; infrastructure and process
e) the appointment of competent persons, environment?
including any required qualification; e) The availability and use of
f) the validation, and periodic revalidation, of the monitoring and measuring
ability to achieve planned results of the processes resources?
for production and service provision, where the f) The competence and required
resulting output cannot be verified by subsequent qualification of persons?
monitoring or measurement; g) Validation and periodic
g) the implementation of actions to prevent human revalidation, of the ability to
error; achieve planned results where
h) the implementation of release, delivery and the resulting output cannot be
post-delivery activities. verified by subsequent
monitoring or measurement?
h) The implementation of
products and services release,
delivery and post-delivery
8.5.1 activities?

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 The organization shall use suitable means to How to identify process outputs
identify outputs when it is necessary to ensure the for ensuring conformity of
conformity of products and services. products and services?
The organization shall identify the status of outputs How to identify the status of
with respect to monitoring and measurement process outputs?
requirements throughout production and service How has the organization
provision. controlled the unique
The organization shall control the unique identification of process outputs,
identification of the outputs when traceability is a where applicable?
requirement, and shall retain the documented What documented information
8.5.2 information necessary to enable traceability is to be retained?
The organization shall exercise care with property
belonging to customers or external providers while How has the organization cared
it is under the organizations control or being used for customer or external
by the organization. providers property while under
The organization shall identify, verify, protect and its control?
safeguard customers or external providers How to identify, verify, protect
property provided for use or incorporation into the and safeguard that property?
products and services. How to report to the customer
When the property of a customer or external or external provider if their
provider is lost, damaged or otherwise found to be property is incorrectly used, lost,
unsuitable for use, the organization shall report this damaged or found to be
to the customer or external provider and retain unsuitable for use?
8.5.3 documented information on what has occurred.
The organization shall preserve the outputs during
production and service provision, to the extent How preservation of process
necessary to ensure conformity to requirements. outputs during production and
NOTE Preservation can include identification, service provision to maintain
handling, contamination control, packaging, conformity to product
storage, transmission or transportation, and requirements is maintained?
8.5.4 protection.
The organization shall meet requirements for post-
delivery activities associated with the products and
How to fulfill requirements for
services. In determining the extent of post-delivery
post delivery activities related
activities that are required, the organization shall
with products and services?
consider:
How to determine risk; nature,
a) statutory and regulatory requirements;
use and intended lifetime;
b) the potential undesired consequences associated
customer feedback; statutory
with its products and services;
and regulatory requirements,
c) the nature, use and intended lifetime of its
while determining the extent of
products and services;
post delivery activities?
d) customer requirements;
8.5.5 e) customer feedback
The organization shall review and control changes How are unplanned changes
for production or service provision, to the extent reviewed and controlled to
necessary to ensure continuing conformity with ensure continuous conformity
requirements. with specified requirements?
The organization shall retain documented Has the organization retained
8.5.6 information describing the results of the review of documented information

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 changes, the person(s) authorizing the change, and showing the results of reviews of
any necessary actions arising from the review. changes, the personnel
authorizing change and any
necessary actions?
How has the planned
The organization shall implement planned arrangement been implemented
arrangements, at appropriate stages, to verify that at appropriate stages to verify
the product and service requirements have been product and service
met. requirements have been met?
The release of products and services to the What evidence has been
customer shall not proceed until the planned retained?
arrangements have been satisfactorily completed, No substantive change How is the release of products
unless otherwise approved by a relevant authority needed. Note and services held until planned
and, as applicable, by the customer. refreshed terminology arrangements for verification of
The organization shall retain documented referring to services in conformity have been
information on the release of products and addition to product. satisfactorily completed, unless
services. The documented information shall approved by a relevant authority,
include: or the customer if applicable?
a) evidence of conformity with the acceptance Whether the documented
criteria; information which shows
b) traceability to the person(s) authorizing the traceability to the person
release. authorizing release of products
8.6 and services is maintained?
How has the organization
ensured that outputs that do not
conform to their requirements
The organization shall ensure that outputs that do are identified and controlled?
not conform to their requirements are identified Whether the organization has
and controlled to prevent their unintended use or taken appropriate action on
delivery. outputs based on the nature of
The organization shall take appropriate action the nonconformity and its effect
Some minor changes;
based on the nature of the nonconformity and its on the conformity of products
There is no longer a
effect on the conformity of products and services. and services?
requirement for a
This shall also apply to nonconforming products How has the organization
documented
and services detected after delivery of products, applied action on nonconforming
procedure, but there is
during or after the provision of services. products and services, detected
a requirement to
The organization shall deal with nonconforming after the delivery of products and
maintain documented
outputs in one or more of the following ways: during or after the provision of
information on actions
a) correction; services?
taken, including
b) segregation, containment, return or suspension Whether the organization has
concessions and
of provision of products and services; used one or more of the
authorizations.
c) informing the customer; following ways to deal with
d) obtaining authorization for acceptance under nonconforming outputs
concession. a) Correction?
Conformity to the requirements shall be verified b) Segregation, containment,
when nonconforming outputs are corrected. return or suspension or provision
of products and services?
c) Information to the customer?
8.7.1 d) Authorization for acceptance

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 under concession?
Whether the organization has
The organization shall retain documented retained documented
information that: information describing:
a) describes the nonconformity; a) The nonconformity?
b) describes the actions taken; b) The actions taken?
c) describes any concessions obtained; c) Any concessions obtained?
d) identifies the authority deciding the action in d) Identification of the authority
respect of the nonconformity. deciding the action in respect of
8.7.2 the nonconformity?
CLAUSE 9
How to determine:
What needs to be monitored and
An enhanced emphasis
measured?
on evaluation of
What are the methods for
The organization shall determine: results, in addition to
monitoring, measuring, analyzing
a) what needs to be monitored and measured; measurement and
and evaluating?
b) the methods for monitoring, measurement, analysis. Monitoring
When monitoring and measuring
analysis and evaluation needed to ensure valid should be based on
are to be performed?
results; risk. Customer
When are the results to be
c) when the monitoring and measuring shall be perception now
analyzed and evaluated?
performed; d) when the results from monitoring includes soliciting
Is there a documented
and measurement shall be analyzed and evaluated. perceptions about the
information showing that
The organization shall evaluate the performance organization and its
monitoring and measurement
and the effectiveness of the quality management products and services.
activities have been implemented
system. The organization shall retain appropriate Preventive action and
in accordance with determined
documented information as evidence of the results. statistical techniques
requirements?
are no longer
How to evaluate the quality
referenced.
performance and the
9.1.1 effectiveness of the QMS?
The organization shall monitor customers How to monitor customer
perceptions of the degree to which their needs and perception of the degree to
expectations have been fulfilled. The organization which requirements have been
shall determine the methods for obtaining, met?
monitoring and reviewing this information. How can the information be
NOTE Examples of monitoring customer obtained relating to customer
perceptions can include customer surveys, views and opinions of your
customer feedback on delivered products and products and services?
services, meetings with customers, market-share What are the methods for
analysis, compliments, warranty claims and dealer obtaining and using this
9.1.2 reports. information?

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 How does the organization
analyze and evaluate data and
information arising from
monitoring, measurement and
other sources?
How the output of analysis and
The organization shall analyze and evaluate
evaluation is used to:
appropriate data and information arising from
Demonstrate conformity of
monitoring and measurement. The results of
products and services to
analysis shall be used to evaluate:
requirements?
a) Conformity of products and services;
Assess and enhance customer
b) The degree of customer satisfaction;
satisfaction? Ensure conformity
c) The performance and effectiveness of the quality
and effectiveness of the QMS?
management system;
Demonstrate that planning has
d) If planning has been implemented effectively;
been successfully implemented?
e) The effectiveness of actions taken to address
Assess the process performance?
risks and opportunities;
Assess the performance of
f) The performance of external providers;
external providers?
g) The need for improvements to the quality
Determine the need or
management system.
opportunities for improvements
in the QMS?
Where are the results of
analysis and evaluation used to
provide inputs to management
9.1.3 review?
Whether the internal audits are
being conducted at planned
The organization shall conduct internal audits at
intervals?
planned intervals to provide information on There is no longer a
Whether they determine if the
whether the quality management system: need for a documented
QMS conforms to the
a) conforms to: procedure. Internal
requirements of ISO 9001:2015
1) the organizations own requirements for its audit programme shall
standard and to the other
quality management system; take into consideration
requirements established by
2) the requirements of this International changes to the
Organization or not?
Standard; organizations.
How do they determine if the
b) is effectively implemented and maintained.
QMS is effectively implemented
9.2.1 and maintained or not?

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 Whether the audit
programme(s) take into
consideration the quality
The organization shall:
objectives, importance of the
a) plan, establish, implement and maintain an audit
processes, customer feedback,
programme(s) including the frequency, methods,
changes impacting the
responsibilities, planning requirements and
organization and the results of
reporting, which shall take into consideration the
previous audits?
importance of the processes concerned, changes
What is the audit criteria and
affecting the organization, and the results of
scope for each audit?
previous audits;
Is selection of auditors and the
b) Define the audit criteria and scope for each
conduct of audits are objective
audit;
and impartial?
c) Select auditors and conduct audits to ensure
Do they audit their own work?
objectivity and the impartiality of the audit process;
How are results reported to
d) Ensure that the results of the audits are reported
management?
to relevant management;
Whether all necessary
e) Take appropriate correction and corrective
corrections and corrective
actions without undue delay;
actions are taken without any
f) Retain documented information as evidence of
delay?
the implementation of the audit program and the
Whether the documented
audit results.
information of the audit program
and the audit results is
9.2.2 maintained?
With what frequency the top
management reviews the
organization's QMS?
How can the QMS be deemed
suitable, adequate and effective?
What types of information are
reviewed in management
reviews?
Overall purpose
Do these include actions; status
remains the same;
of previous reviews; changes to
however inputs should
Top management shall review the organizations internal and external issues;
now include strategic
quality management system, at planned intervals, relevant to the QMS; issues that
items relating to
to ensure its continuing suitability, adequacy, affect strategy; KPIs for
context, risk and
effectiveness and alignment with the strategic nonconformities and corrective
opportunities. Trends
direction of the organization. actions; monitoring and
and indicators should
measurement of results; audit
be used to monitor
results; customer satisfaction;
quality performance.
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
9.3.1 risks and opportunities and their

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 effectiveness; new potential
opportunities for continual
improvement.
Do the management reviews
include decisions and actions
relating to:
Continuous improvement
opportunities?
The need for changes in the
QMS, including resource needs?
What documented information
does the organization has as
evidence of management
reviews?
The management review shall be planned and Whether the organization has
carried out taking into consideration: planned and carried out taking
a) the status of actions from previous management into consideration:
reviews; a) The status of actions from
b) changes in external and internal issues that are previous reviews?
relevant to the quality management system; b) Change in external and
c) information on the performance and internal issues that are relevant
effectiveness of the quality management system, to the QMS?
including trends in: c) Information on the
1) customer satisfaction and feedback from effectiveness and performance of
relevant interested parties; the QMS which includes trends
2) the extent to which quality objectives have in:
been met; 1. Customer satisfaction and
3) process performance and conformity of feedback from interested
products and services; parties?
4) nonconformities and corrective actions; 2. Extent to which quality
5) monitoring and measurement results; objectives have been met?
6) audit results; 3. Process performance and
7) the performance of external providers; conformity of products and
d) the adequacy of resources; services?
e) the effectiveness of actions taken to address 4. Nonconformities and
risks and opportunities for improvement. corrective actions?
5. Monitoring and measuring
results?
6. Results of Audit?
7. Performance of external
providers?
d) The adequacy of resources?
e) Effectiveness of actions taken
to address risks and
opportunities?
f) Opportunities for
9.3.2 improvement?

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 Whether the organization has
ensured that the outputs of the
management review includes
Opportunities for improvement; decisions and actions related to:
b) Any need for changes to the quality a) Opportunities for
management system; improvement?
c) Resource needs. b) Need for changes to the QMS?
The organization shall retain documented c) Resource needs?
information as evidence of the results of Whether the organization is
management reviews. retaining documented
information as evidence of the
results of the management
9.3.3 reviews?
CLAUSE 10
How to determine and select
opportunities for improvement?
The organization shall determine and select
What necessary actions have
opportunities for improvement and implement any
been implemented to meet
necessary actions to meet customer requirements
customer requirements and
and enhance customer satisfaction. These shall
enhanced customer satisfaction?
include: The requirement for a
How to:
a) Improving products and services to meet documented
Improve processes to prevent
requirements as well as to address future needs preventive action
nonconformities?
and expectations; procedure has gone.
Improve products and services to
b) Correcting, preventing or reducing undesired
meet known and predicted
effects;
requirements?
c) Improving the performance and effectiveness of
Correct, prevent or reduce
the quality management system
undesired effects?
10.1 Improve QMS results?

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 When corrective action In case of non conformities,
has been completed, how do you;
When nonconformity occurs, including any arising the organization can React?
from complaints, the organization shall: move on to consider Take action to control and
a) React to the nonconformity and, as applicable: whether any further correct it?
1) Take action to control and correct it; action is required to Deal with the consequences?
2) deal with the consequences; prevent a similar Does the organization evaluate
b) Evaluate the need for action to eliminate the nonconformity the need for action to eliminate
cause(s) of the nonconformity, in order that it does occurring in future. the cause so that it does not
not recur or occur elsewhere, by: This requires the reoccur or occur elsewhere by:
1) Reviewing and analyzing the nonconformity; organization to Reviewing the nonconformity?
2) Determining the causes of the nonconformity; determine what caused Determining the cause of the
3) Determining if similar nonconformities exist, or the nonconformities nonconformity?
could potentially occur; and then to consider Determining if similar
c) Implement any action needed; whether the potential nonconformities exist or could
d) Review the effectiveness of any corrective action for a similar problem potentially occur?
taken; remains. The Actions needed are
e) Update risks and opportunities determined organization is then implemented?
during planning, if necessary; required to implement Review the effectiveness of
f) Make changes to the quality management any actions identified corrective actions taken, if any?
system, if necessary. as needed, review their Make necessary changes to the
Corrective actions shall be appropriate to the effectiveness and make QMS?
effects of the nonconformities encountered. changes to the quality How corrective actions are
management system if appropriate to the effects of the
10.2.1 necessary. nonconformities encountered?
What documented information
The organization shall retain documented is there as evidence of:
information as evidence of: The nature of the
a) The nature of the nonconformities and any nonconformities and subsequent
subsequent actions taken; actions taken?
b) The results of any corrective action. The results of any corrective
10.2.2 action?
How do you continually
Organizations will now
improve the suitability, adequacy
need to demonstrate
and effectiveness of the QMS?
that they are using the
How are outputs of analysis
outputs from their
The organization shall continually improve the and evaluation, and the outputs
analysis and evaluation
suitability, adequacy and effectiveness of the from management reviews are
processes to identify
quality management system. considered to confirm, if there
areas of
The organization shall consider the results of are areas of underperformance
underperformance and
analysis and evaluation, and the outputs from or opportunities that shall be
opportunities for
management review, to determine if there are addressed as part of continual
improvement.
needs or opportunities that shall be addressed as improvement?
Appropriate tools and
part of continual improvement. Which applicable tools and
methodologies should
methodologies for investigation
be employed by the
of causes of underperformance
organization to support
and for supporting continual
this activity.
10.3 improvement are used?

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Call: +91 9316744482 www.euotechworld.net/trainings Mail: trg@eurotechworld.net