Checklist - Audit - ISO 9001-2015

Q# ISO 9001:2015 Clause Audit Question
4 Context of the Organization
4.1 Understanding the organization and its context

4.1q1
How has the organization determined external
The organization shall determine external and internal
and internal issues relevant to its purpose and
issues that are relevant to its purpose and its strategic
strategic direction?
direction and that affect its ability to achieve the
How do these affect the ability to achieve the
intended result(s) of its quality management system.
intended result of the QMS?
4.1q2 How do you monitor and review information

The organization shall monitor and review the about these internal and external issues?
information about these external and internal 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 How have you determined what interested
organization’s ability to consistently provide products parties are relevant to the QMS?
and services that meet customer and applicable How have you determined what requirements
statutory and regulatory requirements, the those parties have that are relevant to the
organization shall determine: QMS?
How has impact or potential impact been
a) the interested parties that are relevant to the determined?
quality management system;
b) the requirements of these interested parties that
are relevant to the quality management system.
4.2q2
The organization shall monitor and review the How do you monitor and review the information
information about these interested parties and their about interested parties and their relevant
relevant requirements. requirements?
4.3 Determining the scope of the quality management system

4.3q1
The organization shall determine the boundaries and How have the boundaries and applicability of
applicability of the quality management system to the QMS been used to establish the scope of
establish its scope. the organization?
on Audit Evidence
nization determined external

s relevant to its purpose and
?
ct the ability to achieve the
the QMS?
or and review information

al and external issues?
arising from legal, technological,

onal, national, regional or local.
elated to values, culture
rested parties
ermined what interested
nt to the QMS?
ermined what requirements
that are relevant to the
r potential impact been
or and review the information

arties and their relevant
ndaries and applicability of

d to establish the scope of
Page 1
4.3q2 When determining this scope, the organization shall How have: The external and internal issues;
consider: The requirements of relevant interested parties
and; The products and services of the
a) the external and internal issues referred to in organization been considered when
4.1; determining the scope of the organization?
b) c) the requirements of relevant interested parties
referred to in 4.2;
4.3q3 Where a requirement of this International Standard

within the determined scope can be applied, then it How has the application of the International
shall be applied by the organization. Standard within the scope been determined,
and how has it been applied by the
organization?
4.3q4 If any requirement(s) of this International Standard

cannot be applied, this shall not affect the How have any requirements of the
organization’s ability or responsibility to ensure International Standard been determined as not
conformity of products and services. 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: Where is the scope available? Where is it
- products and services covered by the maintained as documented information?
quality management system; Does it state what products and services are
covered by the QMS? Does it justify how
- justification for any instance where a instances of requirements of the QMS cannot
requirement of this International Standard be applied?
cannot be applied.
4.4 Quality management system and its processes

4.4q1
The organization shall establish, implement, maintain How has the QMS been established? Show me
and continually improve a quality management how this is implemented. How is it maintained
system, including the processes needed and their and continually improved? How have the
interactions, in accordance with the requirements of processes been determined and how do they
this International Standard. interact?
on Audit Evidence
ternal and internal issues;
of relevant interested parties
and services of the
considered when
ope of the organization?
ation of the International

e scope been determined,
n applied by the
uirements of the
dard been determined as not
me how conformity of
ces are not affected by this.
Scope required as documented information.

e available? Where is it
umented information?
products and services are
S? Does it justify how
rements of the QMS cannot
been established? Show me

ented. How is it maintained
proved? How have the
termined and how do they
Page 2
4.4q2 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
The organization shall determine the processes needed performance indicators needed to operate and
for the quality management system and their control those processes? What resources are
application throughout the organization and shall needed and how are these made available?
determine: a) the inputs required and the outputs How are responsibilities and authorities
expected from these processes; b) the sequence and assigned for those processes? How are risks
interaction of these processes; c) the criteria, and opportunities considered and what plans
methods, including measurements and related are made to implement actions to address
performance indicators needed to ensure the effective them? What methods are used to monitor,
operation, and control of these processes; d) the measure and evaluate processes and, if
resources needed and ensure their availability; e) the needed, what changes are made to achieve
assignment of the responsibilities and authorities for intended results? How are opportunities to
these processes; f) the risks and opportunities in improve the processes and the QMS
accordance with the requirements of 6.1, and plan and determined?
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.
4.4q3 The organization shall maintain documented What documented information exists to
information to the extent necessary to support the support the operation of processes? How is this
operation of processes and retain documented documented information retained? How is
information to the extent necessary to have confidence confidence that the processes are being carried
that the processes are being carried out as planned. out as planned determined?
5 Leadership
5.1 Leadership and commitment
5.1.1 Leadership and commitment for the quality management system

on Audit Evidence
esses been determined for
re the inputs and outputs for
What is the sequence and
processes? What are the
measurement and related
ators needed to operate and
esses? What resources are
re these made available?
ilities and authorities
processes? How are risks
considered and what plans
ment actions to address
ods are used to monitor,
uate processes and, if
nges are made to achieve
How are opportunities to
sses and the QMS
d information exists to Documented information to support the operation of processes.

ion of processes? How is this
mation retained? How is
e processes are being carried
ermined?
ent system
Page 3
5.1.1q1
Top management shall demonstrate leadership and Show me how top management demonstrates
commitment with respect to the quality management leadership and commitment w.r.t. the QMS by
system by: a) taking accountability of the effectiveness taking accountability of the effectiveness of the
of the quality management system; b) ensuring that QMS. How is the quality policy and objectives
the quality policy and quality objectives are established established for the QMS and how are they
for the quality management system and are compatible compatible with the strategic direction and the
with the strategic direction and the context of the organizational context? How is the quality
organization; c) ensuring that the quality policy is policy communicated within the organization?
communicated, understood and applied within the Show me how this is understood and applied.
organization; d) ensuring the integration of the quality How are the requirements of the QMS
management system requirements into the integrated into the business processes? How do
organization’s business processes; e) promoting you promote awareness of the process
awareness of the process approach; f) ensuring that approach? How do you ensure that resources
the resources needed for the quality management needed for the QMS area available? How do
system are available; g) communicating the you communicate the importance of effective
importance of effective quality management and of quality management? How do you
conforming to the quality management system communicate the importance of conforming to
requirements; h) ensuring that the quality the QMS requirements? How do you ensure
management system achieves its intended results; i) that the QMS achieves its intended results?
engaging, directing and supporting persons to How do you engage, direct and support people
contribute to the effectiveness of the quality to contribute to the effectiveness of the QMS?
management system; j) promoting continual How do you promote continual improvement?
improvement; k) supporting other relevant How do you support other relevant
management roles to demonstrate their leadership as management roles to demonstrate leadership
it applies to their areas of responsibility. in their areas of responsibility?
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

on Audit Evidence
management demonstrates
mmitment w.r.t. the QMS by
ty of the effectiveness of the
uality policy and objectives
QMS and how are they
e strategic direction and the
text? How is the quality
ed within the organization?
is understood and applied.
ements of the QMS
business processes? How do
eness of the process
o you ensure that resources
MS area available? How do
the importance of effective
nt? How do you
mportance of conforming to
ents? How do you ensure
eves its intended results?
e, direct and support people
e effectiveness of the QMS?
te continual improvement?
rt other relevant
to demonstrate leadership
sponsibility?
ly to mean those activities that

public, private, for profit or not
Page 4
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 Show me how top management demonstrates
and met; b) the risks and opportunities that can affect leadership and commitment w.r.t. customer
conformity of products and services and the ability to focus ensuring requirements and applicable
enhance customer satisfaction are determined and statutory and regulatory requirements are
addressed; c) the focus on consistently providing determined and met. How are risks and
products and services that meet customer and opportunities that can affect conformity of
applicable statutory and regulatory requirements is products and services determined? How is the
maintained; d) the focus on enhancing customer ability to enhance customer satisfaction
satisfaction is maintained. 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 To p m a n a g e m e n t s h a l l e s t a b l i s h , r e v i
e w a n d maintain a quality policy that: a) is
appropriate to the purpose and context of the How does top management establish, review
organization; b) provides a framework for setting and and maintain a quality policy? How is it
reviewing quality objectives; c) includes a commitment determined to be appropriate to the purpose
to satisfy applicable requirements; d) includes a and context of the organization? Does it
commitment to continual improvement of the quality provide a framework for setting and reviewing
management system. 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
5.2.2q1 The quality policy shall: a) be available as documented
information; b) be communicated, understood and
Where is the quality policy available as
applied within the organization; c) be available to
documented information? How is it
relevant interested parties, as appropriate. communicated? Show me how it is understood
and applied within the organization. How have
you made it available to relevant interested
parties?
5.3 Organizational roles, responsibility and authorities

5.3q1
How does top management ensure that
Top management shall ensure that the responsibilities
responsibilities and authorities for relevant
and authorities for relevant roles are assigned,
roles are assigned, communicated and
communicated and understood within the organization.
understood within the organization?
on Audit Evidence
management demonstrates
mmitment w.r.t. customer
quirements and applicable
ulatory requirements are
met. How are risks and
can affect conformity of
ces determined? How is the
customer satisfaction
dressed? How is the focus
viding products and services
er and applicable statutory
quirements maintained? How
ction maintained?
agement establish, review

ality policy? How is it
appropriate to the purpose
organization? Does it
rk for setting and reviewing
Does it contain a
tisfy applicable
es it include a commitment to
ment of the QMS?
Quality Policy as document information

y policy available as
rmation? How is it
how me how it is understood
n the organization. How have
ble to relevant interested
agement ensure that

d authorities for relevant
communicated and
the organization?
Page 5
5.3q2 How does top management assign the
responsibility and authority for: Ensuring that
the QMS conforms to the International
standard? Ensuring processes are delivering
Top management shall assign the responsibility and their intended outputs? How is the
authority for: a) ensuring that the quality management performance of the QMS, opportunities for
system conforms to the requirements of this improvement and the need for change or
International Standard; b) ensuring that the processes innovation reported to top management? How
are delivering their intended outputs; c) reporting on is customer focus promoted within the
the performance of the quality management system, organization? How is the integrity of the QMS
on opportunities for improvement and on the need for maintained when changes to the QMS are
change or innovation, and especially for reporting to planned and implemented?
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.
6 Planning for the quality management system
6.1 Actions to address risks and opportunities
6.1.1
6.1.1q1 How are the internal and external issues and
interested parties considered when planning
When planning for the quality management system, for the QMS? How are risks and opportunities
the organization shall consider the issues referred to in determined and addressed so that the QMS
4.1 and the requirements referred to in 4.2 and can::
determine the risks and opportunities that need to be
addressed to: a) give assurance that the quality a) b) achieve its intended results; Prevent or
management system can achieve its intended result(s); c) reduce undesired effects; Achieve
b) prevent, or reduce, undesired effects; c) achieve continual improvement?
continual improvement.
6.1.2
6.1.2q1 How are actions planned to address risks and
opportunities? How are actions integrated and
The organization shall plan: a) actions to address these implemented into the QMS processes? How do
risks and opportunities; b) how to: 1) integrate and you evaluate the effectiveness of the actions?
implement the actions into its quality management
system processes (see 4.4); 2) evaluate the
effectiveness of these actions.
6.1.2q2 Actions taken to address risks and opportunities shall

be proportionate to the potential impact on the How are actions taken to address risks and
conformity of products and services. opportunities determined as being appropriate
to the potential impact on the conformity of
products and services?
on Audit Evidence
agement assign the
authority for: Ensuring that
to the International
g processes are delivering
puts? How is the
e QMS, opportunities for
the need for change or
d to top management? How
promoted within the
w is the integrity of the QMS
changes to the QMS are
emented?
al and external issues and

considered when planning
are risks and opportunities
ddressed so that the QMS
ntended results; Prevent or

sired effects; Achieve
provement?
anned to address risks and

w are actions integrated and
the QMS processes? How do
ffectiveness of the actions?
ken to address risks and

rmined as being appropriate
pact on the conformity of
ces?
Page 6
6.2.2.1 Product design skills
6.2.2.1q 1
How do you determine that personnel with
The organization shall ensure that personnel with
product design responsibility are competent to
product design responsibility are competent to achieve
achieve design requirements? How do you
design requirements and are skilled in applicable tools
determine skills required in applicable tools and
and techniques. Applicable tools and techniques shall
techniques? How do you identify applicable
be identified by the organization.
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
Where are the quality objectives and are these

The organization shall establish quality objectives at
at all relevant functions, levels and processes?
relevant functions, levels and processes. The quality
Are they consistent with the quality policy? Are
objectives shall: a) be consistent with the quality
they measureable? Do they consider applicable
policy, b) be measurable; c) take into account
requirements? Are they relevant to the
applicable requirements; d) be relevant to conformity
conformity of products and services and do
of products and services and the enhancement of
they enhance customer satisfaction? Are they
customer satisfaction; e) be monitored; f) be
monitored? How? How often? How are they
communicated; g) be updated as appropriate. The
communicated? How are they updated? Where
organization shall retain documented information on
is the documented information on the
the quality objectives.
quality objectives?
6.2.2
6.2.2q1 How does the organization determine what will
be done, with what resources, when completed
When planning how to achieve its quality objectives, and how will results be evaluated for quality
the organization shall determine: a) what will be done; objectives?
b) what resources will be required; c) who will be
responsible; d) when it will be completed; e) how the
results will be evaluated.
6.3 Planning of changes

on Audit Evidence
mine that personnel with

ponsibility are competent to
uirements? How do you
quired in applicable tools and
o you identify applicable
es?
k in order to pursue an
aring the risk, or retaining risk
Documented information on quality objectives
lity objectives and are these

tions, levels and processes?
t with the quality policy? Are
? Do they consider applicable
e they relevant to the
ducts and services and do
tomer satisfaction? Are they
How often? How are they
ow are they updated? Where
d information on the
nization determine what will

t resources, when completed
s be evaluated for quality
Page 7
6.3q1 Where the organization determines the need for How are changes to the QMS planned
change to the quality management system (see 4.4) systematically? Demonstrate the purpose and
the change shall be carried out in a planned and potential consequences of changes;
systematic manner. The organization shall consider: a) Demonstrate the integrity of the QMS;
the purpose of the change and any of its potential Demonstrate how resources are made
consequences; b) the integrity of the quality available? Demonstrate how responsibility and
management system; c) the availability of resources; authority is allocated or reallocated.
d) the allocation or reallocation of responsibilities and
authorities.
7 Support
7.1 Resources
7.1.1 General
7.1.1q1
The organization shall determine and provide the Demonstrate how resources are determined for
resources needed for the establishment, the establishment, implementation,
implementation, maintenance and continual maintenance and continual improvement of the
improvement of the quality management system. The QMS. Show me how the capabilities and
organization shall consider: a) the capabilities of, and constraints on internal resources are
constraints on, existing internal resources; b) what considered. Show me how needs from external
needs to be obtained from external providers. providers are considered.
7.1.2 People
7.1.2q1 How do you provide persons necessary to
To ensure that the organization can consistently meet consistently meet customer, applicable
customer and applicable statutory and regulatory statutory and regulatory requirements for the
requirements, the organization shall provide the QMS including the necessary processes?
persons necessary for the effective operation of the
quality management system, including the processes
needed.
7.1.3 Infrastructure
on Audit Evidence
o the QMS planned
emonstrate the purpose and
ences of changes;
ntegrity of the QMS;
resources are made
strate how responsibility and
ed or reallocated.
resources are determined for

implementation,
continual improvement of the
w the capabilities and
rnal resources are
me how needs from external
dered.
e persons necessary to
customer, applicable
latory requirements for the
necessary processes?
Page 8
7.1.3q1
How do you determine, provide and maintain
The organization shall determine, provide and maintain
the infrastructure for the operation of
the infrastructure for the operation of its processes to
processes to achieve products and service
achieve conformity of products and services.
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

7.1.4q1
The organization shall determine, provide and maintain
How do you determine, provide and maintain
the environment necessary for the operation of its
the environment for the operation of processes
processes and to achieve conformity of products and
to achieve products and service conformity?
services.
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 How are the resources determined for ensuring
Where monitoring or measuring is used for evidence of valid and reliable monitoring and measuring
conformity of products and services to specified results, where used?
requirements the organization shall determine the
resources needed to ensure valid and reliable
monitoring and measuring results.
7.1.5q2 How do you ensure that resources provided are

The organization shall ensure that the resources suitable for the specific monitoring and
provided: a) are suitable for the specific type of measurement activities and are maintained to
monitoring and measurement activities being ensure continued fitness for purpose?
undertaken; b) are maintained to ensure their
continued fitness for their purpose.
7.1.5q3 Show me the documented information

The organization shall retain appropriate documented which is evidence of fitness for purpose of
information as evidence of fitness for purpose of monitoring and measurement resources.
monitoring and measurement resources.
on Audit Evidence
mine, provide and maintain

or the operation of
ve products and service
ification to, and agreement
mine, provide and maintain

or the operation of processes
s and service conformity?
logical, environmental and other
rces determined for ensuring

monitoring and measuring
d?
e that resources provided are

ecific monitoring and
vities and are maintained to
fitness for purpose?
umented information Documented information of fitness for purpose of monitoring &

of fitness for purpose of measurement resources.
easurement resources.
Page 9
7.1.5q4 Where applicable, show me how measurement
instruments are: Verified or calibrated at
Where measurement traceability is: a statutory or specified intervals against national or
regulatory requirement; a customer or relevant international measurement standards; If there
interested party expectation; or considered by the are no standards, show me the documented
organization to be an essential part of providing information which is used as the basis used
confidence in the validity of measurement results; for calibration or verification. Show me how
measuring instruments shall be: -verified or calibrated measurement instruments are identified to
at specified intervals or prior to use against determine their calibration status. Show me
measurement standards traceable to international or how they are safeguarded from adjustments.
national measurement standards. Where no such Show me how they are safeguarded from
standards exist, the basis used for calibration or damage and deterioration.
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.
7.1.5q5 How do you determine the validity of previous

The organization shall determine if the validity of measurements if you find an instrument to be
previous measurement results has been adversely defective during verification or calibration?
affected when an instrument is found to be defective What appropriate actions can you take?
during its planned verification or calibration, or during
its use, and take appropriate corrective action as
necessary.
7.1.6 Organizational knowledge

7.1.6q1 The organization shall determine the knowledge
necessary for the operation of its processes and to How do you determine necessary knowledge
achieve conformity of products and services. for the operation of processes? How do you
determine necessary knowledge to achieve
conformity of products and services?
7.1.6q2 This knowledge shall be maintained, and made

How do you maintain this knowledge and how
available to the extent necessary.
do you make it available to the extent
necessary?
7.1.6q3 How do you consider current knowledge and
When addressing changing needs and trends, the how do you acquire additional knowledge when
organization shall consider its current knowledge and addressing changing needs and trends?
determine how to acquire or access the necessary
additional knowledge.
ion Audit Evidence
show me how measurement Documented information for the basis of calibration or
Verified or calibrated at verification where no standards exist.
against national or
surement standards; If there
show me the documented
ch is used as the basis used
verification. Show me how
ruments are identified to
alibration status. Show me
guarded from adjustments.
y are safeguarded from
rioration.
mine the validity of previous

you find an instrument to be
verification or calibration?
actions can you take?
mine necessary knowledge

of processes? How do you
ary knowledge to achieve
ducts and services?
ain this knowledge and how

ailable to the extent
der current knowledge and

re additional knowledge when
ng needs and trends?
Page 10
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 Show me how: You determine the necessary
these persons are competent on the basis of competence of people doing work under your
appropriate education, training, or experience; c) control that affects quality performance; How
where applicable, take actions to acquire the necessary do you determine competence on the basis of
competence, and evaluate the effectiveness of the appropriate education, training or experience?
actions taken; d) retain appropriate documented How do you take actions to acquire necessary
information as evidence of competence. competence where applicable and how do you
evaluate the effectiveness of those actions?
Show me documented information where
appropriate of competence.
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 How are people aware of: The quality policy?
Relevant quality objectives? Their contribution
Persons doing work under the organization’s control to the effectiveness of the QMS? The benefits
shall be aware of: a) the quality policy; b) relevant of improved performance? The implications of
quality objectives; c) their contribution to the not conforming with the QMS requirements?
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.
7.4 Communication
ion Audit Evidence
rty and lessons learned. NOTE 2
(e.g. learning from failures and
experts within the organization);
th customers or providers).
Documented information as evidence of competence where

appropriate.
u determine the necessary
eople doing work under your
ts quality performance; How
competence on the basis of
tion, training or experience?
actions to acquire necessary
e applicable and how do you
tiveness of those actions?
ented information where
mpetence.
entoring of, or the re- assignment
ware of: The quality policy?

bjectives? Their contribution
ss of the QMS? The benefits
rmance? The implications of
th the QMS requirements?
Page 11
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 How do you determine internal and external
to communicate; d) how to communicate. 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 What documented information do you have
as required by this standard? What
The organization’s quality management system shall documented information do you have as
include: a) documented information required by this being necessary for the effectiveness of your
International Standard; b) documented information QMS?
determined by the organization as being necessary for
the effectiveness of the quality management system.
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 Show me that your documented information
contains: Identification; Description; In what
When creating and updating documented information media format? Show me how the documented
the organization shall ensure appropriate: a) information is reviewed and approved for
identification and description (e.g. a title, date, author, suitability and adequacy.
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.
7.5.3 Control of documented information
7.5.3.1
7.5.3.1q 1 Show me how you control documented
information. Show me how you make it
Documented information required by the quality
available and suitable for use. How do you
management system and by this International
Standard shall be controlled to ensure: a) it is available protect your documented information?
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).
ion Audit Evidence
mine internal and external

elevant to the QMS? How do
What? When? With Whom?
ed information do you have Documented information required by this standard.

s standard? What Documented information necessary for the effectiveness of the
ormation do you have as QMS.
or the effectiveness of your
differ from one organization to

ucts and services; b) the
r documented information Documented information (in various media) needs

cation; Description; In what identification, description. Review / approval process?
ow me how the documented
iewed and approved for
equacy.
control documented Control of documented information. Suitability and availability for

ow me how you make it use. How is it protected?
able for use. How do you
mented information?
Page 12
7.5.3.2
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); When controlling documented information, how
d) retention and disposition. do you address: Distribution; Access;
Retrieval; Use; Storage and preservation;
Legibility; Control of changes; Retention and
disposition.
7.5.3.2q 2 How do you identify as appropriate and control

Documented information of external origin determined documented information of external origin
by the organization to be necessary for the planning which you have determined as necessary for
and operation of the quality management system shall the QMS
be identified as appropriate, and controlled.
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

ion Audit Evidence
Control of documented information. Change control, distribution,

access, retrieval, use, storage, preservation, legibility, retention and
disposition.
documented information, how
Distribution; Access;
torage and preservation;
of changes; Retention and
fy as appropriate and control Control of external documented information.

ormation of external origin
etermined as necessary for
information only, or the

Page 13
8.1q1 How are processes needed to meet
requirements for provision of products and
services planned, implemented and controlled?
How are requirements for products and services
The organization shall plan, implement and control the determined? How is criteria for processes and
processes, as outlined in 4.4, needed to meet acceptance for products and services
requirements for the provision of products and services determined? How are resources determined?
and to implement the actions determined in 6.1, by: a) How is process control implemented? Show me
determining requirements for the product and services; the documented information that shows
b) establishing criteria for the processes and for the confidence in that the processes have been
acceptance of products and services; c) determining carried out as planned and can demonstrate
the resources needed to achieve conformity to product conformity of products and services.
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.
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 How do you control planned changes? How do
review the consequences of unintended changes, you review the consequences of unintended
taking action to mitigate any adverse effects, as changes? What action is taken to mitigate any
necessary. adverse effects?
8.1q4 The organization shall ensure that outsourced How do you control outsourced processes?
processes are controlled in accordance with 8.4.
8.2 Determination of requirements for products and services
8.2.1 Customer communication

8.2.1q1 The organization shall establish the processes for What are your processes for communicating
communicating with customers in relation to: a) with customers? How do you communicate
information relating to products and services; b) information relating to: Products; Services;
enquiries, contracts or order handling, including Enquiries; Contracts; Order handling;
changes; c) obtaining customer views and perceptions, Customer views, perceptions and complaints;
including customer complaints; d) the handling or Handling or treatment of customer property;
treatment of customer property, if applicable; e) Specific requirements for contingency actions?
specific requirements for contingency actions, when
relevant.
ion Audit Evidence
s needed to meet Documented information to show processes have been carried
provision of products and out as planned and can demonstrate conformity of products
implemented and controlled? and services.
ents for products and services
is criteria for processes and
oducts and services
are resources determined?
ntrol implemented? Show me
information that shows
the processes have been
nned and can demonstrate
ducts and services.
ermined that the output from

ess is suitable for your
ol planned changes? How do

nsequences of unintended
tion is taken to mitigate any
ol outsourced processes?
ervices
cesses for communicating
How do you communicate
ng to: Products; Services;
cts; Order handling;
perceptions and complaints;
ment of customer property;
ents for contingency actions?
Page 14
8.2.2 Determination of requirements related to products and services

8.2.2q1 The organization shall establish, implement and
maintain a process to determine the requirements for What is your process to determine the
the products and services to be offered to potential requirements for products and services to be
customers. offered to potential customers? How do you
establish, implement and maintain this
process?
8.2.2q2 How do you define product and service

requirements including statutory and regulatory
The organization shall ensure that: a) product and
requirements? How do you ensure that you
service requirements (including those considered
have the ability to meet the defined
necessary by the organization), and applicable
requirements and substantiate any claims for
statutory and regulatory requirements, are defined; b)
your products and services?
it has the ability to meet the defined requirements and
substantiate the claims for the products and services it
offers.
8.2.3 Review of requirements related to products and services

8.2.3q1 How do you review: Customer requirements for
delivery and post-delivery? Requirements
The organization shall review, as applicable: a) necessary for customers’ specified or intended
requirements specified by the customer, including the use, where known; Additional statutory and
requirements for delivery and post- delivery activities; regulatory requirements applicable to products
b) requirements not stated by the customer, but and services; Any other contract or order
necessary for the customers' specified or intended use, requirements.
when known; c) additional statutory and regulatory
requirements applicable to the products and services;
d) contract or order requirements differing from those
previously expressed.
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 Show me that the review is conducted prior to
services to the customer and shall ensure contract or your commitment to supply products and
order requirements differing from those previously services to your customers. How do you resolve
defined are resolved. contract or order requirements which differ
from those previously defined?
8.2.3q3 How do you confirm customer requirements

Where the customer does not provide a documented where the customer does not provide a
statement of their requirements, the customer documented statement?
requirements shall be confirmed by the organization
before acceptance.
8.2.3q4 Documented information describing the results of the
review, including any new or changed requirements for Show me where you retain documented
the products and services, shall be retained. information which describes results of the
review including any new or changed
requirements.
ion Audit Evidence
d services
ess to determine the

products and services to be
al customers? How do you
ent and maintain this
e product and service

uding statutory and regulatory
ow do you ensure that you
o meet the defined
substantiate any claims for
d services?
ces
w: Customer requirements for
-delivery? Requirements
omers’ specified or intended
; Additional statutory and
ements applicable to products
y other contract or order
review is conducted prior to

to supply products and
ustomers. How do you resolve
equirements which differ
usly defined?
m customer requirements
er does not provide a
ment?
Documented information of reviews describing new or changed

ou retain documented
ch describes results of the
requirements to products and services.
ny new or changed
Page 15
8.2.3q5 Where requirements for products and services are Show me the documented information
changed, the organization shall ensure that relevant containing changes to products and services.
documented information is amended and that relevant How do you ensure that relevant personnel are
personnel are made aware of the changed made aware of those changes?
requirements.
8.3 Design and development of products and services

8.3.1 General
8.3.1q1 How do you establish, implement and maintain

Where the detailed requirements of the organization’s a design and development process (where
products and services are not already established or detailed requirements of your products and
not defined by the customer or by other interested services are not already established or defined
parties, such that they are adequate for subsequent by the customer or other parties).
production or service provision, the organization shall
establish, implement and maintain a design and
development process.
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

ion Audit Evidence
umented information Documented information of amended reviews and how relevant
es to products and services. personnel are made aware of those changes.
e that relevant personnel are
ose changes?
lish, implement and maintain

elopment process (where
ents of your products and
ready established or defined
r other parties).
pment of processes for production

address the whole service delivery
uses 8.3 and 8.5 together.
Page 16
8.3.2q1 In determining the stages and controls for design and When determining the stages and control for
development, the organization shall consider: a) the design and development, show me how you
nature, duration and complexity of the design and consider: The nature, duration and complexity
development activities; b) requirements that specify of the activities; Requirements that specify
particular process stages, including applicable design particular process stages including applicable
and development reviews; c) the required design and reviews; Required verification and validation;
development verification and validation; d) the Responsibilities and authorities; How interfaces
responsibilities and authorities involved in the design are controlled between individuals and parties;
and development process; e) the need to control The need for involvement of customer and user
interfaces between individuals and parties involved in groups. Show me documented information
the design and development process; f) the need for that confirms design and development
involvement of customer and user groups in the design requirements have been met.
and development process; g) the necessary
documented information to confirm that design and
development requirements have been met.
8.3.3 Design and development inputs

ion Audit Evidence
g the stages and control for Documented information that confirms design & development
pment, show me how you requirements have been met.
ure, duration and complexity
Requirements that specify
s stages including applicable
d verification and validation;
nd authorities; How interfaces
ween individuals and parties;
vement of customer and user
documented information
ign and development
e been met.
Page 17
8.3.3q1 Can you show me how you determine:
Requirements essential for the type of products
and services being designed and developed,
The organization shall determine: a) requirements including as applicable: Functional &
essential for the specific type of products and services performance requirements; Statutory and
being designed and developed, including, as regulatory requirements; Standards or codes of
applicable, functional and performance requirements; practice where there is a commitment to
b) applicable statutory and regulatory requirements; c) implement; Internal and external resources
standards or codes of practice that the organization needed for the design and development of
has committed to implement; d) internal and external products and services; Potential consequences
resource needs for the design and development of of failure; Level of control expected of the
products and services; e) the potential consequences design and development process by customers
of failure due to the nature of the products and and other relevant parties.
services; f) the level of control expected of the design
and development process by customers and other
relevant interested parties.
8.3.3q2
How do you determine that inputs are
Inputs shall be adequate for design and development
adequate, complete and unambiguous for
purposes, complete, and unambiguous. Conflicts
design and development? How do you resolve
among inputs shall be resolved.
conflicts among inputs?
8.3.4 Design and development controls

8.3.4q1
The controls applied to the design and development

How do controls that are applied to the design
process shall ensure that: a) the results to be achieved
and development process ensure: Results
by the design and development activities are clearly
achieved by design and development activities
defined; b) design and development reviews are
are clearly defined? Design and development
conducted as planned; c) verification is conducted to
reviews are conducted as planned? Outputs
ensure that the design and development outputs have
meet the input requirements by verification/
met the design and development input requirements;
Validation is conducted to ensure that the
d) validation is conducted to ensure that the resulting
resulting products and services are capable of
products and services are capable of meeting the
meeting the requirements for the specified
requirements for the specified application or intended
application or intended use (when known)?
use (when known).
8.3.5 Design and development outputs

ion Audit Evidence
how you determine:
ential for the type of products
g designed and developed,
cable: Functional &
irements; Statutory and
ments; Standards or codes of
ere is a commitment to
nal and external resources
esign and development of
vices; Potential consequences
f control expected of the
opment process by customers
nt parties.
mine that inputs are

te and unambiguous for
pment? How do you resolve
puts?
hat are applied to the design

process ensure: Results
n and development activities
d? Design and development
ucted as planned? Outputs
quirements by verification/
ucted to ensure that the
and services are capable of
rements for the specified
nded use (when known)?
Page 18
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 How do you ensure that design and
services; c) include or reference monitoring and development outputs: Meet the input
measuring requirements, and acceptance criteria, as requirements for design and development? Are
applicable; d) ensure products to be produced, or adequate for the subsequent processes for the
services to be provided, are fit for intended purpose provision of products and services? Include or
and their safe and proper use. 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?
8.3.5q2
The organization shall retain the documented Show me the documented information
information resulting from the design and development which results from the design and development
process. process.
8.3.6 Design and development changes

8.3.6q1 How do you review, control and identify
The organization shall review, control and identify changes made to the design inputs and outputs
changes made to design inputs and design outputs during design and development of products
during the design and development of products and and services ensuring no impact on conformity
services or subsequently, to the extent that there is no to requirements?
adverse impact on conformity to requirements.
8.3.6q2 Documented information on design and development Show me the documented information for
changes shall be retained. 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 How do you ensure externally provided
processes, products, and services conform to specified processes, products and services conform to
requirements. specified requirements?
8.4.1q2
The organization shall apply the specified requirements Show me how you apply specified requirements
for the control of externally provided products and for the control of externally provided products
services when: a) products and services are provided and services when: Products and services are
by external providers for incorporation into the provided by external providers for incorporation
organization’s own products and services; b) products into your own products and services; You
and services are provided directly to the customer(s) provide products and services directly to
by external providers on behalf of the organization; c) customers by external providers on your behalf;
a process or part of a process is provided by an A process or part-process is provided by an
external provider as a result of a decision by the external provider as a result of a decision to
organization to outsource a process or function. outsource a process or function.
ion Audit Evidence
e that design and

uts: Meet the input
design and development? Are
subsequent processes for the
cts and services? Include or
ing and measuring
acceptance criteria, as
e products to be produced, or
vided, are fit for intended
safe and proper use?
Documented information from the design and development

umented information
m the design and development process.
w, control and identify

the design inputs and outputs
development of products
ring no impact on conformity
umented information for

pment changes. Documented information for design and development changes.
es
e externally provided
ts and services conform to
ments?
apply specified requirements

externally provided products
n: Products and services are
nal providers for incorporation
ducts and services; You
and services directly to
ernal providers on your behalf;
-process is provided by an
as a result of a decision to
ss or function.
Page 19
8.4.1q3 The organization shall establish and apply criteria for
the evaluation, selection, monitoring of performance Show me how you establish and apply criteria
and re-evaluation of external providers based on their for evaluation, selection, monitoring of
ability to provide processes or products and services in performance and re-evaluation of external
accordance with specified requirements. providers. How do you assess their ability to
provide processes or products and services in
accordance with specified requirements?
8.4.1q4 The organization shall retain appropriate documented What documented information do you have
information of the results of the evaluations, of the results of evaluations, monitoring of
monitoring of the performance and re- evaluations of performance and re- evaluations of external
the external providers. providers?
8.4.2 Type and extent of control of external provision

8.4.2q1
In determining the type and extent of controls to be How do you determine the controls applied to
applied to the external provision of processes, products the external provision of processes, products
and services, the organization shall take into and services and take into consideration: a)
consideration: a) the potential impact of the externally The potential impact of the externally provided
provided processes, products and services on the processes, products and services on the ability
organization’s ability to consistently meet customer to consistently meet customer and applicable
and applicable statutory and regulatory requirements; statutory and regulatory requirements? b) The
b) the perceived effectiveness of the controls applied perceived effectiveness of the controls applied
by the external provider. by the external provider?
8.4.2q2
The organization shall establish and implement
What verification or other activities do you
verification or other activities necessary to ensure the
have to ensure externally provided processes,
externally provided processes, products and services
products and services do not adversely affect
do not adversely affect the organization's ability to
your ability to consistently deliver conforming
consistently deliver conforming products and services
products and services to your customers?
to its customers.
8.4.2q3 When processes or functions have been
outsourced to external providers, how do you
Processes or functions of the organization which have
consider a) and b) in 8.4.1 and how do you
been outsourced to an external provider remain within
define the controls intended to be applied to
the scope of the organization’s quality management
the external provider and to the resulting
system; accordingly, the organization shall consider a)
process output?
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.
ion Audit Evidence
establish and apply criteria

ection, monitoring of
re-evaluation of external
you assess their ability to
or products and services in
specified requirements?
ed information do you have Documented information of external providers’ performance.

valuations, monitoring of
re- evaluations of external
mine the controls applied to

sion of processes, products
ake into consideration: a)
act of the externally provided
ts and services on the ability
eet customer and applicable
ulatory requirements? b) The
eness of the controls applied
ovider?
or other activities do you

ternally provided processes,
ices do not adversely affect
sistently deliver conforming
ices to your customers?
r functions have been
ernal providers, how do you
in 8.4.1 and how do you
s intended to be applied to
der and to the resulting
Page 20
8.4.3 Information for external providers

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 Show me how you communicate to external
services, methods, processes or equipment; c) providers, applicable requirements for:
competence of personnel, including necessary Products and services to be provided or the
qualification; d) their interactions with the processes to be performed on behalf of the
organization's quality management system; e) the organization; Approval or release of products
control and monitoring of the external provider’s and services, methods, processes or
performance to be applied by the organization; f) equipment; Competence of personnel,
verification activities that the organization, or its including necessary qualification; Their
customer, intends to perform at the external provider’s interactions with the organization's quality
premises. 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 Before you communicate with external
requirements prior to their communication to the providers, how do you ensure the adequacy of
external provider. 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 What controlled conditions do you have for
for production and service provision, including delivery production and service provision, including
and post-delivery activities. delivery and post-delivery activities?
ion Audit Evidence
communicate to external
ble requirements for:
ices to be provided or the
erformed on behalf of the
roval or release of products
thods, processes or
petence of personnel,
ary qualification; Their
he organization's quality
em; The control and
external provider’s
e applied by the organization;
ies that the organization, or
nds to perform at the external
es.
unicate with external

you ensure the adequacy of
ments?
onditions do you have for

rvice provision, including
delivery activities?
Page 21
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 Can you show me controlled conditions for: a)
achieved; c) monitoring and measurement activities at the availability of documented information
appropriate stages to verify that criteria for control of
defining the characteristics of the products and
processes and process outputs, and acceptance criteria
services; b) the availability of documented
for products and services, have been met. d) the use,
information defining the activities to be
and control of suitable infrastructure and process
performed and the results to be achieved; c)
environment; e) the availability and use of suitable
monitoring and measurement activities at
monitoring and measuring resources; f) the appropriate stages to verify that criteria for
competence and, where applicable, required control of processes and process outputs, and
qualification of persons; g) the validation, and periodic acceptance criteria for products and services,
revalidation, of the ability to achieve planned results of
have been met. d) the use, and control of
any process for production and service provision where
suitable infrastructure and process
the resulting output cannot be verified by subsequent
environment; e) the availability and use of
monitoring or measurement; h) the implementation of
suitable monitoring and measuring resources;
products and services release, delivery and post-
f) the competence and, where applicable,
delivery activities.
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.
8.5.2 Identification and traceability

8.5.2q1
Where necessary to ensure conformity of products and What means do you use to identify process
services, the organization shall use suitable means to outputs to ensure conformity of products and
identify process outputs. services?
8.5.2q2 How do you identify the status of process

The organization shall identify the status of process outputs?
outputs with respect to monitoring and measurement
requirements throughout production and service
provision.
8.5.2q3 How do you control the unique identification of

Where traceability is a requirement, the organization process outputs, where applicable? What
shall control the unique identification of the process documented information do you retain?
outputs, and retain any documented information
necessary to maintain traceability.
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

ion Audit Evidence
Documented information defining characteristics of the
products and services
controlled conditions for: a)

documented information
cteristics of the products and
vailability of documented
ning the activities to be
e results to be achieved; c)
easurement activities at
s to verify that criteria for
es and process outputs, and
a for products and services,
) the use, and control of
cture and process
he availability and use of
ng and measuring resources;
and, where applicable,
ion of persons; g) the
riodic revalidation, of the
planned results of any
ction and service provision
g output cannot be verified
onitoring or measurement; h)
on of products and services
and post-delivery activities.
ou use to identify process

conformity of products and
fy the status of process
ol the unique identification of Documented information of traceability, where required.

where applicable? What
ormation do you retain?
the organization’s customer or

lude products, services,
s
Page 22
8.5.3q1 The organization shall exercise care with property What care do you provide for customer or
belonging to the customer or external providers while it external provider’s property while under your
is under the organization's control or being used by the control? How do you identify, verify, protect
organization. The organization shall identify, verify, and safeguard that property which is provided
protect and safeguard the customer’s or external for use or incorporation into your products or
provider’s property provided for use or incorporation services?
into the products and services.
8.5.3q2 What means do you use to report to the

When property of the customer or external provider is customer or external provider if their property
incorrectly used, lost, damaged or otherwise found to is incorrectly used, lost, damaged or found to
be unsuitable for use, the organization shall report this be unsuitable for use?
to the customer or external provider.
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 How do you ensure preservation of process
outputs during production and service provision, to the outputs during production and service provision
extent necessary to maintain conformity to to maintain conformity to product
requirements. 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 How do you meet requirements for post-
for post-delivery activities associated with the products delivery activities associated with products and
and services. services?
8.5.5q2
In determining the extent of post-delivery activities

How do you determine: Risk; Nature, use and
that are required, the organization shall consider: a)
intended lifetime; Customer feedback;
the risks associated with the products and services; b)
Statutory and Regulatory requirements, when
the nature, use and intended lifetime of the products
determining the extent of post- delivery
and services; c) customer feedback; d) statutory and
activities required with products and services?
regulatory requirements.
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

ion Audit Evidence
provide for customer or
s property while under your
you identify, verify, protect
at property which is provided
ration into your products or
ou use to report to the

nal provider if their property
, lost, damaged or found to
use?
ustomer premises, intellectual
e preservation of process
oduction and service provision
rmity to product
sion or transportation, and
requirements for post-

associated with products and
mine: Risk; Nature, use and

Customer feedback;
ulatory requirements, when
xtent of post- delivery
with products and services?
ual obligations such as

al.
Page 23
8.5.6q1 How do you review and control unplanned
The organization shall review and control unplanned changes to ensure continuing conformity with
changes essential for production or service provision to specified requirements?
the extent necessary to ensure continuing conformity
with specified requirements.
8.5.6q2 The organization shall retain documented information What documented information can you show
describing the results of the review of changes, the me which describes the results of reviews of
personnel authorizing the change, and any necessary changes, the personnel authorizing change and
actions. any necessary actions?
8.6 Release of products and services

8.6q1
The organization shall implement the planned
Show me how planned arrangement have been
arrangements at appropriate stages to verify that
implemented at appropriate stages to verify
product and service requirements have been met.
product and service requirements have been
Evidence of conformity with the acceptance criteria
met. Show me what evidence you retain.
shall be retained.
8.6q2
Show me how the release of products and
The release of products and services to the customer
services is held until planned arrangements for
shall not proceed until the planned arrangements for
verification of conformity have been
verification of conformity have been satisfactorily
satisfactorily completed, unless approved by a
completed, unless otherwise approved by a relevant
relevant authority, or the customer if
authority and, as applicable, by the customer.
applicable. Show me documented
Documented information shall provide traceability to
information which shows traceability to the
the person(s) authorizing release of products and
person authorizing release of products and
services for delivery to the customer.
services.
8.7 Control of non-conforming process outputs, products and services

8.7q1
The organization shall ensure process outputs, products How do you identify and control process
and services that do not conform to requirements are outputs, products and services that do not
identified and controlled to prevent their unintended conform to requirements and prevent their
use or delivery. unintended use or delivery?
8.7q2 The organization shall take appropriate corrective

action based on the nature of the nonconformity and What appropriate corrective actions are taken
its impact on the conformity of products and services. based on the nature of the nonconformity and
This applies also to nonconforming products and its impact on the conformity of products and
services detected after delivery of the products or services? How do you apply this to
during the provision of the service. nonconformity detected after delivery?
ion Audit Evidence
w and control unplanned
e continuing conformity with
ments?
ed information can you show Documented information describing results of review of

es the results of reviews of changes, personnel and actions.
onnel authorizing change and
tions?
nned arrangement have been

ppropriate stages to verify
ce requirements have been
at evidence you retain.
Documented information providing traceability, authorizing

release of products and release of products and services.
ntil planned arrangements for
formity have been
pleted, unless approved by a
, or the customer if
me documented
ch shows traceability to the
g release of products and
cts and services
fy and control process

and services that do not
ements and prevent their
delivery?
corrective actions are taken

re of the nonconformity and
conformity of products and
you apply this to
ected after delivery?
Page 24
8.7q3 How you deal with nonconforming process
outputs, products and services in terms of:
Correction; Segregation, containment, return or
As applicable, the organization shall deal with suspension of provision of products and
nonconforming process outputs, products and services services? Informing the customer? Obtaining
in one or more of the following ways: a) correction; b) authorization for use as-is? Release,
segregation, containment, return or suspension of continuation or re-provision of the products and
provision of products and services; c) informing the service? Acceptance under concession?
customer; d) obtaining authorization for: - use “as-is’;
- release, continuation or re-provision of the products
and services; - acceptance under concession.
8.7q4 Where nonconforming process outputs, products and

services are corrected, conformity to the requirements How do you verify conformance where process
shall be verified. outputs, products and services are corrected
following nonconformance?
8.7q5 The organization shall retain documented information What documented information do you keep
of actions taken on nonconforming process outputs, following actions taken to address
products and services, including on any concessions nonconformities, including any concessions
obtained and on the person or authority that made the obtained and on the person or authority that
decision regarding dealing with the nonconformity. made the decision regarding dealing with the
nonconformance.
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 Show me how you determine: What needs to be
monitoring and measuring shall be performed; d) monitored and measured? Methods for
when the results from monitoring and measurement monitoring, measurement, analysis and
shall be analysed and evaluated. evaluation to ensure valid results? When to
perform monitoring and measuring? When
results shall be analysed and evaluated?
9.1.1q2 What documented information can you show

The organization shall ensure that monitoring and me that monitoring and measurement activities
measurement activities are implemented in accordance have been implemented in accordance with
with the determined requirements and shall retain determined requirements?
appropriate documented information as evidence of
the results.
ion Audit Evidence
h nonconforming process
and services in terms of:
gation, containment, return or
vision of products and
ng the customer? Obtaining
use as-is? Release,
-provision of the products and
nce under concession?
conformance where process

and services are corrected
ormance?
ed information do you keep Documented information for actions taken following

aken to address nonconformance, including concessions and authority granted.
ncluding any concessions
he person or authority that
n regarding dealing with the
determine: What needs to be

easured? Methods for
urement, analysis and
ure valid results? When to
g and measuring? When
alysed and evaluated?
d information can you show Documented information of monitoring and measurement

g and measurement activities activities in accordance with determined requirements.
mented in accordance with
ements?
Page 25
9.1.1q3
The organization shall evaluate the quality
Show me how you evaluate the quality
performance and the effectiveness of the quality
performance and the effectiveness of the QMS.
management system.
9.1.2 Customer satisfaction
9.1.2q1
The organization shall monitor customer perceptions of How do you monitor customer perception of the
the degree to which requirements have been met. degree to which requirements have been met?
9.1.2q2
The organization shall obtain information relating to How do you obtain information relating to
customer views and opinions of the organization and customer views and opinions of your products
its products and services. and services?
9.1.2q3
The methods for obtaining and using this information What methods for obtaining and using this
shall be determined. 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 So me how you analyse and evaluate data and
appropriate data and information arising from information arising from monitoring,
monitoring, measurement and other sources. measurement and other sources.
9.1.3q2
The output of analysis and evaluation shall be used to: Show me how the output of analysis and
a) demonstrate conformity of products and services to evaluation is used to: Demonstrate conformity
requirements; b) assess and enhance customer of products and services to requirements?
satisfaction; c) ensure conformity and effectiveness of Assess and enhance customer satisfaction?
the quality management system; d) demonstrate that Ensure conformity and effectiveness of the
planning has been successfully implemented; e) QMS? Demonstrate that planning has been
assess the performance of processes; f) assess the successfully implemented? Assess process
performance of external provider(s); g) determine the performance? Assess performance of external
need or opportunities for improvements within the providers? Determine the need or opportunities
quality management system. 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
ion Audit Evidence
evaluate the quality

the effectiveness of the QMS.
or customer perception of the

equirements have been met?
n information relating to
nd opinions of your products
obtaining and using this

u have?
nion surveys, customer data on
y claims and dealer reports.
nalyse and evaluate data and

g from monitoring,
other sources.
output of analysis and

to: Demonstrate conformity
ervices to requirements?
ce customer satisfaction?
and effectiveness of the
te that planning has been
mented? Assess process
sess performance of external
mine the need or opportunities
s within the QMS?
he results of analysis and

ed to provide inputs to
ew.
Page 26
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) Are internal audits being conducted at planned
the organization’s own requirements for its quality intervals? Do they determine whether the QMS
management system; 2) the requirements of this conforms to the requirements of ISO 9001 and
International Standard; b) is effectively implemented to the other requirements established by
and maintained. Organization? (Review records to demonstrate
conformance) Do they determine whether the
QMS is effectively implemented and
maintained? (Review records)
9.2.2
9.2.2q1 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 organization shall: a) plan, establish, implement
the audit criteria and scope for each audit?
and maintain an audit programme(s) including the
Can you demonstrate that selection of auditors
frequency, methods, responsibilities, planning
and the conduct of audits are objective and
requirements and reporting, which shall take into
impartial and that auditors don’t audit their
consideration the quality objectives, the importance of
own work? How are audit results reported to
the processes concerned, customer feedback, changes
relevant management? Can you demonstrate
impacting on the organization, and the results of
that necessary correction and corrective actions
previous audits; b) define the audit criteria and scope
are taken without undue delay? Can you show
for each audit; c) select auditors and conduct audits to
me documented information of the audit
ensure objectivity and the impartiality of the audit
programme and the audit results?
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.
NOTE See ISO 19011 for guidance.
9.3 Management Review
9.3.1
9.3.1q1
Top management shall review the organization's quality What is the frequency that top management
management system, at planned intervals, to ensure reviews the organization's QMS? How is the
its continuing suitability, adequacy, and effectiveness. QMS deemed suitable, adequate and effective?
ion Audit Evidence
s being conducted at planned

y determine whether the QMS
equirements of ISO 9001 and
rements established by
view records to demonstrate
they determine whether the
y implemented and
iew records)
audit programme(s) that Documented information of the audit programme and results
ration the quality objectives,
processes, customer
s impacting the organization
previous audits? Where are
and scope for each audit?
ate that selection of auditors
f audits are objective and
auditors don’t audit their
re audit results reported to
ment? Can you demonstrate
rrection and corrective actions
undue delay? Can you show
information of the audit
he audit results?
ency that top management

ization's QMS? How is the
able, adequate and effective?
Page 27
9.3.1q2 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
The management review shall be planned and carried nonconformities and corrective actions;
out taking into consideration: a) the status of actions monitor and measurement of results; audit
from previous management reviews; b) changes in results; customer satisfaction; issues
external and internal issues that are relevant to the concerning external providers; issues
quality management system including its strategic concerning other relevant parties; adequacy of
direction; c) information on the quality performance, resources and effectiveness of QMS; process
including trends and indicators for: 1) nonconformities performance; conformity of products and
and corrective actions; 2) monitoring and services; actions taken to address risks and
measurement results; 3) audit results; 4) customer opportunities and their effectiveness; new
satisfaction; 5) issues concerning external providers potential opportunities for continual
and other relevant interested parties; 6) adequacy of improvement.
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.
9.3.2
9.3.2q1
The outputs of the management review shall include
Show me that management reviews include
decisions and actions related to: a) continual
decisions and actions relating to: Continual
improvement opportunities; b) any need for changes to
improvement opportunities; The need for
the quality management system, including resource
changes to the QMS including resource needs.
needs.
9.3.2q2
The organization shall retain documented information Show me what documented information you
as evidence of the results of management reviews. have as evidence of management reviews.
10 Improvement
10.1 General
10.1q1 The organization shall determine and select
opportunities for improvement and implement How do you determine and select opportunities
necessary actions to meet customer requirements and for improvement? What necessary actions have
enhance customer satisfaction. you implemented so that you have met
customer requirements and enhanced
customer satisfaction?
10.1q2
This shall include, as appropriate: a) improving
Show me how you have: Improved processes to
processes to prevent nonconformities; b) improving
prevent nonconformities; Improved products
products and services to meet known and predicted
and services to meet known and predicted
requirements; c) improving quality management
requirements; Improved QMS results.
system results.
ion Audit Evidence
rmation are reviewed in
ews? These must include:
previous reviews; changes to
ssues relevant to the QMS;
strategy; KPIs for
nd corrective actions;
urement of results; audit
satisfaction; issues
al providers; issues
relevant parties; adequacy of
ectiveness of QMS; process
formity of products and
taken to address risks and
their effectiveness; new
nities for continual
nagement reviews include

ons relating to: Continual
ortunities; The need for
MS including resource needs.
Documented information of management reviews.

cumented information you
of management reviews.
mine and select opportunities

What necessary actions have
so that you have met
ments and enhanced
tion?
have: Improved processes to
rmities; Improved products
eet known and predicted
proved QMS results.
Page 28
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
10.2.1
10.2.1q 1
When a nonconformity occurs, including those arising

from complaints, the organization shall: a) react to the When nonconformities occur, show me how;
nonconformity, and as applicable: 1) take action to You react; Take action to control and correct it;
control and correct it; 2) deal with the consequences; Deal with the consequences; Evaluate the need
b) evaluate the need for action to eliminate the for action to eliminate the cause so that it does
cause(s) of the nonconformity, in order that it does not not recur or occur elsewhere by: Reviewing the
recur or occur elsewhere, by: 1) reviewing the nonconformity; Determining the cause of the
nonconformity; 2) determining the causes of the nonconformity; Determining if similar
nonconformity; 3) determining if similar nonconformities exist or could potentially
nonconformities exist, or could potentially occur; c) occur; Actions needed are implemented;
implement any action needed; d) review the Review the effectiveness of corrective actions
effectiveness of any corrective action taken; e) make taken, if any; Make necessary changes to the
changes to the quality management system, if QMS.
necessary.
10.2.1q 2 Corrective actions shall be appropriate to the effects of

Show me how correction actions were
the nonconformities encountered.
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
10.2.2q 1
The organization shall retain documented information What documented information can you show
as evidence of: a) the nature of the nonconformities me as evidence of: The nature of the
and any subsequent actions taken; b) the results of nonconformities and subsequent actions taken;
any corrective action. The results of any corrective action.
10.3 Continual improvement

10.3q1
The organization shall continually improve the Demonstrate that you continually improve the
suitability, adequacy, and effectiveness of the quality suitability, adequacy and effectiveness of the
management system. QMS.
10.3q2 The organization shall consider the outputs of analysis

and evaluation, and the outputs from management Demonstrate that outputs of analysis and
review, to confirm if there are areas of evaluation and the outputs from management
underperformance or opportunities that shall be review are considered to confirm if there are
addressed as part of continual improvement. areas of underperformance or opportunities
that shall be addressed as part of continual
improvement.
ion Audit Evidence
(e.g. continual improvement), by

.g. transformation).
ities occur, show me how;

ction to control and correct it;
sequences; Evaluate the need
nate the cause so that it does
elsewhere by: Reviewing the
etermining the cause of the
etermining if similar
xist or could potentially
eded are implemented;
veness of corrective actions
ke necessary changes to the
rection actions were

effects of the
ncountered.
rmity. NOTE 2 Corrective action
Documented information of the nature of nonconformities,

ed information can you show subsequent actions and results of corrective action.
: The nature of the
nd subsequent actions taken;
corrective action.
you continually improve the

acy and effectiveness of the
outputs of analysis and

e outputs from management
ered to confirm if there are
rformance or opportunities
essed as part of continual
Page 29
10.3q3
Where applicable, the organization shall select and What applicable tools and methodologies for
utilise applicable tools and methodologies for investigation of the causes of
investigation of the causes of underperformance and underperformance and to support continual
for supporting continual improvement. improvement are selected?
ISO 9001:2008 to ISO/DIS 9001

Correlation Matrix
ISO 9001:2008 ISO/DIS 9001
4 Quality management system 4 Quality management system
4.1 General requirements 4.4 Quality management system and its
4.2 Documentation requirements 7.5 Documented information
4.2.1 General 7.5.1 General

4.2.2 Quality manual
4.3 Determining the scope of the quality

system 7.5.1 General 4.4 Quality mana
and its processes
4.2.3 Control of documents

7.5.2 Creating and updating 7.5.3 Contro
Information
4.2.4 Control of records

7.5.2 Creating and updating 7.5.3 Contro
Information
5 Management responsibility 5 Leadership

5.1 Management commitment
5.1 Leadership and commitment 5.1.1 L
commitment for the quality managemen
5.2 Customer focus 5.1.2 Customer focus
5.3 Quality policy 5.2 Quality policy
5.4 Planning 6 Planning for the quality managem
5.4.1 Quality objectives 6.2 Quality objectives and planning to ac

ion Audit Evidence
ools and methodologies for

he causes of
e and to support continual
selected?
008 to ISO/DIS 9001

rrelation Matrix
ISO/DIS 9001
ty management system
management system and its processes
nted information
ning the scope of the quality management

General 4.4 Quality management system
sses
g and updating 7.5.3 Control of documented
g and updating 7.5.3 Control of documented
ership
hip and commitment 5.1.1 Leadership and

for the quality management system
mer focus
policy
ing for the quality management system
objectives and planning to achieve them

Page 30
5.4.2 Quality management system planning 6 Planning for the quality managem
6.1 Actions to address risks and opportun

6.3 Planning of changes
5.5 Responsibility, authority and communication 5 Leadership

5.5.1 Responsibility and authority
5.3 Organizational roles, responsibilities a
5.5.2 Management representative

Title removed 5.3 Organizational roles, r
authorities
5.5.3 Internal communication 7.4 Communication
5.6 Management review 9.3 Management review
5.6.1 General 9.3.1 Management review
5.6.2 Review input 9.3.1 Management review
5.6.3 Review output 9.3.2 Management review
6 Resource management 7.1 Resources

6.1 Provision of resources
7.1.1 General 7.1.2 People
6.2 Human resources

Title removed
6.2.1 General 7.2 Competence

6.2.2 Competence, training and awareness
7.2 Competence 7.3 Awareness
6.3 Infrastructure 7.1.3 Infrastructure
6.4 Work environment 7.1.4 Environment for the operation of pro
7 Product realization 8 Operation
7.1 Planning of product realization 8.1 Operational planning and control

7.2 Customer-related processes
8.2 Determination of requirements for pr
services
8.2.2 Determination of requirements relat

7.2.1 Determination of requirements related to the product
services
ing for the quality management system
o address risks and opportunities

of changes
ership
tional roles, responsibilities and authorities
5.3 Organizational roles, responsibilities and
ication
ment review
ement review
ement review
ement review
es
l 7.1.2 People
Title removed 7.2 Competence
ence
ence 7.3 Awareness
ucture
ment for the operation of processes
ation
nal planning and control
nation of requirements for products and
ination of requirements related to products and

Page 31
7.2.2 Review of requirements related to the product
8.2.3 Review of requirements related to th
services
7.2.3 Customer communication 8.2.1 Customer communication
7.3 Design and development 8.5 Production and service provision

7.3.1 Design and development planning
8.3 Design and development of products
General 8.3.2 Design and development p
7.3.2 Design and development inputs 8.3.3 Design and development Inputs
7.3.3 Design and development outputs 8.3.5 Design and development outputs
7.3.4 Design and development review 8.3.4 Design and development controls
7.3.5 Design and development verification 8.3.4 Design and development controls
7.3.6 Design and development validation 8.3.4 Design and development controls
7.3.7 Control of design and development changes 8.3.6 Design and development changes
7.4 Purchasing
8.4 Control of externally provided produc
7.4.1 Purchasing process

8.4.1 General 8.4.2 Type and extent of c
provision
7.4.2 Purchasing information 8.4.3 Information for external providers
7.4.3 Verification of purchased product 8.6 Release of products and services
7.5 Production and service provision 8.5 Production and service provision
7.5.1 Control of production and service provision
8.5.1 Control of production and service pr
delivery activities
8.5.1 Control of production and service pr

7.5.2 Validation of processes for production and service
provision
7.5.3 Identification and traceability 8.5.2 Identification and traceability

7.5.4 Customer property
8.5.3 Property belonging to customers or
7.5.5 Preservation of product 8.5.4 Preservation
7.6 Control of monitoring and measuring equipment 7.1.5 Monitoring and measuring resources
of requirements related to the products and
er communication
on and service provision
nd development of products and services 8.3.1

Design and development planning
and development Inputs
and development outputs
and development controls
and development changes
f externally provided products and services
8.4.2 Type and extent of control of external
tion for external providers
of products and services
of production and service provision 8.5.5 Post-

ties
of production and service provision
cation and traceability
y belonging to customers or external providers
ation
ing and measuring resources

Page 32
8.0 Measurement, analysis and improvement
9.1 Monitoring, measurement, analysis a
8.1 General 9.1.1 General
8.2 Monitoring and measurement 9.1 Monitoring, measurement, analysis a
8.2.1 Customer satisfaction 9.1.2 Customer satisfaction
8.2.2 Internal audit 9.2 Internal audit
8.2.3 Monitoring and measurement of processes 9.1.1 General
8.2.4 Monitoring and measurement of product 8.6 Release of products and services
8.3 Control of nonconforming product
8.7 Control of nonconforming process ou
services
8.4 Analysis of data 9.1.3 Analysis and evaluation
8.5 Improvement 10 Improvement

8.5.1 Continual improvement
10.1 General 10.3 Continual Improvem
8.5.2 Corrective action 10.2 Nonconformity and corrective action

8.5.3 Preventive action
Clause removed 6.1 Actions to addres
opportunities (see 6.1.1, 6.1.2)
ng, measurement, analysis and evaluation
ng, measurement, analysis and evaluation
mer satisfaction
audit
of products and services
of nonconforming process outputs, products and
s and evaluation
ement
l 10.3 Continual Improvement
formity and corrective action
oved 6.1 Actions to address risks and

es (see 6.1.1, 6.1.2)
Page 33
ISO/DIS 9001 to ISO 9001:2008
Correlation Matrix
ISO/DIS 9001 ISO 9001:2008
4 Context of the organization 1.0 Scope
4.1 Understanding the organization and its context 1.1 General

1.1 General
4.2 Understanding the needs and expectations of interested
parties
4.3 Determining the scope of the quality management

1.2 Application 4.2.2 Quality manual
system
4.4 Quality management system and its processes
Quality management system 4.1 Genera
5 Leadership 5 Management responsibility
5.1 Leadership and commitment 5.1 Management commitment

5.1 Management commitment
5.1.1 Leadership and commitment for the quality
management system
5.1.2 Customer focus 5.2 Customer focus
5.2; 5.2.1 & 5.2.2 Quality policy 5.3 Quality policy
5.5.1 Responsibility and authority 5.5.2 M

5.3 Organizational roles, responsibilities and authorities
representative
6 Planning for the quality management system 5.4.2 Quality management system planni
6.1 Actions to address risks and opportunities
5.4.2 Quality management system planni
Preventive action
6.2 Quality objectives and planning to achieve them 5.4.1 Quality objectives
6.3 Planning of changes 5.4.2 Quality management system planni
7 Support 6 Resource management
7.1 Resources 6 Resource management
7.1.1 General 6.1 Provision of resources
7.1.2 People 6.1 Provision of resources
7.1.3 Infrastructure 6.3 Infrastructure

001 to ISO 9001:2008
rrelation Matrix
ISO 9001:2008
on 4.2.2 Quality manual
gement system 4.1 General requirements
gement responsibility
ment commitment
ment commitment
r focus
policy
sibility and authority 5.5.2 Management

e
management system planning
management system planning 8.5.3

tion
objectives
management system planning
urce management
urce management
n of resources
n of resources
cture
Page 34
7.1.4 Environment for the operation of processes 6.4 Work environment
7.1.5 Monitoring and measuring resources 7.6 Control of monitoring and measuring
7.1.6 Organizational knowledge New

7.2 Competence
6.2.1 General 6.2.2 Competence, trainin
7.3 Awareness 6.2.2 Competence, training and awarenes
7.4 Communication 5.5.3 Internal communication
7.5 Documented information 4.2 Documentation requirements
7.5.1 General 4.2.1 General

7.5.2 Creating and updating
4.2.3 Control of documents 4.2.4 Contro
7.5.3 Control of documented Information

4.2.3 Control of documents 4.2.4 Contro
8 Operation 7 Product realization
8.1 Operational planning and control 7.1 Planning of product realization

7.2 Customer-related processes
8.2 Determination of requirements for products and services
8.2.1 Customer communication 7.2.3 Customer communication
8.2.2 Determination of requirements related to products and

7.2.1 Determination of requirements relat
services
7.2.2 Review of requirements related to th
8.2.3 Review of requirements related to the products and
services
8.3 Design and development of products and services 7.3 Design and development
8.3.1 General New
8.3.2 Design and development planning 7.3.1 Design and development planning
8.3.3 Design and development Inputs 7.3.2 Design and development inputs
8.3.4 Design and development controls
7.3.4 Design and development review 7.3
development verification 7.3.6 Design an
validation
8.3.5 Design and development outputs 7.3.3 Design and development outputs
8.3.6 Design and development changes 7.3.7 Control of design and development
vironment
of monitoring and measuring equipment
l 6.2.2 Competence, training and awareness
tence, training and awareness
communication
ntation requirements
of documents 4.2.4 Control of records
of documents 4.2.4 Control of records
ct realization
of product realization
r-related processes
er communication
ination of requirements related to the product
of requirements related to the product
nd development
and development planning
and development inputs
and development review 7.3.5 Design and

verification 7.3.6 Design and development
and development outputs
of design and development changes

Page 35
7.4.1 Purchasing process
8.4 Control of externally provided products and services
8.4.1 General 7.4.1 Purchasing process

8.4.2 Type and extent of control of external provision
7.4.1 Purchasing process 7.4.3 Verificatio
product
8.4.3 Information for external providers 7.4.2 Purchasing information
8.5 Production and service provision 7.5 Production and service provision
8.5.1 Control of production and service provision 7.5.1 Control of production and service pr
8.5.2 Identification and traceability 7.5.3 Identification and traceability

7.5.4 Customer property
8.5.3 Property belonging to customers or external providers
8.5.4 Preservation 7.5.5 Preservation of product
8.5.5 Post-delivery activities 7.5.1 Control of production and service pr
8.5.6 Control of changes 7.3.7 Control of design and development

8.6 Release of products and services
8.2.4 Monitoring and measurement of pro
Verification of purchased product
8.3 Control of nonconforming product
8.7 Control of nonconforming process outputs, products and
services
9 Performance evaluation New

9.1 Monitoring, measurement, analysis and evaluation 8 Measurement, analysis and improve
9.1.1 General 8.1 General
9.1.2 Customer satisfaction 8.2.1 Customer satisfaction
9.1.3 Analysis and evaluation 8.4 Analysis of data
9.2 Internal audit 8.2.2 Internal audit
9.3 Management review 5.6 Management review
10 Improvement 8.5 Improvement
10.1 General 8.5.1 Continual improvement

10.2 Nonconformity and corrective action
8.3 Control of nonconforming product 8.5
action
10.3 Continual Improvement 8.5.1 Continual improvement
sing process
sing process
sing process 7.4.3 Verification of purchased
sing information
cation and traceability

er property
ation of product
of design and development changes
ing and measurement of processes 7.4.3

purchased product
of nonconforming product
ement, analysis and improvement
er satisfaction
s of data
al audit
ement review
ement
al improvement
of nonconforming product 8.5.2 Corrective

al improvement
Page 36
Page 37

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Q# ISO 9001:2015 Clause Audit Question

4 Context of the Organization

4.1 Understanding the organization and its context

4.1q2 How do you monitor and review information

4.2 Understanding the needs and expectations of interested parties

4.3 Determining the scope of the quality management system

nization determined external

or and review information

arising from legal, technological,

r potential impact been

or and review the information

ndaries and applicability of

4.3q3 Where a requirement of this International Standard

4.3q4 If any requirement(s) of this International Standard

4.3q5 The scope shall be available and be maintained as

4.4 Quality management system and its processes

ation of the International

Scope required as documented information.

been established? Show me

5.1 Leadership and commitment

5.1.1 Leadership and commitment for the quality management system

d information exists to Documented information to support the operation of processes.

5.1.2 Customer focus

ly to mean those activities that

5.2 Quality policy

5.3 Organizational roles, responsibility and authorities

agement establish, review

Quality Policy as document information

agement ensure that

6 Planning for the quality management system

6.1 Actions to address risks and opportunities

6.1.2q2 Actions taken to address risks and opportunities shall

al and external issues and

ntended results; Prevent or

anned to address risks and

ken to address risks and

6.2 Quality objectives and planning to achieve them

Where are the quality objectives and are these

6.3 Planning of changes

mine that personnel with

Documented information on quality objectives

lity objectives and are these

nization determine what will

resources are determined for

7.1.4 Environment for the operation of processes

7.1.5 Monitoring and measuring resources

7.1.5q2 How do you ensure that resources provided are

7.1.5q3 Show me the documented information

mine, provide and maintain

ification to, and agreement

mine, provide and maintain

logical, environmental and other

rces determined for ensuring

e that resources provided are

umented information Documented information of fitness for purpose of monitoring &

7.1.5q5 How do you determine the validity of previous

7.1.6 Organizational knowledge

7.1.6q2 This knowledge shall be maintained, and made

mine the validity of previous