Checklist ISO 9001-2015

Internal Quality Management System Audit Checklist (ISO9001:2015)
Q# ISO 9001:2015 Clause Audit Question Audit Evidence

4 Context of the Organization
4.1 Understanding the organization and its context
4.1q1 The organization shall determine external and How has the organization determined
internal issues that are relevant to its purpose and external and internal issues relevant to its
its strategic direction and that affect its ability to purpose and strategic direction?
achieve the intended result(s) of its quality How do these affect the ability to achieve
management system. the intended result of the QMS?
4.1q2 The organization shall monitor and review the How do you monitor and review information
information about these external and internal about these internal and external issues?
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 parties are relevant to the QMS?
products and services that meet customer and How have you determined what
applicable statutory and regulatory requirements, requirements those parties have that are
the organization shall determine: relevant to the QMS?
a) the interested parties that are relevant to the How has impact or potential impact been
quality management system; determined?
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 about these interested parties and information about interested parties and
their relevant requirements. their relevant requirements?
4.3 Determining the scope of the quality management system

4.3q1 The organization shall determine the boundaries How have the boundaries and applicability
and applicability of the quality management of the QMS been used to establish the
system to establish its scope. scope of the organization?
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4.3q2 When determining this scope, the organization How have:
shall consider: The external and internal issues;
a) the external and internal issues referred to in The requirements of relevant interested
4.1; parties and;
b) the requirements of relevant interested The products and services of the
parties referred to in 4.2; organization been considered when
c) the products and services of the determining the scope of the organization?
organization.
4.3q3 Where a requirement of this International Standard How has the application of the International
within the determined scope can be applied, then Standard within the scope been
it shall be applied by the organization. determined, and how has it been applied
by the organization?
4.3q4 If any requirement(s) of this International Standard How have any requirements of the
cannot be applied, this shall not affect the International Standard been determined as
organization’s ability or responsibility to ensure not applicable? Show me how conformity of
conformity of products and services. products and services are not affected by
this.
4.3q5 The scope shall be available and be maintained as Where is the scope available? Where is it Scope required as documented information.
documented information stating the: maintained as documented information?
- products and services covered by the Does it state what products and services
quality management system; are covered by the QMS?
- justification for any instance where a Does it justify how instances of
requirement of this International requirements of the QMS cannot be
Standard cannot be applied. applied?
4.4 Quality management system and its processes

4.4q1 The organization shall establish, implement, How has the QMS been established? Show
maintain and continually improve a quality me how this is implemented. How is it
management system, including the processes maintained and continually improved? How
needed and their interactions, in accordance with have the processes been determined and
the requirements of this International Standard. how do they interact?
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4.4q2 The organization shall determine the processes How have the processes been determined
needed for the quality management system and for the QMS?
their application throughout the organization and What are the inputs and outputs for those
shall determine: processes?
a) the inputs required and the outputs expected What is the sequence and interaction of the
from these processes; processes?
b) the sequence and interaction of these What are the criteria, methods,
processes; measurement and related performance
c) the criteria, methods, including measurements indicators needed to operate and control
and related performance indicators needed to those processes?
ensure the effective operation, and control of What resources are needed and how are
these processes; these made available?
d) the resources needed and ensure their How are responsibilities and authorities
availability; assigned for those processes?
e) the assignment of the responsibilities and How are risks and opportunities considered
authorities for these processes; and what plans are made to implement
f) the risks and opportunities in accordance with actions to address them?
the requirements of 6.1, and plan and implement What methods are used to monitor,
the appropriate actions to address them; measure and evaluate processes and, if
g) the methods for monitoring, measuring, as needed, what changes are made to
appropriate, and evaluation of processes and, if achieve intended results?
needed, the changes to processes to ensure that How are opportunities to improve the
they achieve intended results; processes and the QMS determined?
h) opportunities for improvement of the processes
and the quality management system.
4.4q3 The organization shall maintain documented What documented information exists to Documented information to support the operation of
information to the extent necessary to support the support the operation of processes? How is processes.
operation of processes and retain documented this documented information retained? How
information to the extent necessary to have is confidence that the processes are being
confidence that the processes are being carried carried out as planned determined?
out as planned.
5 Leadership
5.1 Leadership and commitment
5.1.1 Leadership and commitment for the quality management system
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5.1.1q1 Top management shall demonstrate leadership Show me how top management
and commitment with respect to the quality demonstrates leadership and commitment
management system by: w.r.t. the QMS by taking accountability of
a) taking accountability of the effectiveness of the the effectiveness of the QMS.
quality management system; How is the quality policy and objectives
b) ensuring that the quality policy and quality established for the QMS and how are they
objectives are established for the quality compatible with the strategic direction and
management system and are compatible with the the organizational context?
strategic direction and the context of the How is the quality policy communicated
organization; within the organization? Show me how this
c) ensuring that the quality policy is is understood and applied.
communicated, understood and applied within the How are the requirements of the QMS
organization; integrated into the business processes?
d) ensuring the integration of the quality How do you promote awareness of the
management system requirements into the process approach?
organization’s business processes; How do you ensure that resources needed
e) promoting awareness of the process approach; for the QMS area available?
f) ensuring that the resources needed for the How do you communicate the importance
quality management system are available; of effective quality management?
g) communicating the importance of effective How do you communicate the importance
quality management and of conforming to the of conforming to the QMS requirements?
quality management system requirements; How do you ensure that the QMS achieves
h) ensuring that the quality management system its intended results?
achieves its intended results; How do you engage, direct and support
i) engaging, directing and supporting persons to people to contribute to the effectiveness of
contribute to the effectiveness of the quality the QMS?
management system; How do you promote continual
j) promoting continual improvement; improvement?
k) supporting other relevant management roles to How do you support other relevant
demonstrate their leadership as it applies to their management roles to demonstrate
areas of responsibility. leadership 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
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5.1.2q1 Top management shall demonstrate leadership Show me how top management
and commitment with respect to customer focus demonstrates leadership and commitment
by ensuring that: w.r.t. customer focus ensuring
a) customer requirements and applicable statutory requirements and applicable statutory and
and regulatory requirements are determined and regulatory requirements are determined
met;
b) the risks and opportunities that can affect and met.
conformity of products and services and the ability How are risks and opportunities that can
to enhance customer satisfaction are determined affect conformity of products and services
and addressed; determined?
c) the focus on consistently providing products and How is the ability to enhance customer
services that meet customer and applicable satisfaction determined and addressed?
statutory and regulatory requirements is How is the focus on consistently providing
maintained; products and services that meet customer
d) the focus on enhancing customer satisfaction is and applicable statutory and regulatory
maintained.
requirements maintained?
How is customer satisfaction maintained?
5.2 Quality policy

5.2.1
5.2.1q1 Top management shall establish, review and How does top management establish,
maintain a quality policy that: review and maintain a quality policy?
a) is appropriate to the purpose and context of the How is it determined to be appropriate to
organization; the purpose and context of the
b) provides a framework for setting and reviewing organization?
quality objectives; Does it provide a framework for setting and
c) includes a commitment to satisfy applicable reviewing quality objectives?
requirements; Does it contain a commitment to satisfy
d) includes a commitment to continual improvement applicable requirements?
of the quality management system. Does it include a commitment to continual
improvement of the QMS?
5.2.2
5.2.2q1 The quality policy shall: Where is the quality policy available as Quality Policy as document information
a) be available as documented information; documented information?
b) be communicated, understood and applied How is it communicated?
within the organization; Show me how it is understood and applied
c) be available to relevant interested parties, within the organization.
as appropriate. How have you made it available to relevant
interested parties?
5.3 Organizational roles, responsibility and authorities

5.3q1 Top management shall ensure that the How does top management ensure that
responsibilities and authorities for relevant roles responsibilities and authorities for relevant
are assigned, communicated and understood roles are assigned, communicated and
within the organization. understood within the organization?
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5.3q2 Top management shall assign the responsibility How does top management assign the
and authority for: responsibility and authority for:
a) ensuring that the quality management system Ensuring that the QMS conforms to the
conforms to the requirements of this International International standard?
Standard; Ensuring processes are delivering their
b) ensuring that the processes are delivering their intended outputs?
intended outputs; How is the performance of the QMS,
c) reporting on the performance of the quality opportunities for improvement and the
management system, on opportunities for need for change or innovation reported to
improvement and on the need for change or top management?
innovation, and especially for reporting to top How is customer focus promoted within the
management; organization?
d) ensuring the promotion of customer focus How is the integrity of the QMS maintained
throughout the organization; when changes to the QMS are planned and
e) ensuring that the integrity of the quality implemented?
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 When planning for the quality management How are the internal and external issues
system, the organization shall consider the issues and interested parties considered when
referred to in 4.1 and the requirements referred to planning for the QMS?
in 4.2 and determine the risks and opportunities How are risks and opportunities determined
that and addressed so that the QMS can::
need to be addressed to: a) achieve its intended results;
a) give assurance that the quality management b) Prevent or reduce undesired effects;
system can achieve its intended result(s); c) Achieve continual improvement?
b) prevent, or reduce, undesired effects;
c) achieve continual improvement.
6.1.2
6.1.2q1 The organization shall plan: How are actions planned to address risks
a) actions to address these risks and and opportunities?
opportunities; How are actions integrated and
b) how to: implemented into the QMS processes?
1) integrate and implement the actions into its How do you evaluate the effectiveness of
quality management system processes (see 4.4); the actions?
2) evaluate the effectiveness of these actions.
6.1.2q2 Actions taken to address risks and opportunities How are actions taken to address risks and
shall be proportionate to the potential impact on opportunities determined as being
the conformity of products and services. appropriate to the potential impact on the
conformity of products and services?
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6.2.2.1 Product design skills
6.2.2.1q The organization shall ensure that personnel with How do you determine that personnel with
1 product design responsibility are competent to product design responsibility are competent
achieve design requirements and are skilled in to achieve design requirements? How do
applicable tools and techniques. you determine skills required in applicable
Applicable tools and techniques shall be identified tools and techniques? How do you identify
by the organization. applicable tools and techniques?
NOTE Options to address risks and opportunities can include: avoiding risk, taking risk in order to pursue an
opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk, or
retaining risk by informed decision.
6.2 Quality objectives and planning to achieve them

6.2.1
6.2.1q1 The organization shall establish quality objectives Where are the quality objectives and are Documented information on quality objectives
at relevant functions, levels and processes. these at all relevant functions, levels and
The quality objectives shall: processes?
a) be consistent with the quality policy, Are they consistent with the quality policy?
b) be measurable; Are they measureable?
c) take into account applicable requirements; Do they consider applicable requirements?
d) be relevant to conformity of products and Are they relevant to the conformity of
services and the enhancement of customer products and services and do they
satisfaction; enhance customer satisfaction?
e) be monitored; Are they monitored? How? How often?
f) be communicated; How are they communicated?
g) be updated as appropriate. How are they updated?
The organization shall retain documented Where is the documented information on
information on the quality objectives. the quality objectives?
6.2.2
6.2.2q1 When planning how to achieve its quality How does the organization determine what
objectives, the organization shall determine: will be done, with what resources, when
a) what will be done; completed and how will results be
b) what resources will be required; evaluated for quality objectives?
c) who will be responsible;
d) when it will be completed;
e) how the results will be evaluated.
6.3 Planning of changes
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6.3q1 Where the organization determines the need for How are changes to the QMS planned
change to the quality management system (see systematically?
4.4) the change shall be carried out in a planned Demonstrate the purpose and potential
and systematic manner. consequences of changes;
The organization shall consider: Demonstrate the integrity of the QMS;
a) the purpose of the change and any of its Demonstrate how resources are made
potential consequences; available?
b) the integrity of the quality management system; Demonstrate how responsibility and
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
resources needed for the establishment, determined for the establishment,
implementation, maintenance and continual implementation, maintenance and continual
improvement of the quality management system. improvement of the QMS.
The organization shall consider: Show me how the capabilities and
a) the capabilities of, and constraints on, existing constraints on internal resources are
internal resources; considered.
b) what needs to be obtained from external Show me how needs from external
providers. providers are considered.
7.1.2 People
7.1.2q1 To ensure that the organization can consistently How do you provide persons necessary to
meet customer and applicable statutory and consistently meet customer, applicable
regulatory requirements, the organization shall statutory and regulatory requirements for
provide the persons necessary for the effective the QMS including the necessary
operation of the quality management system, processes?
including the processes needed.
7.1.3 Infrastructure
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7.1.3q1 The organization shall determine, provide and How do you determine, provide and
maintain the infrastructure for the operation of its maintain the infrastructure for the operation
processes to achieve conformity of products and of processes to achieve products and
services. service conformity?
NOTE 1 Any product realization change affecting customer requirements requires notification to, and
agreement from, the customer.
7.1.4 Environment for the operation of processes

7.1.4q1 The organization shall determine, provide and How do you determine, provide and
maintain the environment necessary for the maintain the environment for the operation
operation of its processes and to achieve of processes to achieve products and
conformity of products and services. service conformity?
NOTE Environment for the operation of processes can include physical, social, psychological, environmental
and other factors (such as temperature, humidity, ergonomics and cleanliness).
7.1.5 Monitoring and measuring resources

7.1.5q1 Where monitoring or measuring is used for How are the resources determined for
evidence of conformity of products and services to ensuring valid and reliable monitoring and
specified requirements the organization shall measuring results, where used?
determine the resources needed to ensure valid
and reliable monitoring and measuring results.
7.1.5q2 The organization shall ensure that the resources How do you ensure that resources
provided: provided are suitable for the specific
a) are suitable for the specific type of monitoring monitoring and measurement activities and
and measurement activities being undertaken; are maintained to ensure continued fitness
b) are maintained to ensure their continued fitness for purpose?
for their purpose.
7.1.5q3 The organization shall retain appropriate Show me the documented information Documented information of fitness for purpose of monitoring
documented information as evidence of fitness for which is evidence of fitness for purpose of & measurement resources.
purpose of monitoring and measurement monitoring and measurement resources.
resources.
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7.1.5q4 Where measurement traceability is: a statutory or Where applicable, show me how Documented information for the basis of calibration or
regulatory requirement; a customer or relevant measurement instruments are: verification where no standards exist.
interested party expectation; or considered by the Verified or calibrated at specified intervals
organization to be an essential part of providing against national or international
confidence in the validity of measurement results; measurement standards;
measuring instruments shall be: If there are no standards, show me the
-verified or calibrated at specified intervals or prior documented information which is used as
to use against measurement standards traceable the basis used for calibration or verification.
to international or national measurement Show me how measurement instruments
standards. Where no such standards exist, the are identified to determine their calibration
basis used for calibration or verification shall be status.
retained as documented information; Show me how they are safeguarded from
-identified in order to determine their calibration adjustments.
status; Show me how they are safeguarded from
-safeguarded from adjustments, damage or damage and deterioration.
deterioration that would invalidate the calibration
status and subsequent measurement results.
7.1.5q5 The organization shall determine if the validity of How do you determine the validity of
previous measurement results has been adversely previous measurements if you find an
affected when an instrument is found to be instrument to be defective during
defective during its planned verification or verification or calibration?
calibration, or during its use, and take appropriate What appropriate actions can you take?
corrective action as necessary.
7.1.6 Organizational knowledge

7.1.6q1 The organization shall determine the knowledge How do you determine necessary
necessary for the operation of its processes and to knowledge for the operation of processes?
achieve conformity of products and services. 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
available to the extent necessary. how do you make it available to the extent
necessary?
7.1.6q3 When addressing changing needs and trends, the How do you consider current knowledge
organization shall consider its current knowledge and how do you acquire additional
and determine how to acquire or access the knowledge when addressing changing
necessary additional knowledge. needs and trends?
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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: Show me how: Documented information as evidence of competence where
a) determine the necessary competence of You determine the necessary competence appropriate.
person(s) doing work under its control that affects of people doing work under your control
its quality performance; that affects quality performance;
b) ensure that these persons are competent on the How do you determine competence on the
basis of appropriate education, training, or basis of appropriate education, training or
experience; experience?
c) where applicable, take actions to acquire the How do you take actions to acquire
necessary competence, and evaluate the necessary competence where applicable
effectiveness of the actions taken; and how do you evaluate the effectiveness
d) retain appropriate documented information as of those actions?
evidence of competence. 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 Persons doing work under the organization’s How are people aware of:
control shall be aware of: The quality policy?
a) the quality policy; Relevant quality objectives?
b) relevant quality objectives; Their contribution to the effectiveness of
c) their contribution to the effectiveness of the the QMS?
quality management system, including the benefits The benefits of improved performance?
The implications of not conforming with the
of improved quality performance; QMS requirements?
d) the implications of not conforming with the
quality management system requirements.
7.4 Communication
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7.4q1 The organization shall determine the internal and How do you determine internal and
external communications relevant to the quality external communications relevant to the
management system including: QMS?
a) on what it will communicate; How do you determine:
b) when to communicate; What?
c) with whom to communicate; When?
With Whom?
d) how to communicate. How?
7.5 Documented information

7.5.1 General
7.5.1q1 The organization’s quality management system What documented information do you Documented information required by this standard.
shall include: have as required by this standard? Documented information necessary for the effectiveness of
a) documented information required by this What documented information do you the QMS.
International Standard; have as being necessary for the
b) documented information determined by the effectiveness of your QMS?
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 When creating and updating documented Show me that your documented Documented information (in various media) needs
information the organization shall ensure information contains: identification, description.
appropriate: Identification; Review / approval process?
a) identification and description (e.g. a title, date, Description;
author, or reference number); In what media format?
b) format (e.g. language, software version,
graphics) and media (e.g. paper, electronic); Show me how the documented information
c) review and approval for suitability and is reviewed and approved for suitability and
adequacy. adequacy.
7.5.3 Control of documented information

7.5.3.1
7.5.3.1q Documented information required by the quality Show me how you control documented Control of documented information.
1 management system and by this International information. Suitability and availability for use.
Standard shall be controlled to ensure: Show me how you make it available and How is it protected?
a) it is available and suitable for use, where and suitable for use.
when it is needed; How do you protect your documented
b) it is adequately protected (e.g. from loss of information?
confidentiality, improper use, or loss of integrity).
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7.5.3.2
7.5.3.2q For the control of documented information, the When controlling documented information, Control of documented information.
1 organization shall address the following how do you address: Change control, distribution, access, retrieval, use, storage,
activities, as applicable: Distribution; preservation, legibility, retention and disposition.
a) distribution, access, retrieval and use; Access;
b) storage and preservation, including Retrieval;
preservation of legibility; Use;
c) control of changes (e.g. version control); Storage and preservation;
d) retention and disposition. Legibility;
Control of changes;
Retention and disposition.
7.5.3.2q Documented information of external origin How do you identify as appropriate and Control of external documented information.
2 determined by the organization to be necessary control documented information of
for the planning and operation of the quality external origin which you have determined
management system shall be identified as as necessary for the QMS
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
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8.1q1 The organization shall plan, implement and control How are processes needed to meet Documented information to show processes have been
the processes, as outlined in 4.4, needed to meet requirements for provision of products and carried out as planned and can demonstrate conformity of
requirements for the provision of products and services planned, implemented and products and services.
services and to implement the actions determined controlled?
in 6.1, by: How are requirements for products and
a) determining requirements for the product and services determined?
services; How is criteria for processes and
b) establishing criteria for the processes and for acceptance for products and services
the acceptance of products and services; determined?
c) determining the resources needed to achieve How are resources determined?
conformity to product and service requirements; How is process control implemented?
d) implementing control of the processes in Show me the documented information
accordance with the criteria; that shows confidence in that the
e) retaining documented information to the extent processes have been carried out as
necessary to have confidence that the processes planned and can demonstrate conformity of
have been carried out as planned and to products and services.
demonstrate conformity of products and services
to requirements.
8.1q2 The output of this planning shall be suitable for the How have you determined that the output
organization's operations. from the planning process is suitable for
your operations?
8.1q3 The organization shall control planned changes How do you control planned changes? How
and review the consequences of unintended do you review the consequences of
changes, taking action to mitigate any adverse unintended changes? What action is taken
effects, as necessary. to mitigate any 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 with customers in relation to: communicating with customers? How do
a) information relating to products and services; you communicate information relating to:
b) enquiries, contracts or order handling, including Products;
changes; Services;
c) obtaining customer views and perceptions, Enquiries;
including customer complaints; Contracts;
d) the handling or treatment of customer property, Order handling;
if applicable; Customer views, perceptions and
e) specific requirements for contingency actions, complaints;
when relevant. Handling or treatment of customer
property;
Specific requirements for contingency
actions?
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8.2.2 Determination of requirements related to products and services
8.2.2q1 The organization shall establish, implement and What is your process to determine the
maintain a process to determine the requirements requirements for products and services to
for the products and services to be offered to be offered to potential customers? How do
potential customers. you establish, implement and maintain this
process?
8.2.2q2 The organization shall ensure that: How do you define product and service
a) product and service requirements (including requirements including statutory and
those considered necessary by the organization), regulatory requirements?
and applicable statutory and regulatory How do you ensure that you have the
requirements, are defined; ability to meet the defined requirements
b) it has the ability to meet the defined and substantiate any claims for your
requirements and substantiate the claims for the products and services?
products and services it offers.
8.2.3 Review of requirements related to products and services

8.2.3q1 The organization shall review, as applicable: a) How do you review:
requirements specified by the customer, Customer requirements for delivery and
including the requirements for delivery and post- post-delivery?
delivery activities; Requirements necessary for customers’
b) requirements not stated by the customer, but specified or intended use, where known;
necessary for the customers' specified or intended
use, when known; Additional statutory and regulatory
c) additional statutory and regulatory requirements requirements applicable to products and
applicable to the products and services; services;
d) contract or order requirements differing from Any other contract or order requirements.
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 Show me that the review is conducted prior
organization’s commitment to supply products and to your commitment to supply products and
services to the customer and shall ensure contract services to your customers. How do you
or order requirements differing from those resolve contract or order requirements
previously defined are resolved. which differ from those previously defined?
8.2.3q3 Where the customer does not provide a How do you confirm customer
documented statement of their requirements, the requirements where the customer does not
customer requirements shall be confirmed by the provide a documented statement?
organization before acceptance.
8.2.3q4 Documented information describing the results of Show me where you retain documented Documented information of reviews describing new or
the review, including any new or changed information which describes results of the changed requirements to products and services.
requirements for the products and services, shall review including any new or changed
be retained. requirements.
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8.2.3q5 Where requirements for products and services are Show me the documented information Documented information of amended reviews and how
changed, the organization shall ensure that containing changes to products and relevant personnel are made aware of those changes.
relevant documented information is amended and services. How do you ensure that relevant
that relevant personnel are made aware of the personnel are made aware of those
changed requirements. changes?
8.3 Design and development of products and services

8.3.1 General
8.3.1q1 Where the detailed requirements of the How do you establish, implement and
organization’s products and services are not maintain a design and development
already established or not defined by the customer process (where detailed requirements of
or by other interested parties, such that they are your products and services are not already
adequate for subsequent production or service established or defined by the customer or
provision, the organization shall establish,
implement and maintain a design and other parties).
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
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8.3.2q1 In determining the stages and controls for design When determining the stages and control Documented information that confirms design &
and development, the organization shall consider: for design and development, show me how development requirements have been met.
a) the nature, duration and complexity of the you consider:
design and development activities; The nature, duration and complexity of the
b) requirements that specify particular process activities;
stages, including applicable design and Requirements that specify particular
development reviews; process stages including applicable
c) the required design and development reviews;
verification and validation; Required verification and validation;
d) the responsibilities and authorities involved in Responsibilities and authorities;
the design and development process; How interfaces are controlled between
e) the need to control interfaces between individuals and parties;
individuals and parties involved in the design and The need for involvement of customer and
development process; user groups.
f) the need for involvement of customer and user Show me documented information that
groups in the design and development process; confirms design and development
g) the necessary documented information to requirements have been met.
confirm that design and development
requirements have been met.
8.3.3 Design and development inputs
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8.3.3q1 The organization shall determine: Can you show me how you determine:
a) requirements essential for the specific type of Requirements essential for the type of
products and services being designed and products and services being designed and
developed, including, as applicable, functional and developed, including as applicable:
performance requirements; Functional & performance requirements;
b) applicable statutory and regulatory Statutory and regulatory requirements;
requirements; Standards or codes of practice where there
c) standards or codes of practice that the is a commitment to implement;
organization has committed to implement; Internal and external resources needed for
d) internal and external resource needs for the the design and development of products
design and development of products and services; and services;
e) the potential consequences of failure due to the Potential consequences of failure;
nature of the products and services; Level of control expected of the design and
f) the level of control expected of the design and development process by customers and
development process by customers and other other relevant parties.
relevant interested parties.
8.3.3q2 Inputs shall be adequate for design and How do you determine that inputs are
development purposes, complete, and adequate, complete and unambiguous for
unambiguous. Conflicts among inputs shall be design and development? How do you
resolved. resolve conflicts among inputs?
8.3.4 Design and development controls

8.3.4q1 The controls applied to the design and How do controls that are applied to the
development process shall ensure that: design and development process ensure:
a) the results to be achieved by the design and Results achieved by design and
development activities are clearly defined; development activities are clearly defined?
b) design and development reviews are conducted Design and development reviews are
as planned; conducted as planned?
c) verification is conducted to ensure that the Outputs meet the input requirements by
design and development outputs have met the verification/
design and development input requirements; Validation is conducted to ensure that the
d) validation is conducted to ensure that the resulting products and services are capable
resulting products and services are capable of of meeting the requirements for the
meeting the requirements for the specified specified application or intended use (when
application or intended use (when known). known)?
8.3.5 Design and development outputs
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8.3.5q1 The organization shall ensure that design and How do you ensure that design and
development outputs: development outputs:
a) meet the input requirements for design and Meet the input requirements for design and
development; development?
b) are adequate for the subsequent processes for Are adequate for the subsequent
the provision of products and services; processes for the provision of products and
c) include or reference monitoring and measuring services?
requirements, and acceptance criteria, as Include or reference monitoring and
applicable; measuring requirements, and acceptance
d) ensure products to be produced, or services to criteria, as applicable?
be provided, are fit for intended purpose and their Ensure products to be produced, or
safe and proper use. 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 Documented information from the design and development
information resulting from the design and which results from the design and process.
development process. development process.
8.3.6 Design and development changes

8.3.6q1 The organization shall review, control and identify How do you review, control and identify
changes made to design inputs and design changes made to the design inputs and
outputs during the design and development of outputs during design and development of
products and services or subsequently, to the products and services ensuring no impact
extent that there is no adverse impact on on conformity to requirements?
conformity to requirements.
8.3.6q2 Documented information on design and Show me the documented information for Documented information for design and development
development changes shall be retained. design and development changes. changes.
8.4 Control of externally provided products and services
8.4.1 General
8.4.1q1 The organization shall ensure that externally How do you ensure externally provided
provided processes, products, and services processes, products and services conform
conform to specified requirements. to specified requirements?
8.4.1q2 The organization shall apply the specified Show me how you apply specified
requirements for the control of externally provided requirements for the control of externally
products and services when: provided products and services when:
a) products and services are provided by external Products and services are provided by
providers for incorporation into the organization’s external providers for incorporation into
own products and services; your own products and services;
b) products and services are provided directly to You provide products and services directly
the customer(s) by external providers on behalf of to customers by external providers on your
the organization; behalf;
c) 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
organization to outsource a process or function. to outsource a process or function.
Page 19
8.4.1q3 The organization shall establish and apply criteria Show me how you establish and apply
for the evaluation, selection, monitoring of criteria for evaluation, selection, monitoring
performance and re-evaluation of external of performance and re-evaluation of
providers based on their ability to provide external providers. How do you assess
processes or products and services in accordance their ability to provide processes or
with specified requirements. products and services in accordance with
specified requirements?
8.4.1q4 The organization shall retain appropriate What documented information do you Documented information of external providers’ performance.
documented information of the results of the have of the results of evaluations,
evaluations, monitoring of the performance and re- monitoring of performance and re-
evaluations of the external providers. evaluations of external providers?
8.4.2 Type and extent of control of external provision

8.4.2q1 In determining the type and extent of controls to How do you determine the controls applied
be applied to the external provision of processes, to the external provision of processes,
products and services, the organization shall take products and services and take into
into consideration: consideration:
a) the potential impact of the externally provided a) The potential impact of the externally
processes, products and services on the provided processes, products and services
organization’s ability to consistently meet on the ability to consistently meet customer
customer and applicable statutory and regulatory and applicable statutory and regulatory
requirements; requirements?
b) the perceived effectiveness of the controls b) The perceived effectiveness of the
applied by the external provider. controls applied 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 have to ensure externally provided
the externally provided processes, products and processes, products and services do not
services do not adversely affect the organization's adversely affect your ability to consistently
ability to consistently deliver conforming products deliver conforming products and services to
and services to its customers. your customers?
8.4.2q3 Processes or functions of the organization which When processes or functions have been
have been outsourced to an external provider outsourced to external providers, how do
remain within the scope of the organization’s you consider a) and b) in 8.4.1 and how do
quality management system; accordingly, the you define the controls intended to be
organization shall consider a) and b) above and applied to the external provider and to the
define both the controls it intends to apply to the resulting process output?
external provider and those it intends to apply to
the resulting process output.
Page 20
8.4.3 Information for external providers
8.4.3q1 The organization shall communicate to external Show me how you communicate to
providers applicable requirements for the external providers, applicable requirements
following: for:
a) the products and services to be provided or the Products and services to be provided or the
processes to be performed on behalf of the processes to be performed on behalf of the
organization; organization;
b) approval or release of products and services, Approval or release of products and
methods, processes or equipment; services, methods, processes or
c) competence of personnel, including necessary equipment;
qualification; Competence of personnel, including
d) their interactions with the organization's quality necessary qualification;
management system; Their interactions with the organization's
e) the control and monitoring of the external quality management system;
provider’s performance to be applied by the The control and monitoring of the external
organization; provider’s performance to be applied by the
f) verification activities that the organization, or its organization;
customer, intends to perform at the external Verification activities that the organization,
provider’s premises. or its customer, intends to perform at the
external provider’s premises.
8.4.3q2 The organization shall ensure the adequacy of Before you communicate with external
specified requirements prior to their providers, how do you ensure the
communication to the external provider. adequacy of specified requirements?
8.5 Production and service provision

8.5.1 Control of production and service provision
8.5.1q1 The organization shall implement controlled What controlled conditions do you have for
conditions for production and service provision, production and service provision, including
including delivery and post-delivery activities. delivery and post-delivery activities?
Page 21
8.5.1q2 Controlled conditions shall include, as applicable: Can you show me controlled conditions for: Documented information defining characteristics of the
a) the availability of documented information that a) the availability of documented products and services
defines the characteristics of the products and information defining the characteristics of
services; the products and services;
b) the availability of documented information that b) the availability of documented
defines the activities to be performed and the information defining the activities to be
results to be achieved; performed and the results to be achieved;
c) monitoring and measurement activities at c) monitoring and measurement activities
appropriate stages to verify that criteria for control at appropriate stages to verify that criteria
of processes and process outputs, and for control of processes and process
acceptance criteria for products and services, outputs, and acceptance criteria for
have been met. products and services, have been met.
d) the use, and control of suitable infrastructure d) the use, and control of suitable
and process environment; infrastructure and process environment;
e) the availability and use of suitable monitoring e) the availability and use of suitable
and measuring resources; monitoring and measuring resources;
f) the competence and, where applicable, required f) the competence and, where applicable,
qualification of persons; required qualification of persons;
g) the validation, and periodic revalidation, of the g) the validation, and periodic revalidation,
ability to achieve planned results of any process of the ability to achieve planned results of
for production and service provision where the any process for production and service
resulting output cannot be verified by subsequent provision where the resulting output cannot
monitoring or measurement; be verified by subsequent monitoring or
h) the implementation of products and services measurement;
release, delivery and post-delivery activities. 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 What means do you use to identify process
and services, the organization shall use suitable outputs to ensure conformity of products
means to identify process outputs. and services?
8.5.2q2 The organization shall identify the status of How do you identify the status of process
process outputs with respect to monitoring and outputs?
measurement requirements throughout production
and service provision.
8.5.2q3 Where traceability is a requirement, the How do you control the unique Documented information of traceability, where required.
organization shall control the unique identification identification of process outputs, where
of the process outputs, and retain any applicable? What documented
documented information necessary to maintain information do you retain?
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
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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 external provider’s property while under
while it is under the organization's control or being your control?
used by the organization. The organization shall How do you identify, verify, protect and
identify, verify, protect and safeguard the safeguard that property which is provided
customer’s or external provider’s property for use or incorporation into your products
provided for use or incorporation into the products or services?
and services.
8.5.3q2 When property of the customer or external What means do you use to report to the
provider is incorrectly used, lost, damaged or customer or external provider if their
otherwise found to be unsuitable for use, the property is incorrectly used, lost, damaged
organization shall report this to the customer or or found to be unsuitable for use?
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 How do you ensure preservation of process
process outputs during production and service outputs during production and service
provision, to the extent necessary to maintain provision to maintain conformity to product
conformity to 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 How do you meet requirements for post-
requirements for post-delivery activities associated delivery activities associated with products
with the products and services. and services?
8.5.5q2 In determining the extent of post-delivery activities How do you determine:
that are required, the organization shall consider: Risk;
a) the risks associated with the products and Nature, use and intended lifetime;
services; Customer feedback;
b) the nature, use and intended lifetime of the Statutory and Regulatory requirements,
products and services; when determining the extent of post-
c) customer feedback; delivery activities required with products
d) statutory and regulatory requirements. and services?
NOTE Post-delivery activities can include actions under warranty provisions, contractual obligations such as
maintenance services, and supplementary services such as recycling or final disposal.
8.5.6 Control of changes
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8.5.6q1 The organization shall review and control How do you review and control unplanned
unplanned changes essential for production or changes to ensure continuing conformity
service provision to the extent necessary to with specified requirements?
ensure continuing conformity with specified
requirements.
8.5.6q2 The organization shall retain documented What documented information can you Documented information describing results of review of
information describing the results of the review of show me which describes the results of changes, personnel and actions.
changes, the personnel authorizing the change, reviews of changes, the personnel
and any necessary actions. authorizing change and any necessary
actions?
8.6 Release of products and services

8.6q1 The organization shall implement the planned Show me how planned arrangement have
arrangements at appropriate stages to verify that been implemented at appropriate stages to
product and service requirements have been met. verify product and service requirements
Evidence of conformity with the acceptance have been met. Show me what evidence
criteria shall be retained. you retain.
8.6q2 The release of products and services to the Show me how the release of products and Documented information providing traceability, authorizing
customer shall not proceed until the planned services is held until planned arrangements release of products and services.
arrangements for verification of conformity have for verification of conformity have been
been satisfactorily completed, unless otherwise satisfactorily completed, unless approved
approved by a relevant authority and, as by a relevant authority, or the customer if
applicable, by the customer. Documented applicable. Show me documented
information shall provide traceability to the information which shows traceability to 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, How do you identify and control process
products and services that do not conform to outputs, products and services that do not
requirements are identified and controlled to conform to requirements and prevent their
prevent their unintended use or delivery. unintended use or delivery?
8.7q2 The organization shall take appropriate corrective What appropriate corrective actions are
action based on the nature of the nonconformity taken based on the nature of the
and its impact on the conformity of products and nonconformity and its impact on the
services. This applies also to nonconforming conformity of products and services? How
products and services detected after delivery of do you apply this to nonconformity detected
the products or during the provision of the service.
after delivery?
Page 24
8.7q3 As applicable, the organization shall deal with How you deal with nonconforming process
nonconforming process outputs, products and outputs, products and services in terms of:
services in one or more of the following ways: Correction;
a) correction; Segregation, containment, return or
b) segregation, containment, return or suspension suspension of provision of products and
of provision of products and services;
c) informing the customer; services?
d) obtaining authorization for: Informing the customer?
- use “as-is’; Obtaining authorization for use as-is?
- release, continuation or re-provision of the Release, continuation or re-provision of the
products and services; products and service?
- acceptance under concession. Acceptance under concession?
8.7q4 Where nonconforming process outputs, products How do you verify conformance where
and services are corrected, conformity to the process outputs, products and services are
requirements shall be verified. corrected following nonconformance?
8.7q5 The organization shall retain documented What documented information do you Documented information for actions taken following
information of actions taken on nonconforming keep following actions taken to address nonconformance, including concessions and authority
process outputs, products and services, including nonconformities, including any concessions
on any concessions obtained and on the person or granted.
obtained and on the person or authority
authority that made the decision regarding dealing that made the decision regarding dealing
with the nonconformity.
with the nonconformance.
9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
9.1.1q1 The organization shall determine: Show me how you determine:

a) what needs to be monitored and measured; b) What needs to be monitored and
the methods for monitoring, measurement, measured?
analysis and evaluation, as applicable, to ensure Methods for monitoring, measurement,
valid results; analysis and evaluation to ensure valid
c) when the monitoring and measuring shall be results?
performed; When to perform monitoring and
d) when the results from monitoring and measuring?
measurement shall be analysed and evaluated. When results shall be analysed and
evaluated?
9.1.1q2 The organization shall ensure that monitoring and What documented information can you Documented information of monitoring and measurement
measurement activities are implemented in show me that monitoring and measurement activities in accordance with determined requirements.
accordance with the determined requirements and activities have been implemented in
shall retain appropriate documented information accordance with determined requirements?
as
evidence of the results.
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
management system. QMS.
9.1.2 Customer satisfaction

9.1.2q1 The organization shall monitor customer How do you monitor customer perception
perceptions of the degree to which requirements of the degree to which requirements have
have been met. been met?
9.1.2q2 The organization shall obtain information relating How do you obtain information relating to
to customer views and opinions of the organization customer views and opinions of your
and its products and services. products and services?
9.1.2q3 The methods for obtaining and using this What methods for obtaining and using this
information 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
appropriate data and information arising from and information arising from monitoring,
monitoring, measurement and other sources. measurement and other sources.
9.1.3q2 The output of analysis and evaluation shall be Show me how the output of analysis and
used to: evaluation is used to:
a) demonstrate conformity of products and Demonstrate conformity of products and
services to requirements; services to requirements?
b) assess and enhance customer satisfaction; Assess and enhance customer
c) ensure conformity and effectiveness of the satisfaction?
quality management system; Ensure conformity and effectiveness of the
d) demonstrate that planning has been QMS?
successfully implemented; Demonstrate that planning has been
e) assess the performance of processes; successfully implemented?
f) assess the performance of external provider(s); Assess process performance?
g) determine the need or opportunities for Assess performance of external providers?
improvements within the quality management Determine the need or opportunities for
system. improvements within the QMS?
9.1.3q3 The results of analysis and evaluation shall also Show me where the results of analysis and
be used to provide inputs to management review. evaluation are used to provide inputs to
management review.
9.2 Internal audit

9.2.1
Page 26
9.2.1q1 The organization shall conduct internal audits at Are internal audits being conducted at
planned intervals to provide information on planned intervals? Do they determine
whether the quality management system; whether the QMS conforms to the
a) conforms to: requirements of ISO 9001 and to the other
1) the organization’s own requirements requirements established by Organization?
for its quality management system; (Review records to demonstrate
2) the requirements of this International conformance)
Standard; Do they determine whether the QMS is
b) is effectively implemented and maintained. effectively implemented and maintained?
(Review records)
9.2.2
9.2.2q1 The organization shall: Can you show me audit programme(s) that Documented information of the audit programme and results
a) plan, establish, implement and maintain an takes into consideration the quality
audit programme(s) including the frequency, objectives, importance of the processes,
methods, responsibilities, planning requirements customer feedback, changes impacting the
and reporting, which shall take into consideration organization and the results of previous
the quality objectives, the importance of the audits?
processes concerned, customer feedback, Where are the audit criteria and scope for
changes each audit?
impacting on the organization, and the results of Can you demonstrate that selection of
previous audits; auditors and the conduct of audits are
b) define the audit criteria and scope for each objective and impartial and that auditors
audit; don’t audit their own work?
c) select auditors and conduct audits to ensure How are audit results reported to relevant
objectivity and the impartiality of the audit process; management?
d) ensure that the results of the audits are Can you demonstrate that necessary
reported to relevant management; correction and corrective actions are taken
e) take necessary correction and corrective without undue delay?
actions without undue delay; Can you show me documented
f) retain documented information as evidence of information of the audit programme and
the implementation of the audit programme and the audit results?
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 What is the frequency that top
quality management system, at planned intervals, management reviews the organization's
to ensure its continuing suitability, adequacy, and QMS? How is the QMS deemed suitable,
effectiveness. adequate and effective?
Page 27
9.3.1q2 The management review shall be planned and What kinds of information are reviewed in
carried out taking into consideration: management reviews? These must include:
a) the status of actions from previous actions status of previous reviews;
management reviews; changes to internal/external issues relevant
b) changes in external and internal issues that are to the QMS;
relevant to the quality management system issues that affect strategy;
including its strategic direction; KPIs for nonconformities and corrective
c) information on the quality performance, actions;
including trends and indicators for: monitor and measurement of results;
1) nonconformities and corrective actions; audit results;
2) monitoring and measurement results; customer satisfaction;
3) audit results; issues concerning external providers;
4) customer satisfaction; issues concerning other relevant parties;
5) issues concerning external providers and other adequacy of resources and effectiveness of
relevant interested parties; QMS;
6) adequacy of resources required for maintaining process performance;
an effective quality management system; conformity of products and services;
7) process performance and conformity of actions taken to address risks and
products and services; opportunities and their effectiveness;
d) the effectiveness of actions taken to address new potential opportunities for continual
risks and opportunities (see clause 6.1); improvement.
e) new potential opportunities for continual
improvement.
9.3.2
9.3.2q1 The outputs of the management review shall Show me that management reviews
include decisions and actions related to: include decisions and actions relating to:
a) continual improvement opportunities; b) any Continual improvement opportunities;
need for changes to the quality management The need for changes to the QMS including
system, including resource needs. resource needs.
9.3.2q2 The organization shall retain documented Show me what documented information Documented information of management reviews.
information as evidence of the results of you have as evidence of management
management reviews. reviews.
10 Improvement
10.1 General
10.1q1 The organization shall determine and select How do you determine and select
opportunities for improvement and implement opportunities for improvement? What
necessary actions to meet customer requirements necessary actions have you implemented
and enhance customer satisfaction. so that you have met customer
requirements and enhanced customer
satisfaction?
10.1q2 This shall include, as appropriate: Show me how you have:
a) improving processes to prevent Improved processes to prevent
nonconformities; nonconformities;
b) improving products and services to meet known Improved products and services to meet
and predicted requirements; known and predicted requirements;
c) improving quality management system results. Improved 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 When a nonconformity occurs, including those When nonconformities occur, show me
1 arising from complaints, the organization shall: how;
a) react to the nonconformity, and as applicable: You react;
1) take action to control and correct it; Take action to control and correct it;
2) deal with the consequences; Deal with the consequences;
b) evaluate the need for action to eliminate the Evaluate the need for action to eliminate
cause(s) of the nonconformity, in order that it does the cause so that it does not recur or occur
not recur or occur elsewhere, by: elsewhere by:
1) reviewing the nonconformity; Reviewing the nonconformity;
2) determining the causes of the nonconformity; Determining the cause of the
3) determining if similar nonconformities exist, or nonconformity;
could potentially occur; Determining if similar nonconformities exist
c) implement any action needed; or could potentially occur;
d) review the effectiveness of any corrective action Actions needed are implemented;
taken; Review the effectiveness of corrective
e) make changes to the quality management actions taken, if any;
system, if necessary. Make necessary changes to the QMS.
10.2.1q Corrective actions shall be appropriate to the Show me how correction actions were
2 effects of 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 The organization shall retain documented What documented information can you Documented information of the nature of nonconformities,
1 information as evidence of: show me as evidence of: subsequent actions and results of corrective action.
a) the nature of the nonconformities and any The nature of the nonconformities and
subsequent actions taken; subsequent actions taken;
b) the results of 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
suitability, adequacy, and effectiveness of the the suitability, adequacy and effectiveness
quality management system. of the QMS.
10.3q2 The organization shall consider the outputs of Demonstrate that outputs of analysis and
analysis and evaluation, and the outputs from evaluation and the outputs from
management review, to confirm if there are areas management review are considered to
of underperformance or opportunities that shall be confirm if there are areas of
addressed as part of continual improvement. underperformance or opportunities that
shall be addressed as part of continual
improvement.
Page 29
10.3q3 Where applicable, the organization shall select What applicable tools and methodologies
and utilise applicable tools and methodologies for for investigation of the causes of
investigation of the causes of underperformance underperformance and to support continual
and 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 processes
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
management system
7.5.1 General
4.4 Quality management system and its processes
4.2.3 Control of documents 7.5.2 Creating and updating
7.5.3 Control of documented Information
4.2.4 Control of records 7.5.2 Creating and updating
7.5.3 Control of documented Information
5 Management responsibility 5 Leadership
5.1 Management commitment 5.1 Leadership and commitment
5.1.1 Leadership and commitment for the quality
management system
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 management system
5.4.1 Quality objectives 6.2 Quality objectives and planning to achieve them
Page 30
5.4.2 Quality management system planning 6 Planning for the quality management system
6.1 Actions to address risks and opportunities
6.3 Planning of changes
5.5 Responsibility, authority and communication 5 Leadership

5.5.1 Responsibility and authority 5.3 Organizational roles, responsibilities and
authorities
5.5.2 Management representative Title removed
5.3 Organizational roles, responsibilities and
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
7.2 Competence
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 processes
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 products and
services
7.2.1 Determination of requirements related to the 8.2.2 Determination of requirements related to products
product and services
Page 31
7.2.2 Review of requirements related to the product 8.2.3 Review of requirements related to the products
and 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 and services
8.3.1 General
8.3.2 Design and development planning
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 products and
services
7.4.1 Purchasing process 8.4.1 General
8.4.2 Type and extent of control of external 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 provision
8.5.5 Post-delivery activities
7.5.2 Validation of processes for production and service 8.5.1 Control of production and service provision
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 external
providers
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
Page 32
8.0 Measurement, analysis and improvement 9.1 Monitoring, measurement, analysis and
evaluation
8.1 General 9.1.1 General
8.2 Monitoring and measurement 9.1 Monitoring, measurement, analysis and

evaluation
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 outputs,
products and 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 Improvement
8.5.2 Corrective action 10.2 Nonconformity and corrective action
8.5.3 Preventive action Clause removed
6.1 Actions to address risks and opportunities (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
4.2 Understanding the needs and expectations of 1.1 General
interested parties
4.3 Determining the scope of the quality 1.2 Application
management system 4.2.2 Quality manual
4.4 Quality management system and its processes 4 Quality management system
4.1 General requirements
5 Leadership 5 Management responsibility
5.1 Leadership and commitment 5.1 Management commitment
5.1.1 Leadership and commitment for the quality 5.1 Management commitment
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
5.3 Organizational roles, responsibilities and 5.5.1 Responsibility and authority
authorities 5.5.2 Management representative
6 Planning for the quality management system 5.4.2 Quality management system planning
6.1 Actions to address risks and opportunities 5.4.2 Quality management system planning
8.5.3 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 planning
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
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 equipment
7.1.6 Organizational knowledge New
7.2 Competence 6.2.1 General
6.2.2 Competence, training and awareness
7.3 Awareness 6.2.2 Competence, training and awareness
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 Control of records
7.5.3 Control of documented Information 4.2.3 Control of documents
4.2.4 Control of records
8 Operation 7 Product realization
8.1 Operational planning and control 7.1 Planning of product realization
8.2 Determination of requirements for products and 7.2 Customer-related processes
services
8.2.1 Customer communication 7.2.3 Customer communication
8.2.2 Determination of requirements related to products 7.2.1 Determination of requirements related to the
and services product
8.2.3 Review of requirements related to the products 7.2.2 Review of requirements related to the product
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
7.3.5 Design and development verification
7.3.6 Design and development 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 changes
Page 35
8.4 Control of externally provided products and 7.4.1 Purchasing process
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 Verification of purchased 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 provision
8.5.2 Identification and traceability 7.5.3 Identification and traceability
8.5.3 Property belonging to customers or external 7.5.4 Customer property
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 provision
8.5.6 Control of changes 7.3.7 Control of design and development changes
8.6 Release of products and services 8.2.4 Monitoring and measurement of processes
7.4.3 Verification of purchased product
8.7 Control of nonconforming process outputs, 8.3 Control of nonconforming product
products and services
9 Performance evaluation New
9.1 Monitoring, measurement, analysis and 8 Measurement, analysis and improvement
evaluation
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
8.5.2 Corrective action
10.3 Continual Improvement 8.5.1 Continual improvement
Page 36
Page 37

Checklist ISO 9001-2015

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What are the main components of an ISO 9001 quality management system that are audited?

What are the main components of an ISO 9001 quality management system that are audited?

How does the organization determine requirements of interested parties and monitor information about them?

How does the organization determine requirements of interested parties and monitor information about them?

Internal Quality Management System Audit Checklist (ISO9001:2015)

Q# ISO 9001:2015 Clause Audit Question Audit Evidence

4.2 Understanding the needs and expectations of interested parties

4.3 Determining the scope of the quality management system

4.4 Quality management system and its processes

5.1.2 Customer focus

5.2 Quality policy

5.3 Organizational roles, responsibility and authorities

6 Planning for the quality management system

6.2 Quality objectives and planning to achieve them

6.3 Planning of changes

7.1.4 Environment for the operation of processes

7.1.5 Monitoring and measuring resources

7.1.6 Organizational knowledge

7.5 Documented information

7.5.2 Creating and updating

7.5.3 Control of documented information

8.2 Determination of requirements for products and services

8.2.3 Review of requirements related to products and services

8.3 Design and development of products and services

8.3.2 Design and development planning

8.3.3 Design and development inputs

8.3.4 Design and development controls

8.3.5 Design and development outputs

8.3.6 Design and development changes

8.4.2 Type and extent of control of external provision

8.5 Production and service provision

8.5.2 Identification and traceability

8.5.3 Property belonging to customers or external providers

8.5.5 Post-delivery activities

8.5.6 Control of changes

8.6 Release of products and services

8.7 Control of non-conforming process outputs, products and services

9.1.1q1 The organization shall determine: Show me how you determine:

9.1.2 Customer satisfaction

9.1.3 Analysis and evaluation

9.2 Internal audit

NOTE See ISO 19011 for guidance.

9.3 Management Review

10.2 Nonconformity and corrective action

10.3 Continual improvement

ISO 9001:2008 to ISO/DIS 9001

ISO 9001:2008 ISO/DIS 9001

5.5 Responsibility, authority and communication 5 Leadership

8.2 Monitoring and measurement 9.1 Monitoring, measurement, analysis and

8.2.1 Customer satisfaction 9.1.2 Customer satisfaction

ISO/DIS 9001 ISO 9001:2008

7 Support 6 Resource management

9.1.1 General 8.1 General

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