Internal Quality Management System Audit Checklist (ISO 9001:2015)

Q# ISO 9001:2015 Clause Audit Question Audit Evidence

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

NOTE 1 Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, market,
cultural, social, and economic environments, whether international, national, regional or local.
NOTE 2 Understanding the internal context can be facilitated by considering issues related to values, culture knowledge and performance of
the organization.
4.2 Understanding the needs and expectations of interested parties
4.2q1 Due to their impact or potential impact on the organization’s How have you determined what interested parties are
ability to consistently provide products and services that meet relevant to the QMS?
customer and applicable statutory and regulatory requirements, How have you determined what requirements those parties
the organization shall determine: have that are relevant to the QMS?
a) the interested parties that are relevant to the quality How has impact or potential impact been determined?
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 information about How do you monitor and review the information about
these interested parties and their relevant requirements. interested parties and their relevant requirements?
4.3 Determining the scope of the quality management system
4.3q1 The organization shall determine the boundaries and How have the boundaries and applicability of the QMS been
applicability of the quality management system to establish its used to establish the scope of the organization?
scope.
4.3q2 When determining this scope, the organization shall consider: How have:
a) the external and internal issues referred to in 4.1; The external and internal issues;
b) the requirements of relevant interested parties referred to in The requirements of relevant interested parties and;
4.2; The products and services of the organization been
c) the products and services of the organization. considered when determining the scope of the organization?
4.3q3 Where a requirement of this International Standard within the How has the application of the International Standard within
determined scope can be applied, then it shall be applied by the the scope been determined, and how has it been applied by
organization. the organization?
4.3q4 If any requirement(s) of this International Standard cannot be How have any requirements of the International Standard
applied, this shall not affect the organization’s ability or been determined as not applicable? Show me how
responsibility to ensure conformity of products and services. conformity of products and services are not affected by this.
4.3q5 The scope shall be available and be maintained as documented Where is the scope available? Where is it maintained as Scope required as documented
information stating the: documented information? information.
- products and services covered by the quality Does it state what products and services are covered by the
management system; QMS?
- justification for any instance where a requirement of Does it justify how instances of requirements of the QMS
this International Standard cannot be applied. cannot be applied?

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Q# ISO 9001:2015 Clause Audit Question Audit Evidence
4.4 Quality management system and its processes
4.4q1 The organization shall establish, implement, maintain and How has the QMS been established? Show me how this is
continually improve a quality management system, including the implemented. How is it maintained and continually improved?
processes needed and their interactions, in accordance with the How have the processes been determined and how do they
requirements of this International Standard. interact?
4.4q2 The organization shall determine the processes needed for the How have the processes been determined for the QMS?
quality management system and their application throughout the What are the inputs and outputs for those processes?
organization and shall determine: What is the sequence and interaction of the processes?
a) the inputs required and the outputs expected from these What are the criteria, methods, measurement and related
processes; performance indicators needed to operate and control those
b) the sequence and interaction of these processes; processes?
c) the criteria, methods, including measurements and related What resources are needed and how are these made
performance indicators needed to ensure the effective operation, available?
and control of these processes; How are responsibilities and authorities assigned for those
d) the resources needed and ensure their availability; processes?
e) the assignment of the responsibilities and authorities for these How are risks and opportunities considered and what plans
processes; are made to implement actions to address them?
f) the risks and opportunities in accordance with the What methods are used to monitor, measure and evaluate
requirements of 6.1, and plan and implement the appropriate processes and, if needed, what changes are made to achieve
actions to address them; intended results?
g) the methods for monitoring, measuring, as appropriate, and How are opportunities to improve the processes and the QMS
evaluation of processes and, if needed, the changes to determined?
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 information to the What documented information exists to support the Documented information to support
extent necessary to support the operation of processes and operation of processes? How is this documented information the operation of processes.
retain documented information to the extent necessary to have retained? How is confidence that the processes are being
confidence that the processes are being carried out as planned. carried out as planned determined?

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

5.1.2q1 Top management shall demonstrate leadership and commitment Show me how top management demonstrates leadership and
with respect to customer focus by ensuring that: commitment w.r.t. customer focus ensuring requirements and
a) customer requirements and applicable statutory and applicable statutory and regulatory requirements are
regulatory requirements are determined and met; determined and met.
b) the risks and opportunities that can affect conformity of How are risks and opportunities that can affect conformity of
products and services and the ability to enhance customer products and services determined?
satisfaction are determined and addressed; How is the ability to enhance customer satisfaction
c) the focus on consistently providing products and services that determined and addressed?
meet customer and applicable statutory and regulatory
How is the focus on consistently providing products and
requirements is maintained;
services that meet customer and applicable statutory and
d) the focus on enhancing customer satisfaction is maintained.
regulatory requirements maintained?
How is customer satisfaction maintained?

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 5.2 Quality policy
5.2.1
5.2.1q1 Top management shall establish, review and maintain a quality How does top management establish, review and maintain a
policy that: quality policy?
a) is appropriate to the purpose and context of the organization; How is it determined to be appropriate to the purpose and
b) provides a framework for setting and reviewing quality objectives; context of the organization?
c) includes a commitment to satisfy applicable requirements; Does it provide a framework for setting and reviewing quality
d) includes a commitment to continual improvement of the quality objectives?
management system. 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: Where is the quality policy available as documented Quality Policy as document
a) be available as documented information; information? information
b) be communicated, understood and applied within the How is it communicated?
organization; Show me how it is understood and applied within the
c) be available to relevant interested parties, as appropriate. organization.
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 responsibilities and How does top management ensure that responsibilities and
authorities for relevant roles are assigned, communicated and authorities for relevant roles are assigned, communicated and
understood within the organization. understood within the organization?
5.3q2 Top management shall assign the responsibility and authority How does top management assign the responsibility and
for: authority for:
a) ensuring that the quality management system conforms to the Ensuring that the QMS conforms to the International
requirements of this International Standard; standard?
b) ensuring that the processes are delivering their intended Ensuring processes are delivering their intended outputs?
outputs; How is the performance of the QMS, opportunities for
c) reporting on the performance of the quality management improvement and the need for change or innovation reported
system, on opportunities for improvement and on the need for to top management?
change or innovation, and especially for reporting to top How is customer focus promoted within the organization?
management; How is the integrity of the QMS maintained when changes to
d) ensuring the promotion of customer focus throughout the the QMS are planned and implemented?
organization;
e) ensuring that the integrity of the quality management system
is maintained when changes to the quality management system
are planned and implemented.

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 6 Planning for the quality management system
6.1 Actions to address risks and opportunities
6.1.1
6.1.1q1 When planning for the quality management system, the How are the internal and external issues and interested
organization shall consider the issues referred to in 4.1 and the parties considered when planning for the QMS?
requirements referred to in 4.2 and determine the risks and How are risks and opportunities determined and addressed so
opportunities that that the QMS can::
need to be addressed to: a) achieve its intended results;
a) give assurance that the quality management system can b) Prevent or reduce undesired effects;
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 and opportunities?
a) actions to address these risks and opportunities; How are actions integrated and implemented into the QMS
b) how to: processes?
1) integrate and implement the actions into its quality How do you evaluate the effectiveness of the actions?
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 How are actions taken to address risks and opportunities
proportionate to the potential impact on the conformity of determined as being appropriate to the potential impact on the
products and services. conformity of products and services?

6.2.2.1 Product design skills

6.2.2.1q The organization shall ensure that personnel with product design How do you determine that personnel with product design
1 responsibility are competent to achieve design requirements and responsibility are competent to achieve design requirements?
are skilled in applicable tools and techniques. How do you determine skills required in applicable tools and
Applicable tools and techniques shall be identified by the techniques? How do you identify applicable tools and
organization. techniques?
NOTE Options to address risks and opportunities can include: avoiding risk, taking risk in order to pursue an opportunity, eliminating the risk
source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed decision.
6.2 Quality objectives and planning to achieve them
6.2.1
6.2.1q1 The organization shall establish quality objectives at relevant Where are the quality objectives and are these at all relevant Documented information on quality
functions, levels and processes. functions, levels and processes? objectives
The quality objectives shall: Are they consistent with the quality policy?
a) be consistent with the quality policy, Are they measureable?
b) be measurable; Do they consider applicable requirements?
c) take into account applicable requirements; Are they relevant to the conformity of products and services
d) be relevant to conformity of products and services and the and do they enhance customer satisfaction?
enhancement of customer satisfaction; Are they monitored? How? How often?
e) be monitored; How are they communicated?
f) be communicated; How are they updated?
g) be updated as appropriate. Where is the documented information on the quality
The organization shall retain documented information on the objectives?
quality objectives.

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 6.2.2
6.2.2q1 When planning how to achieve its quality objectives, the How does the organization determine what will be done, with
organization shall determine: what resources, when completed and how will results be
a) what will be done; evaluated for quality 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
6.3q1 Where the organization determines the need for change to the How are changes to the QMS planned systematically?
quality management system (see 4.4) the change shall be Demonstrate the purpose and potential consequences of
carried out in a planned and systematic manner. changes;
The organization shall consider: Demonstrate the integrity of the QMS;
a) the purpose of the change and any of its potential Demonstrate how resources are made available?
consequences; Demonstrate how responsibility and authority is allocated or
b) the integrity of the quality management system; reallocated.
c) the availability of resources;
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 resources Demonstrate how resources are determined for the
needed for the establishment, implementation, maintenance and establishment, implementation, maintenance and continual
continual improvement of the quality management system. improvement of the QMS.
The organization shall consider: Show me how the capabilities and constraints on internal
a) the capabilities of, and constraints on, existing internal resources are considered.
resources; Show me how needs from external providers are considered.
b) what needs to be obtained from external providers.
7.1.2 People
7.1.2q1 To ensure that the organization can consistently meet customer How do you provide persons necessary to consistently meet
and applicable statutory and regulatory requirements, the customer, applicable statutory and regulatory requirements for
organization shall provide the persons necessary for the the QMS including the necessary processes?
effective
operation of the quality management system, including the
processes needed.
7.1.3 Infrastructure
7.1.3q1 The organization shall determine, provide and maintain the How do you determine, provide and maintain the
infrastructure for the operation of its processes to achieve infrastructure for the operation of processes to achieve
conformity of products and services. products and service conformity?
NOTE 1 Any product realization change affecting customer requirements requires notification to, and agreement from, the customer.
7.1.4 Environment for the operation of processes
7.1.4q1 The organization shall determine, provide and maintain the How do you determine, provide and maintain the environment
environment necessary for the operation of its processes and to for the operation of processes to achieve products and
achieve 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).

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

7.1.6q2 This knowledge shall be maintained, and made available to the How do you maintain this knowledge and how do you make it
extent necessary. available to the extent necessary?
7.1.6q3 When addressing changing needs and trends, the organization How do you consider current knowledge and how do you
shall consider its current knowledge and determine how to acquire additional knowledge when addressing changing
acquire or access the necessary additional knowledge. needs and trends?
NOTE 1 Organizational knowledge can include information such as intellectual property and lessons learned.
NOTE 2 To obtain the knowledge required, the organization can consider:
a) internal sources (e.g. learning from failures and successful projects, capturing undocumented knowledge and experience of topical experts
within the organization);
b) external sources (e.g. standards, academia, conferences, gathering knowledge with customers or
providers).

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 7.2 Competence
7..2q1 The organization shall: Show me how: Documented information as
a) determine the necessary competence of person(s) doing work You determine the necessary competence of people doing evidence of competence where
under its control that affects its quality performance; work under your control that affects quality performance;
b) ensure that these persons are competent on the basis of How do you determine competence on the basis of appropriate.
appropriate education, training, or experience; appropriate education, training or experience?
c) where applicable, take actions to acquire the necessary How do you take actions to acquire necessary competence
competence, and evaluate the effectiveness of the actions where applicable and how do you evaluate the effectiveness
taken; of those actions?
d) retain appropriate documented information as evidence of Show me documented information where appropriate of
competence. 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 control shall be How are people aware of:
aware of: The quality policy?
a) the quality policy; Relevant quality objectives?
b) relevant quality objectives; Their contribution to the effectiveness of the QMS?
The benefits of improved performance?
c) their contribution to the effectiveness of the quality The implications of not conforming with the QMS
management system, including the benefits of improved quality requirements?
performance;
d) the implications of not conforming with the quality
management system requirements.
7.4 Communication
7.4q1 The organization shall determine the internal and external How do you determine internal and external communications
communications relevant to the quality management system relevant to the QMS?
including: How do you determine:
a) on what it will communicate; What?
When?
b) when to communicate; With Whom?
c) with whom to communicate; How?
d) how to communicate.
7.5 Documented information
7.5.1 General
7.5.1q1 The organization’s quality management system shall include: What documented information do you have as required by Documented information required
a) documented information required by this International this standard? by this standard.
Standard; What documented information do you have as being Documented information necessary
b) documented information determined by the organization as necessary for the effectiveness of your QMS? for the effectiveness of the QMS.
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.

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 7.5.2 Creating and updating
7.5.2q1 When creating and updating documented information the Show me that your documented information contains: Documented information (in various
organization shall ensure appropriate: Identification; media) needs identification,
a) identification and description (e.g. a title, date, author, or Description; description.
reference number); In what media format?
b) format (e.g. language, software version, graphics) and media Review / approval process?
Show me how the documented information is reviewed and
(e.g. paper, electronic); approved for suitability and adequacy.
c) review and approval for suitability and adequacy.
7.5.3 Control of documented information
7.5.3.1
7.5.3.1q Documented information required by the quality management Show me how you control documented information. Control of documented information.
1 system and by this International Standard shall be controlled to Show me how you make it available and suitable for use. Suitability and availability for use.
ensure: How do you protect your documented information? How is it protected?
a) it is available and suitable for use, where and when it is
needed;
b) it is adequately protected (e.g. from loss of confidentiality,
improper use, or loss of integrity).
7.5.3.2
7.5.3.2q For the control of documented information, the organization shall When controlling documented information, how do you Control of documented information.
1 address the following address: Change control, distribution, access,
activities, as applicable: Distribution; retrieval, use, storage, preservation,
a) distribution, access, retrieval and use; Access; legibility, retention and disposition.
b) storage and preservation, including preservation of legibility; Retrieval;
c) control of changes (e.g. version control); Use;
d) retention and disposition. Storage and preservation;
Legibility;
Control of changes;
Retention and disposition.
7.5.3.2q Documented information of external origin determined by the How do you identify as appropriate and control documented Control of external documented
2 organization to be necessary for the planning and operation of information of external origin which you have determined as information.
the quality management system shall be identified 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.

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 8 Operation
8.1 Operational planning and control
8.1q1 The organization shall plan, implement and control the How are processes needed to meet requirements for Documented information to show
processes, as outlined in 4.4, needed to meet requirements for provision of products and services planned, implemented and processes have been carried out as
the provision of products and services and to implement the controlled? planned and can demonstrate
actions determined in 6.1, by: How are requirements for products and services determined? conformity of products and
a) determining requirements for the product and services; How is criteria for processes and acceptance for products and
b) establishing criteria for the processes and for the acceptance services determined?
services.
of products and services; How are resources determined?
c) determining the resources needed to achieve conformity to How is process control implemented?
product and service requirements; Show me the documented information that shows
d) implementing control of the processes in accordance with the confidence in that the processes have been carried out as
criteria; planned and can demonstrate conformity of products and
e) retaining documented information to the extent necessary to services.
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 How have you determined that the output from the planning
organization's operations. process is suitable for your operations?

8.1q3 The organization shall control planned changes and review the How do you control planned changes? How do you review the
consequences of unintended changes, taking action to mitigate consequences of unintended changes? What action is taken
any adverse effects, as necessary. to mitigate any adverse effects?
8.1q4 The organization shall ensure that outsourced processes are How do you control outsourced processes?
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?
communicating with customers in relation to: How do you communicate information relating to:
a) information relating to products and services; Products;
b) enquiries, contracts or order handling, including changes; Services;
c) obtaining customer views and perceptions, including customer Enquiries;
complaints; Contracts;
d) the handling or treatment of customer property, if applicable; Order handling;
e) specific requirements for contingency actions, when relevant. Customer views, perceptions and complaints;
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 maintain a What is your process to determine the requirements for
process to determine the requirements for the products and products and services to be offered to potential customers?
services to be offered to potential customers. How do you establish, implement and maintain this process?
8.2.2q2 The organization shall ensure that: How do you define product and service requirements
a) product and service requirements (including those considered including statutory and regulatory requirements?
necessary by the organization), and applicable statutory and How do you ensure that you have the ability to meet the
regulatory requirements, are defined; defined requirements and substantiate any claims for your
b) it has the ability to meet the defined requirements and products and services?
substantiate the claims for the 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: How do you review:
a) requirements specified by the customer, including the Customer requirements for delivery and post-delivery?
requirements for delivery and post-delivery activities; Requirements necessary for customers’ specified or intended
b) requirements not stated by the customer, but necessary for use, where known;
the customers' specified or intended use, when known; Additional statutory and regulatory requirements applicable to
c) additional statutory and regulatory requirements applicable to products and services;
the products and services; Any other contract or order requirements.
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 Show me that the review is conducted prior to your
commitment to supply products and services to the customer commitment to supply products and services to your
and shall ensure contract or order requirements differing from customers. How do you resolve contract or order
those previously defined are resolved. requirements which differ from those previously defined?
8.2.3q3 Where the customer does not provide a documented statement How do you confirm customer requirements where the
of their requirements, the customer requirements shall be customer does not provide a documented statement?
confirmed by the organization before acceptance.
8.2.3q4 Documented information describing the results of the review, Show me where you retain documented information which Documented information of reviews
including any new or changed requirements for the products and describes results of the review including any new or changed describing new or changed
services, shall be retained. requirements. requirements to products and
services.
8.2.3q5 Where requirements for products and services are changed, the Show me the documented information containing changes Documented information of
organization shall ensure that relevant documented information to products and services. How do you ensure that relevant amended reviews and how relevant
is amended and that relevant personnel are made aware of the personnel are made aware of those changes? 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 organization’s products How do you establish, implement and maintain a design and
and services are not already established or not defined by the development process (where detailed requirements of your
customer or by other interested parties, such that they are products and services are not already established or defined
adequate for subsequent production or service provision, the by the customer or other parties).
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.

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

8.3.3 Design and development inputs

8.3.3q1 The organization shall determine: Can you show me how you determine:
a) requirements essential for the specific type of products and Requirements essential for the type of products and services
services being designed and developed, including, as being designed and developed, including as applicable:
applicable, functional and performance requirements; Functional & performance requirements;
b) applicable statutory and regulatory requirements; Statutory and regulatory requirements;
c) standards or codes of practice that the organization has Standards or codes of practice where there is a commitment
committed to implement; to implement;
d) internal and external resource needs for the design and Internal and external resources needed for the design and
development of products and services; development of products and services;
e) the potential consequences of failure due to the nature of the Potential consequences of failure;
products and services; Level of control expected of the design and development
f) the level of control expected of the design and development process by customers and other relevant parties.
process by customers and other relevant interested parties.
8.3.3q2 Inputs shall be adequate for design and development purposes, How do you determine that inputs are adequate, complete
complete, and unambiguous. Conflicts among inputs shall be and unambiguous for 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 development process How do controls that are applied to the design and
shall ensure that: development process ensure:
a) the results to be achieved by the design and development Results achieved by design and development activities are
activities are clearly defined; clearly defined?
b) design and development reviews are conducted as planned; Design and development reviews are conducted as planned?
c) verification is conducted to ensure that the design and Outputs meet the input requirements by verification/
development outputs have met the design and development Validation is conducted to ensure that the resulting products
input requirements; and services are capable of meeting the requirements for the
d) validation is conducted to ensure that the resulting products specified application or intended use (when known)?
and services are capable of meeting the requirements for the
specified application or intended use (when known).

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 8.3.5 Design and development outputs
8.3.5q1 The organization shall ensure that design and development How do you ensure that design and development outputs:
outputs: Meet the input requirements for design and development?
a) meet the input requirements for design and development; Are adequate for the subsequent processes for the provision
b) are adequate for the subsequent processes for the provision of products and services?
of products and services; Include or reference monitoring and measuring requirements,
c) include or reference monitoring and measuring requirements, and acceptance criteria, as applicable?
and acceptance criteria, as applicable; Ensure products to be produced, or services to be provided,
d) ensure products to be produced, or services to be provided, are fit for intended purpose and their safe and proper use?
are fit for intended purpose and their safe and proper use.
8.3.5q2 The organization shall retain the documented information Show me the documented information which results from Documented information from the
resulting from the design and development process. the design and development process. design and development process.
8.3.6 Design and development changes
8.3.6q1 The organization shall review, control and identify changes How do you review, control and identify changes made to the
made to design inputs and design outputs during the design and design inputs and outputs during design and development of
development of products and services or subsequently, to the products and services ensuring no impact on conformity to
extent that there is no adverse impact on conformity to requirements?
requirements.
8.3.6q2 Documented information on design and development changes Show me the documented information for design and Documented information for design
shall be retained. development changes. 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
processes, products, and services conform to specified and services conform to specified requirements?
requirements.
8.4.1q2 The organization shall apply the specified requirements for the Show me how you apply specified requirements for the
control of externally provided products and services when: control of externally provided products and services when:
a) products and services are provided by external providers for Products and services are provided by external providers for
incorporation into the organization’s own products and services; incorporation into your own products and services;
b) products and services are provided directly to the customer(s) You provide products and services directly to customers by
by external providers on behalf of the organization; external providers on your behalf;
c) a process or part of a process is provided by an external A process or part-process is provided by an external provider
provider as a result of a decision by the organization to as a result of a decision to outsource a process or function.
outsource a process or function.
8.4.1q3 The organization shall establish and apply criteria for the Show me how you establish and apply criteria for evaluation,
evaluation, selection, monitoring of performance and re- selection, monitoring of performance and re-evaluation of
evaluation of external providers based on their ability to provide external providers. How do you assess their ability to provide
processes or products and services in accordance with specified processes or products and services in accordance with
requirements. specified requirements?
8.4.1q4 The organization shall retain appropriate documented What documented information do you have of the results of Documented information of external
information of the results of the evaluations, monitoring of the evaluations, monitoring of performance and re-evaluations of providers’ performance.
performance and re-evaluations of the external providers. external providers?

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

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 8.5 Production and service provision
8.5.1 Control of production and service provision
8.5.1q1 The organization shall implement controlled conditions for What controlled conditions do you have for production and
production and service provision, including delivery and post- service provision, including delivery and post-delivery
delivery activities. activities?
8.5.1q2 Controlled conditions shall include, as applicable: Can you show me controlled conditions for: Documented information defining
a) the availability of documented information that defines the a) the availability of documented information defining the characteristics of the products and
characteristics of the products and services; characteristics of the products and services; services
b) the availability of documented information that defines the b) the availability of documented information defining the
activities to be performed and the results to be achieved; activities to be performed and the results to be achieved;
c) monitoring and measurement activities at appropriate stages c) monitoring and measurement activities at appropriate
to verify that criteria for control of processes and process stages to verify that criteria for control of processes and
outputs, and acceptance criteria for products and services, have process outputs, and acceptance criteria for products and
been met. services, have been met.
d) the use, and control of suitable infrastructure and process d) the use, and control of suitable infrastructure and process
environment; environment;
e) the availability and use of suitable monitoring and measuring e) the availability and use of suitable monitoring and
resources; measuring resources;
f) the competence and, where applicable, required qualification f) the competence and, where applicable, required
of persons; qualification of persons;
g) the validation, and periodic revalidation, of the ability to g) the validation, and periodic revalidation, of the ability to
achieve planned results of any process for production and achieve planned results of any process for production and
service provision where the resulting output cannot be verified service provision where the resulting output cannot be verified
by subsequent monitoring or measurement; by subsequent monitoring or measurement;
h) the implementation of products and services release, delivery h) the implementation of products and services release,
and post-delivery activities. delivery and post-delivery activities.
8.5.2 Identification and traceability
8.5.2q1 Where necessary to ensure conformity of products and services, What means do you use to identify process outputs to ensure
the organization shall use suitable means to identify process conformity of products and services?
outputs.
8.5.2q2 The organization shall identify the status of process outputs with How do you identify the status of process outputs?
respect to monitoring and measurement requirements
throughout production and service provision.
8.5.2q3 Where traceability is a requirement, the organization shall How do you control the unique identification of process Documented information of
control the unique identification of the process outputs, and outputs, where applicable? What documented information traceability, where required.
retain any documented information necessary to maintain 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.

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

8.5.3q2 When property of the customer or external provider is incorrectly What means do you use to report to the customer or external
used, lost, damaged or otherwise found to be unsuitable for use, provider if their property is incorrectly used, lost, damaged or
the organization shall report this to the customer or external found to be unsuitable for use?
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 outputs How do you ensure preservation of process outputs during
during production and service provision, to the extent necessary production and service provision to maintain conformity to
to maintain conformity to requirements. product requirements?
NOTE Preservation can include identification, handling, packaging, storage, transmission or transportation, and protection.
8.5.5 Post-delivery activities
8.5.5q1 As applicable, the organization shall meet requirements for post- How do you meet requirements for post-delivery activities
delivery activities associated with the products and services. associated with products and services?

8.5.5q2 In determining the extent of post-delivery activities that are How do you determine:
required, the organization shall consider: Risk;
a) the risks associated with the products and services; Nature, use and intended lifetime;
b) the nature, use and intended lifetime of the products and Customer feedback;
services; Statutory and Regulatory requirements, when determining the
c) customer feedback; extent of post-delivery activities required with products and
d) statutory and regulatory requirements. services?
NOTE Post-delivery activities can include actions under warranty provisions, contractual obligations such as maintenance services, and
supplementary services such as recycling or final disposal.
8.5.6 Control of changes
8.5.6q1 The organization shall review and control unplanned changes How do you review and control unplanned changes to ensure
essential for production or service provision to the extent continuing conformity with specified requirements?
necessary to ensure continuing conformity with specified
requirements.
8.5.6q2 The organization shall retain documented information describing What documented information can you show me which Documented information describing
the results of the review of changes, the personnel authorizing describes the results of reviews of changes, the personnel results of review of changes,
the change, and any necessary actions. authorizing change and any necessary actions? personnel and actions.

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

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 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; What needs to be monitored and measured?
b) the methods for monitoring, measurement, analysis and Methods for monitoring, measurement, analysis and
evaluation, as applicable, to ensure valid results; evaluation to ensure valid results?
c) when the monitoring and measuring shall be performed; When to perform monitoring and measuring?
d) when the results from monitoring and measurement shall be When results shall be analysed and evaluated?
analysed and evaluated.
9.1.1q2 The organization shall ensure that monitoring and measurement What documented information can you show me that Documented information of
activities are implemented in accordance with the determined monitoring and measurement activities have been monitoring and measurement
requirements and shall retain appropriate documented implemented in accordance with determined requirements? activities in accordance with
information as determined requirements.
evidence of the results.
9.1.1q3 The organization shall evaluate the quality performance and the Show me how you evaluate the quality performance and the
effectiveness of the quality management system. effectiveness of the QMS.

9.1.2 Customer satisfaction

9.1.2q1 The organization shall monitor customer perceptions of the How do you monitor customer perception of the degree to
degree to which requirements have been met. which requirements have been met?
9.1.2q2 The organization shall obtain information relating to customer How do you obtain information relating to customer views and
views and opinions of the organization and its products and opinions of your products and services?
services.
9.1.2q3 The methods for obtaining and using this information shall be What methods for obtaining and using this information do you
determined. have?
NOTE Information related to customer views can include customer satisfaction or opinion surveys, customer data on delivered products or
services quality, market-share analysis, compliments, warranty claims and dealer reports.

9.1.3 Analysis and evaluation

9.1.3q1 The organization shall analyse and evaluate appropriate data Show me how you analyse and evaluate data and information
and information arising from monitoring, measurement and other arising from monitoring, measurement and other sources.
sources.
9.1.3q2 The output of analysis and evaluation shall be used to: Show me how the output of analysis and evaluation is used
a) demonstrate conformity of products and services to to:
requirements; Demonstrate conformity of products and services to
b) assess and enhance customer satisfaction; requirements?
c) ensure conformity and effectiveness of the quality Assess and enhance customer satisfaction?
management system; Ensure conformity and effectiveness of the QMS?
d) demonstrate that planning has been successfully Demonstrate that planning has been successfully
implemented; implemented?
e) assess the performance of processes; Assess process performance?
f) assess the performance of external provider(s); Assess performance of external providers?
g) determine the need or opportunities for improvements within Determine the need or opportunities for improvements within
the quality management system. the QMS?
9.1.3q3 The results of analysis and evaluation shall also be used to Show me where the results of analysis and evaluation are
provide inputs to management review. used to provide inputs to management review.

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 9.2 Internal audit
9.2.1
9.2.1q1 The organization shall conduct internal audits at planned Are internal audits being conducted at planned intervals? Do
intervals to provide information on whether the quality they determine whether the QMS conforms to the
management system; requirements of ISO 9001 and to the other requirements
a) conforms to: established by Organization? (Review records to demonstrate
1) the organization’s own requirements for its quality conformance)
management system; Do they determine whether the QMS is effectively
2) the requirements of this International Standard; implemented and maintained? (Review records)
b) is effectively implemented and maintained.
9.2.2
9.2.2q1 The organization shall: Can you show me audit programme(s) that takes into Documented information of the
a) plan, establish, implement and maintain an audit consideration the quality objectives, importance of the audit programme and results
programme(s) including the frequency, methods, responsibilities, processes, customer feedback, changes impacting the
planning requirements and reporting, which shall take into organization and the results of previous audits?
consideration the quality objectives, the importance of the Where are the audit criteria and scope for each audit?
processes concerned, customer feedback, changes Can you demonstrate that selection of auditors and the
impacting on the organization, and the results of previous audits; conduct of audits are objective and impartial and that auditors
b) define the audit criteria and scope for each audit; don’t audit their own work?
c) select auditors and conduct audits to ensure objectivity and How are audit results reported to relevant management?
the impartiality of the audit process; Can you demonstrate that necessary correction and
d) ensure that the results of the audits are reported to relevant corrective actions are taken without undue delay?
management; Can you show me documented information of the audit
e) take necessary correction and corrective actions without programme and the audit results?
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.

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 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 reviews the
management system, at planned intervals, to ensure its organization's QMS? How is the QMS deemed suitable,
continuing suitability, adequacy, and effectiveness. adequate and effective?
9.3.1q2 The management review shall be planned and carried out taking What kinds of information are reviewed in management
into consideration: reviews? These must include:
a) the status of actions from previous management reviews; actions status of previous reviews;
b) changes in external and internal issues that are relevant to changes to internal/external issues relevant to the QMS;
the quality management system including its strategic direction; issues that affect strategy;
c) information on the quality performance, including trends and KPIs for nonconformities and corrective actions;
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 relevant adequacy of resources and effectiveness of QMS;
interested parties; process performance;
6) adequacy of resources required for maintaining an effective conformity of products and services;
quality management system; actions taken to address risks and opportunities and their
7) process performance and conformity of products and effectiveness;
services; new potential opportunities for continual improvement.
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 decisions Show me that management reviews include decisions and
and actions related to: actions relating to:
a) continual improvement opportunities; Continual improvement opportunities;
b) any need for changes to the quality management system, The need for changes to the QMS including resource needs.
including resource needs.
9.3.2q2 The organization shall retain documented information as Show me what documented information you have as Documented information of
evidence of the results of management reviews. evidence of management reviews. management reviews.
10 Improvement
10.1 General
10.1q1 The organization shall determine and select opportunities for How do you determine and select opportunities for
improvement and implement necessary actions to meet improvement? What necessary actions have you
customer requirements and enhance customer satisfaction. implemented 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 nonconformities; Improved processes to prevent nonconformities;
b) improving products and services to meet known and predicted Improved products and services to meet known and predicted
requirements; requirements;
c) improving quality management system results. Improved QMS results.
NOTE Improvement can be effected reactively (e.g. corrective action), incrementally (e.g. continual improvement), by step change (e.g.
breakthrough), creatively (e.g. innovation) or by re-organization (e.g. transformation).

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 10.2 Nonconformity and corrective action
10.2.1
10.2.1q1 When a nonconformity occurs, including those arising from When nonconformities occur, show me how;
complaints, the organization shall: You react;
a) react to the nonconformity, and as applicable: Take action to control and correct it;
1) take action to control and correct it; Deal with the consequences;
2) deal with the consequences; Evaluate the need for action to eliminate the cause so that it
b) evaluate the need for action to eliminate the cause(s) of the does not recur or occur elsewhere by:
nonconformity, in order that it does not recur or occur elsewhere, Reviewing the nonconformity;
by: Determining the cause of the nonconformity;
1) reviewing the nonconformity; Determining if similar nonconformities exist or could
2) determining the causes of the nonconformity; potentially occur;
3) determining if similar nonconformities exist, or could Actions needed are implemented;
potentially occur; Review the effectiveness of corrective actions taken, if any;
c) implement any action needed; Make necessary changes to the QMS.
d) review the effectiveness of any corrective action taken;
e) make changes to the quality management system, if
necessary.
10.2.1q2 Corrective actions shall be appropriate to the effects of the Show me how correction actions were appropriate to the
nonconformities encountered. effects of the nonconformities encountered.
NOTE 1 In some instances, it can be impossible to eliminate the cause of a nonconformity.
NOTE 2 Corrective action can reduce the likelihood of recurrence to an acceptable level.
10.2.2
10.2.2q1 The organization shall retain documented information as What documented information can you show me as Documented information of the
evidence of: evidence of: nature of nonconformities,
a) the nature of the nonconformities and any subsequent actions The nature of the nonconformities and subsequent actions
taken; taken; subsequent actions and results of
b) the results of any corrective action. The results of any corrective action. corrective action.
10.3 Continual improvement
10.3q1 The organization shall continually improve the suitability, Demonstrate that you continually improve the suitability,
adequacy, and effectiveness of the quality management system. adequacy and effectiveness of the QMS.
10.3q2 The organization shall consider the outputs of analysis and Demonstrate that outputs of analysis and evaluation and the
evaluation, and the outputs from management review, to confirm outputs from management review are considered to confirm if
if there are areas of underperformance or opportunities that shall there are areas of underperformance or opportunities that
be addressed as part of continual improvement. shall be addressed as part of continual improvement.
10.3q3 Where applicable, the organization shall select and utilise What applicable tools and methodologies for investigation of
applicable tools and methodologies for investigation of the the causes of underperformance and to support continual
causes of underperformance and for supporting continual improvement are selected?
improvement.

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