Statement
The primary focus of quality management is to meet customer requirements and to strive to exceed customer expectations.
Rationale
Understanding the current and future needs and expectations of customers and other interested parties contributes to the sustained success of the organization. Every aspect of customer interaction provides an opportunity to build and retain the confidence of customers and other interested parties.
Key benefits
Some potential key benefits are: improved customer experience; increased customer satisfaction; improved customer loyalty; enhanced repeat business; enhanced reputation of the organization; expanded customer base.
Possible actions include:
understand and take action on the current and future needs and expectations of customers and other interested parties; link the organization's policies and objectives to customer needs and expectations; communicate customer needs and expectations throughout the organization; plan, design, develop, produce, deliver, support and improve products and services to meet customer needs and expectations; measure and monitor customer satisfaction and take appropriate actions; determine and address risks and opportunities that can affect customer satisfaction and experience; actively manage relationships with customers to achieve sustained success.

Statement
Leaders at all levels establish unity of purpose and direction and create conditions in which people are engaged in achieving the organization's quality objectives.
Rationale
Creation of unity of purpose and the direction and engagement of people enable an organization to align its strategies, policies, processes and resources to achieve its objectives.
Key benefits
Some potential key benefits are: increased effectiveness and efficiency in meeting the organization's quality objectives; better coordination of the organization's processes; improved communication between levels and functions of the organization; development and improvement of the capability of the organization and its people to deliver desired results.
Possible actions include:
communicate the organization's mission, vision, strategy, policies and processes throughout the organization; create and sustain shared values, fairness, and trust at all levels of the organization; establish and promote a quality culture and ethical behaviour; encourage an organization-wide commitment to quality; ensure that leaders at all levels are positive examples to people in the organization; encourage risk-based thinking to proactively address issues to enhance desired effects; provide people with the required resources, training and authority to act with accountability; inspire, encourage and recognize the contribution of people.

Statement
Competent, empowered and engaged people at all levels throughout the organization are essential to enhance the organization's capability to create and deliver value for customers and other interested parties.

Rationale
In order to manage an organization effectively and efficiently, it is important to respect and involve all people at all levels. Recognition, empowerment and enhancement of competence facilitate the engagement of people in achieving the organization's quality objectives.

Key benefits
Some potential key benefits are:
- improved understanding of the organization's quality objectives by people in the organization and increased motivation to achieve them;
- enhanced involvement of people in improvement activities;
- enhanced personal development, initiatives and creativity;
- enhanced people satisfaction;
- enhanced trust and collaboration throughout the organization;
- increased attention to shared values and culture throughout the organization.

Possible actions include:
- communicate with people to promote understanding and awareness of the importance of their individual contribution;
- promote collaboration throughout the organization;
- facilitate open discussion and sharing of knowledge and experience;
- empower people to determine constraints to performance and to take initiatives without fear;
- recognize and acknowledge people's motivation, contribution, learning and improvement;
- enable self-evaluation of performance against personal objectives;
- conduct surveys to assess people's satisfaction, communicate the results and take appropriate actions.

Statement
Consistent and predictable results are achieved more effectively and efficiently when activities are understood and managed as interrelated or interacting processes that function as a coherent system.
Rationale
The QMS consists of interrelated or interacting processes. Understanding how results are produced by this system enables an organization to improve the system and its performance.
Key benefits
Some potential key benefits are: enhanced ability to focus effort on key processes and opportunities for improvement; consistent and predictable results through a system of aligned processes; optimized performance through effective process management, efficient use of resources and reduced cross-functional barriers; enabling the organization to provide confidence to interested parties related to its consistency, effectiveness and efficiency.
Possible actions include:
define objectives of the system and processes necessary to achieve them; establish authority, responsibility and accountability for managing processes; understand the organization's capabilities and determine resource constraints prior to action; determine process interdependencies and analyse the effect of modifications to individual processes on the system as a whole; manage processes and their interrelations as a system to achieve the organization's quality objectives effectively and efficiently; ensure the necessary information is available to operate and improve the processes and to measure, monitor, analyse and evaluate the performance of the overall system; manage risks which can affect outputs of the processes and overall outcomes of the QMS.

Statement
Successful organizations have an ongoing focus on improvement.
Rationale
Improvement is essential for an organization to maintain current levels of performance, to react to changes in its internal and external conditions, to manage risks and to create new opportunities.
Key benefits
Some potential key benefits are: improved process performance, organizational capability and customer satisfaction; enhanced focus on root cause investigation and determination, followed by prevention and corrective actions; enhanced ability to anticipate and react to internal and external risks and opportunities; enhanced consideration of both incremental and breakthrough improvement; effective use of learning for improvement; enhanced drive for innovation.
Possible actions include:
promote the establishment of improvement objectives at all levels of the organization; educate and train people at all levels on how to apply basic tools and methodologies to achieve improvement objectives; ensure people are competent to successfully promote and complete improvement actions; develop and deploy processes to implement improvement projects throughout the organization; track, review and audit the planning, implementation, completion and results of improvement actions; integrate improvement consideration into development of new or modified products, services and processes; recognize and acknowledge improvement.

Statement
Decisions based on the analysis and evaluation of data and information are more likely to produce desired results and lead the organization to improve.

Rationale
Decision-making can be a complex process and it always involves some uncertainty. It often involves multiple types and sources of inputs, as well as their interpretation, which can be subjective. It is important to understand cause and effect relationships and potential unintended consequences. Facts, evidence and data analysis lead to greater objectivity and confidence in decision-making for the benefit of all the organization's interested parties.

Key benefits
Some potential key benefits are:
- improved decision-making processes;
- improved assessment of process performance and ability to achieve objectives;
- improved operational effectiveness and efficiency;
- increased ability to review, challenge and change opinions and decisions;
- increased ability to demonstrate the effectiveness of past decisions.

Possible actions include:
- determine, measure and monitor key indicators to demonstrate the organization's performance;
- make all data and information needed available to the relevant people;
- ensure that data and information are sufficiently accurate, reliable, secure and available;
- analyse and evaluate data and information using suitable methods;
- ensure people are competent to analyse and evaluate data and information as needed;
- make decisions and take actions based on evidence, balanced with experience and intuition.

Statement
For sustained success, organizations manage their relationships with interested parties.
Rationale
Interested parties influence the performance of an organization. Sustained success is more likely to be achieved when the organization manages relationships with all of its interested parties to optimize their impact on its performance. Relationship management with its provider and partner networks is of particular importance.
Key benefits
Some potential key benefits are: enhanced performance of the organization and its interested parties through responding to the opportunities and constraints related to each interested party; common understanding of objectives and values among interested parties; increased capability to create value for interested parties by sharing resources and competence and managing relevant risks and opportunities; enhanced supply chain management that provides a stable flow of products and services.
Possible actions include:
determine interested parties (such as providers, partners, customers, regulators, investors, people, communities or society as a whole) and their relationship with the organization; determine and prioritize interested party relationships that should be managed; establish relationships that balance short-term gains with long-term considerations; gather and share information, expertise and resources with interested parties; measure performance and provide performance feedback to interested parties, as appropriate, to enhance improvement initiatives; establish collaborative development and improvement activities with providers, partners and other interested parties; encourage and recognize improvements and achievements by providers and partners.

This document specifies requirements for a quality management system when an organization:
a) needs to demonstrate its ability to consistently provide products and services that meet customer and
applicable statutory and regulatory requirements;
b) aims to enhance customer satisfaction through the effective application of the system, including
processes for improvement of the system and the assurance of conformity to customer and applicable
statutory and regulatory requirements.
All the requirements of this document are generic.
This document is applicable to any organization, regardless of its type or size, or the products and services
it provides.
NOTE 1 In this document, the terms “product” or “service” only apply to products and services intended for, or
required by, a customer.
NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.

The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 9000, Quality management — Fundamentals and vocabulary

For the purposes of this document, the terms and definitions given in ISO 9000 and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at h t t p s :// www .iso .org/ obp
— IEC Electropedia: available at h t t p s :// www .electropedia .org
3.1
organization
person or group of people that has its own functions with responsibilities, authorities and relationships to
achieve its objectives (3.6)
Note 1 to entry: The concept of organization includes, but is not limited to, sole-trader, company, corporation, firm,
enterprise, authority, partnership, charity or institution, or part or combination thereof, whether incorporated or not,
public or private.
Note 2 to entry: If the organization is part of a larger entity, the term “organization” refers only to the part of the larger
entity that is within the scope of the quality management system (3.4.1).
3.2
interested party
stakeholder
person or organization (3.1) that can affect, be affected by, or perceive itself to be affected by a decision or
activity
EXAMPLE Customers, owners, people in an organization, providers, bankers, regulatory authorities, unions,
partners or society that can include competitors or opposing pressure groups.
3.3
top management
person or group of people who directs and controls an organization (3.1) at the highest level
Note 1 to entry: Top management has the power to delegate authority and provide resources within the organization.
Note 2 to entry: If the scope of the management system (3.4) covers only part of an organization, then top management
refers to those who direct and control that part of the organization.
3.4
management system
set of interrelated or interacting elements of an organization (3.1) to establish policies (3.5) and objectives
(3.6), as well as processes (3.8) to achieve those objectives
Note 1 to entry: A management system can address a single discipline or several disciplines.
Note 2 to entry: The management system elements include the organization’s structure, roles and responsibilities,
planning and operation.
Note 3 to entry: The management system elements can include the organization’s policies, practices, rules and beliefs.
Note 4 to entry: An organization manages its interrelated elements in an orderly manner to achieve its objectives.
Note 5 to entry: The scope of a management system can include the whole of the organization, specific and identified
functions of the organization, specific and identified sections of the organization, or one or more functions across a
group of organizations.
3.4.1
quality management system
part of the overall management system (3.4) of an organization (3.1) related to quality
3.5
policy
intentions and direction of an organization (3.1) as formally expressed by its top management (3.3)
3.5.1
quality policy
policy (3.5) related to quality
Note 1 to entry: The quality policy:
— is generally consistent with the overall policy of the organization (3.1);
— can be aligned with the organization’s vision and mission;
— provides a framework for the setting of quality objectives.
Note 2 to entry: The quality management principles presented in ISO 9000 [2] can form a basis for the establishment of
a quality policy.
3.6
objective
result to be achieved
Note 1 to entry: An objective can be strategic, tactical or operational.
Note 2 to entry: Objectives can relate to different disciplines (e.g. finance, health and safety, environment). They can
be, for example, organization-wide or specific to a project, product, service or process (3.8).
Note 3 to entry: An objective can be expressed in other ways, such as an intended result, as a purpose, as an operational
criterion, as a quality objective (3.6.1) or by the use of other words with similar meaning (e.g. aim, goal, target).
Note 4 to entry: In the context of quality management systems (3.4.1), quality objectives (3.6.1) are set by the organization
(3.1), consistent with the quality policy (3.5.1), to achieve specific results.
3.6.1
quality objective
objective (3.6) related to quality
Note 1 to entry: Quality objectives are generally based on the organization’s (3.1) quality policy (3.5.1).
Note 2 to entry: Quality objectives are generally specified for relevant functions, levels and processes ( 3.8) in the
organization.
3.7
risk
effect of uncertainty
Note 1 to entry: An effect is a deviation from the expected — positive or negative.
Note 2 to entry: Uncertainty is the state, even partial, of deficiency of information related to, understanding or
knowledge of, an event, its consequence, or likelihood.
Note 3 to entry: Risk is often characterized by reference to potential events and consequences, or a combination of
these.
Note 4 to entry: Risk is often expressed in terms of a combination of the consequences of an event (including changes
in circumstances) and the associated likelihood of occurrence.
Note 5 to entry: The word “risk” is sometimes used when there is the possibility of only negative consequences.
3.8
process
set of interrelated or interacting activities that uses or transforms inputs to deliver a result
Note 1 to entry: Whether the result of a process is called an output, a product or a service depends on the context of
the reference.
Note 2 to entry: Inputs to a process are generally the outputs of other processes and outputs of a process are generally
the inputs to other processes.
Note 3 to entry: Two or more interrelated and interacting processes in series can also be referred to as a “process”.
Note 4 to entry: Processes in an organization (3.1) are generally planned and carried out under controlled conditions
to ensure that intended results can be achieved.
Note 5 to entry: A process where the conformity ( 3.15) of the resulting output cannot be readily or economically
validated is frequently referred to as a “special process”.
3.9
competence
ability to apply knowledge and skills to achieve intended results
3.10
documented information
information required to be controlled and maintained by an organization (3.1) and the medium on which it
is contained
Note 1 to entry: Documented information can be in any format and media and from any source.
Note 2 to entry: Documented information can refer to:
— the management system (3.4), including related processes (3.8);
— information created in order for the organization to operate (documentation);
— evidence of results achieved (records).
3.11
performance
measurable result
Note 1 to entry: Performance can relate either to quantitative or qualitative findings.
Note 2 to entry: Performance can relate to managing activities, processes ( 3.8), products, services, systems or
organizations (3.1).
3.12
continual improvement
recurring activity to enhance performance (3.11)
3.13
effectiveness
extent to which planned activities are realized and planned results are achieved
3.14
requirement
need or expectation that is stated, generally implied or obligatory
Note 1 to entry: “Generally implied” means that it is custom or common practice for the organization ( 3.1) and
interested parties (3.2) that the need or expectation under consideration is implied.
Note 2 to entry: A specified requirement is one that is stated, e.g. in documented information (3.10).
Note 3 to entry: A qualifier can be used to denote a specific type of requirement, e.g. product requirement, service
requirement, quality management requirement, customer requirement, quality requirement.
Note 4 to entry: Requirements can be generated by different interested parties or by the organization itself.
Note 5 to entry: It can be necessary for achieving high customer satisfaction to fulfil an expectation of a customer even
if it is neither stated nor generally implied or obligatory.
3.15
conformity
fulfilment of a requirement (3.14)
Note 1 to entry: The term “conformance” is synonymous but deprecated.
3.16
nonconformity
non-fulfilment of a requirement (3.14)
3.17
corrective action
action to eliminate the cause(s) of a nonconformity (3.16) and to prevent recurrence
Note 1 to entry: Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent
occurrence.
3.18
audit
systematic and independent process (3.8) for obtaining evidence and evaluating it objectively to determine
the extent to which the audit criteria are fulfilled
Note 1 to entry: An audit can be an internal audit (first party) or an external audit (second party or third party), and it
can be a combined audit (combining two or more disciplines).
Note 2 to entry: An internal audit is conducted by the organization (3.1) itself, or by an external party on its behalf.
Note 3 to entry: “Audit evidence” and “audit criteria” are defined in ISO 19011 [4].
Note 4 to entry: The fundamental elements of an audit include the determination of the conformity (3.15) of an object
according to a procedure carried out by people selected to ensure impartiality and objectivity of the audit process.
Note 5 to entry: Internal audits are conducted for management review and other internal purposes and can form
the basis for an organization’s declaration of conformity. Independence can be demonstrated by the freedom from
responsibility for the activity being audited.
Note 6 to entry: Second-party audits are conducted by parties having an interest in the organization, such as
customers, or by other persons on their behalf. Third-party audits are conducted by external, independent auditing
organizations such as those providing certification or registration of conformity or governmental agencies.
Note 7 to entry: An audit can also be a joint audit conducted by two or more auditing organizations.
3.19
measurement
process (3.8) to determine a value
Note 1 to entry: According to ISO 3534-2:2006 [5], the value determined is generally the value of a quantity.
3.20
monitoring
determining the status of a system, a process (3.8) or an activity
Note 1 to entry: To determine the status, there can be a need to check, supervise or critically observe.
Note 2 to entry: Monitoring can also determine the status of a product or a service.
Note 3 to entry: Monitoring is generally a determination of the status of an object, carried out at different stages or at
different times.

person or group of people that has its own functions with responsibilities, authorities and relationships to
achieve its objectives (3.6)
Note 1 to entry: The concept of organization includes, but is not limited to, sole-trader, company, corporation, firm,
enterprise, authority, partnership, charity or institution, or part or combination thereof, whether incorporated or not,
public or private.
Note 2 to entry: If the organization is part of a larger entity, the term “organization” refers only to the part of the larger
entity that is within the scope of the quality management system (3.4.1).

stakeholder
person or organization (3.1) that can affect, be affected by, or perceive itself to be affected by a decision or
activity
EXAMPLE Customers, owners, people in an organization, providers, bankers, regulatory authorities, unions,
partners or society that can include competitors or opposing pressure groups.

person or group of people who directs and controls an organization (3.1) at the highest level
Note 1 to entry: Top management has the power to delegate authority and provide resources within the organization.
Note 2 to entry: If the scope of the management system (3.4) covers only part of an organization, then top management
refers to those who direct and control that part of the organization.

set of interrelated or interacting elements of an organization (3.1) to establish policies (3.5) and objectives
(3.6), as well as processes (3.8) to achieve those objectives
Note 1 to entry: A management system can address a single discipline or several disciplines.
Note 2 to entry: The management system elements include the organization’s structure, roles and responsibilities,
planning and operation.
Note 3 to entry: The management system elements can include the organization’s policies, practices, rules and beliefs.
Note 4 to entry: An organization manages its interrelated elements in an orderly manner to achieve its objectives.
Note 5 to entry: The scope of a management system can include the whole of the organization, specific and identified
functions of the organization, specific and identified sections of the organization, or one or more functions across a
group of organizations.

part of the overall management system (3.4) of an organization (3.1) related to quality

intentions and direction of an organization (3.1) as formally expressed by its top management (3.3)

policy (3.5) related to quality
Note 1 to entry: The quality policy:
— is generally consistent with the overall policy of the organization (3.1);
— can be aligned with the organization’s vision and mission;
— provides a framework for the setting of quality objectives.
Note 2 to entry: The quality management principles presented in ISO 9000 [2] can form a basis for the establishment of
a quality policy.

result to be achieved
Note 1 to entry: An objective can be strategic, tactical or operational.
Note 2 to entry: Objectives can relate to different disciplines (e.g. finance, health and safety, environment). They can
be, for example, organization-wide or specific to a project, product, service or process (3.8).
Note 3 to entry: An objective can be expressed in other ways, such as an intended result, as a purpose, as an operational
criterion, as a quality objective (3.6.1) or by the use of other words with similar meaning (e.g. aim, goal, target).
Note 4 to entry: In the context of quality management systems (3.4.1), quality objectives (3.6.1) are set by the organization
(3.1), consistent with the quality policy (3.5.1), to achieve specific results.

objective (3.6) related to quality
Note 1 to entry: Quality objectives are generally based on the organization’s (3.1) quality policy (3.5.1).
Note 2 to entry: Quality objectives are generally specified for relevant functions, levels and processes ( 3.8) in the
organization.

effect of uncertainty
Note 1 to entry: An effect is a deviation from the expected — positive or negative.
Note 2 to entry: Uncertainty is the state, even partial, of deficiency of information related to, understanding or
knowledge of, an event, its consequence, or likelihood.
Note 3 to entry: Risk is often characterized by reference to potential events and consequences, or a combination of
these.
Note 4 to entry: Risk is often expressed in terms of a combination of the consequences of an event (including changes
in circumstances) and the associated likelihood of occurrence.
Note 5 to entry: The word “risk” is sometimes used when there is the possibility of only negative consequences.

set of interrelated or interacting activities that uses or transforms inputs to deliver a result
Note 1 to entry: Whether the result of a process is called an output, a product or a service depends on the context of
the reference.
Note 2 to entry: Inputs to a process are generally the outputs of other processes and outputs of a process are generally
the inputs to other processes.
Note 3 to entry: Two or more interrelated and interacting processes in series can also be referred to as a “process”.
Note 4 to entry: Processes in an organization (3.1) are generally planned and carried out under controlled conditions
to ensure that intended results can be achieved.
Note 5 to entry: A process where the conformity ( 3.15) of the resulting output cannot be readily or economically
validated is frequently referred to as a “special process”.

ability to apply knowledge and skills to achieve intended results

information required to be controlled and maintained by an organization (3.1) and the medium on which it
is contained
Note 1 to entry: Documented information can be in any format and media and from any source.
Note 2 to entry: Documented information can refer to:
— the management system (3.4), including related processes (3.8);
— information created in order for the organization to operate (documentation);
— evidence of results achieved (records).

measurable result
Note 1 to entry: Performance can relate either to quantitative or qualitative findings.
Note 2 to entry: Performance can relate to managing activities, processes ( 3.8), products, services, systems or
organizations (3.1).

recurring activity to enhance performance (3.11)

extent to which planned activities are realized and planned results are achieved

need or expectation that is stated, generally implied or obligatory
Note 1 to entry: “Generally implied” means that it is custom or common practice for the organization ( 3.1) and
interested parties (3.2) that the need or expectation under consideration is implied.
Note 2 to entry: A specified requirement is one that is stated, e.g. in documented information (3.10).
Note 3 to entry: A qualifier can be used to denote a specific type of requirement, e.g. product requirement, service
requirement, quality management requirement, customer requirement, quality requirement.
Note 4 to entry: Requirements can be generated by different interested parties or by the organization itself.
Note 5 to entry: It can be necessary for achieving high customer satisfaction to fulfil an expectation of a customer even
if it is neither stated nor generally implied or obligatory.

fulfilment of a requirement (3.14)
Note 1 to entry: The term “conformance” is synonymous but deprecated.

non-fulfilment of a requirement (3.14)

action to eliminate the cause(s) of a nonconformity (3.16) and to prevent recurrence
Note 1 to entry: Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent
occurrence.

systematic and independent process (3.8) for obtaining evidence and evaluating it objectively to determine
the extent to which the audit criteria are fulfilled
Note 1 to entry: An audit can be an internal audit (first party) or an external audit (second party or third party), and it
can be a combined audit (combining two or more disciplines).
Note 2 to entry: An internal audit is conducted by the organization (3.1) itself, or by an external party on its behalf.
Note 3 to entry: “Audit evidence” and “audit criteria” are defined in ISO 19011 [4].
Note 4 to entry: The fundamental elements of an audit include the determination of the conformity (3.15) of an object
according to a procedure carried out by people selected to ensure impartiality and objectivity of the audit process.
Note 5 to entry: Internal audits are conducted for management review and other internal purposes and can form
the basis for an organization’s declaration of conformity. Independence can be demonstrated by the freedom from
responsibility for the activity being audited.
Note 6 to entry: Second-party audits are conducted by parties having an interest in the organization, such as
customers, or by other persons on their behalf. Third-party audits are conducted by external, independent auditing
organizations such as those providing certification or registration of conformity or governmental agencies.
Note 7 to entry: An audit can also be a joint audit conducted by two or more auditing organizations.

process (3.8) to determine a value
Note 1 to entry: According to ISO 3534-2:2006 [5], the value determined is generally the value of a quantity.

determining the status of a system, a process (3.8) or an activity
Note 1 to entry: To determine the status, there can be a need to check, supervise or critically observe.
Note 2 to entry: Monitoring can also determine the status of a product or a service.
Note 3 to entry: Monitoring is generally a determination of the status of an object, carried out at different stages or at
different times.

The organization shall determine external and internal issues that are relevant to its purpose and its
strategic direction and that affect its ability to achieve the intended result(s) of its quality management
system.
The organization shall determine whether climate change is a relevant issue.
The organization shall monitor and review information about these external and internal issues.
NOTE 1 Issues can include positive and negative factors or conditions for consideration.
NOTE 2 Understanding the external context can be facilitated by considering legal, technological, competitive,
market, cultural, political, social, economic and environmental issues at the international, national, regional or local
level.
NOTE 3 Understanding the internal context can be facilitated by considering issues related to the organization’s
strategic direction, values, culture, resources, knowledge and performance.

The organization shall determine:
a) the interested parties that are relevant to the quality management system;
b) the relevant requirements of these interested parties;
c) which of these requirements will be addressed through the quality management system.
The organization shall monitor and review information about these interested parties and their relevant
requirements.
NOTE Relevant interested parties can have requirements related to climate change.

The organization shall determine the boundaries and applicability of the quality management system to
establish its scope.
When determining this scope, the organization shall consider:
a) the external and internal issues referred to in 4.1;
b) the requirements referred to in 4.2;
c) the products and services of the organization.
The organization shall apply all the requirements of this document if they are applicable within the
determined scope of its quality management system.
The scope shall state the types of products and services covered.
The scope shall include justification for any requirement of this document that the organization determines
is not applicable to its quality management system.
The scope shall be available as documented information.
Conformity to this document can only be claimed if the requirements determined as not being applicable do
not affect the organization’s ability or responsibility to ensure the conformity of its products and services
and the enhancement of customer satisfaction.

system, including the processes needed and their interactions, in accordance with the requirements of this
document.
The organization shall:
a) determine the processes needed for the quality management system and their application throughout
the organization;
b) determine the inputs required and the outputs expected from these processes;
c) determine the sequence and interaction of these processes;
d) determine and apply the criteria and methods needed (including monitoring, measurements and related
performance indicators) to ensure the effective operation and control of these processes;
e) determine the resources needed for these processes and ensure their availability;
f) assign the responsibilities and authorities for these processes;
g) address the risks and opportunities as determined in accordance with the requirements of 6.1;
h) evaluate these processes and implement any changes needed to ensure that these processes achieve
their intended results;
i) improve the processes and the quality management system.

a) to support the operation of the organization’s processes;
b) as evidence that the processes are being carried out as planned.

Top management shall demonstrate leadership and commitment with respect to the quality management
system by:
a) ensuring that the quality policy and quality objectives are established and are compatible with the
strategic direction of the organization;
b) ensuring the integration of the quality management system requirements into the organization’s
business processes;
c) ensuring that the resources needed for the quality management system are available;
d) communicating the importance of effective quality management and of conforming to the quality
management system requirements;
e) ensuring that the quality management system achieves its intended result(s);
f) directing and supporting persons to contribute to the effectiveness of the quality management system;
g) promoting continual improvement;
h) supporting other relevant roles to demonstrate their leadership, as it applies to their areas of
responsibility;
i) promoting quality culture and ethical behaviour;
j) promoting the use of the process approach;
k) promoting risk-based thinking and opportunity-based thinking;
l) taking accountability for the effectiveness of the quality management system.
NOTE 1 Reference to “business” in this document can be interpreted broadly to mean those activities that are core
to the purposes of the organization’s existence.
NOTE 2 An organization’s quality culture and ethical behaviour are reflected in its shared values, attitudes,
practices and actions.

Top management shall demonstrate leadership and commitment with respect to customer focus by ensuring
that:
a) customer and applicable statutory and regulatory requirements are determined, understood and
consistently met;
b) the risks and opportunities that can affect conformity of products and services and the ability to
enhance customer satisfaction are determined and addressed;
c) the focus on enhancing customer satisfaction is maintained.

a) is appropriate to the purpose of the organization;
b) provides a framework for setting quality objectives;
c) includes a commitment to meet applicable requirements;
d) includes a commitment to continual improvement of the quality management system;
e) takes into account the context of the organization and supports its strategic direction.

a) be available as documented information;
b) be communicated within the organization;
c) be available to interested parties, as appropriate;
d) be implemented, understood and applied within the organization.

Top management shall ensure that the responsibilities and authorities for relevant roles are assigned and
communicated within the organization.
Top management shall assign the responsibility and authority for:
a) ensuring that the quality management system conforms to the requirements of this document;
b) reporting on the performance of the quality management system to top management;
c) ensuring that the processes are delivering their intended results;
d) ensuring the promotion of customer focus throughout the organization;
e) reporting on opportunities for improvement to top management;
f) ensuring that the integrity of the quality management system is maintained, including when changes to
the quality management system are planned and implemented.

When planning for the quality management system, the organization shall consider the issues referred to
in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be
addressed to:
a) give assurance that the quality management system can achieve its intended result(s);
b) prevent, or reduce, undesired effects;
c) achieve continual improvement;
d) enhance desired effects.

The organization shall determine, analyse and evaluate risks that can have an undesired effect on its
ability to continually and consistently provide conforming products and services and enhance customer
satisfaction.
The organization shall plan:
a) actions to address these risks;
b) how to:
1) integrate and implement the actions into its quality management system processes;
2) evaluate the effectiveness of these actions.
Actions taken shall be proportionate to the potential impact of the risks on the intended results of the
quality management system.
NOTE 1 Determined risks can include risks related to the ability to provide conforming products and services
during and after a disruption.
NOTE 2 Actions to address risks 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.

The organization shall determine, analyse and evaluate opportunities that can have a desired effect on its
ability to continually and consistently provide conforming products and services and enhance customer
satisfaction.
The organization shall plan:
a) actions to address these opportunities;
b) how to:
1) integrate and implement the actions into its quality management system processes;
2) evaluate the effectiveness of these actions.
Actions taken to address opportunities shall be appropriate to the organization’s context and support the
achievement of desired results.
NOTE Actions to address opportunities can include adopting new practices, launching new products or services,
creating new partnerships, leveraging emerging technologies, implementing initiatives, and other actions to address
the current and changing needs and expectations of an organization’s customers and other relevant interested parties.

The quality objectives shall:
a) be consistent with the quality policy;
b) be measurable;
c) take into account applicable requirements;
d) be monitored;
e) be communicated;
f) be updated as appropriate;
g) be available as documented information;
h) be relevant to the conformity of products and services and the ability to enhance customer satisfaction.

a) what will be done;
b) what resources will be required;
c) who will be responsible;
d) when it will be completed;
e) how the results will be evaluated.

When the organization determines the need for changes to the quality management system, the changes
shall be carried out in a planned manner.
To ensure changes are implemented effectively to achieve intended results, the organization shall consider:
a) the purpose of the changes and their potential consequences;
b) the potential impact on the integrity of the quality management system;
c) the availability of resources and information;
d) the allocation or reallocation of responsibilities and authorities;
e) the communication of the changes;
f) how the effectiveness of the changes will be monitored and evaluated;
g) how the results of the changes will be reviewed.

The organization shall determine and provide the resources needed for the establishment, implementation,
maintenance and continual improvement of the quality management system.
The organization shall consider:
a) the capabilities of, and constraints on, existing internal resources;
b) what needs to be obtained from external providers.

The organization shall determine and provide the persons necessary for the effective implementation of its
quality management system and for the operation and control of its processes.

The organization shall determine, provide and maintain the infrastructure necessary for the operation of its
processes and to achieve conformity of products and services.
NOTE For all types of work (e.g. on site, remote or a combination thereof) infrastructure can include:
a) buildings and associated utilities;
b) equipment, including hardware and software;
c) transportation resources;
d) information and communication technology.

The organization shall determine, provide and maintain the environment necessary for the operation of its
processes and to achieve conformity of products and services.
NOTE A suitable environment can include a combination of factors, which can differ depending on the products
and services provided. Relevant factors can include:
a) social (e.g. non-discriminatory, calm, non-confrontational);
b) psychological (e.g. stress-reducing, burnout prevention, emotionally protective);
c) physical (e.g. temperature, heat, humidity, light, airflow, hygiene, noise).
Some factors can be influenced by the organizational quality culture and ethical behaviour.

The organization shall determine and provide the resources needed to ensure valid and reliable results
when monitoring or measuring is used to verify the conformity of products and services to requirements.
The organization shall ensure that the resources provided:
a) are suitable for the specific type of monitoring and measurement activities being undertaken;
b) are maintained to ensure their continuing fitness for their purpose.
Appropriate documented information shall be available as evidence of fitness for purpose of the monitoring
and measurement resources.

When traceability of measurement results is a requirement, or is considered by the organization to be an
essential part of providing confidence in the validity of measurement results, measuring equipment shall be:
a) calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards
traceable to international or national measurement standards; when no such measurement standards
exist, the basis used for calibration or verification shall be available as documented information;
b) identified in order to determine its calibration or verification status;
c) safeguarded from adjustments, damage or deterioration that can invalidate measurement results.
When measuring equipment is found to be unfit for its intended purpose, the organization shall determine
whether the validity of previous measurement results has been adversely affected and shall take appropriate
action as necessary.

The organization shall determine the knowledge necessary for the operation of its processes and to achieve
the intended results of its quality management system.
This knowledge shall be retained, applied and shared to the extent necessary.
When addressing changing needs and trends, the organization shall consider its current knowledge and
determine how to acquire or access any necessary additional knowledge and required updates.
NOTE Organizational knowledge can take different forms, such as:
— experience-based knowledge held by people;
— knowledge acquired through education, training and learning from others;
— knowledge embedded in methods, processes and products;
— knowledge represented in documented information, digital systems and other media.

The organization shall:
a) determine the necessary competence of person(s) doing work under its control that affects its quality
management system performance;
b) ensure that these persons are competent on the basis of appropriate education, training or experience;
c) where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness of
the actions taken.
Appropriate documented information shall be available as evidence 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.

The organization shall ensure that persons doing work under the organization’s control are aware of:
a) the quality policy;
b) their contribution to the effectiveness of the quality management system, including the benefits of
improved performance;
c) the implications of not conforming to the quality management system requirements;
d) relevant quality objectives;
e) the organizational quality culture and ethical behaviour.

The organization shall determine the internal and external communications relevant to the quality
management system, including:
a) on what it will communicate;
b) when to communicate;
c) with whom to communicate;
d) how to communicate;
e) who communicates.

The organization’s quality management system shall include:
a) documented information required by this document;
b) documented information determined by the organization as being necessary for the effectiveness of the
quality management system.
NOTE The extent of documented information for a quality management system can differ from one organization
to another due to:
— the size of organization and its type of activities, processes, products and services;
— the complexity of processes and their interactions;
— the competence of persons.

When creating and updating documented information, the organization shall ensure appropriate:
a) identification and description (e.g. a title, date, author, reference number);
b) format (e.g. language, software version, graphics) and media (e.g. paper, electronic);
c) review and approval for suitability and adequacy.

be controlled to ensure:
a) it is available and suitable for use, where and when it is needed;
b) it is adequately protected (e.g. from loss of confidentiality, improper use or loss of integrity).

as applicable:
a) distribution, access, retrieval and use;
b) storage and preservation, including preservation of legibility;
c) control of changes (e.g. version control);
d) retention and disposition.
Documented information of external origin determined by the organization to be necessary for the planning
and operation of the quality management system shall be identified as appropriate and controlled.
Documented information available as evidence of conformity shall be protected from unintended alterations.
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.

The organization shall plan, implement and control the processes needed to meet requirements for the
provision of products and services, and to implement the actions determined in Clause 6, by:
a) determining the requirements for products and services (see 8.2);
b) establishing criteria for the acceptance of products and services;
c) establishing criteria for the processes;
d) implementing control of the processes in accordance with the criteria;
e) determining the resources needed to achieve conformity to the product and service requirements.
Documented information shall be available to the extent necessary to have confidence that the processes
have been carried out as planned.
The organization shall control planned changes and review the consequences of unintended changes, taking
action to mitigate any adverse effects, as necessary.
The organization shall ensure that externally provided processes, products or services that are relevant to
the quality management system are controlled (see 8.4).
Documented information shall be available to the extent necessary as evidence of the conformity of products
and services.

Communication with customers shall include:
a) providing information relating to products and services;
b) handling enquiries, contracts or orders, including changes;
c) obtaining customer feedback relating to products and services, including customer complaints;
d) handling or controlling customer property;
e) providing information related to contingency actions, when relevant, including any related to
disruptions to the provision of products or services.
NOTE Customer communication can include direct contacts through meetings, emails and document exchange or
indirectly through website content, publications, social media, responses to frequently asked questions and training.

When determining the requirements for the products and services to be offered to customers, the
organization shall ensure that:
a) the requirements for the products and services are defined, including:
1) any applicable statutory and regulatory requirements;
2) those considered necessary by the organization;
b) it can meet the claims for the products and services it offers.

services to be offered to customers. Before committing to supply products and services to a customer, the
organization shall conduct a review that includes:
a) requirements defined by the customer, including requirements for delivery and post-delivery activities
when applicable;
b) requirements not defined by the customer, but necessary for the specified or intended use, when known;
c) requirements specified by the organization;
d) statutory and regulatory requirements applicable to the products and services;
e) contract or order requirements differing from those previously expressed.
The organization shall ensure that contract or order requirements differing from those previously defined
are resolved.
When the customer does not provide a documented statement of their requirements, the organization shall
confirm the customer requirements before acceptance.
NOTE In some situations, such as internet sales, a formal review is impractical for each order. Instead, the review
can cover relevant product or service information, such as websites or catalogues.

a) the results of the review;
b) any new or changed requirements for the products and services.

When requirements for products and services are changed, the organization shall ensure that the relevant
documented information is updated and communicated to the relevant interested parties.

The organization shall establish, implement and maintain a design and development process that is
appropriate to ensure the subsequent provision of products and services.
NOTE The design and development process can include cycles of review, verification, validation and feedback,
allowing for an iterative approach throughout the design and development stages.

In determining the stages and controls for design and development, the organization shall consider:
a) the nature, duration and complexity of the design and development activities;
b) the required process stages, including applicable design and development reviews;
c) the required design and development verification and validation activities;
d) the responsibilities and authorities involved in the design and development process;
e) the internal and external resource needs for the design and development of products and services;
f) the need to control interfaces between persons involved in the design and development process;
g) the need for involvement of customers and other relevant interested parties in the design and
development process;
h) the requirements for the subsequent provision of products and services;
i) the level of control expected for the design and development process by customers and other relevant
interested parties;
j) the documented information needed as evidence that design and development requirements have been
met.

The organization shall determine the requirements essential for the specific types of products and services
to be designed and developed. The organization shall consider:
a) functional and performance requirements;
b) information derived from previous similar design and development activities;
c) statutory and regulatory requirements;
d) standards or codes of practice that it has committed to implement;
e) the potential consequences of failure due to the nature of the products and services.
Inputs shall be complete, unambiguous and adequate for design and development purposes.
Conflicting design and development inputs shall be resolved.
Documented information shall be available as evidence of design and development inputs.
NOTE Design and development inputs are not always fully defined or known initially. Instead, they can evolve as
the design progresses, through repeated cycles of development activity.

The organization shall apply controls to the design and development process to ensure that:
a) the results to be achieved are defined;
b) reviews are conducted to evaluate the ability of the results of design and development to meet
requirements;
c) verification activities are conducted to ensure that the design and development outputs meet the input
requirements;
d) validation activities are conducted to ensure that the resulting products and services meet the
requirements for the specified application or intended use;
e) necessary actions are taken to address problems determined during the reviews, or verification and
validation activities;
f) documented information is available as evidence of these activities.
NOTE Design and development reviews, verification and validation have distinct purposes. They can be conducted
separately or in any combination, as is suitable for the products and services of the organization.

The organization shall ensure that design and development outputs:
a) meet the input requirements;
b) are adequate for the subsequent processes for the provision of products and services;
c) include or reference monitoring and measuring requirements, as appropriate, and acceptance criteria;
d) specify the characteristics of the products and services, and the information on the products and
services, that are essential for their intended purpose including their safe and proper provision.
Documented information shall be available as evidence of design and development outputs.

The organization shall determine, review and control changes made during, or subsequent to, the design
and development of products and services, to the extent necessary to ensure that there is no adverse impact
on conformity to requirements.
Documented information shall be available as evidence of:
a) design and development changes;
b) results of reviews;
c) authorization of the changes;
d) actions taken to prevent adverse impacts.

The organization shall ensure that externally provided processes, products and services conform to
requirements.
The organization shall determine the controls to be applied to externally provided processes, products and
services when:
a) products and services from external providers are intended for incorporation into the organization’s
own products and services;
b) products and services are provided directly to customers by external providers on behalf of the
organization;
c) a process, or part of a process, is provided by an external provider.
The organization shall determine and apply criteria for the evaluation, selection, monitoring of performance,
and re-evaluation of external providers, based on their ability to provide processes, products or services in
accordance with requirements.
Documented information shall be available as evidence of these activities and any necessary actions arising
from the evaluations.

The organization shall ensure that externally provided processes, products and services do not adversely
affect the organization’s ability to consistently deliver conforming products and services to its customers.
The organization shall:
a) ensure that externally provided processes are within the control of its quality management system;
b) define both the controls that it intends to apply to an external provider and those it intends to apply to
the resulting output;
c) take into account:
1) the potential impact of the externally provided processes, products and services on the organization’s
ability to consistently meet customer and applicable statutory and regulatory requirements;
2) the effectiveness of the controls applied by the external provider;
d) determine the verification, or other activities, necessary to ensure that the externally provided
processes, products and services meet the requirements.

The organization shall ensure the adequacy of requirements prior to their communication to the external
provider.
The organization shall communicate its requirements to external providers, as appropriate, for:
a) the processes, products and services to be provided;
b) the approval of:
1) products and services;
2) methods, processes and equipment;
3) the release of products and services;
c) competence, including any required qualifications;
d) the external providers’ interactions with the organization and, as applicable, its customers and other
relevant interested parties;
e) the control and monitoring it applies to the performance of its external providers;
f) verification or validation activities that the organization, or its customer, intends to perform at the
external providers’ premises or other location.

The organization shall implement production and service provision under controlled conditions.
The controlled conditions shall include, as applicable:
a) the availability and use of documented information that defines:
1) the characteristics of the products or services;
2) the activities to be performed;
3) the results to be achieved;
b) the availability and use of suitable monitoring and measuring resources;
c) the implementation of monitoring and measurement activities at appropriate stages to verify that
criteria for control of processes or their outputs, and acceptance criteria for products and services, have
been met;
d) the use of suitable infrastructure and environment for the operation of processes;
e) the appointment of competent persons, including any required qualifications;
f) the validation, and periodic revalidation, of the ability to achieve planned results of the processes
for production and service provision, where the resulting output cannot be verified by subsequent
monitoring or measurement;
g) the implementation of actions to prevent human error;
h) the implementation of release, delivery and post-delivery activities.

The organization shall:
a) use suitable means to identify outputs when it is necessary to ensure the conformity of products and
services;
b) identify the status of outputs with respect to monitoring and measurement requirements throughout
production and service provision;
c) control the unique identification of the outputs when traceability is a requirement;
d) ensure that documented information necessary to enable traceability is available as evidence.

The organization shall exercise care with property belonging to customers or external providers while it is
under the organization’s control or being used by the organization.
The organization shall identify, verify, protect and safeguard property belonging to customers or external
providers that is provided for use or incorporation into the products and services.
When the property belonging to a customer or external provider is lost, damaged or otherwise found to
be unsuitable for use, the organization shall report this to the customer or external provider. Documented
information shall be available as evidence of what has occurred.
NOTE Property belonging to a customer or external provider can include materials, components, tools and
equipment, premises, intellectual property and personal data.

The organization shall preserve the outputs during production and service provision, to the extent necessary
to ensure conformity to requirements.
NOTE Preservation can include identification, handling, contamination control, packaging, storage, transmission
or transportation, and protection.

The organization shall meet the requirements for post-delivery activities associated with the products and
services.
In determining the extent of post-delivery activities that are required, the organization shall consider:
a) statutory and regulatory requirements;
b) the potential undesired consequences associated with its products and services;
c) the nature, use and intended lifetime of its products and services;
d) customer requirements;
e) customer feedback.
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.

The organization shall review and control changes for production or service provision, to the extent
necessary to ensure continuing conformity with requirements.
Documented information shall be available as evidence of the results of the review of changes, the person(s)
authorizing the change and any necessary actions arising from the review.

The organization shall implement planned arrangements, at appropriate stages, to verify that the product
and service requirements have been met.
The release of products and services to the customer shall not proceed until the planned arrangements have
been satisfactorily completed, unless otherwise approved by a relevant authority and, as applicable, by the
customer.
Documented information shall be available as evidence of the release of products and services. The
documented information shall include:
a) evidence of conformity with the acceptance criteria;
b) traceability to the person(s) authorizing the release.

controlled to prevent their unintended use or delivery.
The organization shall take appropriate action based on the nature of the nonconformity and its effect on
the conformity of products and services. This includes nonconformities detected after product delivery or
during or after service provision.
The organization shall deal with nonconforming outputs in one or more of the following ways:
a) correction;
b) segregation, containment, return or suspension of provision of products and services;
c) informing the customer;
d) obtaining authorization for acceptance under concession.
When nonconforming outputs are corrected, the organization shall verify conformity to the requirements.

a) the nature of the nonconformity;
b) the actions taken;
c) any concessions obtained;
d) the authority deciding the action in respect of the nonconformity.

The organization shall determine:
a) what needs to be monitored and measured;
b) the methods for monitoring, measurement, analysis and evaluation, as applicable, to ensure valid
results;
c) when the monitoring and measuring shall be performed;
d) when the results from monitoring and measurement shall be analysed and evaluated.
The organization shall evaluate the performance and the effectiveness of the quality management system.
Documented information shall be available as evidence of the results.

The organization shall monitor customer satisfaction. The organization shall determine the methods for
obtaining, monitoring and reviewing customer satisfaction information.
NOTE Sources of information to support understanding of customer satisfaction can include customer surveys,
customer feedback on delivered products and services, meetings with customers, market-share analysis, compliments,
complaints, warranty claims, dealer reports or social media.

The organization shall analyse and evaluate relevant data and information arising from monitoring and
measurement.
The results of analysis shall be used to evaluate:
a) the conformity of products and services;
b) customer satisfaction;
c) the performance and effectiveness of the quality management system;
d) the effectiveness of planning implementation;
e) the effectiveness of actions taken to address risks;
f) the effectiveness of actions taken to address opportunities;
g) the performance of external providers;
h) the need for improvements to the quality management system.
NOTE Methods to analyse data can include statistical techniques.

The organization shall conduct internal audits at planned intervals to provide information on whether the
quality management system:
a) conforms to:
1) the organization’s own requirements for its quality management system;
2) the requirements of this document;
b) is effectively implemented and maintained.

The organization shall plan, establish, implement and maintain (an) audit programme(s), including the
frequency, methods, responsibilities, planning requirements and reporting.
When establishing the internal audit programme(s), the organization shall consider the importance of the
processes concerned, the results of previous audits and changes affecting the organization.
The organization shall:
a) define the audit objectives, criteria and scope for each audit;
b) select auditors and conduct audits to ensure objectivity and the impartiality of the audit process;
c) ensure that the results of audits are reported to relevant managers;
d) take appropriate correction and corrective actions without undue delay.
Documented information shall be available as evidence of the implementation of the audit programme(s)
and the audit results.
NOTE See ISO 19011 [4] for guidance on auditing management systems.

Top management shall review the organization’s quality management system, at planned intervals, to
ensure its continuing suitability, adequacy, effectiveness and alignment with the strategic direction of the
organization.

The management review shall include:
a) the status of actions from previous management reviews;
b) changes in external and internal issues that are relevant to the quality management system;
c) changes in needs and expectations of interested parties that are relevant to the quality management
system;
d) information on the quality management system performance, including trends in:
1) nonconformities and corrective actions;
2) monitoring and measurement results;
3) audit results;
4) customer satisfaction and feedback from relevant interested parties;
5) the extent to which quality objectives have been met;
6) process performance and conformity of products and services;
7) the performance of external providers;
e) opportunities for improvement;
f) the adequacy of resources;
g) the effectiveness of actions taken to address risks (see 6.1.2);
h) the effectiveness of actions taken to address opportunities (see 6.1.3).

The results of the management review shall include decisions related to continual improvement opportunities
and any need for changes to the quality management system and resource needs.
Documented information shall be available as evidence of the results of management reviews.

The organization shall continually improve the suitability, adequacy and effectiveness of the quality
management system.
The organization shall consider the results of monitoring, measurement, analysis and evaluation of data
and information, and the results of management review, to determine opportunities. The organization shall
address these opportunities as part of continual improvement.
Actions shall include:
a) improving processes, products and services;
b) addressing future needs and expectations;
c) correcting, preventing or reducing undesired effects.
NOTE Improvement can be achieved through incremental or breakthrough change, innovation or reorganization
initiatives.

a) react to the nonconformity, and as applicable:
1) take action to control and correct it;
2) deal with the consequences;
b) evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not
recur or occur elsewhere, by:
1) reviewing the nonconformity;
2) determining the causes of the nonconformity;
3) determining if similar nonconformities exist, or can potentially occur;
c) implement any action needed;
d) review the effectiveness of any corrective action taken;
e) update the risks and opportunities determined during planning, if necessary;
f) make changes to the quality management system, if necessary.
Corrective actions shall be appropriate to the effects of the nonconformities encountered.
NOTE Customer complaints can be a source of nonconformities.

a) the nature of the nonconformities and any subsequent actions taken;
b) the results of any corrective action.