Welcome again to this blog. In this entry I start the analysis of the groups of requirements corresponding to Clause 5 of the ISO 9001: 2015 standard, so I am starting with Sub-clause 5.1 Leadership and commitment. As we will see, this subclause is of great importance and contains a large number of requirements, so in this post we will analyze Section 5.1.1 General.
The group of requirements contained in Sub-clause 4.4
of this standard, were analyzed in three parts.
In the first of these parts, I analyzed the first four requirements of this sub-clause, referring to aspects that an organization should accomplish with regarding the quality management system, that is, that the QMS shall be established, shall be implemented, shall be maintained and shall be continuously improved. (If you want to access the entry of this firstpart, please click here).
In the entry
corresponding to the second part of
this analysis, I present a description of the process approach that this standard requires, as well as the description of what a process is, the elements that make it
up, the line of action to establish a process,
as well as the Plan-Do-Check-Act (PDCA)
Cycle that should be used to establish and document a process; and also in that entry I
analyze the requirements from No. 33 to No. 38 according to
the identification of requirements of this sub-clause (If you wish to access the entry of this second part, please click here).
In the third part of this discussion, I
present to you a description of the remaining requirements corresponding to that Sub-Clause 4.4, which deal with the determination and application of various elements
necessary for the processes management.
(If you want to access the entry of this third party, please click here).
Before
beginning with the analysis of the requirements of this Section
5.1.1 General, I consider it important
to present to you some additional useful information for a better understanding
and application of all the requirements of this Section
5.1.1.
The first
thing we should know, or remember, is that directing is one of the components of the management
process for any productive organization, and it is what makes the organization operate its processes and
activities necessary for its productive performance. And within that directing component, leadership is an essential element, so that it motivates, involves and guides all
the organization's staff to achieve its objectives and, through
these, fulfill its vision and its mission. There are different styles or ways of exercising leadership in an organization, which we are not going to discuss here, but what
is important is to recognize the importance of exercising that leadership, and that leaders should be identified, supported
and followed by the organization and they should be aligned with the mission, vision and organizational objectives.
Now, going
into what is indicated in the quality management system standards, this Clause 5 Leadership
in the ISO 9001 standard, is that leadership in quality management systems is not only considered by the requirements contained in this subclause, but it forms one of the "Principles of quality management" presented in the ISO 9000:2015 standard in its Clause
2: Fundamental concepts and principles of quality management, in which it mentions that the concepts and principles of quality management described in it provide the organization with the ability to meet the challenges presented
by an environment that is profoundly different from that of recent decades The context in which an organization works today is characterized by accelerated
change, globalization of markets, limited resources and the emergence of
knowledge as a main resource. The
impact of quality extends beyond customer
satisfaction and can also have a direct impact on the organization's reputation.
The principles of quality management are, in
accordance with the ISO 9000:2015 standard, the following:
- customer
focus;
- leadership;
- engagement
of people;
- process
approach;
- improvement;
- evidence-based
decision making;
- relationship
management.
All of these quality
management principles should be applied, and their related processes managed, by the organization´s top management.
However, as
in this entry we are going to
analyze the requirements derived of Section 5.1.1.
Leadership and commitment, I present
to you the complete information, contained in this standard, about the leadership principle in quality management.
In addition to this information presented on this Leadership principle, it is convenient to consider the information presented in Technical Specification ISO/TS 9002: 2016 — Quality management systems — Guidelines for the application of ISO 9001:2015.
This document
tells us that the intent of this section is to ensure that top management demonstrates leadership and commitment by taking an
active role in engaging, promoting, and ensuring, communicating and monitoring
the performance and effectiveness of the quality management system. The ways it can be applied are based on various
factors, such as the size and complexity of the organization, management
style and organizational
culture.
This technical specification explains that
for an organization, “top management” may include, for example, the chief executive officer, managing
director, general manager, chairman, board of directors, executive directors,
managing partners, single owner, partners and senior executives/managers. Top
management has the power
to delegate authority and provide resources within the organization. If the scope of the management
system covers only
part of an organization, then top management refers to those who direct and control that part of
the organization.
It tells us
that each organization has different needs and its own specific solution
that will be decided by top management. It is important for top management to ensure that the organization´s quality
management system processes are integrated with its business processes.
It is also
important to recognize that leadership is an ability, inborn or acquired, to inspire others by influencing
actions, decisions, and behaviors in positive ways. Therefore, the concept
refers to a practice that has accompanied humanity throughout history and that
has been practiced in corporate environments so that leaders and their teams work towards the same goal.
In order for
an organization to establish and operate a quality
management system, in which
all the personnel that make it up should participate, or a large proportion of
it, it is considered convenient that there are several leaderships within it, at all levels, but all aligned with the
leadership exercised by
top management, so that
visible leadership is
generated, that all these personnel are involved in this effort, that know and
understand what each person is expected to do, with whom they can support in
case of doubts, that they can commit to do things in the best possible way, and
that they obtain the best possible results.
One of the
most common failures in organizations
that have established quality management systems, based on the ISO 9001: 2015 standard, is that top management does not exercise appropriate leadership to establish its corresponding management
system. Many managers hold the belief that exercising leadership is giving orders to the staff, either in writing
or verbally, and demanding that they comply with them, and that these staff
will automatically carry out all the activities entrusted to them and comply
with all responsibilities assigned to them, continuously and without defects or
failures. But this is not so simple. The exercise of leadership is a continuous and complex activity that
establishes communication, motivates, involves, commits, guides, follows up,
ensures the achievement of the expected result, and makes all participants feel
proud and recognized for their achievements. It is therefore important that top
management take this leadership seriously, and ensure that all requirements established by the standard on this section and this entire clause are met.
It is also
important to mention that we should be careful when analyzing this Section 5.1.1 within Sub-Clause 5.1 – Leadership and commitment, as well as to meet its requirements, since the said section is titled “General”, which causes many people to downplay it, thinking
it means their requirements are irrelevant, which they are not. Each of them
contains essential elements for top management.
I start then,
after this brief introduction to the subject, with the analysis of these requirements, related to leadership and commitment, which I will
analyze in this post, and which are the following:
All these requirements derived from Section 5.1.1 –
General, as a component of Sub-Clause 5.1 -Leadership and Commitment, refer to top management, and each of them establishes a necessary element for this top management to demonstrate its leadership and commitment
with respect to quality
management system, but it is
important that we identify each of these elements, avoiding confusion due to
the similar wording of these requirements.
Many of these
requirements that derive
from this Sub-clause
5.1 have the
problem that they are so logical and simple that many people do not understand
them, do not give them the necessary importance, or believe that since they are
general requirements they are already meeting them, which is far from
reality. It is quite common that organizations that have established their quality
management system in accordance with this ISO 9001: 2015 standard, do not formally meet these requirements, so it should be considered that every organization must take the appropriate measures to comply with
all applicable requirements in its quality management systems, such as all of those in this Section 5.1.1.
Requirement No. 58:
Top
management shall demonstrate leadership and commitment
with respect to the quality management system by taking accountability for the
effectiveness of the quality management system.
The Technical
Specification TS 9002: 2016 includes a
section that indicates for top management to make it clear that they understand and are accountable for the effectiveness of the quality
management system by taking responsibility
for its activities and by being able to explain the results that are achieved;
although certain authorities and responsibilities (see Sub-clause 5.3 in ISO 9001:2015) can be delegated, the accountability remains with top management.
It is
important that top management assume this obligation, regardless of whether or
not the expected results are achieved, that is, whether or not the quality
management system is effective.
The following
six requirements are presented in the same paragraph of the standard, and share the same text, so it is
necessary to differentiate the wording for each of them to avoid generating
confusion.
Requirement No. 59:
Top
management shall demonstrate leadership and commitment
with respect to the quality management system by ensuring that the quality policy is established for the quality management system of the organization.
When we
analyze the requirements derived from Subclause 5.2
of this ISO 9001 standard, we will see in depth what the quality policy is and what components and characteristics this
element of the quality management system should have.
What is
important, in relation to this requirement, is that top management ensures that a quality policy is established for its quality management system, since this policy
is the primary strategic element within the quality management system.
Requirement No. 60:
Top
management shall demonstrate leadership and commitment
with respect to the quality management system by ensuring that the quality policy is compatible with the context of the organization.
It is
important that when establishing and reviewing the quality policy, top management ensures that all information derived from meeting
the requirements of Sub-Clauses 4.1
to 4.4 of the ISO 9001 standard is considered, that is, external
and internal issues that the organization has established and are relevant to its purpose and strategic direction, and that
affect its ability to achieve the intended
results of its quality management system, the needs and expectations of interested parties that have been
determined, the scope of this QMS that has been determined, as well as the quality
management system itself and all its processes and interactions.
As you
probably have observed, in this text two terms have been incorporated that are very
relevant in order for an organization to be able to comply with these requirements, and they are the following: purpose and strategic direction. Interestingly, these terms appear several times, both in the ISO 9001:
2015 standard, and in the ISO 9002: 2016
technical specification, in addition
to other management system standards, and refer
to elements of great importance to the organization, however, these terms are not defined in these normative
documents, nor in ISO 9000:2015. Therefore, we will have to define these terms, in order to identify
and understand them.
We will take
an in-depth look at these terms when we get to the requirements of Section
5.2.1 Establishment of quality policy, as a component of Sub-Clause 5.2 – Policy. It is enough for now that we stay with the following definitions:
Requirement No. 61: Top management shall demonstrate leadership and commitment with respect to the quality management system by ensuring that the quality policy is compatible with the strategic direction of the organization.
To meet this requirement, top management should ensure that it establishes the quality policy considering all relevant elements of strategic
management, from the organization's purpose, mission, vision, values, policies, objectives and goals, with the aim of so that it does not conflict with
another strategic element of the organization, be it from this management
system or from another.
Requirement No. 62: Top management shall
demonstrate leadership and commitment with respect to the quality management system by ensuring that the quality objectives are established for the quality management system of the organization.
Technical Specification TS 9002:2016 indicates that top management should ensure that quality objectives (see ISO 9001:2015, Sub-clause 6.2) are established for the quality management system; These quality objectives could be established or reviewed during regular meetings of top management, such as those for strategic planning or management review purposes.
As with the quality policy, in order not to get ahead of ourselves, we will
also analyze the quality objectives and their characteristics in detail, when we analyze the requirements derived from Sub-clause 6.2 -
Quality objectives and planning to achieve them. What is important is that the establishment of
these quality objectives is a demonstration of leadership exercised by top
management in relation to the quality
management system.
Requirement No. 63: Top management shall
demonstrate leadership and commitment with respect to the quality management system by ensuring that the quality objectives are compatible with the context of the organization.
When setting and reviewing quality objectives, top management should ensure that all information derived from meeting requirements of Sub-Clauses 4.1 to 4.4 is considered, that is, external
and internal issues that the organization has established and that are relevant to its purpose and strategic direction, and affect your ability to achieve the intended results of your quality management system, the determined needs and expectations of interested parties, the determined scope of the QMS , as well as
the quality management system itself and all its processes
and interactions.
Requirement No. 64: Top management shall demonstrate leadership and commitment with respect to the quality management system by ensuring that the quality objectives are compatible with the strategic direction of the organization.
In order to meet this requirement, top management should ensure that they establish quality
objectives considering all relevant elements for strategic management, from the organization's purpose,
mission, vision, values, policies, objectives and goals, with the aim of so that it does not conflict with
another organization´s strategic element, be it from this management
system or from another.
Regarding these last six requirements, the technical Specification TS 9002: 2016 indicates that top management should ensure that the quality policy (see Sub-clause 5.2 of ISO 9001:2015) and quality objectives (see Sub-clause 6.2 of ISO 9001:2015) are established taking into account the strategic direction and context of the organization; The quality policy and quality objectives may be established or reviewed during regular meetings of top
management, such as
those for strategic planning or management review purposes.
Requirement No. 65: Top management shall
demonstrate leadership and commitment with respect to the quality management system by ensuring the integration of the quality management system requirements
into the organization’s business processes.
Regarding this requirement, the Technical specification TS 9002: 2016 indicates that top management should ensure that the organization's quality management system processes are integrated and managed within its overall business processes, and not treated as
“add-on” or conflicting activities.
As I mentioned previously, this requirement, like most of those that derive from this sub-clause, have the problem that they are so logical and
simple that many people do not understand them, or do not give them the
necessary importance. It is quite common that organizations that have established their QMS in
accordance with this ISO 9001: 2015 standard, do not formally meet this requirement, so they fall into what the aforementioned TS 9002 mentions, that is, that these quality management systems are not integrated into the production systems or their business processes, which is why they
often remain as an added element, like a tumor or a wart, not as an integral
part of the organization's management system, which means that it does not generate the
benefits that would be expected from such a system.
Requirement No. 66: Top management shall
demonstrate leadership and commitment with respect to the quality management system by promoting the use of the process approach.
Regarding this requirement, the Technical Specification TS 9002: 2016 indicates that top
management should promote the process approach, for example, ensuring effective interaction
between processes, with a systematic approach designed to achieve an effective flow of inputs and outputs.
In this sense, it is important to consider that top management is not
necessarily going to design all the processes
that make up the organization's quality management system; however, this requirement assigns it the responsibility of promoting that in all areas where they are
carried out activities or processes
are developed and carried out, the process
approach is applied. This will help to show its leadership and commitment,
as well as promote the establishment of appropriate interactions between processes, considering their inputs and
outputs.
Requirement No. 67: Top management shall
demonstrate leadership and commitment with respect to the quality management system by promoting the use of the risk-based
thinking.
Regarding this requirement, the Technical specification TS 9002: 2016 indicates that top management should promote risk-based
thinking, for example, by ensuring cooperation when dealing with risks and opportunities.
As with the previous requirement, when top management promotes risk-based thinking,
in addition to showing its leadership and commitment,
it promotes the identification and consideration of all risks, as well as all opportunities,
that the organization may face in its processes management, in order to manage these risks and opportunities optimally.
Requirement No. 68: Top management shall
demonstrate leadership and commitment with respect to the quality management system by ensuring that the resources needed for the quality management system are available.
Regarding this requirement, the Technical specification TS 9002: 2016 indicates that top
management should monitor the current and projected workload
and schedules, to ensure that adequate resources of the quality management system are provided (people, tools, equipment, etc.), when and where they are
needed.
The key in order to meet this requirement is the provision of all the necessary resources for the quality management system, with precision and timeliness.
Requirement No. 69: Top management shall
demonstrate leadership and commitment with respect to the quality management system by communicating the importance of effective
quality
management.
Regarding this requirement, the Technical Specification TS 9002: 2016 indicates that top
management should communicate, via internal meetings, email,
personal conversations, the organization's intranet, etc., the value and benefits of the Quality management system.
Top management should let all staff know that one of the characteristics that the quality management system should have is that it be effective, that is, that it achieve all the
established objectives and goals. The purpose of establishing this system should not be
to establish it, but to achieve the planned results, and all personnel involved in the system should be
aware of and committed to it.
Requirement No. 70: Top management shall demonstrate leadership and commitment with respect to the quality management system by communicating the importance of conforming
to the quality
management system requirements.
Regarding this requirement, the Technical Specification TS 9002: 2016 indicates that top
management should communicate, through internal meetings,
email, personal conversations, the organization's intranet, etc., the value and
benefits of adherence to the requirements of the quality management system.
It is important to consider that the quality
management system requirements specified in this ISO 9001: 2015
standard are complementary to the requirements
for products
and services, and that of those, should be considered all that are applicable
to the organization's quality management system.
Requirement
No. 71: Top
management shall demonstrate leadership and commitment
with respect to the quality management system by ensuring that the quality management system achieves its intended result.
Regarding this requirement, the Technical Specification TS 9002: 2016 indicates that top management should ensure that the quality management system achieves its expected
results by monitoring its outputs; Sometimes actions may be required to correct or improve the processes of
the system or its components, and top management should ensure that that
whatever actions are needed are properly assigned and resourced.
The following three requirements are presented in the
same paragraph of the standard, and share the same text, so it is necessary to differentiate the wording for each of them to
avoid generating confusion.
Requirement
No. 72: Top
management shall demonstrate leadership and commitment
with respect to the quality management system by engaging persons to contribute to the effectiveness of the quality management system.
The key to this requirement is that top management
achieves, through exercising of its leadership and commitment, engage
persons to contribute to the effectiveness of the quality management system.
Within the definitions presented by the Collins
Dictionary on this term "engaging", the most convenient one is the following:
Requirement No. 73: Top management shall demonstrate leadership and commitment with respect to the quality management system by directing persons to contribute to the effectiveness of the quality management system.
The key for meeting this requirement is that top management achieves, through exercising
its leadership and commitment,
direct people to contribute to the effectiveness of the quality management
system.
Within the definitions presented by the Collins
Dictionary on this term "directing", the most appropriate is
the following:
Requirement No. 74: Top management shall demonstrate leadership and commitment with respect to the quality management system by supporting persons to contribute to the effectiveness of the quality management system.
The key for meeting this requirement is that top management achieves, through exercising its leadership and commitment,
support people to contribute to the effectiveness of the quality
management system.
Among the
definitions presented on this term "supporting", the most convenient are the following:
Regarding this requirement, the Technical Specification TS 9002: 2016 indicates that top management should engage, should direct and should support persons in the organization to contribute to the effectiveness of the quality management system by communicating with them (see Sub-clause 7.4 of ISO 9001:2015); This could include top management serving as the champion on projects when improvements are needed, and encouraging employees and others to participate as members of improvement teams.
Requirement No. 75:
Top
management shall demonstrate leadership and commitment
with respect to the quality management system by promoting improvement.
In relation
to what is established here, we should remember that continuous improvement is a necessity for a quality
management system to maintain
its validity and benefits over time.
Regarding
this requirement, the Technical specification TS 9002: 2016 indicates that top management should promote improvement
while ensuring that information and recommendations from audits and other assessments and management review (see Sub-Clause 9.3 of ISO 9001:2015) are communicated
to responsible persons (which can also help demonstrate the value and benefits
of improvements);
Requirement No. 76:
Top
management shall demonstrate leadership and commitment
with respect to the quality management system by supporting other relevant management roles to
demonstrate their leadership as it applies to their areas of responsibility.
What this requirement establishes for us is that top
management should
support all management functions, in order to demonstrate their leadership and commitment,
promoting that all relevant units, areas and functions of the organization fulfill their own roles and responsibilities.
Regarding
this requirement, the Technical specification TS 9002: 2016 indicates that top management should provide support and guidance to persons in other relevant
managerial roles, to help them demonstrate leadership as it applies to their own specific areas of influence; this could
include mentoring and supporting them in making specific decisions which help
the organization conform better to requirements, or to drive improvements
when needed.
Effective leadership and commitment can lead to a better
understanding by people in the organization of how they contribute to the quality
management system, which can
help the organization consistently achieve its intended results.
In the next entry I will continue with the
analysis of requirements of this Subclause 5.1, corresponding to Section 5.1.2 – Customer focus.
Author:
Ernesto Palomares Hilton
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