Welcome back to this page. I hope, as always, that the information presented here is of interest to you and that it helps to deepen your knowledge of ISO 9001:2015 and its requirements somewhat.
In the
previous entry we carried out the analysis of the first three requirements of this section of the standard. If you want to access this text, click here.
In this entry I will continue with the analysis of the following
nine requirements of this group corresponding to Section 5.2.1 Establishing the quality policy, which in turn is part of Sub-clause 5.2 –
Policy, of this ISO 9001 standard.
It is
important that when we consider establishing, implementing, verifying,
reviewing, auditing and maintaining the quality policy, we take into account all elements presented in that previous
entry, as well as those presented in this one.
In order that
you can identify all the requirements that are broken down in this Section 5.2.1
of the ISO 9001 standard, I present the complete list again:
Allow me to
present you as a simple example of this characteristic that I comment on in
these standards, considering only what
refers to subparagraph
a) of this section. The text states the
following:
“Top
management shall establish, implement and maintain a quality
policy that is appropriate to the purpose and context of the organization and supports its strategic direction”.
When reading
this text, have you been able to
identify the nine requirements specified here? And if so, would you be identifying
each of them with the same level of
importance?
Many people,
when reading this type of text,
subjectively establish a different level
of importance to requirements, as they are presented in the text, considering
that the first one that appears is the most important, and the others decrease
in level of importance in progressive order. This phenomenon achieves that when
trying to comply with these requirements in organizations, they give preference to the first ones that are
indicated in the text, and the
others are given less relevance, and some of them are not even considered as
specific requirements. That is, they become invisible to those organizations, and therefore there are requirements that have never been identified, so they are never met. And just as it
happens with the personnel of the organizations, it also happens with the auditors, both internal and external, even if they are qualified, as well as with the evaluators of certification and accreditation
bodies.
This is the motivation I have had to carry out this type of analysis of requirements of these management system standards, although it may seem excessive or repetitive, but in this way I can help all the people whose activity is related to this type of management system.
If you doubt
what I am mentioning here, I suggest that you analyze the documentation of the quality management system of the organization in which you work and compare whether the first requirement of this Section 5.2.1
is given the same treatment as the I presented in
the previous entry, with No. 92, which
states: "Top management shall establish a quality policy that is appropriate to the purpose of the organization"
Now compare
that description with the one corresponding to the requirement that I present to you in this entry, with No. 100, which is the last one that is presented in this subsection, and that says: "Top management shall maintain a quality policy that support the strategic direction of the organization.
There you
will see if the different requirements are given equal importance in your organization.
A very clear
example in relation to what I am commenting on here, we can see in the Technical
Specification ISO/TS 9002: 2016 - Quality management systems — Guidelines for
the application of the ISO 9001:2015 Standard. In the previous post I presented what this specification indicates in relation to Section 5.2.1, which states that the intent
of this sub-clause
is to ensure that a quality policy is established which aligns with the strategic direction of the organization, including the organization’s overall understanding of what quality means to itself and for its customers. The quality
policy describes the
intentions and direction of the organization as formally expressed by its top
management.
Interestingly,
in this description it only refers to the quality policy being established, but it does not even mention that this policy shall be
implemented and also maintained. And in the same way, in reference to subparagraph a)
of the standard, it mentions nothing more than that said policy should be
appropriate to the organization and support the strategic direction, but it does not specify that it should be appropriate to the purpose and context of the organization.
That is where
we find the main difficulty when an organization tries to establish a management system in accordance with this standard, not to identify all requirements or not to give the same importance
for their identification and fulfillment.
The ISO 9001:2015 Standard establishes the
following requirements, individually separated, and I present them with
the corresponding progressive numbering, as I have been presenting all requirements of this standard that I have been analyzing.
Requirement No. 95: Top management shall
implement a quality policy that is appropriate to the purpose of the organization.
What this requirement tells us is that once top management has established the quality policy, top management itself should implement it. So that we all can understand this requirement clearly, I present the definition of this term:
Based on this
definition, we can understand that top management should give practical effect to this policy, and ensure
that it is accomplished throughout the organization, at all relevant levels and functions, each of the
elements (intentions and direction) that make up said quality policy, and that are appropriate to the purpose of the organization. That is, that the entire operation of the quality
management system and all its processes,
is oriented to fulfill the established mission, with the identified values, and to achieve the vision in the expected time.
Requirement No. 96: Top management shall
implement a quality policy that is appropriate to the context of the organization.
With the
previous requirement
we saw what the term “implement” means. Based on this definition, we can understand
that top management should give practical effect to this policy, and ensure
that it is accomplished throughout the organization, at all relevant levels and functions, each of the
elements (intentions and direction) that make up
said policy, and that they are
appropriate to the context of the organization.
Requirement No. 97: Top management shall implement a quality
policy that supports the organization´s strategic direction.
When
analyzing requirement
No. 95 we saw what
it means to "implement" the quality
policy, and with requirement No. 94
we saw what the strategic direction of the organization is.
So, to meet
this requirement, it is important that when top management is implementing this quality policy, it ensures that this implementation supports the formulation of the strategic
plan, as well as the deployment of that plan through the
specific objectives, plans, goals and design and operation of the processes.
Requirement No. 98: Top management shall maintain a quality policy that is appropriate to the purpose of the organization.
What this requirement tells us is
that once top management has established and implemented the quality
policy, top management itself should maintain it. For this,
I present the definition of this term:
This means
that top management should preserve from failure or decline the quality policy, before any adjustment that should be made, for any change that may
exist in relation to the purpose of the organization, in order for this policy to maintain its validity over time, and continue to be
applicable for all relevant functions and levels.
Requirement No. 99: Top
management shall
maintain a quality
policy that is
appropriate to the context of the organization.
With the
previous requirement we saw what
the term “maintain” means in
relation to the quality policy. Based on
this definition, top management should preserve said policy, for any
change or update that may have been generated in relation to the context of the organization, so that this policy maintains its validity over time and continues to
be applicable. for all relevant functions and levels, considering the review and updating of information sources
for, where appropriate, considering the updating of internal and external issues
determined by the organization that are
relevant for its purpose and that affect its capacity to achieve the intended
results of its quality
management system, the needs and expectations of interested parties, the scope of the QMS as set out in
Sub-Clause
4.3, and also the
characteristics and processes of the
QMS itself, as
set out in Sub-Clause
4.4 of this standard.
Requirement No. 100: Top management shall maintain a quality policy that supports the organization`s strategic direction.
When
analyzing requirement
No. 98, we saw what it means to "maintain" the quality policy, and with requirement No. 97
we saw what the strategic direction of the organization is.
So, to meet
this requirement, it is important that when top
management is carrying
out the necessary actions to "maintain" this quality
policy, it ensures that support for the reformulation of the strategic
plan is “maintained”, as well as the deployment of that plan through the specific
objectives, plans, goals and design
and operation of the processes.
Requirement No. 101: Top management shall establish a quality policy that provides a framework for setting quality
objectives.
This requirement also refers to the establishment of the quality policy by top
management, as we saw previously in the requirements numbered 92, 93 and 94, but in particular this requires that the
aforementioned policy provide a framework for establishing
the objectives of the QMS.
If you have
read the ISO 9001 standard, you will
know that there is a Clause 6 - Planning, dedicated to this topic of QMS Planning. However, what
we should understand with this requirement No. 101, is that the quality policy should provide the basis for
that planning. The important point in relation to this is: How can we identify that
framework, within that policy, to establish the objectives of this management system?
Remember that
when developing and issuing management system standards, ISO has not
invented anything new, inventing is not its function. It has been selecting the best practices and integrating
knowledge that for more than a hundred years has been developed in management areas, from
the concepts of scientific management to date. The most relevant thing about these standards is that they
have identified some valuable elements of the administrative process as standard requirements to integrate
a management system so that an organization that implements it can build confidence in its
performance.
It is
considered that for an organization to establish its objectives (specific or quantifiable),
within any productive system, it should
be able to count on some strategic elements on which to base itself.
We have
already mentioned what the mission, vision and values are, as well as the importance they have to
identify the purpose of the organization, that is, the justification for the existence of
the organization, what it intends to achieve in the future, in a
determined time and with what bases of behavior accepted by the organization itself.
These
elements are of a general type, basic for any organization, and do not have to refer to any particular management system. From this, top management should break down this purpose and specify other strategic elements, from general to particular, so that all corresponding areas, functions
and levels of the organization participate
actively to achieve this purpose.
After those
three elements already mentioned (mission, vision and values), the next
strategic level is commonly known as general objectives. Top management should
identify all the general objectives, or global intentions, that are necessary for the organization to fulfill its purpose. As the name implies,
these objectives have a broad coverage and do not need to be
quantifiable. They can refer to any relevant item concerned with quality, such as productive areas of interest, investment
and profit aspects, technological focus, competitiveness, among others, but it
is important that there be one or more of them that are related to the quality
management system.
The next
strategic level is known as policies, which are the guidelines and direction elements that the organization establishes as general behavior guides for all the organization's personnel.
With respect
to this requirement
of the standard, what is needed is that top management issues a documented
statement, which the standard calls the quality policy, which should be made up of all the general objectives (intentions) and all policies (guidelines, orientation or direction elements) that guide the entire organization towards where it should move forward and what is
expected to be achieved in terms of quality.
Since the
first version of ISO 8402 – Quality management and quality assurance
— Vocabulary (now updated to ISO 9000:
2015), which was published in 1986, it was considered
to use the term global intentions instead of general objectives, even if the concept was the same, to avoid confusion between the
different levels of objectives
(general or specific), as well as using the direction term instead of policies, to leave this term as identification of the requirement and the core strategic element of these management
systems based on standards.
Based on
these elements that make up the quality policy, the corresponding planning areas will have the appropriate framework
so that from each of the intentions or general objectives established in the aforementioned policy, all the objectives (specific ) necessary to comply with that intention, and that from each of these objectives the planning of all the activities necessary to comply with each one of them can be established, and by following the established guidelines (direction elements), they are fulfilled all the intentions (general objectives), and with that, the purpose of the organization can be achieved. All this, through appropriate processes management.
Requirement No. 102: Top management shall implement a quality policy that provides a framework for setting quality objectives.
This requirement also refers to implement the quality policy by top management, as we also saw previously in the requirements numbered 95, 96 and 97, but in particular this requires that when the aforementioned policy is implemented, it provides this appropriate framework for the formulation of the strategic plan, as well as its deployment in the objectives of the quality management system.
Requirement No. 103: Top management shall maintain a quality policy that provides a framework for setting quality
objectives.
This requirement also refers to maintain the quality policy by top management, as we also saw previously in the requirements numbered
as 98, 99 and 100, but in
particular this requirement specifies that when the aforementioned policy is maintained, it continues to provide an appropriate framework for establishing the objectives of the quality
management system. This means
that when the organization carry on updates to its purpose (mission, vision or values), or updates the elements that make up the context of the organization, it should consider these adjustments in the maintenance of the quality
policy, so that it continues providing an appropriate framework for the establishment or adjustment of quality objectives.
In the next entry we will continue with the analysis of the requirements derived from Section 5.2.1
of ISO 9001:2015.
As always, I
will be grateful to the readers who raise their doubts or comments about this
analysis.
Author:
Ernesto Palomares Hilton
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