Welcome to
this post in the blog GESTEC by Ernesto Palomares Hilton.
If you have
read some of the entries that I have published here, you will have seen that I
have dedicated space to individually analyze the different requirements of some management system standards. My intention in doing this, is to establish a
reference in which all these requirements are visible, since when organizations and the experts involved with them establish,
document, operate and try to improve their management systems, it is common for there to be requirements, within the standard or standards that they intend to comply
with, which remain submerged, that is, they are never identified, therefore
they are not included in their management systems. The main reason for this to happen is the very wording of the
different sections and sub-clauses of these standards, but also the lack of interest of those responsible for identifying and complying with these requirements, and this includes those responsible for organizations, both technical level as well as top
management that establish them, but
also specialists who provide consulting
services and technical support,
both internal and external auditors, including evaluators for certification
bodies.
I hope that
these publications can serve as technical
support to all of them, as well as to all the people who wish to be trained
in these management systems and their reference standards.
In this entry
I continue with the analysis of the groups of requirements corresponding to Sub-clause 5.1 Leadership and commitment of the ISO 9001:
2015 standard, so this time I will focus
on the requirements
derived from Section 5.1.2 – Customer focus.
I analyzed requirements contained in Section 5.1.1 – General
of this standard in a previous entry (If you wish to access the entry corresponding tothe analysis of this section, please click here).
I begin then by mentioning that the requirements derived from this section are directly related to the first of the quality management principles mentioned in the ISO 9001:2015 standard, and which are the following:
- customer
focus;
- leadership;
- engagement
of people;
- process
approach;
- improvement;
- evidence-based
decision making;
- relationship
management.
However, as in this entry we are going to analyze the requirements of Section 5.1.2 – Customer focus, I present to you the complete information, contained in the ISO 9000:2015 standard, on the customer focus principle in quality management.
I believe
that you will be able to understand, without a full explanation, the importance
for any organization of identifying its customers, their needs and
expectations, as well as monitoring the level of satisfaction of their needs
and taking the necessary actions to increase that satisfaction level, since the
life of any organization depends on that. What I am mentioning is very easy
to read or listen to, but the interesting part is how each organization would identify those needs and expectations and then translate them into
requirements, and how it should prepare its operating and management system to consistently meet them, and then, follow up on that compliance and establish
any improvement actions.
In addition
to this information, and those previously presented on the 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 Standard: 2015.
This technical
specification states that the intent of this section of ISO 9001 is to ensure that top management visibly demonstrates leadership and commitment to keep the organization focused on meeting customer requirements and improving customer
satisfaction.
Customers are generally the individuals or organizations that purchase the organization's products and services; however, they can also be
individuals or organizations such as citizens, customers, patients, students, etc. who are recipients of the organization's products and services.
As with Section 5.1.1, all these requirements derived from Section 5.1.2 – Customer Focus, 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 to the quality
management system, but in this
case related to customer requirements, and it is also important that we identify each of
these elements, avoiding confusion due to the presentation of the text and the similar wording of these requirements.
As I
mentioned in relation to Section 5.1.1, many of these requirements that derive from this Subclause 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 as these are generic type requirements they will already be complying with them automatically, which is far
from reality. It is very 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 remembered that every organization should take the appropriate measures to meet all
applicable requirements in their quality management systems, such as all of those in this Section 5.1.2.
Requirement No. 77:
Top
management shall demonstrate leadership and commitment with respect to customer focus by ensuring
that customer
requirements are determined;
If you remember, or where appropriate read Sub-Clause 4.2 Understanding the needs and
expectations of interested parties, to comply
with it, the organization shall
first determine the interested
parties that are relevant to the quality management system, and then shall
determine the relevant requirements of those interested parties
for the quality management system, in an enlarged
form of quality management system requirements and quality objectives, being customers one of
those interested parties. This is
already specified in that aforementioned Sub-clause 4.2, but in the one we are currently analyzing, Sub-clause 5.1.2, which specifies that it be the top management that shows that leadership and commitment, making sure
that those requirements of the customer.
Technical Specification TS 9002: 2016 states that top
management needs to
ensure that effective processes are
in place to determine customer requirements related to the organization's products and services. It tells us that in many
cases, a focus for on-time delivery
performance and on customer complaints
can provide information on any actions that might be necessary in order to
achieve or improve customer satisfaction.
Requirement No. 78: Top management shall demonstrate leadership and commitment with respect to customer focus by ensuring that customer requirements are understood.
Once the customer's requirements have been determined, top management should establish mechanisms to ensure that, in the relevant areas, units and levels, these requirements are analyzed and understood, so that they can be identified as requirements of the quality management system and their correspondent quality objectives, and that they can be met and fulfilled.
Technical Specification TS 9002: 2016 states that top
management needs to
ensure that these customer requirements related to the organization's products and services are understood.
Requirement No. 79: Top management shall demonstrate leadership and commitment with respect to customer focus by ensuring that customer requirements are consistently met.
In accordance with the different clauses and sub-clauses established in the ISO 9001 standard, the organization should establish and operate quality planning, control and assurance actions, so that the quality objectives are achieved and the customer's requirements are regularly met. However, this requirement specifies that top management should ensure, through whatever mechanisms are necessary, that these customer requirements are being regularly met.
Requirement No. 80:
Top
management shall demonstrate leadership and commitment with respect to customer focus by ensuring
that application statutory and regulatory requirements are determined.
Similar to
what I mentioned to you in relation to requirement No. 77, in Sub-clause
4.2 Understanding the needs and expectations of interested parties, it is mentioned that the organization should first determine the interested
parties that are relevant to the quality management system, and then determine the relevant requirements of those interested
parties for the quality management system, in the in an enlarged
form of quality management system requirements and quality objectives. In this case, also, government regulators agencies are also interested parties in the organization's performance. This is also already specified in that aforementioned sub-clause 4.2, and in the one that we are currently analyzing, Sub-clause 5.1.2, which specifies that it be the organization`s top
management that shows
that leadership and commitment, making sure that those
application statutory and regulatory requirements. It is also important to mention that for many of the organization's customers, one of their requirements is that the organization
comply with statutory
and regulatory requirements, since this gives them confidence that the organization is not in risk of being sanctioned and that it can leave of the market
due to breaches of a statutory and regulatory nature.
Technical Specification TS 9002: 2016 states that top
management needs to
ensure that effective processes are
in place to determine statutory and regulatory requirements related to the organization's products and services.
Requirement No. 81: Top
management shall
demonstrate leadership and commitment with respect to customer focus by ensuring
that application statutory and regulatory requirements are understood.
Once the statutory and regulatory requirements have been determined, top management should establish mechanisms to ensure that, in the
relevant areas, units and levels, these requirements are analyzed and understood, so that they can be identified as quality
management system requirements and their correspondent quality
objectives, and that they can be met and fulfilled.
Technical Specification TS 9002: 2016 states that top
management needs to ensure that these
application statutory and regulatory requirements related to the organization's products and services are understood.
Requirement No. 82: Top
management shall demonstrate leadership and commitment with respect
to customer focus by ensuring that application statutory and
regulatory requirements are consistently
met.
In accordance
with the different clauses and subclauses established in the ISO 9001 standard, the organization should establish and operate quality
planning, control and assurance actions, so that the quality
objectives are achieved and application statutory and regulatory requirements are regularly
met. However, this requirement
specifies that top management should ensure, through whatever mechanisms are necessary, that these application statutory and regulatory requirements are being regularly met.
Requirement No. 83: Top
management shall
demonstrate leadership and commitment with respect to customer focus by ensuring
that the risks that can affect conformity of products and services
are determined.
It is worth
remembering that ISO 9001 standard, in its Clause
0 – Introduction, although it does not
establish any requirements, indicates that risk-based thinking enables an organization to determine the factors that could cause its processes and its quality
management system to deviate
from the planned results, to put in
place preventive controls to
minimize negative effects and maximize the use of opportunities as they arise (for more information on this, you can
see Chapter
A.4 of ISO 9001:2015). These factors may, on the one hand, affect the conformity of products and services,
and on the other, affect the ability to increase customer satisfaction. It is also worth remembering that risks are uncertainty factors, of a
negative type, in which elements of probability of occurrence and severity of
damage are considered.
In order to meet this requirement, top management should establish actions and generate evidence of the exercise of their leadership and commitment, in compliance with Sub-Clause 6.1 - Actions to address risks and opportunities, so that when establishing the different processes, all those risks that may affect the conformity of the organization's products and services are determined.
Requirement No. 84:
Top
management shall
demonstrate leadership and commitment with respect to customer focus by ensuring
that the risks that can affect the ability to enhance customer
satisfaction are determined.
In order to
meet this requirement, top management should establish actions and generate evidence of
the exercise of their leadership and commitment, so that when
establishing the different processes,
all those risks that may affect the organization's ability to improve
customer satisfaction are determined.
According to Technical
Specification TS 9002: 2016, top
management needs to ensure that appropriate actions are
implemented to address risks, so
that expected results are consistently
achieved; if they are not, then a Plan-Do-Check-Act
(PDCA) approach should be followed to ensure that responsibilities are assigned for
implementing further improvements, until customer
needs and expectations are achieved.
Requirement No. 85:
Top
management shall demonstrate leadership and commitment with respect to customer focus by ensuring
that the risks that can affect conformity of products and services
are addressed.
In order to
meet this requirement, top management should establish actions and generate evidence of
the exercise of its leadership and commitment, so that when
operating the different processes,
all those risks that were previously
determined that may affect the conformity
of products and services are addressed.
Technical Specification TS 9002: 2016 states that top management needs to ensure that
appropriate actions are implemented to address risks so that the intended results are consistently achieved.
Requirement No. 86:
Top
management shall demonstrate leadership and commitment
with respect to customer focus by ensuring that the risks that
can affect the ability to enhance customer satisfaction are addressed.
In order to
meet this requirement, top management should establish actions and generate evidence of
the exercise of its leadership and commitment, so that when
operating the different processes,
all those risks that were previously
determined and may affect the organization's ability to enhance customer satisfaction, are addressed.
Requirement No. 87:
Top
management shall demonstrate leadership and commitment with respect to customer focus by ensuring
that the opportunities that can affect conformity of products and
services are determined.
Related to
this requirement, Technical Specification TS 9002: 2016 states that top management should promote risk-based thinking, for example, by
ensuring cooperation in dealing with opportunities.
Similarly to requirement No. 83, when top management promotes risk-based thinking, in addition to showing its leadership and commitment, in compliance with Sub-Clause 6.1 - Actions to address risks and opportunities, it promotes that when establishing processes, all opportunities that may affect the compliance of the organization's products and services are determined, in order to manage these opportunities optimally. It should be considered that opportunities are factors of uncertainty in the expected results, but in a positive way.
Requirement No. 88:
Top
management shall demonstrate leadership and commitment with respect to customer focus by ensuring
that the opportunities that can affect the ability to enhance
customer satisfaction are determined.
Similarly to
the previous requirement, when top management promotes risk-based
thinking, in addition to showing leadership and commitment, it promotes
that by establishing processes, all opportunities that may affect the
ability to enhance customer satisfaction are determined, in order to manage
these opportunities optimally.
Requirement No. 89: Top management shall demonstrate leadership and commitment with respect to customer
focus by ensuring that the opportunities that can affect
conformity of products and services are addressed.
In order to
meet this requirement, top management should establish actions and generate evidence of
the exercise of its leadership and commitment, so that when
operating the different processes,
all those opportunities that were
previously determined that may affect the conformity
of products and services are addressed.
In accordance
with Technical Specification TS 9002: 2016, top management needs to ensure that appropriate actions are
implemented to address opportunities,
so that the intended results are consistently achieved; if they are not
achieved, then a Plan-Do-Check-Act
(PDCA) approach should be followed to ensure that responsibilities are assigned to
implement further improvements,
until customer needs and
expectations are met.
Requirement No. 90:
Top
management shall demonstrate leadership and commitment with respect to customer focus by ensuring
that the opportunities that can
affect the ability to enhance customer satisfaction are addressed.
In the same
way, in order to meet this requirement, top management should establish actions and generate evidence of
the exercise of its leadership and commitment, so that when
operating the different processes,
all those opportunities that were
previously determined that may affect the ability of enhance customer satisfaction,
are addressed.
Requirement No. 91:
Top
management shall demonstrate leadership and commitment with respect to customer focus by ensuring that the focus on enhancing customer satisfaction
is maintained.
Regarding
this requirement, Technical Specification TS 9002: 2016 indicates
that the intent of this subclause is to ensure that top management visibly demonstrates leadership and commitment in
maintaining the organization’s focus on meeting customer requirements and enhancing customer satisfaction.
It tells us that top management needs to ensure that appropriate actions are implemented to address risks and opportunities, so that expected results are consistently achieved; if they are not, then a Plan-Do-Check-Act (PDCA) approach should be followed to ensure that responsibilities are assigned for
implementing further improvements, until customer
needs and expectations are achieved.
Top management can focus on enhancing customer satisfaction by
using the results of analysis and evaluation of customer satisfaction data (see ISO 9001:2015[28], 9.1.2). As a result of this analysis, top management might direct
a change in the customer related processes
and the operations of the organization, including the allocation of resources.
Remember that
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 Sub-clause 5.2 - Policy.
Author:
Ernesto Palomares Hilton
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