Welcome back to this blog. I hope the approach used here to break down and analyze the different requirements of these management system standards will help to reinforce your understanding of the different requirements somewhat. I hope this information is of interest to you.
In previous entries we dealt with the requirements corresponding to Section
5.2.1-Establishing the quality policy, and we did so in three parts, due to the importance and complexity of
the requirements derived from said section, as well as the requirements derived from Section 5.2.2 –
Communicating the quality policy.
On this
occasion we will focus on analyzing the requirements derived from the last sub-clause of those that
make up Clause 5 - Leadership, and I am referring to Subclause
5.3 - Organizational roles, responsibilities and authorities.
As I have
explained to you in a previous entry, the quality policy is the most important element of a quality
management system, because all
the processes and activities carried
out by the organization within that quality
management system will be to comply with the aforementioned quality
policy. That is why in this group of requirements derived from Section
5.2.2 of this standard, all refer to this quality policy, specifying how, and to whom, this element of the quality
management system should be communicated.
In that Section 5.2.2, the ISO 9001:2015 Standard establishes a series of requirements, all directed to top management, since if you remember, we are still analyzing Clause 5 - Leadership, and all requirements that derive from this Sub-clause 5.3 refer to the exercise of leadership by top management to assign responsibilities and authorities at all
levels of the organization. Below I
present to you the list of these requirements derived from Sub-clause 5.3, and I present them with the corresponding
progressive numbering, as we have been presenting, individually, all requirements of this ISO 9001 standard that have been analyzed:
In general,
the Technical Specification TS 9002:2016 - Quality
management systems — Guidelines for the application of the ISO 9001:2015
Standard, in relation to this Sub-clause 5.3 - Organizational roles,
responsibilities and authorities, mentions that the intent of this sub-clause is for top
management to assign relevant roles related to quality
management system, in order to
ensure effectiveness and the
achievement of intended results. Top
management will need to
establish specific responsibilities and authorities for those roles, and ensure that people in the organization understand and are aware of their assignments
through effective communication
activities.
It also
indicates that responsibilities and authorities can be assigned to one or more people. They should
be able to make decisions and effect changes in the area and/or processes to which they have been
assigned. It is essential to emphasize that although authority may be delegated, overall responsibility and accountability for the quality management system remains with
top management.
Mentions that
in some organizations there may be
a limited number of people available with the necessary competence to carry out
the required tasks; it might be helpful to plan so that roles, responsibilities and authorities are shared.
Such plans are valuable during
vacations, when managers are not on site, or in cases of accident or illness.
Top management, in accordance with TS 9002: 2016, should determine the manner in which relevant roles, responsibilities and authorities are
communicated. This could be done through the use of relevant documented information, eg job
descriptions, work instructions, duty statements, organizational charts,
manuals, procedures.
The responsibilities and authorities to be assigned by top
management to the relevant
roles within the quality management system are closely linked, but are not the same, and are
therefore presented here as different elements of different requirements.
If there are several people who carry out the same role within the QMS, the responsibilities assigned to them should be practically the same, for the performance of their roles, but in the case of the assignment of authorities, the situation changes, since the top management should decide to whom of these people will assign the necessary authorities to make decisions and give orders to others.
In accordance
with the list of requirements presented above, the next one to be analyzed, first of this sub-clause, is the following:
Requirement No. 116: Top management shall ensure that the responsibilities for relevant roles are assigned within the organization.
What this requirement points out is that top management should first identify which
are all relevant roles to the quality management system.
As you may have noticed, this standard includes commonly used
terms, but there are some of them that supposedly we all understand, but in fact
each person understands those differently.
That is why it is convenient to use a
dictionary to find the definitions of these types of terms that can cause
confusion if we do not understand and use them in the same way.
For example, among the terms that can cause
this type of confusion, we have the following: “role”.
In light of this definition, the organization should identify all
activities that are performed by one or more persons, for a particular
operation or process that are relevant to the quality management system. It is worth clarifying
that, for this task, it is generally not convenient to include all the roles
or roles that are carried out in the organization, but only those that are
relevant to this system. Among the roles that
most organizations can identify, that are
relevant to the QMS, we could mention the
following: top
management, top
management representative (if the organization have one designated), processes
owners, processes operators, those who create documented information,
those who update it, those who control documented information, those who
generate records (documented information as evidence of conformity), those who maintain records
(documented information maintained as evidence of conformity), inspectors, verifiers, internal auditors, those who initiate corrective actions, those who plan, carry out, verify and
close corrective
actions, among others.
Once we have identified what the term "role" means, in order to
identify the pertinent roles of the QMS from there, it is convenient
to consult other definitions, such as those presented below:
We can understand, then, that once top management has identified all these relevant
roles, it should ensure that, through the deployment of its entire chain of
responsibility and authority, each of these relevant
roles for the QMS have been assigned their corresponding responsibilities, that is, that it has
been indicated, for each of these roles, all the obligations that
correspond to it for the fulfillment of the duty.
There is a situation that is worth raising so that it is well understood. Even though responsibilities should be assigned for all relevant roles within the QMS, top management cannot delegate these responsibilities, they can only share them, but this top management will always have primary responsibility and accountability for the quality management system.
When assigning responsibilities for the relevant roles within the quality management system, top management should take into account that those responsibilities should be clearly assigned to each role and should be sufficient for the person(s) to whom they are going to assign, be able to fulfill the entrusted role.
Requirement
No. 117: Top management shall ensure that the responsibilities for relevant
roles are communicated within the organization.
In accordance with this requirement, top management should ensure that, once responsibilities for relevant roles
to the QMS are assigned, they are
communicated throughout the organization.
To achieve this, it will be important for the organization to present these assigned responsibilities as documented
information, either generally in a quality manual, on a web page,
or as the organization has arranged to present
and describe its quality
management system, so that all personnel have access to this
information, and it can also be done in a more specific and better described
way in documentation of processes, procedures or work instructions.
This ensures that the personnel who carry out
these types of roles for the QMS know what activities
they are responsible for carrying out, and
that all personnel know who carries out those relevant roles of the management system and what their
corresponding responsibilities
are.
Requirement
No. 118: Top management shall ensure that the responsibilities for relevant roles are understood
within the organization.
The intent of this requirement is to ensure that all
personnel have a proper understanding of what those relevant roles are and what are those responsibilities associated with each of
these roles.
Top management will need to establish specific
responsibilities for those roles,
and ensure that people in the organization understand and are aware of those assignments,
in order to ensure the effectiveness of the QMS and the achievement of
the intended
results.
That is why top management should establish
mechanisms to ensure that staff understands these responsibilities, such as informational
meetings, workshops, seminars, evaluations, among others, and generate evidence
of understanding of said responsibilities, at the level of understanding that it deems
appropriate to estimate that they have been understood by all the staff of the organization.
Requirement
No. 119: Top management shall ensure that the authorities for relevant roles are assigned within the organization.
To better understand this requirement, it is convenient to
also present the definition of the term “authority”.
Once top management has identified all the relevant
roles for the QMS, it should ensure that, through the deployment of its entire chain of responsibility and authority, each of these roles
has been assigned its corresponding authorities, that is, that it has
been pointed out, for each of these roles, all the official power to
make decisions for other people or to tell them what they must do, in their
delimited scope.
As we have seen, when an authority is assigned to a
specific role, it is granted the right to give orders or make decisions,
within what corresponds to said role. Contrary to what is indicated in requirement No. 116, concerning the case of responsibility, the authority is delegated.
When assigning authorities to the relevant roles
within the quality
management system, top management should take into account
that these authorities should be clearly assigned
to each role and should be sufficient for the person(s) to whom they are going
to assign, be able to fulfill the entrusted authority. No more, no less.
Requirement
No. 120: Top management shall ensure that the authorities for relevant roles are communicated within the organization.
In accordance with this requirement, top management should ensure that, once authorities are assigned for
the relevant roles to the QMS, they are communicated
to the entire organization.
To achieve this, it will be important for the organization to present these assigned authorities as documented
information, either generally in a quality manual, on a web page, or
as the organization has arranged to present
and describe its quality
management system, so that all personnel have access to this
information, and it can also be done in a more specific and better described
way in documentation of processes, procedures or work instructions.
With this, it is ensured that the personnel
who carry out these types of roles for the QMS know what activities
they are responsible for carrying out, and
that all personnel know who carries out those relevant roles of the management system and who their
corresponding authorities are.
Requirement
No. 121: Top
management shall ensure that the authorities for relevant roles are understood
within the organization.
The intent of this requirement is to ensure that all
personnel have a proper understanding of what those relevant roles are,
what are those authorities associated with each of
these roles,
Top management will need to establish
specific authorities for those relevant roles,
and ensure that people in the organization understand and are aware of those assignments,
in order to ensure the effectiveness of the QMS and the achievement of
the intended
results.
That is why top management should establish mechanisms to ensure that staff understands these authorities, such as briefings,
workshops, seminars, evaluations, among others, and generate evidence of
understanding of said authorities, at the level of understanding that it deems
appropriate to estimate that they have been understood by all the staff of the organization.
Requirement
No. 122: Top management shall assign the responsibility for ensuring that the quality management system conforms to the requirement of this standard.
Top management should assign for one or more persons the responsibility that the quality management system conforms to requirements of this ISO 9001 standard, to ensure that the QMS considers all the
specific roles necessary, such as internal
auditors, or for management
review, among others. The role to which this responsibility is assigned is what in
previous versions of this standard was called "Management representative", which from my
personal point of view, I believe that organizations should continue to
consider this role, which is important to coordinate all efforts within
the QMS. In the event that this responsibility is assigned to
more than one person, it will be important to define their areas of action, so
that there is no interference between them.
Requirement
No. 123: Top management shall assign the authority for ensuring that the quality management system conforms to the requirement of this standard.
Top management should assign for one or more persons the authority for the quality management system to conform to requirements of this ISO 9001 standard, to ensure that the QMS
considers all specific roles required, such as internal
auditors, or for management
review, among others. The role to which this authority is assigned is what in
previous versions of this standard was called "Management representative", which from my
personal point of view, I believe that organizations should continue to consider
this role, which is important to coordinate all efforts within the QMS. In the event that this authority is assigned to
more than one person, it will be important to define their areas of action, so
that there is no interference between them.
Requirement
No. 124: Top management shall assign the responsibility for ensuring that the processes are delivering their intended outputs.
In order to achieve continuity in the
operation of the quality
management system, it is important that each of the processes
is operating and provides the intended outputs. That is why top management should assign the appropriate responsibilities to achieve this operation on a continuous
basis.
In accordance with Technical Specification TS 9002: 2016, these responsibilities could be assigned
to more than one person, each of whom would have different responsibilities, such as monitoring quality objectives, determining whether processes
are achieving their intended outputs, or conduct internal audits.
Requirement
No. 125: Top management shall assign the authority for ensuring that the processes are delivering their intended outputs.
As in the previous requirement, in order to achieve
continuity in the operation of the quality management system, it is important that
each of the processes is operating and provides the intended outputs. That is why top management should assign the appropriate authorities to achieve this
operation on a continuous basis.
In accordance with Technical Specification TS 9002:2016, these authorities could be assigned
to more than one person, each of whom would have different authorities, such as monitoring quality objectives, determining whether processes
are achieving their intended outputs, or conduct internal audits.
Requirement
No. 126: Top management shall assign the responsibility for reporting
on the performance of the quality management system, in particular to top management.
If we remember that top management maintains the primary responsibility and accountability for the quality management system, it is essential that it
is kept informed of the performance of this system.
In accordance with Technical Specification TS 9002:2016, this reporting is
typically carried out as part of the management review process (see ISO 9001:2015 Sub-clause
9.3); One person might be assigned responsibility for coordinating
reporting, with other people taking responsibility for reporting on
specific quality
management system processes.
Requirement
No. 127: Top management shall assign the authority for reporting
on the performance of the quality management system, in particular to top management.
Considering, as mentioned in the previous requirement, that top management maintains primary responsibility and accountability for the quality management system, it is essential that it
be kept informed of the performance of this system.
In accordance with Technical Specification TS 9002:2016, this reporting is
typically carried out as part of the management review process (see ISO 9001:2015 Sub-clause
9.3); Authority could be assigned to a
person to coordinate reporting, with other persons with reporting authority on specific processes
of the quality
management system.
Requirement
No. 128: Top management shall assign the responsibility for reporting
on opportunities for improvement (see 10.1) , in particular to top management.
Top management should also be informed of the opportunities
for improvement that exist with the quality management system, for a fundamental
reason: so that the QMS remains in a cycle of continuous improvement, which in addition to being a specific requirement of the ISO 9001 standard (according to Section
4.4.1), is essential for the operation of the system.
This responsibility for reporting on opportunities for improvement, could be assigned
to someone who has already been assigned some responsibility for the analysis of non-conformities, or for the planning, execution or verification of corrective actions or, if applicable, who
receives and analyzes the internal audit reports.
Requirement
No. 129: Top management shall assign the authority for reporting
on opportunities for improvement (see 10.1) , in particular to top management.
As mentioned in relation to the previous requirement, top management should be
informed of the opportunities for improvement that exist with the quality management system.
This authority for reporting on opportunities for improvement, could be assigned
to someone who has already been assigned some authority for the analysis of non-conformities, or for the planning, execution or verification of corrective actions or, if applicable, who
receives and analyzes the internal audit reports.
Requirement
No. 130: Top
management shall assign the responsibility for ensuring the promotion of customer focus throughout the organization.
As you probably remember, customer focus is one of the principles of quality management, so top management should ensure that customer
focus is continuously promoted throughout the organization. That is why it should
assign that responsibility.
In accordance with Technical Specification TS 9002:2016, this responsibility is assigned to promote
customer
focus (see Section 5.1.2 of ISO 9001:2015); This responsibility is typically assigned
to the person responsible for communicating
with customers and making sure all issues are resolved; This person
is typically part of the customer service or quality function.
Requirement
No. 131: Top management shall assign the authority for ensuring
the promotion of customer
focus throughout the organization.
As we saw with the previous requirement, customer focus is one of the principles of quality management, so top management should ensure that customer focus is continuously promoted
throughout the organization. That is why it should assign
that authority.
Likewise, in accordance with Technical Specification TS 9002:2016, this authority is assigned to
promote customer
focus (see Section 5.1.2 of ISO 9001:2015); This authority is typically assigned
to the person who has authority for communicating with customers and making sure all issues
are resolved; This person is typically part of the customer service
or quality
function.
Requirement
No. 132: Top management shall assign the responsibility for ensuring that the integrity of the quality management system is maintained when changes to the quality management system are implemented.
In accordance with Paragraph
6.3 b) of ISO 9001, when the organization determines the need for
changes to the quality
management system, these changes should be carried out in a planned manner. The organization should consider the integrity
of the quality
management system. That is why top management should assign that
responsibility to one or more people.
In accordance with Technical Specification TS 9002:2016, this responsibility is assigned to maintain
the integrity of the quality management system when making changes such
as the implementation of a new enterprise resource planning (ERP) system, the
decision to hire externally the design and development process, growth
due to new market
opportunities, organizational restructuring, a merger
or acquisition; this responsibility is typically assigned to the persons responsible for ensuring that the quality management system is maintained, and who have the
ability to ensure that changes are not planned without regard to their potential
impacts.
Requirement
No. 133: Top management shall assign the authority for ensuring that the integrity of the quality management system is maintained when changes to the quality management system are implemented.
Similarly, in accordance with Paragraph 6.3 b) of ISO 9001, when the organization determines the need for
changes in the quality
management system, these changes should be carried out in a planned manner. The organization should consider the integrity
of the quality
management system. That is why top management should assign that
authority to one or more people.
Pursuant to Technical Specification TS 9002:2016, this authority is assigned to maintain the integrity of
the quality
management system when making changes such
as the implementation of a new enterprise resource planning (ERP) system, the
decision to hire externally the design and development process, growth
due to new market opportunities, organizational restructuring, a merger
or acquisition; this authority is typically assigned to persons who have authority for ensuring that the quality management system is maintained, and who have the
ability to ensure that changes are not planned without regard to their potential
impacts.
In the next entry we will begin the
analysis of requirements derived from Clause 6 - Planning, so we will be analyzing
the requirements derived from Sub-clause
6.1 - Actions to address risks and opportunities, of this ISO 9001:2015 Standard.
Your doubts or comments that you want to
upload to this blog about the analysis
presented will be welcome.
Author:
Ernesto Palomares Hilton
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