IUMSS Parra 2021

Machine Translated by Google
Methodological application:
the integrated use of management
system standards for the
integration of management
systems*
Paula Alejandra Moreno Parra**
Byron Restrepo Benavidez***
Paola Alejandra Sánchez Martín****
Received: June 16, 2020

Reviewed: March 1, 2021
Accepted: August 13, 2021
* Research result article.

** Bacteriologist and clinical laboratory technician, specialist in Occupational Health Management, specialist
in Health Audit, specialist in Quality Management and Administration and Master of Science
in Quality and Comprehensive Management from the Santo Tomás University, Icontec agreement, Bogotáÿ,
Colombia. Email: paula.morenop@usantotomas.edu.co, paulaleja@gmail.com; ORCID: https://orcid.org/
0000-0002-8200-3357; CvLAC: https://scienti.minciencias.gov.co/
cvlac/visualizador/generarCurriculoCv.do?cod_rh=0001009451
*** Industrial microbiologist, specialist in Quality Management and Administration and Master of Science
in Quality and Comprehensive Management from the Santo Tomás University, Icontec agreement, Bogotáÿ,
Colombia. Email: byronrestrepo@usantotomas.edu.co, restrepob85@gmail.com; ORCID: https://orcid.org/
0000-0002-3839-9702; CVLAC: https://scienti.minciencias.gov.co/
**** Biomedical engineering, specialist in Quality Management and Administration and Master of
Science in Quality and Comprehensive Management from the Santo Tomás University, Icontec agreement, Bogotáÿ,
Colombia. Email: paolaasanchez@usantotomas.edu.co, alepsmart8@gmail.com; ORCID: https://orcid.org/
0000-0002-3694-3970; CVLAC: https://scienti.minciencias.gov.co/
Signs, Research in Management Systems

ISSN: 2145-1389 | e-ISSN: 2463-1140 | DOI: https://doi.org/10.15332/24631140
Vol. 13 No. 2 | July-December 2021
Cite as:
Moreno Parra, PA, Restrepo Benavidez, B. and Sánchez Martínez, PA (2021).

Methodological application: the integrated use of management system standards
for the integration of management systems. Signs, Management Systems Research, 13(2).
https://doi.org/10.15332/24631140.6668
Summary
Various methodologies have been developed since the nineties for the integration of
multiple management systems in all types of organizations.
However, it is currently little known that the International Standard Organization
(ISO) has developed its own integration methodology that allows different
regulatory perspectives to be aligned in a single management. The Integrated Use of
Management System Standard (IUMSS) manual establishes a method of four
main stages (preparation, connection, incorporation and maintenance) in
which the high-level structure serves as a guide to integrate common, homologous
requirements and address specific ones. The objective of the research was to
establish a methodology for integrating the standards: NTC ISO 14001:
2015 environmental management system, NTC ISO 45001:2018 occupational health
and safety system and NTC ISO 13485:2016 quality management systems for medical
devices; making use of the manual through a qualitative and analytical description.
Finally, the validation of the methodology for integrating the standards was carried
out through the Régnier abacus method, concluding that the manual is a
robust tool aimed at reducing excess
redundancies and closing gaps between the requirements of integrated ISO standards
and an organization's processes.
Keywords: integrated management systems, NTC ISO 14001:2015, NTC ISO
45001:2018, NTC ISO 13485:2016, integration methodology, gaps.

Methodological application: the integrated use of management system

standards for management systems integration
Abstract
Various methodologies have been developed since the 1990s for
integrating multiple management systems in all types of organizations.
However, at present it is little known that the International Standard
Organization (ISO) has developed its own integration methodology that
allows aligning different normative perspectives in a single management.
The Manual The Integrated Use of Management System Standard
(IUMSS) sets out a four main stage method (preparation, connection,
incorporation and maintenance) wherein the high-level structure serves as
a guide to integrate common requirements, counterparts and to
address the specific ones. The research objective was to establish a
methodology for the integration of the following standards: NTC ISO
14001: 2015 environmental management system, NTC ISO 45001: 2018
occupational health and safety system and NTC ISO 13485: 2016 quality
management systems for medical devices; by using the manual through a
qualitative and analytical description. Finally, the standards integration
methodology was validated through Régnier's abacus method,
concluding that the manual is a robust tool aimed at reducing excess
redundancies and closing gaps between the integrated ISO standards and
an organization's processes requirements.
Keywords: integrated management systems, NTC ISO 14001: 2015,

NTC ISO 45001: 2018, NTC ISO 13485: 2016, integration methodology,
gaps.

Methodological application: integrated use of management

systems patterns for integration of management systems
Summary
Various methodologies have been developed since the 90s to integrate

multiple management systems in all types of organizations.
Meanwhile, now it is little known that the International Standards Organization
(ISO) has developed its own integration methodology that allows aligning
different normative perspectives in a single process. The Integrated Use of
Management System Standard (IUMSS) Manual establishes a method in four
main stages
(preparation, connection, incorporation and maintenance) not only the structure of
high level serves as a guide to integrate common, equivalent and
specific requirements. The research aims to establish an integration methodology
for two standards: NTC ISO 14001: environmental management system 2015,
NTC ISO 45001:2018 occupational health and safety system and NTC ISO
13485:2016 quality management systems for medical devices; using the manual
through a qualitative and analytical description. Finally, the integration
methodology of two standards was validated through Régnier's abacus
method, concluding that the manual is a robust tool that aims to reduce
excess redundancies and date gaps between the requirements of two
integrated ISO standards and the processes of an organization.
Keywords: integrated management systems, NTC ISO 14001:2015,

NTC ISO 45001:2018, NTC ISO 13485:2016, integration methodology,
lacunas.
Introduction
Nowadays, all types of organizations must face changing markets and

contexts, which forces management areas to strengthen the
administrative structure through management models that support the

strategic direction and promote stability, good
competition, the generation of results with fewer resources, the reduction
of duplicity in processes, mitigation of bureaucracy and
effective increase in performance to positively impact the
needs and demands of all interested parties (Pullés and Bataller Venta, 2016), (Cabrera
et ál., 2015).
When considering the benefits that certain organizations have achieved by
implementing various management systems, several investigations have been carried out.
made on the way in which they should be integrated and for this reason
Progressively each year, studies are carried out on the subject (Bernardo
et al., 2017). On the one hand, the advantages and difficulties have been described
administrative aspects of the integration process related to excess
bureaucracy, redundancies, costs, lack of employee motivation and
managers to manage different management systems at the same time (Bernardo
et al., 2015); and, on the other hand, facilitating methodologies are proposed that
are based on successful cases of various companies and sectors that, through their
experience, promote integration as a determining factor to achieve efficiency
through the optimization of the use of resources, increase the capacity to satisfy the
needs of the
stakeholders, improve the organizational climate, promote work in
team, improve communication in all areas, exchange
knowledge, improve the corporate image, among others (Moumen and

Aoufir, 2017; Bernardo et al., 2017; Gianni et al., 2017).
In the integration of management systems, what is described must be considered
by Wilkinson and Dale (1999); and Karapetrovic and Jonker (2003). In their
works highlight the need to define and establish a methodological
generic or applicable to any type of organization that allows grouping the common
elements between the different systems to be integrated, flexibility to satisfy regulatory
requirements, compatibility with the cycle

PHVA and systemic approaches. Furthermore, it must be taken into account that, if other
activities and operations cannot be integrated, they must be redesigned
so that they become synergistic with the functions that have been
integrated (Nunhes et al., 2017).
However, the existence of multiple integrative methodologies, proposed by
different authors, causes confusion when discerning which of them is appropriate
for the organization that is interested in starting an integration process. In the article
published by Heras et al. (2007) all research is mentioned
carried out between 1997 and 2006 on the elements that should be
addressed at the time of carrying out said process; However, they point out that
It is difficult to think of a fair and specific model for an organization,
taking into account that each process is individual and must be adjusted to the
organizational environment.
In response to the problem raised, the ISO has published in the year
2018, in its second version, a manual that proposes a methodological
base that seeks to integrate the requirements of different standards into a single
management system, effectively and efficiently through a theoretical component
and the description of successful cases in organizations of
any sector.
The manual was developed at the request of the ISO technical management board
For organizations seeking guidance on how to integrate
requirements of multiple ISO standards in the management system. From
first edition in 2008, the IUMSS has had a substantial number
of changes these include the introduction of the high-level structure
ISO, provided in ISO/IEC Directives Part 1, Clause SL.9. With
the purpose of being able to adapt to ISO standards and also those standards
that do not belong to the same family (ISO, 2018).

Given the above, the objective of this article is to describe the

integration methodology, which is derived from the research project
titled Integration of NTCISO 14001:2015 Standards, NTCISO
45001:2018 and NTCISO 13485:2016 and their alignment to a system of
comprehensive management based on GTC 180:2008, in the
marketing sector for medical devices in Colombia (Moreno, Restrepo, and
Sanchez, 2020).
For this, the translation, interpretation and establishment of the

guidelines of the manual (IUMSS) as an integration methodology for
the NTC ISO 14001:2015, NTC ISO 45001:2018 and NTC ISO standards
13485:2016, because it is currently unknown and not found
referenced in previous research where it has been implemented.
For this reason, it is of interest to researchers and organizations
have a document that interprets these official guidelines given
by the ISO to integrate any of its standards, respecting the
specific content of each of them.
Methodology
The research was carried out under a qualitative, descriptive and

analytical, whose scope was to propose the integration of the ISO NTC Standards
14001:2015, NTC ISO 45001:2018 and NTC ISO 13485:2016, taking into account
The methodology proposed in the IUMSS manual takes into account. The process of
Integration begins with the translation and interpretation of the manual, with the aim
of understanding its structure to subsequently develop the integration proposal.
Consecutively, the analysis of the manual was carried out and it was evident that its
design and structure are given in three chapters. Chapter 1 describes the
fundamentals of a management system and how it is implemented.
relate the strategies, plans and processes of an organization; in it

Chapter 2 describes the structure and content of different communication systems.

regulatory management and its application; and, in chapter 3, it is described how
An organization can integrate the requirements of several standards within
a management system. The manual was structured in this way to
that users, depending on the context in which their organization is located,
can resolve specific needs without resorting to reading the entire document
completely.
Based on what the manual (IUMSS) states in chapter 3, the

integration of the requirements of the NTC ISO 14001:2015, NTC ISO standards
45001:2018 and NTC ISO 13485:2016 taking into account the four stages and
eleven substages described in table 2. Additionally, it was taken into account
that the latest updates to the standards in environmental management and
Safety and health at work present the high-level structure and that
The NTC ISO 13485:2016 standard for medical devices does not have
it, but it is homologous to the NTC ISO quality management system
9001:2015.
Finally, the validation of the methodology for integrating the standards was carried
out through the Régnier abacus method, which aims to question experts on
a specific topic and treat their responses.
in real time or remotely from a color scale. As
all methods composed by experts, these are intended to reduce the
uncertainty, confront a group point of view and, at the same time, take
awareness of the greater or lesser variety of opinions (Blogs, 2013). For
apply this methodology, four stages were established, which are
described in table 1, below:

Table 1. Validation Methodology Stages
Validation Tool
Stage Issue Description

Data collection.
Names and surnames.

1 Technical experts in the medical device marketing sector.
Profession.
Position or area of performance.
Representation of the problem addressed.

2 Introduction. Specific objectives to evaluate.
Instructional description of completion.
3 Contextualization. Description by phases of the integrated management system.
Assessment of the tool with multiple selection of colors

according to option, to assign the criteria that each expert
according to the statements made. A comparison matrix is
made at a general level between:
4 Proposed validation instrument.

List of statements about the proposal.
List of experts.
Appreciations: space for additional suggestions and

comments from experts.
Source: own elaboration of the authors.

Results and discussion
Development of the integration stages proposed in the manual

IUMSS
As mentioned above, the manual has suggested integration

as a process of four stages that are further divided into eleven
substages to consider if you intend to carry out a correct methodology of
integration:
Table 2. Integration methodology stages according to the IUMSS
No. Stage classification No. Sub-stages
1 Lead the integration.
Determine the scope of the

1 Preparation. 2
integration.
3 Integration plan.
Structure the management

4
system.
Structure the regulatory
5 requirements
2 Connection.
management system.
6 Map the regulatory requirements

management system
against the management system.
7 Identify and analyze gaps.
3 Incorporation. 8 Close gaps.
9 Verify gap closure.
10 Maintain and improve

4 Maintenance. integration.
eleven Apply lessons learned.
Source: Authors' own elaboration based on the IUMSS.

Stage 1: preparation
Substage 1: lead the integration.
Any integration methodology must be based on organizational

leadership. This must arise as a decision made by management in the
context of an organization based on a strategic or operational need or due to
the degree of maturity in the implementation of
the different management systems. Leading involves recognizing the benefits
and consider the consequences during the integration stages.
In this leadership substage, it is necessary to provide instructions

for the integration of standards requirements into the management system,
Therefore, what is described in table 3, titled instructions, is required.
from leadership to integration.
Table 3. Instructions from leadership for integration

1. Identify integration needs.
2. Adapt the organization's policy to include integration. 3. Determine strategic
initiatives for
5. Determine the risks and integration.
4. Establish the objectives for
opportunities of 6. Communicate the decision to
integration.
integration.
integrate.
The leadership decision, based on these instructions, will provide an integrated

policy that will direct planning, resources, responsibilities, monitoring
and communications during the integration. This approach must be
systemic and must be supported from the top
direction, through the inclusion of planning elements
strategy as well as the allocation of resources, the promotion of a culture
organizational and design for the joint management of key processes (Asif
et al., 2009).

From the ISO high-level structure, leadership is an orientation
to the achievement of the planned results. For the ISO 13485 standard, oriented
towards quality management for medical devices, this structure is not yet defined,
although section 5.1 “management commitment” covers the leadership that senior
management must assume from its quality management system, which will contribute to
the integration process strategies such as decision making, considering the needs of
all interested parties.
Substage 2: Determine the scope of the integration
Once senior management has made the decision to integrate, they must assume
the leadership and commitment to incorporate into a single management several
regulatory schemes to your organization and, to do so, you must establish a
scope in the integration process, taking into account the times and
expected impacts. The scope of each organization will depend on the number
of standards to integrate, the order and levels of integration between processes,
objectives and resources used in the management system.
The scope of integration is largely related to certain drivers, which according to
the IUMMS are what encourage the methodology
of integration and, in accordance with them, the need to carry out
This process is described below:
• Customer requirements: expectation, need or opportunity to

market.
• Internal need: opportunity to improve the efficiency and effectiveness of
the organization.
• Regulations: compliance with demands, legislative or
administrative authorities of regulatory entities or government agencies.
The identification of these drivers implies then recognizing the
external problems and the operating environment of the sector.

Substage 3: integration plan
Any organization that has or has not implemented a

management may use the manual as a guiding tool for the
methodology for integrating the different regulatory schemes that
want to include in your system.
Once the scope is established, the integration must be planned taking into
account the related risks and opportunities. For this, it is proposed to carry
out an integration plan that will allow us to start in a more
effective and efficient integration process, as shown in the table
4, described below:
Table 4. Integration plan

Variables Characteristics
Who owns the project? Responsible for launching and implementing

Owner
the project.
Cross-functional team made up of people who have the skill,

project committee knowledge and availability to complete the job.
Project leader Expert professional in improvement projects.
Created from organizational awareness and the coherence of

Communication strategy
strategic direction to other areas of the organization.
Risks and opportunities Related to the integration project.
Resources
Trained personnel, adequate facilities, systems, information,
support equipment.
Description of detailed steps with assigned roles

Integration activities and responsibilities and timeline to achieve project objectives.
Although the integration activities will be explained further in stage 2

(connection), substages 4, 5 and 6, these must be defined from the
integration plan by referring to what the ( IUMSS) describes on page 57:

• Define the management system model that will adapt to the scope of
the integration.
• Configure standards requirements to integrate into the system
management.
• Map or link the requirements of the standards with the system of

defined management (processes) of the organization.
There are other activities that, in the same way, will be explained in detail in stage 3
(incorporation), substages 7, 8 and 9, which must also be defined from the integration
plan and refer to:
• Analyze gaps, including identifying the level of
compliance and integration or the absence of organizational

processes to meet requirements.
• Close the gaps.
• Verify that the gap closure works.
Finally, other activities are proposed that will also be addressed in stage 4
(maintenance), substages 10 and 11, which must also be defined from the
integration plan and refer to:
• Measure, monitor and continually improve by determining the

key process indicators, and review performance and progress
• Focus on learning by identifying and leveraging
opportunities for more effective and efficient integration
Stage 2: connection
Substage 4: structure the management system
It is necessary to create the structure of a management system that

will function as support and, in turn, will facilitate the understanding of any
scenery.

Substage 5: structure the requirements management system

normative
The first step in linking standards requirements with the management system in
an organization is to consider the relationships between different
processes, resources and objectives. This involves understanding the
connection of the processes carried out during the manufacture of
products or the provision of a service with the other supporting processes and, in
the same way, with the needs of the interested parties. By
For this reason, it is known that organizations manage their activities,
resources and objectives through the process management approach.
To comply with this substage of the integration methodology, it was carried out
a comparison between the three standards to be integrated through a matrix
which is partially shown in table 5. In it all the
applicable requirements of each standard and the common points (similar
requirements that allow integration), homologues (requirements that have
similar points only in two of the three regulatory schemes) and specific
(requirements directly related to a specific one) were identified.
particular standard). The latter must be harmonized within the
integrated management system (see table 5).

Table 5. Requirements comparison matrix
Management systems to integrate numerals of the standards

Consideration of the
Applicable requirements
requirement
NTC ISO NTC ISO NTC ISO
13485:2016 14001:2015 45001:2018
Understanding of the sector and its context. 4 4.1 4.1 Common.
Understanding of requirements and stakeholders. 4 4.2 4.2 Common.

txetnoC
Scope of the integrated management system. 4 4.3 4.3 Common.
The integrated management system. 4.1 4.4 4.4 Counterpart.
Leadership and commitment. 5.1 5.1 5.1 Common.
5.2 * *
Customer focus. Specific.
pihsredaeL
Integrated policy. 5.3 5.2 5.2 Common.
Roles, responsibilities and authorities. 5.5.1 and 5.5.2 5.3 5.3 Common.
* * 5.4
Participatory consultation of workers. Specific.
Risks and opportunities. 5.4.2 6.1 6.1 Counterpart.
Identification and evaluation of environmental * 6.1.2 *

Specific.
aspects.
Hazard identification, occupational risk assessment * * 6.1.2 Specific.

and action planning.
gninnalP
4,5.2, 7.2.2, 7.3.3,

Legal and other requirements. 6.1.3 and 9.1.2 6.1.3 and 9.1.2 Counterpart.
7.4.1 and 8.2.3
Program objectives. 5.4.1 6.2 6.2 Common.
Planning changes. 5.4.2 and 7.3.9 6.1.2, 7.4.2 and 8.1 8.1.3 Counterpart.
Source: self made.

On the other hand, it is important to consider that when there is a system of

management already implemented within an organization and you want to integrate
a new system, it is necessary to first compare the requirements of the
system to integrate with those that are already established and of the same
In this way, your requirements should be analyzed. This provides an effective and
efficient approach for the integration of new regulatory schemes (ISO,
2018).
Substage 6: Map the requirements management system

regulations against the management system
According to the manual (ISO, 2018), mapping is the way value is generated,
because the requirements of the standards confront the processes, resources
and objectives that are stipulated in the management system. This
This way it is a useful task to minimize redundancies and
Maximize organizational synergy.
To comply with this substage of the integration process, the common,

homologous and specific requirements were taken into account, grouped in a
new matrix (see table 6), which is shown
partially. In the vertical column on the left were located the
processes that an organization could hypothetically have and the
most relevant subprocesses also identified generically
(Calso Morales and Álvarez, 2018) to see the considerations of the requirement
(see table 7). The horizontal row at the top represents the
clauses that contain the requirements of the standards and detail the
numerals corresponding to each standard. Following that, the
impact of each of the requirements on the processes with the questions suggested by
the IUMMS given below:

• Where are integration opportunities found when reviewing the

processes, resources and objectives of the organization with the requirements of
the rules?
• How are these requirements met in the processes when reviewing the
norms that have points in common?
• Taking into account the previous question, what processes would be
affected by reviewing the specific requirements of a standard?
• What process would be affected by reviewing the specific requirements of
a norm?
• Taking into account the previous question, will new

processes? And, if so, how can the organization better integrate
these requirements in your management system?
Finally, all those requirements that have an impact on the processes were
marked with an approved symbol and their unification with the management
system is indicated. Additionally, this substage allowed:
• Detect processes that are not related to the requirements of the

rules.
• Identify redundancies in processes.

• Determine the minimum necessary processes that satisfy the
regulatory requirements.
• Establish the community level in the standards requirements.

Table 6. Requirements mapping matrix
Processes Context Leadership
Understanding
Compression of the sector Leadership
Processes requirements and Customer focus
and its context and commitment
stakeholders
NTC ISO NTC ISO NTC ISO

NTC ISO 13485
Requirements
13485/14001/45001 13485/14001/45001 13485/14001/45001
4/4.1/4.1 4/4.2/4.2 5.1 5.2
Logistics and
Operation management
support
Integrated
management
system
Environmental
management
Safety
and health
management in the
Quality and integrated

job
management Device
quality
management
Doctors
Quality assurement
Regulatory
affairs
management

Table 7. Homologous, common and specific requirements
Requirement Considerations
Similar requirements that allow integration taking into account the application of the three
Common
management systems.
Requirements directly related to the requirements of the particular standard and that must be
Specific
harmonized with the integrated management system.
Requirements that have similar points in only two of the three integrated management systems.
Counterpart
*
Does not apply
Source: Authors' own elaboration.
Stage 3: incorporation
Substage 7: Identify and analyze gaps
The objective of this substage is to identify and understand the scope of the
differences between the existing management system and the requirements
established in the standards, by verifying whether the processes that have been defined
in the organization comply and to what extent with the requirements, as long as
when there is the intention to certify or only improve performance and
sustainability. It is also important because it evaluates the level of integration achieved
once the requirements have been incorporated into the organization. Such gaps can
subsequently be eliminated with an appropriate policy, process, procedure or practice.
After this analysis, it will be possible to further minimize redundancies, activities
and unnecessary resources.
To comply with this substage of the integration process, it was
necessary to analyze and understand the processes that a
organization, taking into account the level of compliance with the
requirements of integrated standards. This is because each system
management will present variations in the information stored by the

nature of each standard. It is important to note that the analysis of
gaps is not an easy task, as it requires skill and
collaboration of an entire organization to reach defined agreements and
be able to harmonize the flow of information for each process according to the
standards requirements. However, even if the integration process has not been applied
in an organization and well-documented processes are required for this work, this
analysis will be carried out in accordance with what is described in the IUMSS , taking
into account the integrated systems approach.
(focus on the organization's processes) and that follows the steps that are
relevant to a typical audit and self-assessments of a
management:
• Identify and understand the requirements of the system standards
management.
• Collect and verify information about the management system.
• Compare the information of the management system with the requirements and
evidence of compliance.
• Identify opportunities for integration, overlaps and
synergies through:
o The requirements of different standards.
o The different components of the management system (for example,
processes, resources and objectives).
As you can see, the gap analysis is a detailed report of substages 5 and 6 that may
include:
• The purpose of gap analysis.

• The gap analysis approach.
• A gap analysis matrix.
• A list of the regulatory requirements of the management system

analyzed.

• A list of the analyzed processes.

• Documented information reviewed.
• People interviewed.
• A summary of the findings.

• Actions necessary to close the gaps.
• Schedule and resources for closing gaps.

• Recommendations.
In the same matrix where the requirements mapping was carried out (see table 8),
They will be able to identify with a color scale the processes that, after
analysis carried out, present total or partial compliance, of not
compliance or not to apply, as shown by way of example in the
substage 6 mapping matrix.
Table 8. Gap identification and analysis matrix
Context Leadership
Scope of the Roles,

Leadership
integrated management responsibilities and
and commitment
system authorities
ÿProcesses/
NTC NTC NTC
Requirementsÿ ISO 13485/14001/45001 ISO 13485/14001/45001 ISO 13485/14001/45001
4/4.3/4.3 5.1 5.5.1, 5.5.2/5.3/5.3
Integrated management
ÿÿ ÿÿ ÿÿ
system.
Environmental management. ÿÿ ÿÿ ÿÿ
Quality and
integrated
Health and safety
management ÿÿ ÿÿ ÿÿ
management at work.
Quality management
ÿÿ ÿÿ ÿÿ
medical devices.
ÿ Not applicable
ÿ Complies
ÿ Partial Compliance
ÿ Does not comply

Substage 8: close gaps
Once the report has been prepared that describes in detail the gaps
existing, it is necessary to establish a plan for their closure, which must
include objectives and indicators.
The gaps found will be considered as failures in understanding when applying a
regulatory requirement and, to this end, it will be necessary to identify what type
of systemic weaknesses are being related to broader organizational problems, such as
the interrelationships between
insufficiently defined processes or absence of processes that
address standards requirements; Likewise, there may also be
opportunities for improvement related to the integrated use of standards.
Steps to close gaps may include:
• Determine corrective and improvement actions based on the

gap analysis results.
• Identify the components of the affected management system and
determine corrective actions necessary to close gaps
such as: documented information, the need for training,

etc
• Carry out improvement actions: this should include addressing the

opportunities to integrate multiple requirements or regulatory components of the
management system into a single one, for example, by combining various
processes for the control of documented information or unifying
function-specific policies.
Taking into account the above, the types of
gaps that may exist (see figure 1).

Figure 1. Types of gaps
Lack of Opportunities
Non-compliance
for improvement
with requirements requirements
in integration
Source: self made.
As already mentioned, carry out the exercise of identifying and analyzing

gaps in the present work could not be carried out, because it was not
has the information coming from an organization; however,
Some important steps will be proposed that in practice will help
close the gaps found in table 9, below:
Table 9. Considerations for closing gaps
No. Actions Description
Inquire with process managers and other collaborators if they agree

Discuss the results of the gap analysis
1. with the type of finding and what measures they would take
with employees.
in this regard.
Determine the number of existing gaps.
How many processes and objectives do they affect?

Prioritize results based on relevance
2.
to the business. What resources are required to close them?
What processes would need to be established to comply

with the requirements?
Determine necessary and responsible Each breach must have an owner in the process where the breach
3.
actions occurred with the applicable requirement.
Making use of existing matrices to control and monitor each action.

4. Implement and document actions
taken

No. Actions Description
Demonstrate whether what has been implemented has

been effective or not.
Review all components of the Check that there are no adverse effects on other
5.
management system components of the integration carried out.
Look for redundancies, synergies and more integration

possibilities.
Substage 9: verify gap closure.
According to (ISO, 2018), the performance of the organization's

management system over time is the true indicator of whether the management
system is functioning correctly. There are internal measures within the
organization that can be leading indicators of organizational performance
against objectives. The organizations
They need to look at processes, resources and objectives taking into account
considers the links between the functions and the requirements of the standards of the
integrated management system.
To confirm closure of any gaps and maintain improvements

performed, organizations should review the results through
internal audits and management review. Once the
gap, it is important to verify if the implementation actions
continue and be able to determine if the benefits have been achieved.
Assessments of management system regulatory requirements provide

important information and direct organizations to understand their level of
performance and determine whether corrective actions have been taken.
been effective. Once these actions have been implemented, it will be possible to
then carry out an internal audit or a self-assessment focused on the
identified gaps and related corrective actions, in order to

ensure effective and efficient implementation.


Substage 10: Maintain and improve integration
After an organization completes the gap analysis and closes with

To successfully address the identified gaps, the next step is to ensure that
management system requirements remain implemented
properly. The value of integration is reflected in the performance of the organization.
Verifying implementation by monitoring and periodically reviewing the system
is an integral part of maintaining and improving an effective management system
(IUMSS). For this it is recommended
take into account the following:
• Verify the continued commitment of senior management.

• Review and update documentation.
• Review of the risks and opportunities found.
• Look for areas where value can be added.
• Find better ways to use resources.

• Verify that everything is as integrated as possible.
• Verify compliance with objectives.
• Always consider continuous improvement.

• Try to maintain profits in a sustainable way.
• Monitor stakeholder requirements.

• Validate the processes.
• Verify changes in legal requirements.
Substage 11: Apply lessons learned
As organizations go through the integration process, there are many lessons to be

learned and new challenges that may arise. No
There is only one way to achieve integration or maintain and improve a
integrated management system. Organizations must continue to improve
by understanding the results that have been obtained.

These lessons and challenges can be used to improve the methodologies of
current or future integration. Furthermore, they can be used as a
opportunity to improve other aspects such as:
• Knowledge management.
• Resistance to change.
• Competencies.
• Differences in professional skills.
• Better relate the requirements with the demands of the parties
interested.
When comparing the IUMSS methodology with elements from other
proposals for the integration of management systems, a
close relationship between the structure of the manual proposed by the
ISO and the guiding principles determined by Nunhes et al., (2019). They analyzed 28
common elements identified throughout the most referenced literature between 2006 and
2016 and found that:
• Systemic management.
• Standardization.
• Strategic, tactical and operational integration.

• Organizational learning.
• Debureaucratization.
• Continuous improvement.
They turn out to be the pillars in the development and maintenance of systems
management systems, which are implicitly contained
in each of the stages given in the integration methodology that
proposes the IUMSS manual.

Development of the validation methodology
As stated in Table 1, the validation methodology was carried out through four
stages that allowed us to obtain the following
appreciations:
Stage 1: technical experts
A total of seven experts participated in this stage with profiles and

Selected experience in relation to quality management or
technical direction in small, medium and level organizations
multinational company dedicated to the marketing of medical devices
In colombia.
Stage 2: introduction
The integration methodology was presented in an introductory manner to each

of the experts, describing the general problem and explaining why the integration
stages of the NTC ISO standards were developed.
13485:2016, NTC ISO 14001:2015 and NTC ISO 45001:2018.
As mentioned above, the tool implemented was the

Régnier's abacus, which consists of a range of colors aligned according to the
international convention adopted for traffic light colors. These
Colors indicate the opinion of each expert regarding the statements
made based on the proposed models. At a general level, the colors range from
green to black, from positive opinions, moving to neutral positions, then negative
opinions and, finally, conditional opinions such as blank voting and
reluctance to participate. Thus, they have
the following meaning described in table 10:

Table 10. Color convention and its significance
Voting classification Interpretation
Very favorable. Totally agree opinion.
Favorable. Agree opinion.
Neutral. Acceptable opinion.
Unfavorable. Disagreeing opinion.
Very unfavorable. Totally disagree opinion.
Blank vote. He prefers not to give an opinion.
Reluctance to participate. Prevented from giving an opinion.
Then the description of the instructions was explained step by step, making
emphasis on evaluation criteria according to the matrix and
color convention, under which the most adjustable option is selected
the opinion of each expert (Martínez Narváez, 2018).
Stage 3: contextualization
A description of the development phases was made. All in order to give

a general contextualization of the integration methodology.
Stage 4: proposed validation instrument
For stage four, each expert was asked to evaluate each of the
five statements raised, taking into account the relevance of each
one of the components of the proposals made for the deliverable.

These statements and the respective evaluations of each expert are

can be seen in table 11.

Table 11. Proposed integration statements
Validation instrument based on the Regnier abacus method

Selected experts
Item Statements about the methodology of to. b. c. d. F.

and. g.
integration
The proposal for the integrated management

system proposed based on the IUMSS guide
for the medical device sector is a tool that
1. Favorable Favorable Favorable Favorable Favorable Favorable Very
would help achieve the strategic objectives of favorable
marketing organizations in Colombia.
The proposal for the integration of the three

management systems: quality, environmental
and occupational health and safety for the
2. medical device marketing sector avoids wear
and tear in time, duplication of processes,
non-compliance with requirements and optimizes
the efficient use of Very Very
resources. Favorable Favorable Favorable Favorable Favorable Favorable favorable
The iIntegration methodology proposed by the

IUMMS facilitates the integration of the
3. Very Very Favorable Favorable Very Favorable Very
organization's processes with the favorable favorable favorable Favorable
standards of the different norms to be
integrated.
The quality process and integrated system

proposed in the generic structure of the
integrated management system will optimize
4. Very Very Favorable Favorable Favorable Very Very
the processes and resources of unified favorable favorable Favorable favorable
management, reduce bureaucracy and
consequently reduce costs.

Validation instrument based on the Regnier abacus

Selected experts
method
The IUMSS manual will allow the

integration of other new standards
5. aligned with the high-level structure of the ISO Very Favorable Favorable Favorable Favorable Favorable Very
favorable favorable
or those that allow their equivalence.
Source: self made.

At a general level it can be seen in table 11 that the tool

validation proposal was evaluated obtaining votes on average with
favorable concept, which shows the agreement of the experts
technicians with the integration proposal under the methodology proposed by
the IUMSS.
For items 1 and 2, which resulted in the experts rating as favorable and very
favorable, it is stated that the IUMSS integration tool, implemented for the integration
methodology
proposal, will allow achieving the strategic objectives, will avoid
the expense in times of duplication of processes and non-compliance with
requirements, optimizing the efficient use of resources.
Regarding items 3, 4 and 5, very favorable results were obtained and

favorable, in which it is stated that the integration methodology
proposed by the IUMMS facilitates the integration of the processes of the
organization with the standards of the different norms to integrate.
Conclusions
It is evident, through the research carried out, a need for

interpret, establish and disseminate methodological tools that facilitate
the process of integrating different management systems, which are
flexible to regulatory requirements and in a generic way is
Applicable to all types of organizations.
It is observed, from the results obtained, that any user

may approach the use of the IUMSS manual differently depending on the
organizational core and the planned goals of the processes; However, for this
approach to be successful it must follow a logical structure, which is presented in
this article.

Process-centricity or a process-based approach is

fundamental in the integration of different management systems, due to
which is revealed by how aligned the

process with the requirements of the standards, in addition to being relevant in the
audits.
It is evident that, although NTC ISO 13485:2016 does not have a defined high-
level structure, as in NTC ISO 14001:2015 and NTC
ISO 45001:2018, the integration could be carried out without complications, since
that the standard related to medical devices is associated
homologously to the NTC ISO 9001:2015 standard.
Integration has an ultimate goal, based on finding the

existing relationships between regulatory requirements, processes, resources and
objectives with the purpose of identifying, evaluating and improving them to

increase organizational performance and decrease the overall magnitude of the
system.
The IUMSS manual turns out to be a pedagogical tool that could be widely used
in teaching management systems, due to the clear and structured language that
would make it easier for teachers to understand key concepts in their
students.
It was possible to translate and interpret the IUMSS manual for its application in
any economic sector, taking into account that Colombia is not a
bilingual country and that said manual is only for sale in the English language.
Technical experts consider that the methodology given by the IUMSS is
a robust and easy to understand tool for the methodology of

integration.

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Received: June 16, 2020

Accepted: August 13, 2021

* Research result article.

Signs, Research in Management Systems

Moreno Parra, PA, Restrepo Benavidez, B. and Sánchez Martínez, PA (2021).

multiple management systems in all types of organizations.

However, it is currently little known that the International Standard Organization

regulatory perspectives to be aligned in a single management. The Integrated Use of

Management System Standard (IUMSS) manual establishes a method of four

main stages (preparation, connection, incorporation and maintenance) in

which the high-level structure serves as a guide to integrate common, homologous

establish a methodology for integrating the standards: NTC ISO 14001:

2015 environmental management system, NTC ISO 45001:2018 occupational health

robust tool aimed at reducing excess

and an organization's processes.

Keywords: integrated management systems, NTC ISO 14001:2015, NTC ISO

45001:2018, NTC ISO 13485:2016, integration methodology, gaps.

Signs, Research in Management Systems

Methodological application: the integrated use of management system

Keywords: integrated management systems, NTC ISO 14001: 2015,

Signs, Research in Management Systems

Methodological application: integrated use of management

Various methodologies have been developed since the 90s to integrate

Keywords: integrated management systems, NTC ISO 14001:2015,

Nowadays, all types of organizations must face changing markets and

Signs, Research in Management Systems

strategic direction and promote stability, good

competition, the generation of results with fewer resources, the reduction

of duplicity in processes, mitigation of bureaucracy and

effective increase in performance to positively impact the

When considering the benefits that certain organizations have achieved by

administrative aspects of the integration process related to excess

bureaucracy, redundancies, costs, lack of employee motivation and

managers to manage different management systems at the same time (Bernardo

experience, promote integration as a determining factor to achieve efficiency

stakeholders, improve the organizational climate, promote work in

team, improve communication in all areas, exchange

knowledge, improve the corporate image, among others (Moumen and

In the integration of management systems, what is described must be considered

works highlight the need to define and establish a methodological

elements between the different systems to be integrated, flexibility to satisfy regulatory

requirements, compatibility with the cycle

Signs, Research in Management Systems

activities and operations cannot be integrated, they must be redesigned

integrated (Nunhes et al., 2017).

However, the existence of multiple integrative methodologies, proposed by

different authors, causes confusion when discerning which of them is appropriate

published by Heras et al. (2007) all research is mentioned

It is difficult to think of a fair and specific model for an organization,

2018, in its second version, a manual that proposes a methodological

management system, effectively and efficiently through a theoretical component

and the description of successful cases in organizations of

For organizations seeking guidance on how to integrate

requirements of multiple ISO standards in the management system. From

first edition in 2008, the IUMSS has had a substantial number

of changes these include the introduction of the high-level structure

ISO, provided in ISO/IEC Directives Part 1, Clause SL.9. With

that do not belong to the same family (ISO, 2018).