Quality Manual for Medical Research Companies
Actualization According to GOST R ISO 9001-2015
Ekaterina A. Batcina 1, Galina V. Artamonova 2
Federal State Budgetary Institution «Research Institute for
Complex Issues of Cardiovascular Diseases»
Kemerovo, Russia
1
baciea@kemcardio.ru, 2 artamonova@kemcardio.ru
Ludmila M. Zaharova
Federal State Institution of Higher Education
Kemerovo State University
Kemerovo, Russia
zaharova_lm@mail.ru
Abstract - This article describes the necessary changes and
inovations in the quality management system according to the
new version of GOST R ISO 9001-2015. The experience of
actualization the manual of quality in scientific and medical
institutions through preparing to recertification in accordance
with a requirements of GOST R ISO 9001-2015.
Keywords - The quality manual; GOST R ISO 9001-2015;
GOST R ISO 9001-2008; recertification; quality management
system; environment of the organization; organization knowledge;
representative for quality in organization
I. INTRODUCTION
One of the most advanced and widely mastered, by
international comunity, methods of quality management is a
model of organization quality which normalized by ISO 9000
standard. At the moment, the fifth version of management
model is released, which is aimed at ensuring maximum
efficieny of the organization and the competitiveness of
products[1].
ISO 9001 is a most popular regulatory document in the
world. Being an universal document in its purpose, it’s used in
almost all areas of human activity. Engineering, mining,
energy, education, health, law enforcement – this isn’t
complete list of industries which use this international standard
[2].
Based on ISO 9001 there was created a Russian national
standard GOST R ISO 9001-2015 which contains a new
postulates of model of quality management system (QMS), the
form of application of which as in the previous version,
remains at the discretion of the enterprise. That fact is
conditioned to the organization diversity in the modern world,
because of specificity of each activity provides the
individuality of each specific QMS.
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Marina F. Guskova
Federal State Institution of Higher Education
«Russian University of Transport» (RUT (MIIT)
Moscow, Russia
marina250364@yandex.ru
The organizations, which has been certified during the
transition period (before September 2018) must recertified on
new standard GOST R ISO 9001:2015, which entails
significant and minor changes in QMS.
QMS implementation in research institute for complex
issues of cardiovascular diseases (NII KPSS) had begun in
2009. In 2010 the institution got a certificate of compliance
with the requirements of the 2008 version and in 2017 passed a
recertification of GOST R ISO 9001-2015. The QMS is
harmoniously developed during the 8 years period and forming
the fundamental comprehensive management system of
research institute KPSSZ.
The scientific and medical institution has been set of tasks
to improve the existing QMS, one of which is the updating of
the fundamental document in the field of Quality Manual (QM)
with the GOST R ISO 9001-2015 has been released.
The purpose of research is to present the experience of
scientific and medical institutions to update the quality Manual
in accordance with the requirements of GOST R ISO 9001-
2015.
QM in general is a document that defines QMS, which is
used as a guidance document to ensure the functioning of the
QMS, performance, maintaining it in working condition [3].
QM helps to navigate in an organization activity, to track
processes and their interaction in the system [4,5,6]. Besides
that QM allow to auditors quickly understand the specifics of
the institution during the certification audit. The importance of
the QM is unquestioned. This document acts as the
Constitution of the institution, which establishes the basis for
activities to ensure the highest quality of products or services.
After the new standard is entry into force, the requirement
of development by the organization of QM ceased to be
obligatory. According to paragraph 4.2.2 of GOST R ISO
978-1-5386-6757-6/18/$31.00 ©2018 IEEE
9001-2015: "the organization must develop, update and apply II. ENVIRONMENT OF THE ORGANIZATION
documented information to ensure the functioning of the Understanding an organization's environment is a process
processes", which means that the legitimacy of the absence of that identifies factors that influence an organization's intent,
the QM in the presence of the necessary documented goals, and sustainability. This takes into account internal
information. factors such as values, culture, knowledge and performance of
Management of NII KPSSZ has decided actualize QM the organization. This process also takes into account external
under the QMS reorganization on the requirements of GOST R factors such as legal, technological, competitive, market,
ISO 9001-2015. cultural, social and economic conditions [13].
QM institutions includes eight main sections that duplicate To start this process an analysis was conducted of the
sections of the standard, which is the most common and correct research Institute KPSSZ, and formulated the basic provisions
option for the construction of the document [7]. This is due to included in the same paragraph 4.3 of the current QM scientific
the comparative analysis of QM and GOST R ISO 9001-2015 and medical institutions. Paragraph 4.3. "The environment of
to determine the differences in the structure of documents and the organization" begins with the definition:"the environment
further bring to uniformity. of research Institute of KPSSZ is a set of controls (processes,
structures, technologies, methods, tools, procedures, activities,
Improvement of the ISO 9001 standard can be divided into etc.components) that provide scientific results and the
two groups: modifications and innovations. Change is provision of medical services that meet the requirements of
something that was previously, but has taken a different form consumers and other stakeholders." According to the
or designation; innovation is something that has emerged under requirements of GOST R ISO 9001-2015, the research Institute
ISO 9001 for the first time (table) [8,9,10,11]. of the KPSSZ distinguished the categories of external and
internal consumers, suppliers, and other stakeholders..
TABLE. CHANGES AND INNOVATIONS ISO 9001:2015
Changes III. RISK AND OPPORTUNITY MANAGEMENT
Innovation
ISO 9001:2008 ISO 9001:2015 MEASURES
Product Product and services p.4. Environment of the
organization The new version of ISO 9001 excludes from the basic
Documentation Documented p.6.1. Action on risks concepts "preventive" actions, now they are reflected through
(QM, records, information and opportunities risk-based thinking in the formulation of requirements for the
documented QMS. In paragraph 6.1 standard GOST R ISO 9001-2015
procedures, etc.)) established that the organization should plan actions to respond
Production Environment for the p.7.1.6. Organization to risks, but the specific method of risk management or
environment processes knowledge
functioning documented process of risk management is not mentioned. It
Suppliers External and internal p.8.4. The management leads to the conclusion that the institution itself decides what
supplier of processes, products approach to use, extensive with the use of additional standards
and services provided and guidelines, or sufficient requirements of GOST R ISO
by external suppliers 9001-2015. The research Institute of the KPSSZ fourteen
Consumer Consumer and inextricably linked processes, which is due to the introduction
stakeholders
Product Product and services
of risk-based thinking based on effective methods, which is to
Resource Means of security create passports and control risk maps for each of the processes
management [14]. The process of risk management in the framework of
updating the RK was described in paragraph 5.7 - "risk and
The management of NII KPSS are continually improving opportunity management Measures".
QMS undertakes a range of measures to improve the
IV. ORGANIZATION KNOWLEDGE
functioning of the processes, follow global trends in the field of
the quality. For this reason, it was decided to update the This knowledge is specific to the organization, gained from
terminology of the new version of the standard, showing its experience in a particular field of activity and used to achieve
commitment to the continuous development of the institution in their goals [13]. Requirements relating to in-house knowledge
terms of quality. All changes are shown in the table were have been included in the new version of the standard to
included in the QM of the research Institute KPSSZ, as well as protect against loss of knowledge (staff turnover, software
in other documentary information organizations. failures, etc.) and to support organizations in acquiring new
knowledge (mentoring, benchmarking). The effectiveness of
New version of the standard has no terms replacement scientific institutions in the field of medicine depends largely
requirements of the quality management system of the on the timely and error-free use of knowledge [15].
organization, by the new terms of the ISO 9001:2015 standard,
what can't be said about the innovations required for Since the goal of creating a research Institute KPSSZ is on
implementation [12]. the basis of fundamental and applied research of new and
deepening of existing knowledge in the field of cardiology,
Innovation, in this case, is a more complex and time- angiology and cardiovascular surgery, the process of
consuming process. knowledge management is particularly important. In the
Republic of Kazakhstan were made to claim 6.5, which
describes the process of working with knowledge: sources of

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knowledge, how research and clinical diagnostic activities,
which involves the creation of innovative knowledge, the
described method of storing and sharing knowledge.
V. PROCESS, PRODUCT AND SERVICES CONTROL
PROVIDED BY EXTERNAL SUPPLIERS
From GOST R ISO 9001-2015 follows that organizations
needs to develop processes for identifying potential sources for
purchased materials in order to ensure the effectiveness and
efficiency of procurement processes in general. In the NII
KPSSZ this process is under the control of contract service,
where staff are guided by current Documented procedure, "to
provide resources for units». As part of the update in QM was
added paragraph 6.6 "Management of processes, products and
services provided by external suppliers", which briefly
describes the algorithm for managing processes, products and
services provided by external suppliers. Following algorithm
includes next steps:
1. Formation of requests for resources;
2. Organization of procurement procedures;
3. Support, execution and closing of contracts;
4. Acceptance of purchased goods;
5. Distribution of goods to consumers;
6. The consumption of the resources, control the use of.
Specialists of the contract service of the research Institute
of KPSSZ evaluate the effectiveness of the procurement and
the effectiveness of contractual relations with the counterparty
selected by the results of the procurement, which is proof of the
implementation of the new paragraph of the standard.
Another feature of ISO 9001: 2015 is that there is no
mention of a representative of the quality manual (RQM). In
ISO 9001:2008, according to paragraph 5.5.2-RQM-an
employee who, regardless of other responsibilities, is
responsible and has the authority to ensure the development,
implementation and maintenance of the processes required by
the quality management system. With the loss of the need for
the QM, the need for the RQM disappeared. Despite this, the
standard establishes that the responsibilities of the RQM are
now assigned to top management according to the internal
distribution of responsibility for certain actions in the field of
quality.
At Institute of RQM it is appointed by the order of the
Director of Institute. The RQM is responsible and has the
authority to:
• ensuring the development, implementation and
maintenance of the processes required by the quality
management system;
• analysis of QMS functioning and provision of relevant
reports to top management on QMS functioning and
need for improvement;
• to promote understanding of the requirements of the
consumer;
585
• liaising with external parties on issues related to the
quality management system.
As with the release of the new standard, it was decided not
to abandon the QM, the position of the representative remained
relevant and significant.
Thus, as part of the improvement of the quality
management:
• comparative analysis of GOST R ISO 9001:2008 and
GOST R ISO 9001:2015;
• replacement of terms of the standard GOST R ISO
9001:2008 in terms GOST R ISO 9001:2015;
• described and decorated new items of Kazakhstan: the
environment of the organization, measures to address
risks and opportunities, knowledge of the organization,
management of processes, products and services
provided by external suppliers;
• it was decided to retain the position of the representative
of the quality management.
Projecting the provisions of GOST R ISO 9001-2015
standard on the work of organizations in the field of
information documentation, it can be concluded that when the
RK is abolished, the management of companies may face such
a problem as the uncontrolled functioning of the QMS due to
the lack of a clear structure of quality activities. However, the
standard says about the freedom of organizations to choose the
form of the QM, since 2015 it can be supplemented by various
means of interpretation of information provided that the goal is
met.
In conclusion, it is important to use the quality Manual. A
responsible approach to the creation and maintenance of this
document makes it a useful tool for the effective operation of
the organization and a modern weapon in the competition.
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Information about the authors
1. The author responsible for the correspondence: Bacina Ekaterina
Alekseevna
Federal State Budgetary Institution «Research Institute for Complex
Issues of Cardiovascular Diseases»,650002, Russian Federation,
Kemerovo, 6 Sosnovyj bul'var.
Researcher of laboratory of simulation of management of technology,
master of science.
baciea@kemcardio.ru
2. Zaharova Lyudmila Mihajlovna
Federal State Budgetary Educational Institution of higher professional
education «Kemerovo state University», 650000, Russian Federation,
Kemerovo, 6 Krasnaya st.
Professor of the Department of milk and dairy products technology,
doctor of technical Sciences.
zaharova_lm@mail.ru
3. Artamonova Galina Vladimirovna
Federal State Budgetary Institution «Research Institute for Complex
Issues of Cardiovascular Diseases»,650002, Russian Federation,
Kemerovo, 6 Sosnovyj bul'var.
Deputy Director for research, professor, doctor of medical
Sciences.artamonova@kemcardio.ru