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.
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 90012015.
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
9001-2015: “the organization must develop, update and apply
documented information to ensure the functioning of the
processes”, which means that the legitimacy of the absence of
the QM in the presence of the necessary documented
information.
Management of NII KPSSZ has decided actualize QM
under the QMS reorganization on the requirements of GOST R
ISO 9001-2015.
QM institutions includes eight main sections that duplicate
sections of the standard, which is the most common and correct
option for the construction of the document [7]. This is due to
the comparative analysis of QM and GOST R ISO 9001-2015
to determine the differences in the structure of documents and
further bring to uniformity.
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;
• 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.
@INPROCEEDINGS{8524911,
author={E. A. {Batcina} and G. V. {Artamonova} and M. F. {Guskova} and L. M. {Zaharova}},
booktitle={2018 IEEE International Conference “Quality Management, Transport and Information Security, Information Technologies” (IT QM IS)},
title={Quality Manual for Medical Research Companies Actualization According to GOST R ISO 9001-2015},
year={2018},
volume={},
number={},
pages={583-586},
keywords={biomedical engineering;ISO standards;quality management;user manuals;quality manual;medical research companies actualization;GOST R ISO 9001-2015;quality management system;scientific institutions;medical institutions;innovations;ISO Standards;Organizations;Standards organizations;Quality management;Manuals;Technological innovation;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},
doi={10.1109/ITMQIS.2018.8524911},
ISSN={},
month={Sep.},}