Methods of Quality Menegment, 2024, January

A.I. Aniskin, I.N. Gerasimenko, S.M. Goldobin, Yu.V. Ershova, V.N. Skugarova

QUALITY SPECIALIST: PROFESSIONAL PORTRAIT IN BUSINESS DYNAMICS

The first issue of MQM journal of 2024 opens with the management concilium, the participants of which were experts with extensive practical experience in implementing and improving the QMS. On the one hand, the topic of understanding and effective application of ISO 9001 is truly inexhaustible. On the other hand, this publication is intended to once again focus attention on the fact that the main actors and authors of materials are rin management systems

Keywords: ISO 9001, management system, QMS effect

P. Palmes, D. Isaacs

OPEN TO INTERPRETATION: RECONCILIATION FOR THE INTERPRETATIONS OF ISO 9001:2015

«The organization shall» — this phrase in ISO standards denotes certain requirements. Unfortunately, these requirements are often formulated ambiguously, which gives rise to a variety of interpretations. That is why, ISO/TC 176 provides users of ISO 9001 with the opportunity to ask questions and receive an explanation of a particular provision of the standard. We are talking about the process of its formal interpretation, based on the US experience presented in this article.

Keywords: ISO 9001, requirements, official interpretation, objective evidences, consensus.

OFFICIAL INTERPRETATION OF ISO 9001:2015 REQUIREMENTS: GUIDANCE AND PRACTICAL EXAMPLES

The official interpretation of the requirements of a standard is a service provided by ISO to its member bodies, which are national standards bodies. The interpretation of ISO 9001 is a formal process overseen oversees the subcommittee 2 «Management Systems» of international technical committee ISO/TC 176. Its objective is to achieve consensus among members of ISO/ TC 176/SC 2 on the issue of reconciliation of interpretations of this standard’s specific provisions. The requirements for the form and content of such a request, and also provides examples of officially approved interpretations are considered in the proposed material.

Keywords: ISO 9001, requirements, official interpretation, interpretation request, TC 076 «Management systems».

A.D. Isaeva, E.S. Popkova

ISO 13485 STANDARD: CERTIFICATION FOR STAKEHOLDERS INTERESTS

Meeting the demands of consumers and other stakeholders allows an organization to achieve its goals, increasing its competitiveness. However, managing stakeholder engagement requires the use of appropriate tools. For manufacturers of medical devices, one of these tools is the ISO 13485:2016 standard, which allows to implement and maintain an effective quality management system. The proposed article discusses the main reasons that should encourage an organization and its management to use this standard and be certified for compliance with its requirements.

Keywords: GOST ISO 13485, stakeholders, quality management, QMS effectiveness.

A.Yu. Rogatkin

ISO 9001 STANDARD REVISION: DEVELOPERS POSITION AND USERS INTERESTS. PART 2

At the meeting of ISO/TC 176 «Quality management and quality assurance», held in October 2023 in Kigali (Rwanda), the procedure for ISO 9001 international standard revising was launched. In this regard, it seems important to assess possible options for its revision that may be proposed by its developers. If we keep in mind only «pure» strategies, there are only three of them: conceptual additions due to new topics, structural changes and technical editing of the text. The second part of the article considers the feasibility of including new concepts in the standard, as well as the four UN SDGs.

Keywords: ISO 9001 revising, emerging concepts, requirements, agile practices, process approach.

V.A. Kachalov

ON THE EFFECTIVENESS OF THE «HARMONIZED STRUCTURE» OF INTERNATIONAL STANDARDS FOR MANAGEMENT SYSTEMS. PART 2

The problem faced by organizations that introduced several international standards for management systems at the beginning of the 21st century was as follows: ISO profile technical committees and other international organizations that developed standards for management systems structured them each at their discretion. This led to the need to unify the structure of sections of these standards and the composition of their minimum required key requirements. The second part of the article is devoted to the analysis of the achieved result — the degree of harmonization of international standards for management systems, as well as their Russian counterparts

Keywords: standards for management systems, Harmonized structure, standards’ translation.

V.Yu. Smelov, V.L. Shper, E.I. Khunuzidi, E.A. Akhmetova, Ya.G. Oleksenko

TWO METHODS FOR PROCESSES QUALITY ASSESSMENT AND THE IMPACT OF THE MEASUREMENT SYSTEMS VARIABILITY ON THEM. PART 1

For each group of people, the concept of quality is different. It is even more difficult to assess this quality and, moreover, to quantify it. But under certain conditions, it is still possible for individual cases. However, not every assessment is useful, sometimes it is even harmful, and its results can lead to erroneous management decisions. In the first part of the article, two approaches are considered in detail: the traditional one based on tolerances, and the relatively new one based on the Taguchi quality loss function. The practical consideration of all the issues discussed was carried out taking into account the real data of a particular production.

Keywords: quality assessment, tolerances, reproducibility indices, measurement system, quality loss function.

S.V. Yurchenko

RELATIONSHIP MANAGEMENT IN THE «CUSTOMER  MANUFACTURER  SUPPLIER» CHAIN. PART 1. AGREEMENT ON QUALITY

Effective interaction with consumers and suppliers is one of the key factors ensuring productivity growth, improving the quality of manufactured products, including by reducing the level of defects, and increasing the competitiveness of the manufacturing company as the result. Let's consider the tools for the relationship management in the «Customer — Manufacturer — Supplier» chain, developed and applied at the BSW Management Company OJSC (Republic of Belarus). The first part of the article describes the content and structure of the «Agreement on Quality».

Keywords: relationship management, agreement on quality, customer, supplier, IATF 16949.

Maxim V. Ekaterinin

ON THE PERSPECTIVES OF APPLICATION THE INTERNATIONAL STANDARDS FOR MANAGEMENT SYSTEMS BY RUSSIAN ENTERPRISES

In the current situation, how advisable is it for Russian companies to rely on international standards when developing their management systems? The requirements of which standards, along with ISO 9001, could improve the effectiveness of the QMS of Russian enterprises? What standards on management systems will become most in demand in the near future? These questions are answered by M.V. Ekaterinin, the Chairman of the Editorial and Expert Board of the MQM journal.

Keywords: management systems, ISO 9001, QMS effectiveness, cross-industry requirements, international standards.