This research evaluates the perceptions from the conformity assessment community regarding the auditability of ISO 9001:2015 and the perception of its ease of use by the audited organisations. The ...study is supported on a survey promoted by the Strategic, Planning and Operations Task Group (SPOTG) of Subcommittee 2 of ISO TC 176 (TC 176/SC2) aiming at collect insights on using the standard and identify any need for future revisions. As an overall conclusion, in the view of certification bodies' auditors, programme managers and certification decision-makers, ISO 9001:2015 attained its main objectives. Nevertheless, it is suggested in the forthcoming ISO 9001 review cycle to adopt a more simplified language and to improve the ease of understanding and consistency of interpretations of the ISO 9001:2015 requirements. Additionally, suggestions for making clauses (e.g. 4.1. Understanding the organisation and its context, 6.1 Actions to address risks and opportunities, 7.1.6 Organisational Knowledge, and 4.2 Understanding the needs and expectations of interested parties) easier to apply and improving its auditability have also been identified.
The ISO 9001:2015 standard released in September 2015 contains, for the first time, a specification for 'organizational knowledge' as a resource and during the following three years more than 1.1 ...million organisations seeking recertification will need to take this into account. There are few clear guidelines about the practical implications of addressing this knowledge requirement, and therefore this paper attempts to identify some theoretical and practical frameworks. Firstly, it considers the complementary nature of quality management and knowledge management. Secondly, it conducts the first content analysis of how knowledge has emerged in the evolving ISO 9001 standards and how three of the main elements in the data, information, knowledge and wisdom pyramid are represented. Thirdly, it identifies that the knowledge cycle provides a coherent structure for assisting organisations to understand the new standard and applying knowledge requirements in practice. Next, it examines the issues faced with explicit and tacit knowledge. Finally, it summarises a number of conclusions.
We have recognised significant problems in understanding and applying the standard ISO 9001:2015. In this general review article, we expound that this situation originates from the standardisation ...process and its managerial drawbacks. Our research provides insight into the problematic aspects in the standard. The research is based on analysing the standard text, making observations from the initial application period of the standard half a year after its publication, and searching for an explanation for the situation from the problems in the standardisation process. Our aim is to guide organisations in implementing the standard for business advantages in spite of its existing problems, to identify the responsibility of the implementing organisations, and to provoke and encourage them into creative business-specific solutions. We want that our study also provides more understanding about the general international standardisation procedures and in particular of the management system standards, of which ISO 9001 is the most well known. Our main focus is on the practitioners' viewpoints and the implementation of the standard in the organisations, and the article is based on our own observations and long-term participation on the ISO 9000 standardisation and implementation.
The ISO 9001: 2015 incorporated requirements for risk-management approach in its most recent version as part of the assured quality concept evolution. In this context, the research aims to analyse if ...an organisation has practices implemented to meet the requirements associated with the risk management to enable ISO 9001: 2015 implementation and certification. To accomplish this, a case-based research was adopted at an automotive company. The research results indicated that risk management approach is part of the culture at the analysed company and is already being addressed in some of the organisation's processes, among which are the product development process, supply chain management, and machine and equipment management. The paper also suggests a checklist for assessing the ISO 9001: 2015 risk management requirements compliance, which can be used as a framework for future research replication, including different segments of the industry, as well.
The aim of this research is to evaluate, six months after the issuing of ISO 9001:2015, if the 2015 edition has achieved its aims of being in line with modern management and quality management ...concepts and bring additional value to organizations of all industry and services sectors worldwide. A survey was carried out among IRCA registered auditors and the statistical analysis of the results support the assumption that ISO 9001:2015 is in line with modern business and quality management concepts and will be a useful tool for the companies. Although the authors acknowledge pursuing further in-depth studies, this is a relevant contribution to the validation of ISO 9001:2015 edition and its value for all type of organizations worldwide.
ISO 9001: 2015 adoption: a multi-country empirical research da Fonseca, Luis Miguel Ciravegna Martins; Domingues, José Pedro; Machado, Pilar Baylina ...
Journal of industrial engineering and management,
01/2019, Volume:
12, Issue:
1
Journal Article
Open access
Purpose: This paper aims at identifying obstacles, benefits, leading practices and lessons learned in the transition/certification of the revised standard for quality management systems ISO 9001:2015 ...for organizations in various sector, countries and spanning a range of sizes. Design/methodology/approach: Based on literature review and inputs from experts in management systems certification, a quantitative survey was launched in Portugal, Romania, Switzerland, and Turkey in April 2018, addressed at quality and organizational managers and CEOs from ISO 9001:2015-certified organizations by certification bodies partners of the leading International Quality Network (IQNet). The answers were collected anonymously through an automated online database, until the end of April 2018. The overall response rate was 3.1%, encompassing 222 organizations already certified according to ISO 9001:2015. Findings: The surveyed organizations reported significant benefits from ISO 9001:2015 implementation. Only 3.9% of the respondents considered the 3-year transition period (from September 15, 2015, to September 15, 2018) as too short. The respondents' organizations attended ISO 9001:2015 training and seminars, and collected information from websites, newsletters, books and interpretation guides and directly from certification bodies. Some (29.8%) relied on their own internal resources for the transition processes, while external consultants supported 22.7%. The respondents considered the adoption of risk-based thinking the major difficulty to be overcome, but simultaneously as the major benefit to be realized. The alignment with other management systems, the increased top management commitment, the identification of risks and opportunities and the knowledge management were also reported as significant benefits. The initial timing when organizations started working on the transition process and the activities carried out seem to differ between countries, while the adjustments performed to the existing management systems seem to differ by sector and size of the organization. The benefits attained by the organizations vary according to the perception regarding the information resources made available and organizations should be aware of the advantages of early planning. The organizations that rated the benefits of ISO 9001:2015 adoption higher considered the information resources as adequate and started working with ISO 9001:2015 at an earlier stage, while those that rated the benefits lower stated that the information resources were made available too late. The organizations that successfully managed the ISO 9001:2015 transition/certification process were the ones that attended ISO 9001:2015 training courses and seminars and got useful information from their certification body. This research highlights the relevance of the geographical context, of the organization size and the sector for successful adoption of ISO 9001:2015. The identification and promotion of resources that led to the highest benefits are worth pursuing. The replication of this study can add a time perspective and the assessment if these perceptions are expected to materialize into tangible results such as cost benefits and higher customer satisfaction. Research limitations/implications: Due to the novelty of ISO 9001:2015, these results should be subjected to additional validation and longitudinal analyses. Although measures have been taken to minimize possible bias errors from both non-respondents', and respondents' subjectivity, these limitations of the survey methodology should be acknowledged. Practical implications: The findings of this research provide standardization and certification bodies and quality management systems practitioners with leading practices in the implementation of ISO 9001:2015 and guidance for an efficient and effective transition/adoption. Originality/value: This investigation contributes to the ISO 9001:2015 body of knowledge by mapping the transition/certification processes with a multi-country perspective. The results empirically validate the potential value of transitioning or adopting ISO 9001:2015 and give insights on the implementation methodologies, leading practices to follow, difficulties to overcome and benefits to realize, to maximize the success of ISO 9001:2015 adoption.
Purpose
The purpose of this paper is to discuss factors to support ISO 9001:2015 implementation. A framework for identification and prioritization of factors is applied in Brazilian power train ...suppliers (Tier 1). Brazil is the eighth largest vehicle manufacturer in the world.
Design/methodology/approach
The data analysis presented in this paper is grounded in an empirical study involving ISO 9001 certified Brazilian companies (47 plants) that supply auto parts to power train assembly plants. They represent almost 50 percent of the Tier 1 Brazilian power train suppliers. Data collection and analysis is performed with the participation of managers who are experts in quality management systems and ISO 9001. Analytic hierarchy process (AHP) supports the mixed methods approach. The data analysis is broken down by electrical components, machining, sub-components and small parts manufacturers.
Findings
The factors assessed are top management commitment, team commitment, training, responsibilities and authorities defined, schedule for implementation, quality culture, resource availability, integration between departments, level of bureaucracy as well as level of awareness regarding the ISO 9001 significance. A new factor was identified, which was not cited in the literature, quality staff reliability.
Research limitations/implications
The research is applied to suppliers of powertrain manufacturers and could reflect other sectors. It is important observe that the automotive sector represents a microcosm of the organization in general and many production models stem from there.
Practical implications
Understanding the critical factors is important to ensure that managers allocate resources appropriately during implementation and maintenance of ISO 9001:2015.
Social implications
Organizations around the world have, until 2018, to upgrade their quality systems to ISO 9001:2015 and the results of this paper can support strategies and decision making about that.
Originality/value
This paper evidences the relative importance among factors and ranks item in order of importance for ISO 9001:2015 implementation. Prior studies indicate the need to develop a mixed methods study to examine the role of the critical factors to support the ISO 9001:2015 implementation as done in this paper.
Purpose
International Organization for Standardization (ISO) 9001: 2015 quality management systems places an obligation on organizations to consider the role of organizational knowledge as a ...resource. The purpose of this paper is to systematically relate the key fundamentals of knowledge management to the seven quality management principles of ISO 9001: 2015. It is the first to consider this relationship.
Design/methodology/approach
The paper traces the history of quality standards and the background to the inclusion of an organizational knowledge clause in ISO 9001: 2015. It then systematically considers the seven quality management principles in relation to knowledge management principles.
Findings
The core elements of the knowledge management standard are incorporated with the organizational knowledge clause. Explicit and tacit knowledge are addressed by the ISO standard. Knowledge and its management will become increasingly important in organizations driven by ISO certification requirements.
Research limitations/implications
ISO 9001: 2015 was released in September 2015 which means that organizations have yet to apply the organizational knowledge clause. This paper is a conceptual one which needs to be complemented with empirical research.
Practical implications
This paper identifies the role of knowledge management principles as they apply to ISO 9001: 2015 and the seven quality management principles. More than 1.1 million organizations are certified to ISO 9001, plus many others who use the standard informally. Those involved with organizational quality will need to understand the role of knowledge in the organization.
Social implications
Quality services and products need to be underpinned with strategic knowledge management.
Originality/value
This paper is the first to discuss knowledge management in relation to the seven quality management principles which assist the development of policy for quality management.
Total Quality Management (TQM) facilitates the achievement of continuous quality improvement by implementing several strategies, techniques, system and tools. Out of them, ISO 9001 standard based ...Quality Management System (QMS) was adopted widely by the organisations for achieving continuous quality improvement. Yet the outcome has not been very effective due to the absence of immutability and traceability in the theory and practices of this approach. This deficiency can be overcome if blockchain technology is used. Hence, the need of the hour is to integrate blockchain technology with ISO 9001:2015 standard based QMS. In order to meet this need, a framework has been presented in this paper. This framework facilitates the usage of smart contracts and hyperledger for achieving traceability and immutability while operating the ISO 9001:2015 standard based QMS. Further, the application of Internet of Things and artificial intelligence are indicated for implementing this integrated framework to achieve the goals of implementing TQM. The paper is concluded by mentioning that implementation in organisations in which ISO 9001:2015 standard is under operation would facilitate to check the practical viability of the framework proposed in this paper.
With the update of ISO 9001 in 2015, one of the established requirements was risk-based thinking (RBT), a significant subject discussed by many authors. This paper aims at finding relevant ...contributions to the literature on ISO 9001:2015 and risks approach, critically analysing the existing studies and providing new perspectives for researchers and organisations. To achieve it, the authors conducted a Systematic Literature Review (SLR), by establishing the main subject matter of the research (a), locating studies using defined criteria (b), running the analysis and performing a synthesis (c) and reporting the results (d). From the SLR papers, five clusters were structured, leading to the identification of the most frequent approaches and their constraints. Most papers present a fragmented view of RBT and the majority of authors opt for FMEA, but RBT goes beyond simply 'doing risk management'. The best option for organisations departs from usual practices and approaches the issue in an integrated manner, with a systemic combination of widespread methods with daily practices, embedded in organisational culture. The results of this study enhance the existing knowledge on RBT by confronting the actual practices with the requirements of ISO 9001:2015, providing useful insights, from different perspectives on RBT implementation.
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