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The purpose of this paper is to chronicle a small company's path towards establishing a functioning, effective quality system for a medical device technology and to provide some “do‐it‐yourself” (DIY) tips learned along the way.

When a company comes up with an innovation in medical device technology, where can it go from there to transfer its product into the hands of consumers? If the technology is patented, the company has the option to license it. Alternatively, the company may want to move forward with further product development and marketing on its own (whether patented or not). Getting a medical device into any market typically requires regulatory approval, which cannot be obtained without a quality system. This paper focuses on the foundations of establishing a quality system and obtaining certification and regulatory approval in Canada, the EU, and the USA, and is directed towards small medical device manufacturers. It describes the process within four phases that cover the initial start up, implementation of procedures, certification and regulatory approval, and continual improvement.

Establishing a quality system is a monumental task for any company, but especially so for a small one. However, the benefits of implementing a quality system outweigh the initial setbacks associated with doing so. The descriptions of phases in tandem with the DIY tips presented in this paper are intended to be of help to a small medical device manufacturer wanting to bring their innovative technology to consumers within a major marketplace.

This is an original paper written for the Third Canadian Quality Congress.

The purpose of this paper is to provide a literature review of investigations into the specific disability of deafness in the field of sociology and other closely related fields.

After a pilot search using databases appropriate to social science research, we developed key search terms and, using an inductive approach, we identified major themes in the literature.

Our review shows that deafness has been investigated for a long time in sociology and other related fields, that there is a wide range of themes in scholarly work on the experiences of deaf communities and deaf people, and that conceptualizations of deafness and d/Deaf communities have changed over time. We organize this paper around six major themes we identified, and a few highlighted pieces of scholarship illustrate these themes along the way. We particularly focus on scholarship from the late 1960s through the early 1990s as emblematic of seismic shifts in studying deafness, although we do highlight little known nineteenth century work as well.

This paper captures the legacy of this past scholarship and reveals that deafness is a rich site of inquiry that can contribute to the field of sociology. It is also a valuable resource for any future sociological research into deafness, deaf people, and deaf communities. We conclude with a discussion of our findings, commentary on the extent to which previous scholarship on the sociology of deafness has or has not figured into current scholarship and suggestions for future research.

The purpose of this paper is to evaluate the experience of International Organization for Standardization (ISO) 9001 certified companies, examining their motivations to introduce the standard and their perceived benefits and barriers. In parallel, the research investigated the knowledge and perception of ISO 9004 guideline, analyzing if it could give an added value to certified companies.

A questionnaire was proposed by e-mail to 2,581 Italian ISO 9001 certified companies from January 18 to March 31, 2016; 522 companies participated to the survey.

Companies of different size have been driven by different motivations to certification, reaching different types of benefits, while both large and small ones perceived the greater bureaucratization as an obstacle. The ISO 9004 standard is little known and applied among Italian companies, but the ones which adopted it benefited from it.

A limitation may be derived from the fact that the sample was composed only of Italian companies, although this effect was to understand perceptions and trends of these international standards in the Italian reality.

Analyzing perceived advantages and disadvantages of ISO 9001 and 9004 could be crucial for managers to understand if their joint use is the right strategy to gain competitiveness in the reference markets.

Compared to previous studies in which ISO 9001 was evaluated as a stand-alone standard, the research made a comparative evaluation with ISO 9004, as ISO considers them to be “consistent pair of standards,” covering the literature gap about the effectiveness of the joint use of them.

For many foster alumni, challenges arise as they age out and transition into adulthood and higher education. One area that has been overlooked is how intersecting identity impacts transition among foster youth, especially Black women. Using Scholarly Personal Narrative (SPN) as a methodology, I used myself as the subject to share my lived experiences as a Black woman in foster care through my transition from foster care to adulthood, college, and my career as a Student Affairs professional. Utilizing transition theory and intersectionality as frameworks, I aim to highlight the complex and nuanced challenges of foster youth as they experience major transitions as well as how identity can show up in their professional lives, especially if they are in a field that is tasked with supporting individuals that have a similar lived experience.

The current work provides a framework for the ranking of ontology development methodologies (ODMs).

The framework is a step-by-step approach reinforced by an array of ranking features and a quantitative tool, weighted decision matrix. An extensive literature investigation revealed a set of aspects that regulate ODMs. The aspects and existing state-of-the-art estimates facilitated in extracting the features. To determine weight to each of the features, an online survey was implemented to secure evidence from the Semantic Web community. To demonstrate the framework, the authors perform a pilot study, where a collection of domain ODMs, reported in 2000–2019, is used.

State-of-the-art research revealed that ODMs have been accumulated, surveyed and assessed to prescribe the best probable ODM for ontology development. But none of the prevailing studies provide a ranking mechanism for ODMs. The recommended framework overcomes this limitation and gives a systematic and uniform way of ranking the ODMs. The pilot study yielded NeOn as the top-ranked ODM in the recent two decades.

There is no work in the literature that has investigated ranking the ODMs. Hence, this is a first of its kind work in the area of ODM research. The framework supports identifying the topmost ODMs from the literature possessing a substantial amount of features for ontology development. It also enables the selection of the best possible ODM for the ontology development.

The purpose of this paper is to develop and test a quality management system (QMS) implementation process for a medical devices manufacturer, which are covered by ISO 13485:2007 and RDC No. 59:2000 and based on operations strategy content definitions.

The research strategy is based on the Cambridge approach which is supported by action research techniques for producing “application” processes. This research strategy is also known as the “Process Approach” or “the Engineering Approach” and was developed in the mid-1990s by researchers from the “Institute for Manufacturing” (IFM/University of Cambridge).

The results reveal how real conditions “shape” implementation, indicating solutions for integrating procedures for performance and control indicators that represent manufacturing strategy objectives. The regulatory framework and the manufacturing environment offer these real conditions. The operations strategy that is underlying implementation shows how to reconcile regulation and strategy through its content.

The developed process can be improved by increasing the number of test cases until they bring no new contributions for its evolution. However, because it is a long-term and complex implementation process, the present research was concluded with a full understanding of process development.

The QMS implementation process based on the Cambridge Engineering approach creates several opportunities for discussing QMS design requirements, but also in testing procedures for quality policy deployment. Learning by doing is a practical contribution of the process as a participative component effectively applied in different moments at the mentioned workshops – WSH. The logical organization of the QMS implementation process shows causalities among manufacturing strategy, QMS and performance measurements, creating strategic coherence among the connected elements.

Although many studies had approached the QMS implementation, few of them actually addressed the system integration with the business strategic objectives. None of the studies to date related the implementation to the ISO 13485:2003 and the RDC No. 59.

The case will help learners to analyse how effective handling of an extended marketing mix of 7Ps (product, price, place, promotion, physical evidence, participants and processes) makes a startup profitable in its initial years of inception; understand the significance of the online marketing strategies like digital marketing and social media marketing implemented by firms to attain a competitive edge amongst established local and global competitors; examine the strategic challenges faced by a business enterprise while entering an emerging market; analyse the growth strategies of a startup relative to various market constraints; and propose long-term strategies for sustainable growth for a startup operating in the wearables market.

Founded in 2016, Boat Lifestyle is a Delhi-based Indian startup in fashionable consumer electronics. In the past five years, Boat earned remarkable profits and emerged as one of the most promising startups through its innovative products offerings and promotion. Aiming at its target customer segment, the millennials, it promoted its products through social media marketing such as influencer marketing and brand tie-ins with sports teams and music events. The case focuses on the dynamics of the Indian wearables market that is facing tough competition from global and local players. To ensure continued growth prospects, while maintaining a tight focus on product differentiation, quality, and customer satisfaction, there is a greater need for Boat to rethink its market development and growth strategies regarding new innovations and adopting long-term orientation like diversification and global expansion.

The case aims for teaching business management students at the Undergraduate, Postgraduate, and Executive education level. In addition, the case can be related to the Strategic Management course curriculum and Marketing course curriculum.

Teaching notes are available for educators only.

CSS 11: Strategy

ISO certification is expected to help organisations to enhance quality and efficiency, improve communications, achieve competitive advantage and an increase in market share, reduce costs and achieve a higher stock price. This paper presents the results of a study to identify management attitudes towards ISO 9001:2000. To realise this goal, a sample consisting of 38 managing directors (MD) in Egypt was obtained. Results indicated that Egyptian organisations have a high level of understanding of the purpose of ISO certification. The main motivators behind the implementation of certified quality system in Egypt were to improve the efficiency of the quality system, and to cope with pressures from competitors/foreign partners. The principal perceived benefits of ISO 9001: 2000 for Egyptian organisations include improved documentation, improved efficiency of the quality system and more effective supplier selection.