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Title: | Meeting challenges in achieving and maintaining ISO standards |
Authors: | Portelli, Timothy (2023) |
Keywords: | Pharmaceutical services -- Standards -- Malta International Organization for Standardization |
Issue Date: | 2023 |
Citation: | Portelli, T. (2023). Meeting challenges in achieving and maintaining ISO standards (Master's dissertation). |
Abstract: | The standards developed by the International Organization for Standardization (ISO) are documents that describe internationally recognized procedures in all areas of industry, providing quality assurance to consumers and stakeholders. The aims of the project were to (i) critically review ISO standards that are relevant to organizations, giving importance to those that could help lead to accreditation and (ii) to identify solutions for the challenges faced when attempting to achieve and maintain ISO standards. The methodology was divided into three phases: 1. A literature review was carried out to understand the ISO framework. The challenges that organizations faced while pursuing ISO certification were listed. 2. A questionnaire was developed and validated by a focus group, and disseminated to certified and non-certified organizations. Key topics of the questionnaire included demographics, factors influencing the decision to pursue ISO certification, benefits and challenges that come with ISO certification, and factors that hindered non-certified organizations from pursuing ISO certification. 3. Observational studies were conducted during a three-month period of practice at the Water Services Laboratory with regards to their ISO certification. The results of the literature review show that the challenges organizations faced during the certification process include resistance to cultural change, lack of resources, amount and quality of training required, and lack of staff involvement. The results of the questionnaire showed that the factors that influenced organizations to adhere to ISO include customer satisfaction, gaining a competitive advantage, and customers requiring ISO certified products and services. The benefits that ISO certified organizations gained include increased customer perception and satisfaction, increased efficiency in meeting the organization’s quality objectives, and ensuring that corrective action is taken whenever defects occur. The high cost of obtaining ISO certification was named as the factor that hindered non-certified organizations. The results obtained from the observational studies at the laboratory demonstrate that the influencing factors, challenges faced, and benefits gained are similar to those elucidated from the literature review and questionnaire. Solutions for the challenges faced during ISO certification have been documented. The results of the study show that the benefits of being ISO certified outweigh the challenges faced during accreditation. |
Description: | M.Pharm.(Melit.) |
URI: | https://www.um.edu.mt/library/oar/handle/123456789/116123 |
Appears in Collections: | Dissertations - FacM&SPha - 2023 |
Files in This Item:
File | Description | Size | Format | |
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2318MDSPHR512300012121_1.PDF Restricted Access | 4.83 MB | Adobe PDF | View/Open Request a copy |
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