The International Journal of Conformity Assessment最新文献

{"title":"Experience in Implementing ISO 15189:2012 Accreditation at Chimera Transplant Research Foundation: A Molecular Testing Laboratory","authors":"V. Mishra","doi":"10.55459/ijca/v2i1/vm","DOIUrl":"https://doi.org/10.55459/ijca/v2i1/vm","url":null,"abstract":"ISO15189:2012 is a formal recognition by an authorized national accreditation body that a testing laboratory is competent to carry out specific tasks according to the standard. This article aims to share the experience of reaching ISO 15189:2012 accreditation at Chimera labs. A gap analysis was performed, followed by the preparation and implementation of policies and procedures for the effective implementation of QMS. After six months of intensive work, including mentoring activities, the laboratory was ISO 15189 accredited in the field of medical genetics and related HLA and immunogenetics by the National Accreditation Board for Testing and Calibration Laboratories, India. Our experience suggests that the implementation of a quality management system is possible even in small-sized laboratories with the help of skilled manpower and supportive management.","PeriodicalId":432074,"journal":{"name":"The International Journal of Conformity Assessment","volume":"39 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114652412","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"How Do Accreditation Bodies Manage Risk Associated with the Accreditation Business?","authors":"L.H.D. Bandusoma","doi":"10.55459/ijca/v2i1/lhdb","DOIUrl":"https://doi.org/10.55459/ijca/v2i1/lhdb","url":null,"abstract":"Among other factors, accreditation-focused entities operating various accreditation schemes for conformity assessment bodies are expected to fulfill requirements of international standard ISO/IEC 17011:2017 (Conformity Assessment – Requirements for accreditation bodies providing conformity assessment). Consideration should be made of legal requirements. Additional requirements of the International Accreditation Forum (IAF) and International Laboratory Accreditation Cooperation (ILAC) as well as the requirements of scheme owners, such as CORSIA and GlobalG.A.P., etc., should adhere to the word “risk,” which appears in different places of the ISO/IEC 17011:2017. The main objective of ISO/IEC 17011:2017 is to ensure competence, consistent operation, and impartiality of accreditation bodies accrediting conformity assessment bodies. The term “risk” is defined as the “effect of uncertainty on objectives” (ISO 31000:2018, clause 3.1). Therefore, it is required to consider all possible uncertainties by accreditation bodies (ABs) and initiate suitable actions to prevent or mitigate such risks. Mandatory documents (MDs) published by the International Accreditation Forum (IAF) have addressed how accreditation bodies should consider risks when they operate specific accreditation schemes, such as EMS, FSMS, QMS, OH&SMS, etc. There are no common viewpoints published or discussed in relation to the risks associated with accreditation bodies. This aims to create awareness of possible risks associated with accreditation bodies and share experiences with examples of cases on how accreditation bodies react to uncertain situations with respect to achieving the intended objectives of ISO/IEC 17011.","PeriodicalId":432074,"journal":{"name":"The International Journal of Conformity Assessment","volume":"23 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115330222","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Accreditation of Agri-Food and Medical Laboratories in the UEMOA Region: An Opportunity for the Promotion of Sustainable Public Health","authors":"Marcel Gbaguidi, K. Kouassi, A. Diop","doi":"10.55459/ijca/v2i1/mg.kk.ad","DOIUrl":"https://doi.org/10.55459/ijca/v2i1/mg.kk.ad","url":null,"abstract":"In an increasingly changing and demanding world, Quality Infrastructure is an instrument that is both important and essential in a context marked by health, environmental, economic, and social issues. Among the pillars of Quality Infrastructure, accreditation plays an important role, ensuring the technical competence and integrity of bodies offering conformity assessment services, such as testing, medical testing, calibration, certification, inspection, and validation/verification based on recognized international standards. The objective of this article is to highlight the importance and role of the Système Ouest Africain d’Accréditation/West African Accreditation System (SOAC-WAAS) in preserving and promoting the health of populations and the competitiveness of West African economies. Given the importance of accreditation, the West African Economic and Monetary Union (UEMOA) that gathers eight countries (Benin, Burkina Faso, Côte d'Ivoire, Guinea Bissau, Mali, Niger, Senegal, and Togo) created, in 2005, SOAC-WAAS, a multi-economy accreditation body. The latter is the only authorized accreditation body for the eight UEMOA member states. Its mission is to deliver and promote accreditation in the community area, particularly through the issuance of accreditation certificates to conformity assessment bodies (CABs). To date, SOAC-WAAS has accredited forty-six (46) conformity assessment bodies, including four (4) calibration laboratories, three (3) certification bodies, and thirty-nine (39) testing laboratories. Among the SOAC accredited testing laboratories, one (1) is in the field of forensics and ten (10) are medical laboratories. Fourteen (14) testing laboratories and the three (3) accredited certification bodies are operating in the agri-food sector. This result, which is certainly insufficient for the entire UEMOA region, is still encouraging and contributes to the preservation of health and protection of the population, particularly with regard to accredited agri-food and medical testing laboratories.","PeriodicalId":432074,"journal":{"name":"The International Journal of Conformity Assessment","volume":"22 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"124009923","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparison of International Maritime Organization (IMO) Member State Audit Scheme (IMSAS) with ISO/IEC 17000 conformity assessment standards series and ISO 19011","authors":"Vasileios Lymperopoulos, Sotirios P Karagiannis","doi":"10.55459/ijca/v2i1/vl.sk","DOIUrl":"https://doi.org/10.55459/ijca/v2i1/vl.sk","url":null,"abstract":"This study compares the International Maritime Organization (IMO) Member State Audit Scheme (IMSAS) and ISO/IEC 17000 series as well as ISO 19011. The part that we investigate in this paper is the marine industry audit cycle that the IMO Member State Audit Scheme uses, such as ISM code certification of the vessels over 500 Gross Tonnage (GT) and the IAF peer evaluation of its members’ accreditation bodies. The reasoning for such effort is that both ISM code certification of the vessels over 500 GT and the IAF peer evaluation are long established and more mature assessment practices. The contribution of our study is to create a robust audit cycle for the IMO Member State Audit Scheme, which has not been examined in the literature.","PeriodicalId":432074,"journal":{"name":"The International Journal of Conformity Assessment","volume":"42 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"117230642","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Risk Management, Conformity Assessment, and Evaluation of Organizational Intelligence in Scenarios of Change and Crisis","authors":"N. Gigante","doi":"10.55459/ijca/v2i1/ng","DOIUrl":"https://doi.org/10.55459/ijca/v2i1/ng","url":null,"abstract":"In an environment increasingly dominated by change and crisis, in which the organizations are required to readily adapt their management systems to new needs and emerging risks, the conformity assessment should itself be adaptive and always responsive to the growing complexity of its object. The article aims to explore this issue, first by addressing the topic of \"organizational intelligence.” In the second part, there is a focus on the evolution of the management system standards in a performance perspective, and on risk management as a countermeasure to the progressive reduction of the prescriptive approach. Finally, the idea of a \"complexity assessment\" is proposed, aimed at assessing not only the conformity to requirements within a stable and predictable framework, but also the adaptability and resilience of the organizations, in response to the traumatic transformations of the context.","PeriodicalId":432074,"journal":{"name":"The International Journal of Conformity Assessment","volume":"9 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114877099","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Risks and Opportunities: An Assessor’s Perspective of ISO/IEC 17025 Expectations","authors":"S.C. Soundar Rajan","doi":"10.55459/ijca/v2i1/scsr","DOIUrl":"https://doi.org/10.55459/ijca/v2i1/scsr","url":null,"abstract":"For many laboratories as well as the assessors of testing and calibration laboratories, there has been a lack of clarity about the specific intentions of ISO 17025:2017 under the topic “ Risks and Opportunities” in clause 8.5. This paper presents the author’s understanding and perception of the standard.","PeriodicalId":432074,"journal":{"name":"The International Journal of Conformity Assessment","volume":"15 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132829548","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"‘Risky Business’: A Comprehensive Risk Analysis of an Accreditation Body","authors":"G. Anastasopoulos, P. McCullen, Harry Makam","doi":"10.55459/ijca/v2i1/ga.pm.hm","DOIUrl":"https://doi.org/10.55459/ijca/v2i1/ga.pm.hm","url":null,"abstract":"Risk assessment and risk-based thinking are both key aspects considering the multi-faceted activities inherent in Conformity Assessment. As an Accreditation Body (AB), risk assessment is used to ensure a consistent, data-based approach towards accreditation of conformity assessment bodies. The following paper presents methodology, lessons learned, and best practices found while conducting risk management at the AB level within the Global Conformity Assessment industry. It provides a framework for conducting a Modified Fink Risk Assessment and Analysis for use by various organizations, including accreditation and conformity assessment bodies, such as testing and calibration laboratories, inspection agencies, product and personnel certification bodies, management system certification bodies, etc.","PeriodicalId":432074,"journal":{"name":"The International Journal of Conformity Assessment","volume":"5 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116898152","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}