Martin Ivarsson, manager and part owner at Landeryd’s Mechanical Workshop (LMW), Landeryd, Sweden, initiated this project. This because of a new released ISO 9001 version that LMW has to implement before the 15th of September 2018 to remain certified. Since LMW is ISO 9001:2008 certified the project members only needed to identify the differences among the 2015 and 2008 version to see what LMW has to do to get certified. There are approximately 1.1 million ISO 9001 certificates issued worldwide. An ISO 9001 certification increase organizations ability to satisfy customer needs and customers can rely on that the products and services provided are of consistently good quality. ISO 9001 can also work as a tool to streamline the organization’s processes and make them more efficient. Since the ISO 9001 is reviewed every five year it helps organizations to keep current in an ever- changing world. Landeryd’s Mechanical Workshop has been ISO 9001 certified since 2002 and the “ISO- think” is deeply rooted within the company. LMW is a small owner-controlled company with only 18 employees. ISO 9001:2015 is applicable on different kinds of organizations in various scales. Comparing to previous versions of ISO 9001 the new version is more adaptable. This makes it more beneficial for the organizations but harder for the auditors that certifies. One major conclusion is that LMW will have more freedom of document handling with the new ISO version. This report highlights LMW’s status today in accordance to the new ISO 9001 version, and estimates how much effort that is needed for a successful revision. Readers of this report will benefit from the results, since much is applicable on all types of organizations or companies.

This qualitative study examines positive and negative effects on effectivity as a result of alternative processes (workarounds) performed within an ISO-certificated organizations information system. To identify these workarounds we used contextual inquiry. This gave us an understanding of how the information systems users actually practice their work. The result of our acquired data revealed six major workarounds. To analyze these workarounds in relation to its complicated context we utilized three theoretical models. This gave us a broad understanding of each of the workarounds and made it possible to understand why each workaround was conducted, its implications on effectivity and what kind of a challenge/dilemma it posed. The analysis indicated that the workarounds had what we deduced as negative impact on the organizations effectivity as a whole. Many of the workarounds could have been seen as very effective alternatives to the designed work process but only if valued in a micro-context. The fact that they still occur are most likely the result of the fact that the users of the information system lack understanding of how the organization and its processes are structured as a whole and how their work as well as how they perform it is part of a bigger picture. Finally we present how future research, based on this study, could focus on developing a better model to understand the complicated context. We also propose that studies could investigate the possibility of shaping an ISO-standard which is responsive to the diversity of organizations actual work processes while still ensuring a qualitative standard.

With Chiptech’s current growth rate and size it has become necessary to develop a Quality Management System to enable repeatability, meet customer demands, and protect Chiptech from staff turnover. ISO 9001 was identified as a base for development, with the imperative that the system identified and developed must deliver value for Chiptech. Several frameworks were investigated, along with journal articles and discussions with industry members in order to determine the aspects that would deliver value, and determine the key success factors. Two factors were identified as critical: employee involvement, and the utilisation of metrics – both of which were leveraged for the project results and recommendations. The systems developed have already proved they offer benefits, however, in order to maintain performance Chiptech must a) keep evaluating the measured results, b) ensure that quality forms an integral part of the organisational culture and, c) continue the systematic approach of continual improvement.

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Durante los últimos años hemos evidenciado la importancia de conducir las organizaciones en base a un sistema de gestión de calidad que permita definir la interacción y establezca los controles de cada uno de sus procesos involucrados, la búsqueda de la satisfacción del cliente y difundir la búsqueda de la mejora continua, que le permita adaptarse rápidamente en un mercado que cambia constantemente. El objetivo de realizar este análisis prospectivodescriptivo es diseñar un manual de calidad y procedimientos que permitan estandarizar la documentación de todos los procesos en una organización, en base a una norma internacional certificable como es el caso de la ISO 9001:2008. Es por este motivo que la norma en mención exige, para mantener un sistema de gestión de calidad, un procedimiento que dé las directivas para el control de documentos que sirvan de medio de difusión sobre las actividades que se realizan en cada proceso dentro de la organización, un procedimiento que dé las directivas para el control de los registros generados en cada actividad de la organización, un procedimiento que explique el tratamiento que se le da a cada producto que esté fuera de sus especificaciones, un procedimiento que explique el tratamiento que se le dará a cualquier no conformidad o potencial no conformidad respecto con la norma en mención o a la documentación generada en el sistema y, un procedimiento que de los lineamientos para auditar el sistema de gestión de calidad con la finalidad de comprobar su eficacia y mejora continua. De igual manera, mostrar la importancia de contar con un Manual de Calidad que permita comunicar a la organización la política y objetivos de calidad que la alta dirección desea difundir a cada uno de los colaboradores, los procesos que forman parte del alcance del sistema y de la interacción de cada uno de ellos, además de la mención de los procedimientos complementarios que la organización ha decidido implementar. / --- Over the past years has shown the importance of organizations leads to a quality management system to define the interaction and set controls for each process involved, looking for customer satisfaction and promote the pursuit of continuous improvement, enabling it to adapt quickly in a market which is constantly changing. The aim of this analysis prospective-descriptive is to design a quality manual and procedures which allows standardize documentation for all process in an organization, based on a Certifiable International Standard as ISO 9001:2008. For this reason the norm requires to maintain a quality management system. The norm requires a procedure which gives directives for the control of documents to serve as a means of diffusion on activities that take place in every process within the Organization, also requires to include a procedure that gives directives for the control of records generated in each activity of the Organization, call for a procedure that explain the treatment given to each product that is out of its specifications, requires a procedure that explains the treatment that is given to any non-conformance or potential non- conformance in regards or documentation generated by the system and, call for a procedure to give guidelines to audit the quality management systems in order to check effectiveness and continuous improvement. Similarly, show the importance of having a Quality Manual that allows communicate to the Organization, the quality policy and objectives which was established by the senior management and communicated to each one of the partners, and the processes that are part of the scope of the system and the interaction of each of them, besides the mention of complementary procedures that the Organization has decided to implement. Keywords: System, procedures, manual, processes.

La presente investigación se realizó en la empresa Procomsac, ubicado en el distrito de Chiclayo, cuya actividad económica principal es la fabricación de envases y telas de polipropileno. Este análisis se centra en evaluar el proceso de producción y detectar los efectos contaminantes al medio ambiente, por lo que se propone un sistema de gestión ambiental para la empresa Procomsac basado en la norma ISO 14001 para mejorar los procesos productivos; la cual tiene como finalidad mejorar la evaluación y control ambiental de los procesos de cada una de las áreas de producción de la empresa Procomsac. La idea de proponer este sistema de gestión ambiental es nueva e innovadora, ya que la empresa no cuenta con un sistema de gestión ambiental para reconocer y proponer soluciones, este diseño planteado contribuirá a identificar fácilmente los procesos productivos más vulnerables a sufrir riesgos. Por ello se propone un estudio Aplicado- No experimental, apoyado en los instrumentos de la observación directa, entrevista y encuesta aplicado al personal con el fin de obtener la información en la que se encuentra Procomsac. Finalmente, en el presente trabajo de investigación se presenta las conclusiones y recomendaciones para mejorar los procesos productivos de la empresa, propuesta de un sistema de gestión ambiental basado en las normas ISO 14001, las referencias bibliográficas y los respectivos anexos. / Tesis

Kvalitetsledningsstandard ISO 9001 samt miljöledningsstandard ISO 14001 är idag frekvent förekommande i svenska företag. Standarderna har som syfte att ligga till grund för en organisations ledningssystem och innehåller en mängd kravspecifikationer som anses vara optimala för att en verksamhet ska bedriva ett hållbart kvalitetsarbete. Standarderna ges ut av International Organization for Standardization, vilken förkortas som ISO. Förkortningen grundar sig i det grekiska ordet isos som kan översättas till identisk eller lika. Grundidén för ISO-standarder är nämligen att de är standardiserade riktlinjer som går att applicera på alla organisationer med samma resultat.    Genom en kvalitativ flerfallsstudie så ämnar forskningen att undersöka hur organisationer påverkas av ISO-standarders spridning och institutionalisering, samt vad det har för effekt på dess arbete med kvalitet och hållbarhet. Under arbetets gång så har primärdata samlats in genom sex semi-strukturerade intervjuer med kvalitetschefer, miljöchefer och projektansvariga på ISO-certifierade företag samt hos Swedish Standards Institute. Majoriteten av forskningsanalysen behandlar ISO-standarder i kontexten kring institutionalisering, isomorfism och institutionellt tryck, men den undersöker även företags påstådda motiv, och hur de upplever de organisatoriska konsekvenserna av anpassningen till ett ISO-certifierat ledningssystem.   Utfallet av undersökningen visar att de undersökta företagen påstår sig ha tre olika motiv till att göra en anpassning till ISO-standarder och dessa är: Påtryckningar från intressenter och kundernas krav på certifierade ledningssystem, certifieringar som konkurrensfördel i upphandlingar, samt en tilltro till standardens förmåga att effektivisera den egna verksamheten.   Påtryckningarna från intressenter har visat sig ha en central roll i hur företaget bedriver sitt arbete med standarder. De organisatoriska effekterna upplevs av samtliga respondenter som positiva men ger i de flesta fall inte intryck av att vara bra nog för att motivera den mängd tid och resurser som krävs för att erhålla ett certifikat. Istället sätts processen ofta igång genom ett tryck från omgivningen där kunderna genom sina kravställningar har en förmåga att få företagen att initiera sin anpassning. Svenska organisationer drivs således till att anpassa sig till samma typ av standardiserade sätt att bedriva sitt arbete, vilket gör dem mer homogena med sin omgivning och bidrar till att kvalitets- och miljöarbetet allt mer blir professionaliserat. / Quality management standard ISO 9001 and environmental management standard ISO 14001 are frequently occuring in swedish enterprises. The standards are intented to provide a foundation for an organization’s management system and they contain a series of specifications that are estimated to be optimal for a business to conduct a sustainable and high quality operation. ISO-standards are published by International Organization for Standardization, which is abbreviated as ISO. The abbreviation stems in the greek term isos, which can be translated into equal or alike. The main idea of ISO-standards is that they are a series of standardized guidelines which can be applied to any organization with the same results.   By conducting a qualitative multi-case study the research intends to examine how organizations are affected by the ISO-standards proliferation and institutionalization, as well as its perceived effects on firms’ work with quality and sustainability. Primary data has been gathered during the course of the research by conducting six semi-structured interviews with quality managers, environmental managers and project managers at ISO-certified enterprises as well as the Swedish Standards Institute. The majority of the analysis treats ISO-standards in the context of institutionalization, isomorphism and institutional pressure. Moreover, it also examines the enterprises alleged motives for adaption as well as their experience of the organizational changes a certified management system entails. The results of the research shows that the examined enterprises claims to have three different motives for adaption: Pressure from stakeholders and the customers’ demands for certified management systems, certificates as a competitive advantage in procurements, as well as a trust in the standards ability to streamline the organization.   The pressure from stakeholders have proven to play a central role in how the enterprise conducts work with the standards. The organizational effects are perceived by all respondents as positive. However, in most cases they do not give the impression of being worthy of the time and effort required to achieve a certificate. Instead, the process of acquiring a certificate is often initiated as a direct response to customers’ demands. Thus, the organizations are more inclined to adapting the same kind of standardized ways of planning their operations, which further makes them homogeneous with their environment as well as contributes to the professionalization of quality- and environmental work.