Ask Google

Results for standardization translation from English to Indonesian

Human contributions

From professional translators, enterprises, web pages and freely available translation repositories.

Add a translation

English

Indonesian

Info

English

goegle terjemahan Abstract Purpose - The greatest competitive challenge facing companies today is said to be embracing change. The business environment is in constant flux and companies must grapple with a host of new realities. This backdrop of change has catalyzed a reassessment of traditional managerial concepts and practices. Aims to trace the evolution of a new management paradigm and identifies its main drivers. Design/methodology/approach - The paper provides narrative and analysis. Findings - Assesses the implications of the change in management paradigms for the educational system, highlights needed adjustments in orthodox management education and lingering challenges for management education providers. Originality/value - Provides help in understanding the perspectives of the various business stakeholders that can help academics allocate resources and design programs that cater for the needs of managers in the 21st century. Keywords Change management, Management activities Paper type General review Introduction The dawn of the 21st century has brought with it an unprecedented wave of change. The days of mass production or standardized products appear to be over. The key words for the future are variety, flexibility, and customization. Indeed, a new techno-economic rationale is emerging, with a clear shift towards information intensive rather than energy or material intensive products. Globalization has also brought with it new business opportunities, and a growing global marketplace, where information goods and capital flow freely and customer choice is expanding. Against this backdrop of change, the field of management has suffered some degree of dislocation (Collins, 1996). This dislocation has in turn catalyzed some soul-searching on the part of managers and academicians alike, and a reassessment of traditional managerial concepts and practices. This paper argues that this introspection has resulted in a discernible evolution in traditional theoretical approaches/orientations as well as fundamentally changed organizational practices, to the extent that the changes qualify as a genuine paradigmatic transformation. Noting that a paradigm is a framework of basic assumptions, theories and models that are commonly and strongly accepted and shared within a particular field of activity, at a particular point in time (Mink, 1992; Collins, 1998), this paper synthesizes the main assumptions of what is commonly referred to as the traditional management and identifies the main drivers that facilitated the ascendancy of new paradigm are then addressed. The implications of this paradigm shift for institutions of higher education are in turn assessed to delineate the challenges associated with the evolution of a new management pedagogy in universities. The traditional management paradigm Functional hierarchical line management was the main management paradigm for nearly 200 years. The system was based on the theories of Fayol, Taylor and Weber that viewed the management environment as stable and as such tended to prescribe centralized decision-making processes and hierarchical communication channels (Table I). Organizations were perceived to be rational entities pursuing specific rational goals through their organization into highly formalized, differentiated and efficient structures (Turner and Keegan, 1999; Burnes, 2000; Jaffee, 2001). This mechanistic orientation dominated most businesses in the past and is still commonly encountered especially in the context of developing countries. As shown in Table I, the traditional management paradigm was characterized by its inward focus, with special attention accorded to cutting costs, complying with rules, respecting hierarchy, and dividing labor into simple, specialized jobs. It was narrowly focused on promoting production efficiency and combating waste. Within the spirit of this overarching objective, a range of practices were prescribed and allowed to flourish, including a focus on order giving and control, enforced standardization/cooperation, and authoritarian/disciplinarian approaches to management. This was generally associated with a mechanistic orientation to structural design, emphasizing high specialization, rigid departmentalization, clear chain of command, narrow spans of control, centralization and high formalization (Kreitner, 2002; Robbins and Coulter, 2003). The overriding concern of the traditional paradigm was thus with improving the firm’s productivity, and managing available resources in a static and stable technological environment (Khalil, 2000). Within this context, managers were viewed to be solely accountable for making strategic decisions that all had to embrace and implement (Black and Porter, 2000). They were commonly perceived as watchdogs, police officers and manipulators pertaining to a privileged elite class (Burnes, 2000). Labor was also commonly characterized as unreliable and predisposed to seek the Emphasis on Experimentation, standardization, and the use of diligent scientific observation, time and motion study, systematic worker selection and training and managerial responsibility for monitoring and control A core management process revolving around universal functions (e.g. planning, organizing and controlling) and principles such as division of work, discipline, centralization, order and stability Division of labour, hierarchical authority, formal rules/regulations, and impersonality contributing in turn to efficiency, precision, consistency, subordination, and reduction of friction/personal costs Source: Kreitner (2002); Robbins and Coulter (2003) maximum reward for the minimum effort. Access to information systems and data was therefore tightly controlled as concern about low trust, suspected motives, and fear about confidentiality prevailed (Boyett and Boyett, 2000). Promoting knowledge was also accorded low priority as emphasis on specialization and standardization undermined the need for learning. In such an environment, individuals had a tendency to be inhibited and uncreative, whereby new ideas were dismissed and people were discouraged to take risks, or experiment (Carnall, 2003). The classical management system worked well when markets, products and technologies were slow to change (Turner and Keegan, 1999). Nevertheless, the system’s revealed weaknesses and limitations were gradually exposed with accelerating globalization and technological innovation. Drivers of change A rapidly changing techno-socio-economic environment is presenting new challenges for structuring and managing organizations. Increasing technological complexity and the need to diffuse information and technology within the organizations is proving to be beyond the capacity of the old rigid hierarchal management system. Technological complexity implies the need for higher levels of human knowledge and multi-disciplinary involvement (Bridges, 1996; Boyett and Boyett, 2000). Firms operating in the knowledge economy need to harness growing knowledge, technology and engineering advances and a whole range of new skills and dynamic competencies (Liyanage and Poon, 2002). Knowledge workers on the other hand rightfully perceive the old management system as under-utilizing their expertise and under-estimating their willingness to take initiative and responsibility. New attitudes towards work involve feelings of pride and ownership and employees are becoming more concerned about merit, value, worth, meaning and fulfillment (Stallings, 2000). Customers are also becoming better educated, more enlightened, more sophisticated, more inquisitive and critical - in sum more demanding when it comes to spending (Chapman, 2001). New products are having to be innovative, flexible for customization and of high quality while having a short life cycle in a fickle global market (Turner and Keegan, 1999; Longenecker and Ariss, 2002). On the economic level, the old hierarchal organizations that flourished in a relatively stable market are facing the prospects of a new world order, with permeable geo-political boundaries. The General Agreement on Trade and Tariffs (GATT) and the proliferation of international standards such as ISO 9000 and ISO 14000, allow every company that satisfies the new rules to enter the game. Taken together, these drivers have necessitated a fundamental re-orientation to management, implying that organizations are having to manage in different ways to survive and prosper in the new environment. Some analysts group the different environmental triggers of change into four distinct categories under the acronym PEST (Johnson and Scholes, 1999) or STEP (Goodman, 1995), both of which refer to the political, economic, technological and socio-cultural triggers of change, which have influenced the organizations and their management processes (Figure 1). A new management paradigm Organizations have become increasingly aware that the world has turned on its axis, necessitating a fundamental re-assessment of objectives, operations and management orientation. Therefore the 1980s have witnessed the emergence of a paradigm shift, or to be more accurate the search for new more appropriate paradigms (Collins, 1996; Burnes, 2000). The theories that have most widely affected contemporary management thinking include the behavioral approach, the systems theory, the contingency approach, the culture-excellence approach, and the organizational learning theory, each of which contributed new insights to our understanding of contemporary management processes. The behavioral approach for example turned attention to the human factor in the organization and the importance of group dynamics and complex human motivations. The systems approach alerted managers to the notions of embedded-ness and interdependencies, while the contingency approach underscored adaptability/situational appropriateness. The culture-excellence approach reminded managers to accord more attention to the softer issues of people, values, and employee/customer satisfaction. It also posited innovation as a central driver of excellence in organizations. The organizational learning approach emphasized the usefulness of carefully nurturing and cultivating the capacity to acquire new knowledge and to put it into new applications.  Inspired by these various contributions, traditional management perspectives are being transformed, and the long-held criteria for evaluating organizational and managerial effectiveness are being reinvigorated. While the changes have proved unsettling for many managers and organizations, 21st century corporations are surely charting new grounds where familiar themes and practices are being disrupted and remolded. Business discourse increasingly revolves around intelligence, information and ideas (Handy, 1989) and capitalizing on brainpower and intellectual capital to add value and sustain competitiveness. Management in the 21st century has accordingly taken a new orientation. It is increasingly founded on the ability to cope with constant change and not stability, is organized around networks and not hierarchies, built on shifting partnerships and alliances and not self-sufficiency, and constructed on technological advantage and not bricks and mortar (Carnall, 2003). New organizations are networks of intricately woven webs that are based on virtual integration rather than vertical integration, interdependence rather than independence, and mass customization rather than mass production (Greenwald, 2001). Table II presents the contrasting assumptions of the traditional and new management paradigms. Organizations embracing the new management changes are restructuring their internal processes and management approaches around rapidly changing information and technology. This shift is favoring cellular and matrix organizational structures with fewer layers of management over the old inflexible multi-layered vertical hierarchical organizations (Benveniste, 1994; Cravens et al., 1997). The new management philosophy is also embracing innovation as a key ingredient of success and increased competitiveness (Khalil, 2000; Liyanage and Poon, 2002). This entails developing the creative potential of the organization by fostering new ideas, harnessing people’s creativity and enthusiasm, tapping the innovative potential of employees, and encouraging the proliferation of autonomy and entrepreneurship (Blanchard, 1996; Kuczmarski, 1996; Boyett and Boyett, 2000; Black and Porter, 2000). Modern organizations as such, are making major strides to nurture innovation, positing human knowledge as a key component of their asset base, and creating knowledge bases or repositories to shorten learning curves (Khalil and Wang, 2002; Carnall, 2003). People are treated as the natural resource and capital asset of the organization and the most important source of sustainable competitive advantage. Whereas the traditional paradigm considered labor a commodity to be bought, exploited Table II. Contrasting assumptions of the traditional and new management paradigms Reduction of the direct costs of production as the primary focus of management The operations of an enterprise characterized and analyzed as stable Single critical technology-based product lines with long product lifetimes Managers regarded as decision-makers and labor as passive followers of instruction World markets divided on a national basis, with national firms dominant in domestic markets Source: Adapted from Khalil (2000) Reducing the indirect costs of the enterprise while improving competitiveness Flexible and agile operations and continuous improvement Multi-core technology product lines with shorter product lifetimes Managers regarded as coaches/facilitators and labor as knowledge workers/intellectual capital Global world markets and greater attention to international economic and political structures to exhaustion, and discarded when convenient, a much different orientation currently prevails, requiring the careful nurturing and skillful management of human resources, with a focus on psychological commitment, empowerment, teamwork, trust, and participation. The new management paradigm therefore revolves around teamwork, participation, and learning. It also revolves around improved communication, integration, collaboration, and closer interaction and partnering with customers, suppliers and a wider range of stakeholders. Value creation, quality, responsiveness, agility, innovation, integration and teaming are increasingly regarded as useful guiding principles in the evolving new environment (Table III). Kanter (1989, p. 20) aptly describes the revolution in management practice. She writes: The new game of business requires faster action, more creative maneuvering, more flexibility and closer partnerships with employees and customers than was typical in the traditional corporate bureaucracy. It requires more agile, limber management that pursues opportunity without being bogged down by cumbersome structures or weighty procedures that impede action. Corporate giants, in short, must learn how to dance (Kanter, 1989, p. 20). Against the myriad changes and conflicting expectations, individual managers and executives are being asked to change their approach to running their operations and managing people. The “new” managers we are told must learn to be coaches, team players, facilitators, process managers, human resource executives, visionary leaders, and entrepreneurs (Longenecker and Ariss, 2002). They must also be knowledge-integrating boundary spanners, stimulators of creativity, innovation muses and promoters of learning (Harvey et al., 2002). They must be more bottom-line driven, more innovative, and more focused on the human dynamics of the organization (Chapman, 2001). The 21st century managers are therefore expected to nurture a complex amalgamation of technical, functional, and socio-cultural skills to cope with the new paradigm, that has changed their responsibilities, increased their risks and weakened their control by flattening hierarchy (Nohria and Ghoshal, 1997; Pucik and Saba, 1998; Fish, 1999). They are increasingly conceived as pillars and architects of organizational competitiveness, linking people, opportunities and resources (Chapman, 2001). on the other hand, failing to live up to these expectations may limit the organization’s ability to thrive in an increasingly complex and dynamic environment. While managers search for new approaches to management in an ever-turbulent environment, academics also have to search for new approaches and methodologies. Management education indeed needs to reflect the changing times by overhauling not Value creation Value added constitutes the basic social responsibility of the enterprise Quality Quality as a fundamental requirement influencing competitiveness Responsiveness Responsiveness to external environmental changes and customer demands Agility Flexibility in communications and operations Innovation Fostering new ideas, harnessing people’s creativity and enthusiasm Integration Integration of a portfolio of technologies for a distinctive competitive advantage Teaming Decentralized, multi-functional and multi-disciplinary enterprise teams Source: Adapted from Carnall (2003) only its content and delivery modes, but also its overall approach and orientation (Liyanage and Poon, 2002). Implications for management education In this context of transition and radical change, the field of management education has attracted extensive attention, reflection and criticism. Management education can be described as a formal classroom (off-site) learning experience that attempts to expose managers to new concepts, practices, and situations that can be transferred to the workplace (Longenecker and Ariss, 2002). Formal management education programs may cover a host of specialized topics (e.g. financial management, strategic planning, leadership, negotiation) or may include more comprehensive programs such as certificate granting programs or executive MBA programs. While formal management education is only one way in which managers learn, organizations and individuals often rely on this developmental intervention as a vehicle for improvement (Talbot, 1997). A key question that is increasingly echoed in management education circles concerns the efficacy and relevance of traditional management education. Various criticisms have been raised and doubt has been cast upon the nature, relevance and appropriateness of orthodox management education. Spender (1994, p. 387) for example notes that, “management education ostensibly designed to equip managers to deal with the world seems to have changed little in recent years”. In the US context, Hayes and Abernathy (1980) specifically linked the decline in competitiveness of US industry with the effect of the traditional professional education model on management graduates. Their critique of this model asserted that management graduates learnt analytic detachment over insight, and that methodological rigor prevented them from learning from experience. A similar criticism has been raised in a recent article by Handy (1987), which linked the decline in the UK economy to the increasingly irrelevant management education which many undergraduate students and post experience managers receive. Other criticisms abound. Cheit (1985) for example identified 13 major complaints, which have been made against North American business schools, mostly revolving around emphasizing the wrong pedagogical model, ignoring important work, fostering undesirable attitudes and failing to meet society’s needs. He concluded that graduate business education was not preparing students adequately for the challenges of corporate life. Porter and McKibben (1988) criticized the emphasis in the dominant professional management model on quantitative, analytical and rational ap

Indonesian

goegmenurut adam smith dalam teorinya hubungan antara majikan dan karyawan adalah hubungan "jual-beli" an sich (tak lebih dan tak kurang). Oleh karenanya, jika upah di sector lain naik maka karyawan berlomba lomba berpindah ke sector terebut. artinya, tidak ada ikatan sama sekali sama sekali antara majikan dan karyawan. hubungannya adalah sebatas pekerjaan sehingga turn over karyawan sangat tinggi. artinya tingkat perputaran (keluar masuk) tenaga kerja sangat tinggi. Berbeda dengan konsep syariah yang menegaskan bahwa para karyawan adalah saudara majikan.Dengan demikian majikan menanggung amanah dari allah untuk bertanggung jawab pada karyawan sehingga tidak ada karyawan yang kelaparan,tidak ada yang telanjang dan tidak akan dieksploitasi . le terjemahan

Last Update: 2014-11-05
Usage Frequency: 1
Quality:

Reference: Anonymous
Warning: Contains invisible HTML formatting

English

Contents Page Foreword........................................................................................................................................................... iv 0 Introduction .......................................................................................................................................... v 0.1 General .................................................................................................................................................. v 0.2 Process approach ................................................................................................................................ v 0.3 Relationship with other standards ..................................................................................................... vi 0.4 Compatibility with other management systems ............................................................................... vi 1 Scope..................................................................................................................................................... 1 1.1 General .................................................................................................................................................. 1 1.2 Application............................................................................................................................................ 1 2 Normative references ........................................................................................................................... 2 3 Terms and definitions.......................................................................................................................... 2 4 Quality management system ............................................................................................................... 4 4.1 General requirements ........................................................................................................................... 4 4.2 Documentation requirements .............................................................................................................. 4 5 Management responsibility................................................................................................................. 6 5.1 Management commitment.................................................................................................................... 6 5.2 Customer focus.................................................................................................................................... 6 5.3 Quality policy........................................................................................................................................ 6 5.4 Planning ................................................................................................................................................ 7 5.5 Responsibility, authority and communication................................................................................... 7 5.6 Management review............................................................................................................................. 8 6 Resource management........................................................................................................................ 8 6.1 Provision of resources ......................................................................................................................... 8 6.2 Human resources................................................................................................................................. 9 6.3 Infrastructure........................................................................................................................................ 9 6.4 Work environment................................................................................................................................ 9 7 Product realization............................................................................................................................. 10 7.1 Planning of product realization ......................................................................................................... 10 7.2 Customer-related processes.............................................................................................................. 10 7.3 Design and development.................................................................................................................... 11 7.4 Purchasing.......................................................................................................................................... 13 7.5 Production and service provision ..................................................................................................... 14 7.6 Control of monitoring and measuring devices ................................................................................ 17 8 Measurement, analysis and improvement........................................................................................ 17 8.1 General ................................................................................................................................................ 17 8.2 Monitoring and measurement............................................................................................................ 18 8.3 Control of nonconforming product ................................................................................................... 19 8.4 Analysis of data.................................................................................................................................. 19 8.5 Improvement....................................................................................................................................... 20 Annex A (informative) Correspondence between ISO 13485:2003 and ISO 13485:1996........................... 21 Annex B (informative) Explanation of differences between ISO 13485:2003 and ISO 9001:2000 ............ 25 Bibliography .................................................................................................................................................... 57 ISO 13485:2003(E) iv © ISO 2003 — All rights reserved Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 13485 was prepared by Technical Committee ISO/TC 210, Quality management and corresponding general aspects for medical devices. This second edition cancels and replaces the first edition (ISO 13485:1996), which has been technically revised. It also cancels and replaces ISO 13488:1996. Those organizations which have used ISO 13488 in the past may use this International Standard by excluding certain requirements in accordance with 1.2. This edition of ISO 13485 has a revised title and addresses quality assurance of product, customer requirements, and other elements of quality system management. ISO 13485:2003(E) © ISO 2003 — All rights reserved v 0 Introduction 0.1 General This International Standard specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services. It can also be used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer and regulatory requirements. Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement. It is emphasized that the quality management system requirements specified in this International Standard are complementary to technical requirements for products. The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization's quality management system is influenced by varying needs, particular objectives, the products provided, the processes employed and the size and structure of the organization. It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation. There is a wide variety of medical devices and some of the particular requirements of this International Standard only apply to named groups of medical devices. These groups are defined in Clause 3. 0.2 Process approach This International Standard is based on a process approach to quality management. Any activity that receives inputs and converts them to outputs can be considered as a process. For an organization to function effectively, it has to identify and manage numerous linked processes. Often the output from one process directly forms the input to the next. The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management, can be referred to as the “process approach”. 0.3 Relationship with other standards 0.3.1 Relationship with ISO 9001 While this is a stand-alone standard, it is based on ISO 9001. Those clauses or subclauses that are quoted directly and unchanged from ISO 9001 are in normal font. The fact that these subclauses are presented unchanged is noted in Annex B. Where the text of this International Standard is not identical to the text of ISO 9001, the sentence or indent containing that text as a whole is shown in italics (in blue italics for electronic versions). The nature and reasons for the text changes are noted in Annex B. ISO 13485:2003(E) vi © ISO 2003 — All rights reserved 0.3.2 Relationship with ISO/TR 14969 ISO/TR 14969 is a Technical Report intended to provide guidance for the application of ISO 13485. 0.4 Compatibility with other management systems This International Standard follows the format of ISO 9001 for the convenience of users in the medical device community. This International Standard does not include requirements specific to other management systems, such as those particular to environmental management, occupational health and safety management, or financial management. However, this International Standard enables an organization to align or integrate its own quality management system with related management system requirements. It is possible for an organization to adapt its existing management system(s) in order to establish a quality management system that complies with the requirements of this International Standard. INTERNATIONAL STANDARD ISO 13485:2003(E) © ISO 2003 — All rights reserved 1 Medical devices — Quality management systems — Requirements for regulatory purposes 1 Scope 1.1 General This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The primary objective of this International Standard is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001 (see Annex B). 1.2 Application All requirements of this International Standard are specific to organizations providing medical devices, regardless of the type or size of the organization. If regulatory requirements permit exclusions of design and development controls (see 7.3), this can be used as a justification for their exclusion from the quality management system. These regulations can provide alternative arrangements that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity with this International Standard reflect exclusion of design and development controls [see 4.2.2 a) and 7.3]. If any requirement(s) in Clause 7 of this International Standard is(are) not applicable due to the nature of the medical device(s) for which the quality management system is applied, the organization does not need to include such a requirement(s) in its quality management system [see 4.2.2 a)]. The processes required by this International Standard, which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organization’s quality management system [see 4.1 a)]. In this International Standard the terms “if appropriate” and “where appropriate” are used several times. When a requirement is qualified by either of these phrases, it is deemed to be “appropriate” unless the organization can document a justification otherwise. A requirement is considered “appropriate” if it is necessary in order for  the product to meet specified requirements, and/or  the organization to carry out corrective action. ISO 13485:2003(E) 2 © ISO 2003 — All rights reserved 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 9000:2000, Quality management systems — Fundamentals and vocabulary 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 9000 apply, together with the following. The following terms, used in this edition of ISO 13485 to describe the supply chain, have been changed to reflect the vocabulary currently used: supplier -------------> organization ----------> customer The term “organization” replaces the term “supplier” used in ISO 13485:1996, and refers to the unit to which this International Standard applies. Also, the term “supplier” now replaces the term “subcontractor”. Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean “service”. Wherever requirements are specified as applying to “medical devices”, the requirements apply equally to related services as supplied by the organization. The following definitions should be regarded as generic, as definitions provided in national regulations can differ slightly and take precedence. 3.1 active implantable medical device active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure 3.2 active medical device medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity 3.3 advisory notice notice issued by the organization, subsequent to delivery of the medical device, to provide supplementary information and/or to advise what action should be taken in  the use of a medical device,  the modification of a medical device,  the return of the medical device to the organization that supplied it, or  the destruction of a medical device NOTE Issue of an advisory notice might be required to comply with national or regional regulations. ISO 13485:2003(E) © ISO 2003 — All rights reserved 3 3.4 customer complaint written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety or performance of a medical device that has been placed on the market 3.5 implantable medical device medical device intended  to be totally or partially introduced into the human body or a natural orifice, or  to replace an epithelial surface or the surface of the eye, by surgical intervention, and which is intended to remain after the procedure for at least 30 days, and which can only be removed by medical or surgical intervention NOTE This definition applies to implantable medical devices other than active implantable medical devices. 3.6 labelling written, printed or graphic matter  affixed to a medical device or any of its containers or wrappers, or  accompanying a medical device, related to identification, technical description, and use of the medical device, but excluding shipping documents NOTE Some regional and national regulations refer to “labelling” as “information supplied by the manufacturer.” 3.7 medical device any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of  diagnosis, prevention, monitoring, treatment or alleviation of disease,  diagnosis, monitoring, treatment, alleviation of or compensation for an injury,  investigation, replacement, modification, or support of the anatomy or of a physiological process,  supporting or sustaining life,  control of conception,  disinfection of medical devices,  providing information for medical purposes by means of in vitro examination of specimens derived from the human body, and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means. NOTE This definition has been developed by the Global Harmonization Task Force (GHTF). See bibliographic reference [15]. ISO 13485:2003(E) 4 © ISO 2003 — All rights reserved 3.8 sterile medical device category of medical device intended to meet the requirements for sterility NOTE The requirements for sterility of a medical device might be subject to national or regional regulations or standards. 4 Quality management system 4.1 General requirements The organization shall establish, document, implement and maintain a quality management system and maintain its effectiveness in accordance with the requirements of this International Standard. The organization shall a) identify the processes needed for the quality management system and their application throughout the organization (see 1.2), b) determine the sequence and interaction of these processes, c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective, d) ensure the availability of resources and information necessary to support the operation and mon

Indonesian

tiger

Last Update: 2013-03-18
Usage Frequency: 1
Quality:

Reference: Anonymous
Warning: Contains invisible HTML formatting

Get a better translation with
4,401,923,520 human contributions

Users are now asking for help:



We use cookies to enhance your experience. By continuing to visit this site you agree to our use of cookies. Learn more. OK