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Indonesian

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English

approve

Indonesian

menyetujui, mengaminin

Last Update: 2010-04-13
Subject: General
Usage Frequency: 1
Quality:

English

Approve

Indonesian

Ijinkan

Last Update: 2013-12-21
Subject: Computer Science
Usage Frequency: 1
Quality:

Reference:

English

DEAR ABDUL KADIR, THIS IS TO BRING TO YOUR NOTICE THAT MY CHAMBER AHMED FAWAZ HAVE GOTTEN AN ORDER FROM OUR CLIENT MRS JULLIA BINSUHARTA TO APPROVE YOU WITH THIS CHANGE OF OWNERSHIP OF HER FUND (5.5MILLION US DOLLARS) DEPOSITED IN ACE SECURITY COMPANY HERE AS THE PARTNER WHO CAN RECEIVE THE FUND FROM THE COMPANY. IN ADDITION YOUR ARE REQUIRED TO PRINT OUT THIS POWER OF ATTORNEY (CHANGE OF OWNERSHIP AGREEMENT LETTER OUT AND SIGN YOUR POTION BELOW BECAUSE MRS JULLIA BINSUHARTA ALREADY MADE HER TOM PRINT SIGN, JUST WAITING FOR YOUR OWN SIGNATURE THEN WE CAN PROCEED WITH THE SECURITY COMPANY FOR THE DELIVERY OF THE FUND TO YOUR HOME ADDRESS. AGAIN ONCE WE CONFIRM YOUR SIGNATURE IN THIS CHANGE OF OWNERSHIP AGREEMENT FORM BACK VIA EMAIL, WE WILL IMMEDIATELY INSTRUCT THE SECURITY COMPANY FOR THE DELIVERY. THANKS FOR YOUR CO-OPERATIONS & URGENT RESPONSE NEEDED, BARRISTER AHMED FAWAZ, AHMED FAWAZ & CO CHAMBER, TEL: 447031802790,FAX: 447031825876.

Indonesian

Pelabuhan

Last Update: 2014-03-08
Usage Frequency: 1
Quality:
Reference:
Warning: Contains invisible HTML formatting

English

This page may not be secure. For details, see the security tab.\n\nYou need to approve or reject the loading of this page.

Indonesian

Halaman ini mungkin tidak aman. Untuk detil, lihat tab sekuriti.\n\nAnda harus mengkonfirmasi untuk membuka halaman ini.

Last Update: 2013-12-05
Subject: Computer Science
Usage Frequency: 1
Quality:

Reference:

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
Subject: General
Usage Frequency: 1
Quality:

Reference:
Warning: Contains invisible HTML formatting

English

That ye may approve things that are excellent; that ye may be sincere and without offence till the day of Christ;

Indonesian

Dengan demikian kalian tahu memilih apa yang terbaik, dan hidupmu akan bersih dari cela atau tuduhan apa pun juga pada hari Kristus datang kembali

Last Update: 2012-05-06
Subject: Religion
Usage Frequency: 1
Quality:

Reference:

English

And when I come, whomsoever ye shall approve by your letters, them will I send to bring your liberality unto Jerusalem.

Indonesian

Nanti kalau saya tiba, saya akan mengutus orang-orang yang sudah kalian setujui. Saya akan memberikan kepada mereka surat pengantar, supaya mereka membawa uang sumbangan itu ke Yerusalem

Last Update: 2012-05-06
Subject: Religion
Usage Frequency: 1
Quality:

Reference:

English

This their way is their folly: yet their posterity approve their sayings. Selah.

Indonesian

Begitulah nasib orang yang mengandalkan dirinya, dan masa depan orang yang puas dengan perkataannya

Last Update: 2012-05-06
Subject: Religion
Usage Frequency: 1
Quality:

Reference:

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