| 000 | 02803cam a2200529 a 4500 | ||
|---|---|---|---|
| 005 | 20250919004402.0 | ||
| 008 | 150508s2012 flua bf 001 0 eng | ||
| 020 |
_a9781439866115 _q(hardback : alk. paper) _cRM 530.44 |
||
| 020 |
_a1439866112 _q(hardback : alk. paper) |
||
| 039 | 9 |
_a201509221040 _bzainol _c201509031011 _dfashihah _y05-08-2015 _zfashihah |
|
| 040 |
_aUKM _erda |
||
| 090 | _aWU26.A166i 2012 9 | ||
| 090 |
_aW26 _b.A166i 2012 9 |
||
| 100 | 1 |
_aAbuhav, Itay _eauthor |
|
| 245 | 1 | 0 |
_aISO 13485 : _ba complete guide to quality management in the medical device industry / _cItay Abuhav. |
| 264 | 1 |
_aBoca Raton : _bCRC Press, _c[2012] |
|
| 264 | 4 | _a@2012 | |
| 300 |
_axi, 361 pages : _billustrations ; _c24 cm |
||
| 336 |
_atext _btxt _2rdacontent |
||
| 337 |
_aunmediated _bn _2rdamedia |
||
| 338 |
_avolume _bnc _2rdacarrier |
||
| 500 | _aIncludes index. | ||
| 504 | _aIncludes bibliographical references and index. | ||
| 505 | 0 | _aScope -- Normative references -- Terms and definitions -- Quality management system -- Management responsibility -- Resource management -- Product realization -- Measurement, analysis, and improvement. | |
| 520 | _a'The United States and European Union now require the ISO 13485 Standard certification for medical device manufacturers. Written by an experienced industry professional, this practical book provides a complete guide to the ISO 13485 standard certification for medical device manufacturing in terms of quality control. It covers all the requirements of ISO 13485 and offers a step-by-step comparison between the ISO 13485 and ISO 9001, enabling a sound understanding of these new procedures'--Provided by publisher. | ||
| 650 | 0 |
_aMedical instruments and apparatus _xStandards _vHandbooks, manuals, etc. |
|
| 650 | 0 |
_aMedical instruments and apparatus industry _xQuality control _xStandards _vHandbooks, manuals, etc. |
|
| 650 | 2 |
_aEquipment and Supplies _xstandards. |
|
| 650 | 2 |
_aEquipment Design _xstandards. |
|
| 650 | 2 |
_aManufactured Materials _xstandards. |
|
| 650 | 2 | _aQuality control. | |
| 650 | 7 |
_aEquipement mico-chirurgical. _2eclas |
|
| 650 | 7 |
_aNormes internationales. _2eclas |
|
| 650 | 7 |
_aISO. _2eclas |
|
| 650 | 7 |
_aContr{u3BEC}e de qualit{u296E} _2eclas |
|
| 650 | 7 |
_aManuels. _2eclas |
|
| 776 | 1 |
_cElectronic resource _z 9781439866122 |
|
| 856 | 4 | 1 |
_3CRCnetBASE _uhttp://www.crcnetbase.com/isbn/9781439866122 |
| 907 |
_a.b16140357 _b2019-11-12 _c2019-11-12 |
||
| 942 |
_c01 _n0 _kWU26.A166i 2012 9 |
||
| 914 | _avtls003585946 | ||
| 990 | _azr | ||
| 991 | _aProgram Sains Bioperubatan,Pusat Pengajian Sains Diagnostik dan Kesihatan Gunaan,FSK,KKL | ||
| 998 |
_ad _b2015-08-05 _cm _da _feng _gflu _y0 _z.b16140357 |
||
| 999 |
_c592085 _d592085 |
||