ISO 9001 and regulatory compliance in the medical device industry

被引：0
|
作者：
Tsiakals, J [1 ]
机构：
[1] Amgen Inc, Corp Qual, Thousand Oaks, CA 91320 USA
来源：
QUALITY PROGRESS | 2001年 / 34卷 / 04期
关键词：
Continual improvement - International Organization for Standardization - Quality management systems;
D O I：
暂无
中图分类号：
T [工业技术];
学科分类号：
08 ;
摘要：
(Edited Abstract)
引用
收藏
页码：75 / 77
页数：3
相关论文
共 50 条
  • [1] Will ISO 9001 still apply for the medical device industry?
    Tsiakals, J
    [J]. QUALITY PROGRESS, 2000, 33 (09) : 81 - 84
  • [2] The Impact of Industry 4.0 on the Medical Device Regulatory Product Life Cycle Compliance
    McDermott, Olivia
    Foley, Ida
    Antony, Jiju
    Sony, Michael
    Butler, Mary
    [J]. SUSTAINABILITY, 2022, 14 (21)
  • [3] An update on ISO 9001 and ISO 13485 - Harmonization of the medical device quality standards: The evolution of ISO 13485
    Slickers, KA
    [J]. ASQ'S 56TH ANNUAL QUALITY CONGRESS PROCEEDINGS, 2002, : 21 - 23
  • [4] General magnaplate announces ISO 9001 compliance
    不详
    [J]. SAMPE JOURNAL, 2003, 39 (05) : 93 - 94
  • [5] ISO 9001 has had no effect on quality in the in vitro medical diagnostics industry
    Krouwer, JS
    [J]. ACCREDITATION AND QUALITY ASSURANCE, 2004, 9 (1-2) : 39 - 43
  • [6] ISO 9001 has had no effect on quality in the in vitro medical diagnostics industry
    Jan S. Krouwer
    [J]. Accreditation and Quality Assurance, 2004, 9 : 39 - 43
  • [7] Implementation of ISO 9001 standard in the textile industry
    Hajdarovic, K
    Vincelj, I
    Svaljek, A
    [J]. TEKSTIL, 2004, 53 (08): : 399 - 408
  • [8] Implementation of ISO 9001 in a medical testing laboratory
    Burnett, L
    Rochester, C
    Mackay, M
    Proos, A
    Shaw, W
    Hegedus, G
    [J]. ACCREDITATION AND QUALITY ASSURANCE, 1997, 2 (02) : 76 - 81
  • [9] Implementation of ISO 9001 in a medical testing laboratory
    L. Burnett
    Colin Rochester
    Mark Mackay
    Anné Proos
    Warwick Shaw
    Gabe Hegedus
    [J]. Accreditation and Quality Assurance, 1997, 2 : 76 - 81
  • [10] An evaluation of documentation requirements for ISO 9001 compliance in scrum projects
    Mathrani, Anuradha
    Wickramasinghe, Shanuka
    Jayamaha, Nihal Palitha
    [J]. TQM JOURNAL, 2022, 34 (05): : 901 - 921
12345