rdf-syntax-grammar
mods:
  schema location: http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
  title info:
    non sort: The
    title: FDA and worldwide quality system requirements guidebook for medical devices
  name:
    name part: Daniel, Amiram.
    role:
      role term: creator
  name:
    name part: Kimmelman, Ed.
  type of resource: text
  genre: elektronické knihy
  genre: electronic books
  origin info:
    place:
      place term: wiu
    place:
      place term: Milwaukee, Wis
    publisher: ASQ Quality Press
    date issued: 2008
    edition: 2nd ed.
    issuance: monographic
  language:
    language term: eng
  physical description:
    form: remote
    extent: 1 online resource (xxx, 304 pages)
  abstract: "This new and expanded second edition maintains the organizational approach of the first and includes the requirements and guidance contained in the Quality System Regulation (QSReg), the ISO 13485:2003 standard, and the ISO/TR 14969:2004 guidance document, and, as appropriate, a number of the FDA and Global Harmonization Task Force (GHTF) guidance documents." "This second edition also addresses a number of additional topics, such as the incorporation of risk management into the medical device organization's QMS, QMS issues related to continuation products, the key process interactions within a QMS, effective presentation of and advocacy for a QMS during FDA inspections and third-party assessments, and future FDA compliance and standards activities."--Jacket
  note: compiled and written by Amiram Daniel & Ed Kimmelman.
  note: Includes index.
  note: Revised edition of: FDA and worldwide quality system requirements guide book for medical devices / Kimberly A. Trautman. ©1997.
  note: Plný text je dostupný pouze z IP adres počítačů Univerzity Tomáše Bati ve Zlíně nebo vzdáleným přístupem pro zaměstnance a studenty
  subject:
    geographic code: n-us---
  subject:
    name:
      name part: Umschulungswerkstätten für Siedler und Auswanderer
  subject:
    topic: Medical instruments and apparatus industry
    topic: Law and legislation
    geographic: United States
  subject:
    topic: Quality control
    topic: Law and legislation
    geographic: United States
  subject:
    topic: Medical instruments and apparatus industry
    geographic: United States
    topic: Quality control
  subject:
    topic: Medical instruments and apparatus industry
    topic: Law and legislation
  subject:
    topic: Quality control
    topic: Law and legislation
  subject:
    topic: Medical instruments and apparatus industry
    topic: Quality control
  subject:
    topic: Quality control
  related item:
    title info:
      title: FDA and worldwide quality system requirements guide book for medical devices
    name:
      name part: Trautman, Kimberly A.,
      name part: 1964-
  related item:
    title info:
      title: FDA and worldwide quality system requirements guidebook for medical devices
    name:
      name part: Daniel, Amiram.
    origin info:
      publisher: Milwaukee, Wis. : ASQ Quality Press, 2008
      edition: 2nd ed.
    identifier: (DLC) 2008013052
    identifier: (OCoLC)214066132
  identifier: 9781621982067
  identifier: 1621982068
  identifier: 9780873897402
  identifier: 0873897404
  identifier: https://proxy.k.utb.cz/login
  access condition: Plný text je dostupný pouze z IP adres počítačů Univerzity Tomáše Bati ve Zlíně nebo vzdáleným přístupem pro zaměstnance a studenty
  record info:
    record content source: KNOVL
    record creation date: 130411
    record change date: 20240717213016.0
    record identifier: kn-ocn838150472
    language of cataloging:
      language term: eng