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Quality Systems—Medical Devices—Particular Requirements for the Application of ISO 9001
Abstract
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 nongovernmental, 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.
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Cited by
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A standardized framework for the validation and verification of clinical molecular genetic tests
for the EuroGentest Validation Group, Mattocks, C. J., Morris, M. A., Matthijs, G., Swinnen, E., Corveleyn, A., Dequeker, E., Müller, C. R., Pratt, V., & Wallace, A. (2010) · European Journal of Human Genetics · doi:10.1038/ejhg.2010.101 · Cited by 205
Inhalation Exposure to Carbon Nanotubes (CNT) and Carbon Nanofibers (CNF): Methodology and Dosimetry
Oberdörster, G., Castranova, V., Asgharian, B., & Sayre, P. (2015) · Journal of Toxicology and Environmental Health, Part B · doi:10.1080/10937404.2015.1051611 · Cited by 150
Al-Salem, S. M., Uddin, S., & Lyons, B. (2020) · Marine Pollution Bulletin · doi:10.1016/j.marpolbul.2020.111052 · Cited by 90
Nanomaterial Cell Interactions: Are Current In Vitro Tests Reliable?
Hirsch, C., Roesslein, M., Krug, H. F., & Wick, P. (2011) · Nanomedicine · doi:10.2217/nnm.11.88 · Cited by 71
Metadata
- Venue
- GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 2 - Regulations, Standards, and Guidelines)
- Publisher
- CRC Press
- Published
- 2004-12-30
- Pages
- 408-420
- OpenAlex
- W2496571228
- Cited by
- 2,696
- References
- 0
- FWCI
- 243.23
- Type
- book chapter
- Language
- en
- Open access
- closed
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- CoChat. (2026). Citation check: Quality Systems—Medical Devices—Particular Requirements for the Application of ISO 9001. https://app.cochat.ai/papers/10.3109/9780203026656-18
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- Quality Systems—Medical Devices—Particular Requirements for the Application of ISO 9001. (2004). GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 2 - Regulations, Standards, and Guidelines). https://doi.org/10.3109/9780203026656-18
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Bibliographic data: Semantic Scholar, OpenAlex, Crossref.
Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
