Qualitatsmanagement handbuch 13485


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Qualitatsmanagement handbuch 13485

Klaus Seiler Master of Science in QM Sie haben Fragen? Rufen Sie an: Da die Norm DIN EN ISO harmonisiert ist, haben wir die Vorlage zu den Forderungen mit der ISO verknüpft. Die Nummerierung entspricht der Norm So kann eine Zuordnung zur Norm leicht realisiert werden. Die Anforderungen der DIN EN ISO sind als Zusatz angefügt.

Wir haben die Formblätter und Nachweisformen mit Beispielen gefüllt die jeweils in "rot" gekennzeichnet sind. Der Aufwand zur Anpassung des Musterhandbuchs unter Beachtung von MS-Office Kenntnissen ist gering. Für Unternehmen mit bestehender Zertifizierung, dient das Handbuch zur Umstellung von der alten Norm.

Kein Abo und keine kostenpflichtigen Ergänzungslieferungen! Informationen zum Autor Klaus Seiler, Master of science in quality management, berät Unternehmen bei der Einführung, Weiterentwicklung und Umsetzung von Managementsystemen. Er ist Autor von zahlreichen Musterhandbüchern auf unterschiedlichen Normgrundlagen. Durch seine Erfahrungen als Berater, Sachverständiger, Lead- oder Zertifizierungs-Auditor kennt er die Probleme der Unternehmen bei der Umsetzung von Managementsystemen.

Die Musterdokumentationen sind das Ergebnis aus langjährigen Erfahrungen, der Lehre und aus Beratungen. Technische Dokumentation Medizinprodukte. Risikomanagementakte nach DIN EN ISO Leitfaden resterilisierbare Medizinprodukte. Lieferung: Per Download und oder Hardcover mit CD. Konditionen: Keine Ergänzungslieferungen, Rückgaberecht, Bezahlung per Rechnung oder PayPal.

Besonderes: Alle Disziplinen wie Entwicklung, Produktion, Vertrieb und Dienstleistung sind beachtet. ISBN bei Bestellung über den Buchhandel Downloads : Kein Abo und keine kostenpflichtigen Ergänzungslieferungen! Alle Vorlagen können in MS-Office Programmen bearbeitet werden. Arbeitsanweisungen 4.

ISO 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 and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities e.

ISO can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations. Requirements of ISO are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization. The processes required by ISO that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system by monitoring, maintaining, and controlling the processes.

If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system.

It is the responsibility of the organization to ensure that claims of conformity to ISO reflect any exclusion of design and development controls. If any requirement in Clauses 6, 7 or 8 of ISO is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system.

For any clause that is determined to be not applicable, the organization records the justification as described in 4. Proof returned by secretariat 60 Publication One such way is through applying sound risk management processes to medical devices. Caring about health and safety Uncover how ISO Standards help doctors treat patients and keep people safe at work, at home, wherever. Got a question? Check out our FAQs. Buy this standard.

Therefore this version remains current. This standard is available for free in read-only format. This standard contributes to the following Sustainable Development Goals :. CHF Buy. People also bought ISO Quality management systems.

ISO [Withdrawn] Medical devices. Application of risk management to medical devices. ISO Clinical investigation of medical devices for human subjects. Good clinical practice. ISO Medical devices. Quality management systems. Life cycle Previously Withdrawn. Full report circulated: decision for new DIS ballot. Full report circulated: DIS approved for registration as FDIS.

Final text received or FDIS registered for formal approval. Proof sent to secretariat or FDIS ballot initiated: 8 weeks. Close of voting. Proof returned by secretariat. International Standard under periodical review. Withdrawal of International Standard proposed by TC or SC. This may also interest you. Reducing the risks of medical devices: international guidance just updated Virtually no medical procedure is without risk, but there are many ways to minimize it.

FDA plans to use ISO for medical devices regulation The US Food and Drug Administration FDAthe government department that regulates the medical devices sector, announced its intention to use ISO as the basis for its quality system legislation. New handbook helps medical devices sector improve its quality management system The medical devices industry is one of the most highly regulated sectors in the world. Robots to the rescue! ISO — Medical devices Manage quality throughout the life cycle of a medical device with ISO Customer care.

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