EN ISO 13485:2016/AC:2016
(Corrigendum)Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
ISO 13485:2016 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.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
Requirements of ISO 13485:2016 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 13485:2016 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 13485:2016 reflect any exclusion of design and development controls.
If any requirement in Clauses 6, 7 or 8 of ISO 13485:2016 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 4.2.2.
Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke (ISO 13485:2016)
Diese Internationale Norm legt Anforderungen an ein Qualitätsmanagementsystem fest, das durch eine Organisation angewendet werden kann, die an einer oder mehreren Stufen des Lebenszyklus eines Medizinprodukts beteiligt ist, einschließlich Entwicklung, Produktion, Lagerung und Vertrieb, Installation, Instandhaltung und endgültige Außerbetriebnahme und Entsorgung von Medizinprodukten sowie Entwicklung oder Bereitstellung von damit zusammenhängenden Tätigkeiten (z. B. technischer Support). Die Anforderungen nach dieser Internationalen Norm können auch von Lieferanten oder anderen externen Parteien angewendet werden, die Produkte (z. B. Rohstoffe, Bauteile, Baugruppen, Medizinprodukte, Sterilisationsdienstleistungen, Kalibrierdienstleistungen, Vertriebsdienstleistungen, Instandhaltungsdienstleistungen) für derartige Organisationen bereitstellen. Der Lieferant oder die externe Partei kann die Anforderungen dieser Internationalen Norm entweder freiwillig erfüllen oder kann vertraglich dazu aufgefordert werden.
In verschiedenen Zuständigkeitsbereichen gelten regulatorische Anforderungen an die Anwendung von Qualitätsmanagementsystemen durch Organisationen mit unterschiedlichen Rollen in der Lieferkette für Medizinprodukte. Aus diesem Grund erwartet diese Internationale Norm von der Organisation, dass
— sie ihre Rolle(n) unter anwendbaren regulatorischen Anforderungen identifiziert;
— sie die regulatorischen Anforderungen identifiziert, die für ihre Tätigkeiten unter diesen Rollen gelten;
— sie diese anwendbaren regulatorischen Anforderungen in ihr Qualitätsmanagementsystem einbindet.
Dispositifs médicaux - Systèmes de management de la qualité - Exigences à des fins réglementaires (ISO 13485:2016)
L'ISO 13485:2016 énonce les exigences relatives au système de management de la qualité lorsqu'un organisme doit démontrer son aptitude à fournir régulièrement des dispositifs médicaux et des services associés conformes aux exigences des clients et aux exigences réglementaires applicables. Ces organismes peuvent être impliqués dans une ou plusieurs étapes du cycle de vie incluant la conception et le développement, la production, le stockage et la distribution, l'installation ou les prestations associées d'un dispositif médical, ainsi que la conception, le développement ou la prestation d'activités associées (par exemple support technique). L'ISO 13485:2016 peut également être utilisée par les fournisseurs ou les parties externes qui fournissent des produits, notamment des services associés au système de management de la qualité à de tels organismes.
Les exigences de L'ISO 13485:2016 s'appliquent aux organismes, indépendamment de leur taille ou de leur nature, à l'exception des cas où cela est clairement indiqué. Lorsque les exigences s'appliquent effectivement aux dispositifs médicaux, elles s'appliquent également aux services associés fournis par l'organisme.
Les processus requis par l'ISO 13485:2016, qui sont applicables à l'organisme, mais non mis en ?uvre par celui-ci, relèvent de la responsabilité de ce dernier qui en tient compte dans son système de management de la qualité en surveillant, en tenant à jour et en maîtrisant les processus.
Le fait que des exigences réglementaires applicables autorisent l'exclusion des systèmes de contrôle de conception et de développement peut servir à justifier leur exclusion du système de management de la qualité. Ces exigences réglementaires peuvent prévoir d'autres approches qu'il faut appliquer dans le système de management de la qualité. Il incombe à l'organisme de s'assurer que ses demandes de conformité à l'ISO 13485:2016 correspondent à toute exclusion des systèmes de contrôle de conception et de développement.
Lorsqu'une exigence définie à l'Article 6, 7 ou 8 de l'ISO 13485:2016 ne peut être appliquée en raison des activités entreprises par l'organisme ou de la nature du dispositif médical auquel s'applique le système de management de la qualité, l'organisme n'est pas tenu d'inclure cette exigence dans son système de management de la qualité. Pour les paragraphes apparaissant comme non applicables, l'organisme enregistre la justification comme cela est décrit en 4.2.2.
Medicinski pripomočki - Sistemi vodenja kakovosti - Zahteve za zakonodajne namene (ISO 13485:2016)
General Information
- Status
- Withdrawn
- Publication Date
- 20-Dec-2016
- Withdrawal Date
- 13-Apr-2025
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 28-Mar-2018
- Completion Date
- 14-Apr-2025
Relations
- Effective Date
- 11-Apr-2018
- Effective Date
- 08-Jun-2022
Frequently Asked Questions
EN ISO 13485:2016/AC:2016 is a corrigendum published by the European Committee for Standardization (CEN). Its full title is "Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)". This standard covers: ISO 13485:2016 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.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations. Requirements of ISO 13485:2016 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 13485:2016 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 13485:2016 reflect any exclusion of design and development controls. If any requirement in Clauses 6, 7 or 8 of ISO 13485:2016 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 4.2.2.
ISO 13485:2016 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.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations. Requirements of ISO 13485:2016 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 13485:2016 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 13485:2016 reflect any exclusion of design and development controls. If any requirement in Clauses 6, 7 or 8 of ISO 13485:2016 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 4.2.2.
EN ISO 13485:2016/AC:2016 is classified under the following ICS (International Classification for Standards) categories: 03.100.70 - Management systems; 11.040.01 - Medical equipment in general. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 13485:2016/AC:2016 has the following relationships with other standards: It is inter standard links to EN ISO 13485:2016/AC:2018, EN ISO 13485:2016. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 13485:2016/AC:2016 is associated with the following European legislation: EU Directives/Regulations: 90/385/EEC, 93/42/EEC, 98/79/EC; Standardization Mandates: M/BC/CEN/89/9. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
You can purchase EN ISO 13485:2016/AC:2016 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.NRQRGDMQHMedizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke (ISO 13485:2016)Dispositifs médicaux - Systèmes de management de la qualité - Exigences à des fins réglementaires (ISO 13485:2016)Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)11.020.01Vodenje kakovosti in ravnanje z okoljem v zdravstvuQuality and environmental management in health care03.100.70Sistemi vodenjaManagement systemsICS:Ta slovenski standard je istoveten z:EN ISO 13485:2016/AC:2016SIST EN ISO 13485:2016/AC:2017en01-april-2017SIST EN ISO 13485:2016/AC:2017SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 13485:2016/AC
December 2016
Décembre 2016
Dezember 2016 ICS 03.100.70; 11.040.01 English version Version Française Deutsche Fassung
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Dispositifs médicaux - Systèmes de management de la qualité - Exigences à des fins réglementaires (ISO 13485:2016)
Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke (ISO 13485:2016) This corrigendum becomes effective on 21 December 2016 for incorporation in the official English version of the EN.
Ce corrigendum prendra effet le 21 décembre 2016 pour incorporation dans la version anglaise officielle de la EN.
Die Berichtigung tritt am 21. Dezember 2016 zur Einarbeitung in die offizielle Englische Fassung der EN in Kraft. CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels © 2016 CEN/CENELEC All rights of exploitation in any form and by any means reserved worldwide for CEN national Members and for CENELEC Members. Tous droits d'exploitation sous quelque forme et de quelque manière que ce soit réservés dans le monde entier aux membres nationaux du CEN et aux membres du CENELEC. Alle Rechte der Verwertung, gleich in welcher Form und in welchem Verfahren, sind weltweit den nationalen Mitgliedern von CEN und den Mitgliedern von CENELEC vorbehalten. Ref. No. EN ISO 13485:2016:EN ISO 13485:2016/AC:2016 E
EN ISO 13485:2016 (E) 2 1 Modification to the European foreword The fourth sentence now reads: "This document supersedes EN ISO 13485:2012 and CEN ISO/TR 14969:2005." 2 Modification to Annex ZA The title of the Annex ZA now reads: "Relationship between this European Standard and the Conformity Assessment Requirements of EU Directive 90/385/EEC (as amended)" The first paragraph now reads: "This European Standard has been prepared under a mandate given to CEN/CENELEC by the European Union and the European Free Trade Association to provide a means by which a manufacturer may demonstrate conformity, and by which the Notified Body may assess the manufacturer’s conformity, with the requirements of Directive 90/385/EEC (as amended) on active implantable medical devices." The third paragraph has been deleted. The first sentence of Note 1, now reads: "NOTE 1 Where a reference from a clause of this European Standard to the risk management process is made, the risk management process needs to be in compliance with Directive 90/385/EEC, as amended by 2007/47/EC." The last sentence of Note 2 has been deleted. In Table ZA.1, several cross references have been corrected, e.g. the ones corresponding to: — 3.2, 3rd paragraph (b) — 3.2 3rd paragraph (b) 3rd indent — 3.2, 3rd paragraph (e) In Table ZA.2, several cross references have been corrected, e.g. the ones corresponding to: — 3.2, 3rd paragraph (b), 3rd indent — 3.2, 3rd paragraph (c), 2nd indent In the last paragraph, the warnings 1 and 2 have been grouped under the following warning: WARNING: The preceding text and tables are specifically intended for organizations that
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SLOVENSKI SIST EN ISO 13485:2016/AC
STANDARD april 2017
Medicinski pripomočki – Sistemi vodenja kakovosti – Zahteve za
zakonodajne namene (ISO 13485:2016)
Medical devices – Quality management systems – Requirements for regulatory
purposes (ISO 13485:2016)
Medizinprodukte – Qualitätsmanagementsysteme – Anforderungen für
regulatorische Zwecke (ISO 13485:2016)
Dispositifs médicaux – Systèmes de management de la qualité – Exigences à
des fins réglementaires (ISO 13485:2016)
Referenčna oznaka
ICS 03.100.70; 11.020.01 SIST EN ISO 13485:2016/AC:2017 (sl)
Nadaljevanje na straneh II in od 1 do 4
© 2018-02: Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega standarda ni dovoljeno.
SIST EN ISO 13485:2016/AC : 2017
NACIONALNI UVOD
Popravek SIST EN ISO 13485:2016/AC (sl), Medicinski pripomočki – Sistemi vodenja kakovosti –
Zahteve za zakonodajne namene (ISO 13485:2016), 2017, ima status slovenskega popravka in je
enakovreden evropskemu popravku EN ISO 13485:2016/AC (en, de, fr), Medical devices – Quality
management systems – Requirements for regulatory purposes (ISO 13485:2016), 2016.
NACIONALNI PREDGOVOR
Evropski popravek EN ISO 13485:2016/AC:2016 je pripravil tehnični odbor Evropskega komiteja za
standardizacijo CEN/CLC/TC 3 Vodenje kakovosti in ustrezni splošni vidiki za medicinske pripomočke
(Quality management and corresponding general aspects for medical devices). Slovenski popravek
primeru spora glede besedila slovenskega prevoda v tem popravku je odločilen izvirni evropski popravek
v enem izmed treh uradnih jezikov CEN. Slovensko izdajo popravka je pripravil tehnični odbor SIST/TC
VAZ Varovanje zdravja.
Odločitev za izdajo tega popravka je dne 15. februarja 2017 sprejel SIST/TC VAZ Varovanje zdravja.
OSNOVA ZA IZDAJO POPRAVKA
– privzem popravka EN ISO 13485:2016/AC:2016
OPOMBE
– Povsod, kjer se v besedilu standarda uporablja izraz “evropski popravek”, v SIST EN ISO
13485:2016/AC:2017 to pomeni “slovenski popravek”.
– Uvod in nacionalni predgovor nista sestavni del popravka.
– Ta nacionalni dokument je istoveten EN ISO 13485:2016/AC:2016 in je objavljen z dovoljenjem
CEN-CENELEC
Upravni Cener
Avenue Marnix 17
B-1000 Bruselj
This national document is identical with EN ISO 13485:2016/AC:2016 and is published with the
permission of
CEN-CENELEC
Management Centre
Avenue Marnix 17
B-1000 Brussels
II
EVROPSKI STANDARD EN ISO 13485:2016/AC
EUROPEAN STANDARD
NORME EUROPÉENNE
december 2016
EUROPÄISCHE NORM
ICS 03.100.70; 11.040.01
Slovenska izdaja
Medicinski pripomočki – Sistemi vodenja kakovosti – Zahteve za
zakonodajne namene (ISO 13485:2016)
Medical devices – Dispositifs médicaux – Systèmes Medizinprodukte –
Quality management systems – de management de la qualité – Qualitätsmanagementsysteme –
Requirements for regulatory Exigences à des fins Anforderungen für regulatorische
purposes (ISO 13485:2016) réglementaires (ISO 13485:2016) Zwecke (ISO 13485:2016)
Ta popravek je začel veljati 21. decembra 2016 z vključitvijo v uradno angleško verzijo EN.
CEN
Evropski komite za standardizacijo
European Committee for Standardization
Europäisches Komitee für Normung
Comité Européen de Normalisation
Upravni center CEN-CENELEC: Avenue Marnix 17, B-1000 Bruselj
© 2016 CEN/CENELEC Lastnice avtorskih pravic so vse države Ref. št. EN ISO 13485:2016/AC:2016 E
članice CEN in CENELEC.
SIST EN ISO 13485:2016/AC : 2017
Popravek
1 Sprememba evropskega predgovora
Četrti stavek se sedaj glasi:
“Ta dokument nadomešča EN ISO 13485:2012 in CEN ISO/TR 14969:2005.”
2 Sprememba dodatka ZA
Naslov dodatka ZA se sedaj glasi:
“Povezava med tem evropskim standardom in zahtevami glede ugotavljanja skladnosti Direktive EU
90/385/EGS (z vsemi dopolnili)”
Prvi odstavek se sedaj glasi:
“Ta evropski standard je bil pripravljen v okviru mandata, ki sta ga Evropska unija in Evropsko združenje
za prosto trgovino dala CEN/CENELEC, da bi zagotovila sredstva, s katerimi lahko proizvajalec dokaže
skladnost z zahtevami Direktive 90/385/EGS (z vsemi dopolnili) o aktivnih medicinskih pripomočkih za
vsaditev in s katerimi lahko priglašeni organ ugotovi, ali proizvajalec to skladnost
...
Die EN ISO 13485:2016/AC:2016 ist ein bedeutendes Dokument, das Anforderungen an ein Qualitätsmanagementsystem für Organisationen festlegt, die medizinische Geräte und entsprechende Dienstleistungen bereitstellen. Der Umfang dieser Norm umfasst alle Phasen des Lebenszyklus von Medizinprodukten, einschließlich Design, Entwicklung, Produktion, Lagerung, Verteilung, Installation und Wartung. Dies zeigt die umfassende Relevanz der Norm für alle Beteiligten im Bereich der medizinischen Geräte. Eine der Stärken der ISO 13485:2016 ist ihre Flexibilität. Die Anforderungen sind für Organisationen jeder Größe und Art anwendbar, was bedeutet, dass sowohl große Hersteller als auch kleinere Dienstleister von dieser Norm profitieren können. Diese weitreichende Anwendbarkeit stellt sicher, dass alle beteiligten Akteure, einschließlich Zulieferer, qualitativ hochwertige Produkte und Dienstleistungen liefern, die den regulatorischen Anforderungen entsprechen. Ein weiterer wichtiger Aspekt ist die klare Definition der Verantwortung der Organisation in Bezug auf Prozesse, die nicht intern, sondern extern durchgeführt werden. Die Norm fordert eine Überwachung, Aufrechterhaltung und Kontrolle solcher Prozesse, was zu einer hochwertigen und sicheren Bereitstellung von Dienstleistungen und Produkten beiträgt. Dies verstärkt das Vertrauen der Kunden in die Organisation und ihre Produkte. Die Möglichkeit, von bestimmten Design- und Entwicklungsanforderungen auszuschließen, wenn dies aufgrund von geltenden regulatorischen Anforderungen gerechtfertigt ist, bietet zusätzliche Flexibilität. Dies ermöglicht es Organisationen, ihre Qualitätssysteme an die spezifischen Gegebenheiten ihrer Produkte und Dienstleistungen anzupassen, während sie dennoch die grundlegenden Qualitätsstandards einhalten. Zusammenfassend bietet die ISO 13485:2016 eine umfassende und flexible Grundlage für Qualitätsmanagementsysteme im Bereich der medizinischen Geräte. Ihre Stärken liegen in der breiten Anwendbarkeit, der klaren Verantwortlichkeit und der Möglichkeit, regulatorische Anforderungen effektiv zu integrieren. Die Norm ist daher äußerst relevant für jede Organisation, die ihre Qualitätssysteme optimieren und sicherstellen möchte, dass sie alle Kunden- und regulatorischen Anforderungen konsequent erfüllt.
EN ISO 13485:2016/AC:2016は、医療機器の品質管理システムに関する要求事項を詳細に規定しており、その目的は、医療機器および関連サービスが顧客の要求を満たし、適用される規制要件に常に応える能力を組織が示すことです。この規格は、設計開発、製造、保管、流通、設置、サポートサービスなど、製品のライフサイクルのあらゆる段階に関与する組織に適用されます。また、ISO 13485:2016は、これらの組織に品質管理システムに関連するサービスを提供する供給者や外部パートナーにも適用可能です。 この規格の強みは、サイズや種類に関係なく、すべての組織に適用できることです。医療機器に適用される要求事項は、組織が提供する関連サービスにも同様に適用されるため、包括的な管理が可能です。さらに、組織が実施しないが必要なプロセスについては、そのプロセスを監視、維持、管理する責任が組織にあります。これにより、品質管理システムが確実に機能することが保証されます。 また、規制要件が設計開発の管理を除外することを許可する場合、その除外を正当化することができ、品質管理システムにおいても異なるアプローチを考慮することができます。組織は、ISO 13485:2016への準拠を主張する場合、設計開発管理の除外を反映させる責任があります。 加えて、ISO 13485:2016の第6、7、8条の要求が組織の活動や医療機器の性質によって適用できない場合、その要求を品質管理システムに含める必要はありません。そのために適用不可を記録することが規定されており、組織は明確な理由を持って対応できます。 総じて、EN ISO 13485:2016/AC:2016は、医療機器の製造及び関連サービスを行うための明確なフレームワークを提供し、組織が品質管理システムを効率的に構築し、維持する助けとなります。規格の要求事項を遵守することで、法律的な要求と顧客からの信頼を同時に獲得することができ、競争力のある市場環境においても重要な役割を果たします。
Le document standard SIST EN ISO 13485:2016/AC:2017 présente un ensemble de normes rigoureuses pour les systèmes de gestion de la qualité des dispositifs médicaux, établissant des exigences précises afin de garantir que les organisations peuvent fournir des produits et services conformes aux attentes des clients ainsi qu'aux exigences réglementaires applicables. Le champ d'application d'ISO 13485:2016 est particulièrement vaste, couvrant tous les aspects du cycle de vie d'un dispositif médical, allant de la conception et du développement à la production, le stockage, la distribution, l'installation et le service après-vente. Cela en fait une référence essentielle pour toute organisation impliquée dans la création ou la fourniture de dispositifs médicaux ou de services associés, y compris le support technique. La norme est pertinente pour toutes les tailles et types d'organisations, renforçant son applicabilité dans divers contextes. Parmi les points forts de cette norme, on y trouve la clarté et la flexibilité des exigences. En effet, ISO 13485:2016 permet des exclusions des contrôles de conception et de développement lorsque la réglementation applicable le permet, ce qui offre une certaine souplesse aux organisations dans l’adaptation de leur système de gestion de la qualité. Cette démarche flexible contribue à une mise en œuvre plus efficace de la norme dans des environnements variés. De plus, la norme insiste sur la responsabilité des organisations en matière de contrôle des processus, même lorsque certaines activités ne sont pas exécutées en interne. Cela garantit que la surveillance et le maintien des processus respectent les standards énoncés, promouvant ainsi un haut niveau de qualité dans tous les aspects opérationnels. Les exigences liées aux clauses 6, 7 et 8 de ISO 13485:2016, qui traitent des aspects critiques du système de gestion, renforcent encore l’importance de la documentation et de la justification des exclusions, favorisant ainsi la transparence et la responsabilité au sein des organisations. En somme, le standard SIST EN ISO 13485:2016/AC:2017 est essentiel pour garantir que les dispositifs médicaux fournis par les organisations respectent les exigences élevées de qualité et de conformité réglementaire. Sa structure et sa flexibilité en font un outil adapté aux besoins actuels du secteur, tout en permettant aux organisations de documenter et de justifier leurs processus qualité de manière rigoureuse.
The document EN ISO 13485:2016/AC:2016 presents an important standard for medical devices, emphasizing the creation and maintenance of quality management systems that comply with regulatory requirements. The scope of this standard is comprehensive, outlining the necessary provisions for organizations involved in various aspects of the medical device life cycle. This includes not only the design and development stages but also production, storage, distribution, installation, and servicing. One of the notable strengths of ISO 13485:2016 is its applicability to organizations of all sizes and types, highlighting its versatility in the medical device sector. A critical aspect of the ISO 13485:2016 standard is the requirement for organizations to demonstrate their ability to provide medical devices and related services that consistently meet both customer and regulatory needs. This focus on quality assurance ensures that all processes, even those not performed internally, are monitored and controlled effectively, thereby fostering accountability within the quality management system. Furthermore, the standard addresses the flexibility organizations have regarding design and development controls, allowing them to exclude certain requirements when justified by applicable regulatory mandates. This adaptability is crucial as it enables organizations to tailor their quality management systems to their specific circumstances without compromising compliance. ISO 13485:2016 also clearly stipulates that organizations must document any exclusions or not applicable clauses, enhancing transparency and regulatory compliance. This requirement for justification reinforces the integrity of the quality management system while providing a structured approach to managing exceptions. Overall, EN ISO 13485:2016/AC:2016 stands out because of its relevance to the medical device industry, its comprehensive scope, and the strength it provides organizations in ensuring that they meet regulatory standards consistently. Its focus on accountability, flexibility in requirements, and the necessity for thorough documentation make it an essential standard for organizations aiming to enhance their quality management practices in the medical field.
SIST EN ISO 13485:2016/AC:2017은 의료기기 및 관련 서비스의 품질 관리 시스템에 대한 요구 사항을 명확히 규명한 문서입니다. 이 표준은 의료기기 제조업체와 서비스 제공자가 고객 및 규제 요구 사항을 지속적으로 충족할 수 있는 능력을 입증해야 하는 품질 관리 시스템의 원칙을 강조합니다. ISO 13485:2016의 범위는 제품의 설계 및 개발, 생산, 저장 및 유통, 설치, 유지보수 등 의료기기의 전체 생애 주기 관리에 적용됩니다. 이러한 포괄적인 접근은 조직이 각 단계에서 필요한 품질 관리를 확립하도록 돕습니다. 또한, 이 표준은 의료기기와 관련된 서비스의 제공에도 적용되므로, 종합적인 품질 관리가 이루어질 수 있도록 안내합니다. ISO 13485:2016의 강점은 다양한 조직의 규모와 유형에 적용 가능하다는 점입니다. 따라서 중소기업은 물론 대기업까지 폭넓게 활용할 수 있습니다. 이는 품질 관리 시스템이 모든 조직에서 필수적으로 구현되어야 함을 강조하는 중요한 요소입니다. 또한, 이 표준은 외부 공급자나 서비스를 제공하는 당사자에게도 적용될 수 있어, 협력업체와의 품질 관리 시스템의 일관성을 유지하는 데 기여합니다. 특히, ISO 13485:2016은 조직이 수행하지 않는 프로세스에 대해서도 책임을 지며, 이러한 프로세스의 모니터링, 유지 및 관리 방안을 마련하도록 요구합니다. 이는 조직의 전체 품질 관리 시스템의 신뢰성을 높이는 데 중요한 역할을 합니다. 또한, 규제 요구 사항에 따라 설계 및 개발 통제를 제외할 수 있는 가능성에 대한 언급은 ISO 13485:2016의 유연성을 잘 보여줍니다. 이는 특정 환경에 맞춘 품질 관리 시스템의 수립에 있어 규제 준수를 통한 대안적 접근 방식을 제시합니다. 결론적으로, SIST EN ISO 13485:2016/AC:2017는 의료기기 분야에서 품질 관리 시스템의 표준을 설정하고, 조직들이 규제 요구 사항을 충족하면서도 고품질의 의료기기를 제공할 수 있도록 하는 매우 중요한 문서입니다.
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