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ISO 13485:2016
Medical devices — Quality management systems — Requirements for regulatory purposes- 발행일 : 2016-02-25
- 발행기관 : ISO
상세정보
| 분야 | ISO/TC 210 : Quality management and corresponding general aspects for medical devices |
|---|---|
| 적용범위 | 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. |
| 국제분류(ICS)코드 |
03.100.70 : 관리시스템
11.040.01 : 일반 의료장비 |
| 페이지수 | 36 |
| Edition | 3 |
이력정보
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 13485:2016(REDLINE)상세보기 | Medical devices — Quality management systems — Requirements for regulatory purposes | 2016-02-25 | 표준 |
| 2 | ISO 13485:2016상세보기 | Medical devices — Quality management systems — Requirements for regulatory purposes | 2016-02-25 | 표준 |
| 3 | CSA ISO 13485:16 (R2021)상세보기 | Medical devices - Quality management systems - Requirements for regulatory purposes (Adopted ISO 13485:2016, third edition, 2016-03-01) | 2016-01-01 | 표준 |
| 4 | ISO 13485:2003/Cor 1:2009상세보기 | Medical devices — Quality management systems — Requirements for regulatory purposes — Technical Corrigendum 1 | 2009-07-17 | 구판 |
| 5 | ISO 13485:2003상세보기 | Medical devices — Quality management systems — Requirements for regulatory purposes | 2003-07-03 | 구판 |
| 6 | ISO 13485:1996상세보기 | Quality systems — Medical devices — Particular requirements for the application of ISO 9001 | 1996-12-26 | 구판 |
관련상품
- 관련상품이 존재하지 않습니다.
다른 사람이 함께 구입한 상품
- ISO 14971:2019 - Medical devices — Application of risk management to medical devices
- KS P ISO 13485 - 의료기기 — 품질경영시스템 — 규제 목적을 위한 요구사항
- ISO 10993-1:2018 - Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
- ISO/TR 24971:2020 - Medical devices — Guidance on the application of ISO 14971
- IEC 62366-1:2015+AMD1:2020 CSV - Medical devices - Part 1: Application of usability engineering to medical devices
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