Project Description

ISO 13485 Medical Devices QMS Certification | 醫療器械品質管理體系認證

The rapid development of the DQS competence center for medical devices continued in 2008. By now more than 1,200 customers have been certified by DQS according to the various standards of this business sector; and with its excellent service DQS continues to support them anywhere in the world. This growth is also a result of increasing international requirements. Therefore we will support you while entering new worldwide markets for manufacturers of medical devices.

The increasing internationalization is both for us and our customers challenge and great opportunity at the same time. These are the services that we already offer to our customers worldwide.

ISO 13485:2016 is released by ISO to replace ISO 13485:2003. The new standard has taken in account the medical devices related regulations in primary markets, which will facilitate the implementation of MDSAP in the world.

ISO 14971 provides a generic risk-management framework, from design and development through production and post-production activities, which can be applied in a QMS based on ISO 13485. ISO 14971:2019 has been published with aim to replace ISO 14971:2007.

Primary Changes to ISO 14971:2019

New or updated definitions:

  • “Benefit”: “Positive impact or desirable outcome of the use of a medical device in the health of an individual, or a positive impact on patient management or public health.”
  • “Reasonably foreseeable misuse”: “Use of a product or system in a way not intended by the manufacturer, but which can result from readily predictable human behavior.”
  • “State of the art”: “Developed state of technical capability at a given time as regards products, processes, and services, based on the relevant consolidated findings of science, technology, and experience.”
  • Minor wording changes to some definitions in ISO 14971:2007—such as those for “harm,” “manufacturer,” “user error,” and “in vitro diagnostic medical device.

Risk management process steps in ISO 14971:2019

  • Risk management plan.
  • Risk assessment.
  • Risk control.
  • Evaluation of overall residual risk.
  • Risk management review.
  • Production and post-production activities.

Some other changes to the standard clauses:

  • Section 4.4.  A method to evaluate the overall risk and the criteria for acceptability of the overall risk shall be included.
  • Section 5.2.  Document reasonably foreseeable misuse.
  • Section 5.4.  Hazardous situations to be considered and documented.
  • Section 8.  Disclosure of residual risk statement.
  • Section 9.  Manufacturers shall determine when subsequent reviews of the risk management plan’s execution need to be performed and when the risk management report needs to be updated.
  • Section 10.2.  Review for possible relevance to safety and includes changes in general state of the art.
  • Section 10.3 .  Separates the actions into particular medical devices and risk processes; adds consideration of devices already on the market.

ISO 13485是全世界醫療設備行業最廣泛接受的品質系統,並迅速成為進入此行業供應鏈的通行證之一。此標準是依照 ISO 9001基礎框架,另外根據醫療設備行業特點增加相關特別要求。ISO 13485 對產品設計、開發、採購、生產、運输、安裝和服務等過程制定全面的要求,並強調產品相關風險的管理。遵循此標準的醫療設備製造商表示其已建立品質保證體系以保障公眾的安全,實施 ISO 13485 亦可增加公司的信譽,贏得客戶、醫療工作者和終端使用戶的信任。

不少發達國家都強制或推薦醫療設備產品生產者符合 ISO 13485 或類似體系標準的要求。相應地,多數大型醫療設備產品製造商都對供應商提出了 ISO 13485 的第三方認證要求。

國際標準化組織發佈了用來代替ISO 13485:2003 的ISO 13485:2016。此標準考慮了多個主要市場的醫療設備相關法規,可以促進醫療設備單一審核方案在全球的實施。

Related Training Courses | 相關培訓課程

The courses include ISO 13485 Internal Auditor, Standard Understanding, ISO 14971 Understanding, etc.
課程包括ISO 13485內審員、標準理解、ISO 14971理解、等。

Related Important Posts | 相關重要發佈

[2020.03.03] 香港的本地口罩生產資助計劃

[2020.02.17] 醫用口罩的標準和質量管理體系要求

[2020.02.03] FDA Prematket Notification for Surgical Masks

[2016.03.10] Release of ISO 13485:2016 新版標準

[2017.03.02] MDSAP for Medical Devices

[2017.03.06] MDR & IVDR for Medical Devices to EU

Benefits | 益處

  • Comply to statutory and regulatory requirements 符合法律法規的要求
  • Risk Management 管理風險
  • Prevent errors instead of correcting them 以預防錯誤的觀念取代修正錯誤的想法
  • Enchance customer trust and satisfaction 贏得客戶信賴
  • Save time and operating costs 節省成本與時間

Why DQS? | 為什麼選擇 DQS?

  • DQS is a Notified Body recognized by EU to provide CE Marking Approval service for medical devices
    DQS 是歐盟認可的少數授權公告組織之一,可以爲醫療設備提供 CE 標誌審批服務
  • DQS is one of the few Audit Organizations (A.O.) to provide MDSAP service
    DQS 是少數可以提供醫療設備單一審核方案服務的認證機構之一


Related News 相關新聞:


May 7th, 2020|Comments Off on 醫療器械的CE標誌

This news in Chinese is for local readers about CE Marking for medical devices to EU. 根據歐盟醫療器械法規MRD或MDD的要求,出口至歐洲的醫療器械產品需要有CE標誌 (CE Marking)。取得CE標識的主要步驟如下: 確定途徑 根據MDD或其後的MDR的要求,取得CE標誌的途徑包括: 一種是生產企業的自我申明,此途徑只適用於部分低風險的醫療器械,例如屬於第I類的非滅菌、非重複使用、和無測量功能的醫療器械; 另一種是由根據相關指令需要公告機構 [...]