醫儀品質驗證系統
授課老師:陳世中
評分:
100 學年度第 1 學期 班級: 碩研電機二甲 學號: M9920133 學生姓名: 陳玉銘
作業次號 第 7
次
週
繳交日期
週次
第 11
主 講 人
主題
醫療器材優良製造規範
2011 年 11 月 24 日
鄭宗記
上課日期
2011 年 11 月 24 日
報告內容至少一頁(可自行延伸) 字體:中文標楷體 英文 Times New Roman 字體大小:12 列距:單行
內容重點(含圖、文、表)
Premarket：
Clinical Trials Regulation、Premarket Assessments、GMP Inspections
Postmarket：
Adverse Event Reporting、Compliance Testing、GMP Inspections、Recalls
質量管理體系-ISO 9000 的過程方法：
ISO 13485 的目的：
The main objective was to help foster efforts of international harmonization in medical regulatory
requirements for Quality Management Systems. ISO 13485:2003 by it self is not sufficient, but must be
complemented by specific requirements of local regulatory authorities.
ISO 13485 的主要結構：
1.Scope, 2.Normative reference, 3.Terms & definitions, 4.quality management system, 5.management
responsibility, 6.resource management, 7.product realization, 8.Measurement, analysis and improvement
Clause 5-4 規劃：
Quality objectives
– are established at relevant functions and levels within the organization.
– shall be measurable and consistent with the quality policy
Quality management system planning
– the planning is carried out in order to meet the requirements given in “General
requirements”(4.1), as well as the quality objectives, and
– integrity of the quality management system is maintained when changes to the quality
management system are planned and implemented.
Clause 7 Product realization：
Planning of product realization
- Customer-related processes
- Design and development (D&D)
- Purchasing
- Production and service provision
- Control of monitoring and measuring devices
Clause 7-1 Planning of product realization：
Determine the following:
– quality objectives and requirements for the product;
– the need to establish processes, documents, and provide resources specific to the product;
– required verification, validation, monitoring, inspection and test activities specific to the
product and the criteria for product acceptance;
– records needed to provide evidence that the realization processes and resulting product
fulfill requirements.
Clause 7-3 Design Control：
- General
- Design and development planning
- Organizational and technical interfaces
- Design input
- Design output
--------- Design Transfer ---------- Design review
- Design verification
- Design validation
- Design changes
Clause 7-3-6 Design & development validation：
• Clinical evaluation may be involved in the validation of the design of medical devices.
– The conduct of clinical investigations should conform to applicable regulations/standards.
• As part of design validation, the organization shall perform and maintain records of clinical
evaluations.
• Clinical evaluation may include
– a compilation of relevant scientific literature,
– historical evidence that similar designs and/or materials are clinically safe, or
– a clinical investigation or trial, to ensure that the device performs as intended.
• National or regional regulations may require actual clinical investigations or trials.
Clause 8-5 Improvement：
• General
– shall establish and maintain documented procedures for the issue of advisory notices for
medical devices.
– shall maintain records of all customer complaint investigations.
• When the investigation determines that the activities at remote premises
contributed to the customer complaint, relevant information shall be
communicated between the organization and the remote premises.
– If regulations require, the organization shall establish and maintain documented
procedures to notify the regulatory authority(ies) of those adverse events which meet the
reporting criteria.
Clause 8-5-2 Improvement(Corrective action)：
- Corrective & Preventive Action (CAPA)
• define requirements for
– reviewing nonconformities (including customer complaints),
– determining the causes of nonconformities,
– evaluating the need for action to ensure that nonconformities do not recur,
– determining and implementing action needed,
– records of the results of any investigation and of the actions taken (see 4.2.4), and
– reviewing corrective action taken and its effectiveness.
課後心得:及參考文獻
初步認識了醫療器材製造的規範與 ISO 13485 的目的。相信對往後在醫材方面有很大的幫助。
參考資料：演講者的講義(醫療器材優良製造規範.ppt)