テクニカルレポートとは何か
ISOやIEC等の国際規格には” What” しか記載出来ない。その理由は”How”を書いてしまうとその通り実施していない場合、指摘となってしまうためである。
しかしながら”How” が記載されていない場合、具体的にどのように実施して良いのかが不明となる。
そこで、しばしば ISO や IEC では、テクニカルレポート（TR）と呼ばれる文書を発行する。
テクニカルレポートは、要求事項ではなく例または参照である。
従って、国際規格の要求事項を遵守するために参考にするものであって、必ずしもその通り実施しなければならないものではない。
つまりそれらの遵守は必須ではない。
テクニカルレポートの例
IEC/TR 80002-1『医療機器ソフトウェア－第1部：医療機器ソフトウェアへのISO 14971の適用の手引』は、IEC 62304 『医療機器ソフトウェア－ソフトウェアライフサイクルプロセス』が要求するリスクマネジメント（ISO 14971）に関するテクニカルレポートである。
ISO/TR 80002-2『医療機器ソフトウェア－第2部：医療機器の品質システムで使用するソフトウェアのバリデーション』は、ISO 13485:2016のソフトウェアバリデーション要求事項（箇条4.1.6、7.5.6、7.6）の実施方法を解説する規格である。
リスクマネジメントに関しては、ISO 14971:2007『医療機器－リスクマネジメントの医療機器への適用』がISO14971:2019に改定された際に、ISO/TR 24971『医療機器－ISO 14971適用の指針』が発行された。
ISO 14971:2007にはあった附属書（Annex）のうち、付属書C、F、JがISO/TR 24971に移動された。
つまりこれらの附属書は要求事項ではなく、参考といった位置付けになった。
関連商品
[blogcard url=”https://ecompliance.co.jp/SHOP/MD-QMS-154.html” title=”【JIS T 62366-1：2022対応】ユーザビリティエンジニアリング規程・手順書・様式”]
[blogcard url=”https://ecompliance.co.jp/SHOP/191121P.html” title=”医療機器企業におけるリスクマネジメントセミナー” content=”医療機器企業にとって、リスクを管理することは非常に重要です。しかしながら、リスクマネジメントは難解です。
医療機器業界では、欧州が先行し、90年代からIOS-14971が制定されました。
医療機器には何がしかのリスクが潜んでいます。リスク分析の結果は、設計管理のインプットとなります。
医療機器事故は、ユーザの意図した利用と設計者の思想のギャップによって起こるとされています。
昨今では、ユーザビリティを含め、合理的な誤使用を予測したリスク分析が求められています。
演者は多くの医療機器企業においてリスクマネジメントの指導を行ってきましたが、各社ともに我流で実施していることが多いようです。
それでは、医療機器の安全が確保できず、また回収（改修）も減少しません。
そのためには、リスクマネジメントの基本的な考え方と規制当局の期待を十分に理解しなければなりません。
本セミナービデオでは、難解なリスクマネジメントを初心者にもわかりやすく解説いたします。”]
[blogcard url=”https://ecompliance.co.jp/SHOP/EL-008.html” title=”【セミナービデオ】医療機器企業におけるリスクマネジメントセミナー” content=”医療機器企業にとって、リスクを管理することは非常に重要です。しかしながら、リスクマネジメントは難解です。
医療機器業界では、欧州が先行し、90年代からIOS-14971が制定されました。
医療機器には何がしかのリスクが潜んでいます。リスク分析の結果は、設計管理のインプットとなります。
医療機器事故は、ユーザの意図した利用と設計者の思想のギャップによって起こるとされています。
昨今では、ユーザビリティを含め、合理的な誤使用を予測したリスク分析が求められています。
演者は多くの医療機器企業においてリスクマネジメントの指導を行ってきましたが、各社ともに我流で実施していることが多いようです。
それでは、医療機器の安全が確保できず、また回収（改修）も減少しません。
そのためには、リスクマネジメントの基本的な考え方と規制当局の期待を十分に理解しなければなりません。
本セミナービデオでは、難解なリスクマネジメントを初心者にもわかりやすく解説いたします。”]
[blogcard url=”https://ecompliance.co.jp/SHOP/MD-QMS-026.html” title=”【ISO 14971:2019対応】リスクマネジメント規程・手順書・様式” content=”ISO14971:2019に沿った形のリスクマネジメント規程・手順書・様式です。
医療機器設計におけるリスク分析は、ISO-14971に従って実施されています。
リスクマネジメント実施のための手順や様式を整えておかなければなりません。”]
[blogcard url=https://xn--2lwu4a.jp/qms-md/ title=”QMS（手順書）ひな形 医療機器関連” ]
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