前回に引き続きISO 14971:2019の改定について筆者の分析を紹介したい。
【経営者の責任】
注記に「リスクマネジメントプロセスの適合性レビュ」が追加された。
トップマネジメントは、リスクマネジメントプロセスの継続的な有効性を保証するために、あらかじめ計画された間隔でリスクマネジメントプロセスの適合性をレビュし、あらゆる決定および講じた措置を文書化しなければならない。
注）ISO 14971はQMSの構築を要求していない。もし製造業者がQMSを構築していれば、QMSのレビュの一環として実施しても良い。
【リスク分析】
リスク分析における「4.2 意図する医療機器（付属品を含む）の使用特質の明確化」が「5.2 意図された使用と合理的に予見可能な誤使用」と「5.3 安全性に関する特性の特定」に細分化された。
”合理的に予見可能な誤使用”が追加されたことが大きい。
【リスクコントロール】
リスクコントロールに「製造」「トレーニング」が追記された。
a）本質的に安全な設計と製造
b）医療機器自体または製造プロセスにおける保護対策
c）安全性に関する情報、および必要に応じてユーザーへのトレーニング
【リスクマネジメントファイル】
リスクマネジメントファイル（RMF）にトレーサビリティ要件が追記され、具体的になった。
RMFにおいては、各ハザードについて、次の活動に対してのトレーサビリティをもたなければならない。
・リスク分析
・リスク評価
・リスクコントロール手段の実施と検証
・残留リスクの評価の結果
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