ISO13485:2016とQMSR（案）との差異

https://youtu.be/TFD50pzs3h0

現行のPart 820の要求事項は、全体としてISO 13485:2016の要求事項と実質的に同じである。そのため、QMSRではQSRの要求事項の大多数を削除し、ISO 13485:2016を受け入れることとしている。
ISO 13485:2016とQSRに差異があり、QSRの要求事項を残す部分に関しては、QMSRの「§820.35 記録の管理」、「§820.45機器のラベリングおよび包装の管理」に当該要求事項の規定が設けられている。
また、QMSRではISO 13485:2016に対して追加での用語の定義（「§820.3 用語の意味」）、および概念の明確化（「§820.15 概念の明確化」）も行っている。
さらに、 QMSRでは「§820.10 品質マネジメントシステムの要求事項」においてQMSR（Part 820）以外の米国独自の要求事項の遵守を要求している。QMSRがISO 13485:2016の要求事項自体を変更することは行っていない。13485:2016の要求事項はそのまま受け入れ、FDA独自の要求事項を追加する形をとっている。

現行QSRISO13485:2016QMSR（案）
サブパートAー総則1. 適用範囲 4. 品質マネジメントシステムISO13485:2016を受入
（要求事項は実質的に類似） 用語の定義に差異あり。（「§820.3 用語の意味」）
サブパートBー品質システム要求事項4. 品質管理システム 5. 経営者の責任 6. 資源の運用管理 8. 測定、分析、および改善ISO13485:2016を受入
（要求事項は実質的に類似）
サブパートCー設計管理7. 製品実現ISO13485:2016を受入
（要求事項は実質的に類似）
サブパートDー文書管理4. 品質マネジメントシステム「§820.35記録の管理」で
差異に対処
サブパートEー購買管理7. 製品実現ISO13485:2016を受入
（要求事項は実質的に類似）
サブパートFー識別およびトレーサビリティ7. 製品実現ISO13485:2016を受入
（要求事項は実質的に類似）
サブパートGー製造および工程の管理4. 品質マネジメントシステム 6.  資源の運用管理 7. 製品実現ISO13485:2016を受入
（要求事項は実質的に類似）
サブパートHー受入れ活動7. 製品実現 8. 測定、分析、および改善ISO13485:2016を受入
（要求事項は実質的に類似）
サブパートIー不適合品8. 測定、分析、および改善ISO13485:2016を受入
（要求事項は実質的に類似）
サブパートJー是正処置および予防処置8. 測定、分析、および改善ISO13485:2016を受入
（要求事項は実質的に類似）
サブパートKー包装およびラベリングの管理7. 製品実現「§820.45機器のラベリングおよび包装の管理」で差異に対処
サブパートLー取扱い、保管、流通、および据付け7. 製品実現ISO13485:2016を受入
（要求事項は実質的に類似）
サブパートM ー記録4. 品質マネジメントシステム「§820.35記録の管理」で
差異に対処
サブパートN ー付帯サービス7. 製品実現「§820.35記録の管理」で
差異に対処
サブパートO ー統計的手法7. 製品実現 8. 測定、分析、および改善ISO13485:2016を受入
（要求事項は実質的に類似）
N/AN/A「§820.10 品質マネジメントシステムの要求事項」でQMSR（Part 820）以外の米国の要求事項（Part 803、806等）の遵守を要求

関連商品

[blogcard url=”https://ecompliance.co.jp/SHOP/O094.html” title=”【VOD】QMSRセミナー (Quality Management System Regulation)”
content=”2022年2月23日、FDAは現行のQSR（品質システム規制：21CFR Part 820 Quality System Regulations）をISO 13485:2016に整合させる改正案を公表しました。
QSRは1996年10月7日に現行の規則が発効されて以降、20年以上に渡り米国における医療機器品質システム規制として機能してきたものです。
これまでの間、QSRは軽微な修正はあったものの、改定は一度も実施されてきませんでした。

FDAがQSRによる規制を実施する一方で、品質システム規制に対する当局の期待は時代とともに変化し続けてきました。
日本や欧州、カナダといった多くの国の規制当局は、医療機器の品質システムに関するマネジメント規格であるISO 13485を品質システム規制として取り入れています。
FDAも、他国の規制当局との調和の利点を認識しており、MDSAPへの参加等、規制のハーモナイゼーション活動に取り組んできました。
そして今般、医療機器品質システム規制の国際整合を目指し、QSRのISO13485:2016への調和を目指すこととなりました。

QSRをISO 13485:2016と整合させる規制は「Quality Management System Regulations / QMSR」（品質マネジメントシステム規制）と呼ばれます。
QMSRはISO 13485:2016の要求事項を組み込むことにより、ISO 13485:2016と多くの要求を整合さる予定です。
その一方で、苦情ファイル等の記録の保持に関してISO 13485:2016に追加的要求事項を上乗せしています。

本セミナーでは、QMSRにおける改正点のみではなく、QMSR全般について詳しくわかりやすく解説します。
また、QMSRの要求事項およびISO 13485:2016との差異、QMSRの要求事項を満たすQMS構築について解説します。”]

[blogcard url=”https://ecompliance.co.jp/SHOP/EL-114.html” title=”【セミナービデオ】QMSRセミナー (Quality Management System Regulation)” content=”2022年2月23日、FDAは現行のQSR（品質システム規制：21CFR Part 820 Quality System Regulations）をISO 13485:2016に整合させる改正案を公表しました。
QSRは1996年10月7日に現行の規則が発効されて以降、20年以上に渡り米国における医療機器品質システム規制として機能してきたものです。
これまでの間、QSRは軽微な修正はあったものの、改定は一度も実施されてきませんでした。

FDAがQSRによる規制を実施する一方で、品質システム規制に対する当局の期待は時代とともに変化し続けてきました。
日本や欧州、カナダといった多くの国の規制当局は、医療機器の品質システムに関するマネジメント規格であるISO 13485を品質システム規制として取り入れています。
FDAも、他国の規制当局との調和の利点を認識しており、MDSAPへの参加等、規制のハーモナイゼーション活動に取り組んできました。
そして今般、医療機器品質システム規制の国際整合を目指し、QSRのISO13485:2016への調和を目指すこととなりました。

QSRをISO 13485:2016と整合させる規制は「Quality Management System Regulations / QMSR」（品質マネジメントシステム規制）と呼ばれます。
QMSRはISO 13485:2016の要求事項を組み込むことにより、ISO 13485:2016と多くの要求を整合さる予定です。
その一方で、苦情ファイル等の記録の保持に関してISO 13485:2016に追加的要求事項を上乗せしています。

本セミナーでは、QMSRにおける改正点のみではなく、QMSR全般について詳しくわかりやすく解説します。
また、QMSRの要求事項およびISO 13485:2016との差異、QMSRの要求事項を満たすQMS構築について解説します。”]

[blogcard url=”https://ecompliance.co.jp/SHOP/MD-QMS-101.html” title=”ISO-13485:2016対応】品質マニュアル”
content=”ISO-13485:2016に沿った形の品質マニュアル（ひな形）です。
多くの医療機器企業では、ISO-9001やISO-13485に沿った品質マニュアルを作成していますが、ISO-13485認証審査対応のためには、QSR（品質システム規則：21 CFR 820）に従った品質マニュアルを作成し、説明しなければなりません。

これから作成する医療機器企業様およびISO-13485認証審査を予定している企業様、認証機関から改善指示を受けた企業様向けに、サンプルをご用意いたしました。
MS-Word形式ですので、貴社でご自由に加筆・修正を行っていただけます。”]

[blogcard url=”https://xn--2lwu4a.jp/qms-md/” title=”QMS（手順書）ひな形　医療機器関連販売” ]

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