- QMS調査における ISO 13485 の改訂の取扱いについて
- QMS省令とISO-13485:2016の比較
- FDA QSRとISO-13485:2016の比較
- QMS省令とISO-13485の用語の比較
はじめに
医療機器の品質管理システムの国際規格であるISO-13485:2016が発行された。
ISO-13485:2003年版から12年ぶりの改定となる。
2015年12月29日までFDIS（Final Draft International）に対する投票が行われ、可決された。
ISO-13485:2016は、FDAの強い要請により、FDAのQSRに近いものとなった。
医療機器は、医薬品と異なり、設計管理が非常に重要である。医薬品の不具合のほとんどは製造工程にある。例えば不純物が混入していたとか、規格外の製品（OOS）が製造されたとか、錠剤が欠けていたなどである。しかしながら医療機器の場合、たとえ出図された設計図面の通りに適切に製造したとしても、そもそも設計が間違っていれば安全な医療機器にはならないのである。そこで、FDAは設計管理を重要視している。
ISO-13485:2016においては、品質マネジメントシステムのPDCAサイクルを回す上で欠けていた事項が補足された。
また、製造業者の役割が明確化された。
多くのプロセスで「リスクマネジメント」が要求されている。さらに、多くのプロセスで統計的手法が要求されている。
ISO-13485:2016は、2015年に改定されたISO-9001：2015とは整合していない。
かつては、品質管理システムの国際規格であるISO-9001の医療機器版としてISO-13485が作成されたが、今ではそれぞれ必ずしも整合させることなく、改定が行われた。
筆者はしばしば、ISO-9001とISO-13485は何が違うかということを質問されることがある。答えは明確である。ISO-9001は任意の規格であるのに対して、ISO-13485はもはや規制要件である。なぜならば各国の規制当局がレビュするからである。
ISO-9001:2008においては、製造業のみならず、サービス業にも適用できるような改定が実施されたことが特徴的である。
ISO 9001:2015の構造が大きく変わったため、Annex Aにおいて、ISO 13485:2003とISO FDIS 13485:2015の対比（ISO13485:2003から変更点の説明）をしている。
また、Annex Bにおいては、ISO 9001 :2015とISO FDIS 13485との対比を両方向から項目単位で行っている。
ISO 13485 改定の経緯
2011年4月のISO/TC 210 WG1会議（米国 Malvern/Siemens社）において、IWG1でISO 13485の改定を決定した。 そこでNWIP（新作業提案）が作成された。
また、2013年9月 WG1 リヨン会議と2013年 10月 WG1 ミネアポリス会議において、CD（Comittee Draft）のコメントが審議され、DIS（Draft International）版が作成された。2014年2月～7月にDIS版に対する投票が実施された。
しかしながら、米国、 日本、 英国、 オーストラリア、ベルギー、カナダ、ドイツ、オランダ、スペインの9ヶ国が反対投票し否決された。 日本、EU、カナダは、同時期に改定作業が進められていたISO-9001との整合性に問題があるとして反対した。 一方、米国は、DIS版がEU寄りであることから反対した。つまりFDA QSRとの整合性について問題視したのである。
2014年9月 WG1会議およびISO/TC 210総会（ストックホルム）において、DISの改訂を決議し、DIS第二版を作成した。
2015年2月～5月にISO DIS2 13485に対する 投票が実施された。投票結果は可決され、FDISに進むことが確定した。
2015年6月 WG1デンバー会議と2015年8月 WG1英国Wokingham会議を経て、DIS第二版のコメントの審議が行われ、FDISが完成した。
2015年10月29日にISO FDIS 13485が発行され、同日投票が開始された。投票は2ヶ月間実施され、2015年12月29日に締め切られた。その結果、賛成多数により、可決された。
移行期間について（移行期間満了）
ISO13485:2003からの認証の移行期間はISO-9001と同様で3年間である。改定後3年間は、旧版（ISO13485:2003）での認証が有効である。
また、改定後2年間は、旧版（ISO13485:2003）での認証が可能である。
改定後2年たってから3年までの期間は新版（ISO 13485:2016）でのみ新たな認証が可能である。
ISO-13485:2016の要点
下記の表において、改定版の目次を掲載する。赤字になっている箇条が追加または変更されたものである。
| 0 序文 0.1 一般 0.2 概念の明確化 0.3 プロセスアプローチ 0.4 ISO 9001との関係 0.5 他のマネジメントシステムとの両立性 1 適用範囲 2 引用規格 3 用語および定義 3.1 通知書 3.2 指定代理人 3.3 臨床評価 3.4 苦情 3.5 ディストリビュータ 3.6 埋込み医療機器 3.7 輸入業者 3.8 ラベリング 3.9 ライフサイクル 3.10 製造業者 3.11 医療機器 3.12 医療機器ファミリ 3.13 性能評価 3.14 市販後監視 3.15 購買製品 3.16 リスク 3.17 リスクマネジメント 3.18 無菌バリアシステム 3.19 滅菌医療機器 4 品質マネジメントシステム 4.1 一般要求事項 4.2 文書化に関する要求事項 4.2.1 一般 4.2.2 品質マニュアル 4.2.3 医療機器ファイル 4.2.4 文書管理 4.2.5 記録の管理 5 経営者の責任 5.1 経営者のコミットメント 5.2 顧客重視 5.3 品質方針 5.4 計画 5.4.1 品質目標 5.4.2 品質マネジメントシステム 5.5 責任および権限およびコミュニケーション 5.5.1 責任および権限 5.5.2 管理責任者 5.5.3 内部コミュニケーション 5.6 マネジメントレビュ 5.6.1 一般 5.6.2 マネジメントレビュへのインプット 5.6.3 マネジメントレビュのアウトプット 6 資源の運営管理 6.1 資源の提供 6.2 人的資源 6.3 インフラストラクチャー 6.4 作業環境および汚染管理 6.4.1 作業環境 6.4.2 汚染管理 | 7 製品実現 7.1 製品実現の計画 7.2 顧客関連のプロセス 7.2.1 製品に関連する要求事項の明確化 7.2.2 製品に関連する要求事項のレビュ 7.2.3 コミュニケーション 7.3 設計・開発 7.3.1 一般 7.3.2 設計・開発の計画 7.3.3 設計・開発へのインプット 7.3.4 設計・開発からのアウトプット 7.3.5 設計・開発レビュ 7.3.6 設計・開発の検証 7.3.7 設計・開発のバリデーション 7.3.8 設計・開発の移管 7.3.9 設計・開発の変更管理 7.3.10 設計・開発ファイル 7.4 購買 7.4.1 購買プロセス 7.4.2 購買情報 7.4.3 購買製品の検証 7.5 製造およびサービスの提供 7.5.1 製造およびサービス提供の管理 7.5.2 製品の清浄性 7.5.3 据付け活動 7.5.4 付帯サービス活動 7.5.5 滅菌医療機器に対する特別要求事項 7.5.6 製造およびサービス提供に関するプロセスバリデーション 7.5.7 滅菌および無菌バリアシステムのプロセスのバリデーションに対する特別要求事項 7.5.8 識別 7.5.9 トレーサビリティ 7.5.9.1 一般 7.8.9.2 埋込み医療機器に対する特別要求事項 7.5.10 顧客の所有物 7.5.11 製品の保存 7.6 監視機器および測定機器の管理 8 測定、分析および改善 8.1 一般 8.2 監視および測定 8.2.1 フィードバック 8.2.2 苦情処理 8.2.3 規制当局への報告 8.2.4 内部監査 8.2.5 プロセスの監視および測定 8.2.6 製品の監視および測定 8.3 不適合製品の管理 8.3.1 一般 8.3.2 引き渡し前の不適合製品における処置 8.3.3 引き渡し後に発見された不適合製品における処置 8.3.4 手直し 8.4 データの分析 8.5 改善 8.5.1 一般 8.5.2 是正処置 8.5.3 予防処置 附属書A（参考） ISO 13485:2003とISO 13485：1996との比較 附属書B（参考） ISO 13485:2003とISO 9001：2000の相違に関する説明 参考文献 解説 |
QMS要求事項の明確化
ISO-13485改定の主な目的は、QMS要求事項の明確化である。QMSはPDCAを基本としているが、これまでの内容ではPDCAにおける重要なタスクが完全ではなかった。そこを補っている。
規格の構造
今年9/15にISO-9001が改定された。しかしながら、ISO-13485は、ISO-9001:2015には追従せず、ISO-9001:2008に整合させている。
改定版では、マネジメントシステムの共通のMSS（Management System Standard）要求仕様であるAnnex SLに従わず、従来の構造のままである。
ISO-9001が、今後Annex SLのMSSに従った改定を行った後に、ISO-9001に合わせる方向で、再度Annex SLに従う構造への改定を行うとのことである。
用語の定義の明確化
旧版に比べて、改定版では多くの用語の定義が記載されており充実した。また、それら定義の国際整合にも配慮している。例えば「医療機器」の定義などは、GHTFの定義の変更に合わせた。
ただし、ISO-9001:2008において、「リスク」の定義がISO-31000に整合させ、「諸目的に対する不確かさの影響（effect of uncertainty on objectives）」と変更になったのに対し、ISO-13485は従来通りISO-14971の定義を引用し、「危害の発生確率 とその危害の重大さとの組合せ」としている。
これは、ISO-9001は、製造業のみならず、サービス業を含めあらゆる業種に対応する必要があるためである。しかしながら、ISO-13485やISO-14971においては、この「リスク」の定義は受け入れがたいものである。
用語の定義で特に変更が大きいものは「苦情」であろう。旧版においては、「顧客苦情」と題されていたが、改定版における「苦情」は、顧客のみならず、製造工程からの情報や付帯サービス（サービスマンのサービスレポート等）などの情報も含まれることになった。QSRの定義に近いものとなったわけである。
また、製造業者、ディストリビュータ、インポーター（輸入業者）の区別が明確化された。
特に「製造業者」は、GHTF/SG1/N055:2009 定義 5.1を参照し、明確に定義されている。
さらに改定版においては、医療機器の「ライフサイクル」全般を対象とすることとなり、GVP省令やMDRに代表される「市販後監視」についても定義がなされている。
「無菌バリアシステム」という新しい用語も定義された。
また「4.2.4 文書管理」において、「文書」には「文書」および「記録」が含まれることが明確化された。
「リスク」「ライフサイクル」「規制当局」といった用語は、条文中に頻回出現している。
明確な表現
ISO-13485に限らず、国際規格はインプリメントする組織毎に解釈が異ならないよう、明確でわかりやすく詳しい表現を心掛けている。
改定版では、あえて「修正」と「是正」を併記することによって、それらが異なる概念であることを明確化している。
筆者もしばしばコンサルテーションにおいて遭遇するが、「修正（Correction）」と「是正（Corrective Action）」を混同しているケースが多々見られる。
FDA QSRとの整合
改定版は、FDA QSRの要求事項にかなり近づいたといえる。QSRは1996年に作成されてから未だに一度も改定されていない。（細かな修正はある。）つまり、FDAは20年後の国際規格を先取りしていたといえる。
これは筆者の分析結果であるが、FDAの要求によってISO-13485に盛り込まれたものは以下の事項があると思われる。
文書化
これまでは、明確化するといった表現が多くみられたが、多くは文書化という記述に訂正されている。
医療機器ファイル
4章において「4.2.3 医療機器ファイル」という箇条が追加された。医療機器ファイルは、QSRにおける「DMR（Device Master Record）」のことである。しかしながら、本邦における「製品標準書」に相当するため、特に大きなインパクトはないと思われる。
設計・開発ファイル
設計・開発ファイルは、QSRにおけるDHF（Design History File）に相当する。当該医療機器の設計に関するあらゆる記録（設計変更を含む）を時系列で参照しやすくファイリングしておかなければならない。
設計移管
旧版では、設計・開発計画書のコンテンツとして記載があったのみであるが、「7.3.8 設計・開発の移管」として独立した箇条になった。なお、設計移管と量産移行を混同しているケースを多く見かけるが、これは間違いであるので注意すること。
統計的手法
品質に対する傾向分析などは、統計的手法によらなければならない。例えば、マネジメントレビュは1時間から2時間程度で実施されるのがもっぱらである。そんな短時間に、多くの資料をインプットとして見せられても経営者としては適正に判断し、指示事項を出すことが困難である。
また、プロセスバリデーションにおけるバッチサイズやスケールの妥当性についても統計的手法により証明することが求められている。
さらに「サービスレポート」も統計的手法の対象となった。
設計管理の充実
「設計管理」に対する要求事項が充実した。医療機器の安全性は何といっても適切な設計管理により担保される。
改定版では、設計管理に関して「文書化」が要求された。（従前は「明確化」）
また「設計・開発計画書」の遵守が求められた。「設計・開発計画書」は、自社のQMSに従って作成され、適宜更新しなければならない。また設計業務においては、「設計・開発計画書」に定義したとおりのリソースで、定義したとおりの成果物を作成しなければならない。万が一、「設計・開発計画書」と作成した成果物などの間に不整合があった場合には、指摘に及ぶことがあるだろう。
さらに、設計管理において「トレーサビリティ」や「力量」が追記された。
医療機器を設計する者は、相応の力量がなければならない。
スタッフの力量表を作成し、各部署の力量マップを作成しておくこと。
設計へのインプットに「ユーザビリティ」が追加された。これは、医療機器の使い勝手が悪いために事故につながる恐れがあるためである。従来のリスク分析に加えて、ユーザビリティにも配慮が必要である。
医療機器のネットワーク接続を想定して「インターフェース」が加えられた。昨今の医療機器は、単独で動作するもののみではなく、院内のLANなどに接続する場合も増えてきた。この場合、バリデーションを実施することは当然として、コンピュータウィルスやサイバーテロにも対応しなければならない。
設計検証、設計バリデーションにおいて、必要に応じて「統計的手法」が要求されている。
バリデーションの記録（「結果」）のみではなくバリデーション報告書（「結論」）の作成が求められた。これまでは、「記録書兼報告書」などという成果物も存在したが、今後は記録書と報告書は明確に区別して作成しなければならない。
前述のとおり、「設計・開発の移管」が要求された。
また「設計変更」が充実した。照査な要求事項が記載されており、文書及び記録の保存が求められている。
前述のとおり、「設計・開発ファイル」（FDAのDHFに相当）の作成が要求された。
ソフトウェアバリデーション
これまでは、製造設備におけるソフトウェアバリデーションのみ要求されてきたが、改定版では品質システムを管理するコンピュータシステムなどへ拡張された。
品質システムを管理するコンピュータには、イベント管理システム（例：MasterControl、Trackwise等）やドキュメント管理システム等が含まれる。
ただし、あくまでもリスクベースで対応するべきであり、過剰なコンプライアンスコストはかけるべきではない。
苦情処理の詳細化
旧版において、苦情処理が「製品受領者からの意見」と「改善」に含まれていたが、「8.2.2 苦情処理」において箇条を独立させた。
また、苦情処理に関する要求事項が詳細化された。なお、QSRにおいても苦情ファイルについて詳細な要求をしている。
「修正」と「是正処置」を明確に区別した。
サービスレポートからの情報も苦情処理の対象となった。
全ての苦情に対して原則「CAPA」を要求していたが、この条文は削除された。
全ての苦情について原則「調査の実施」を要求している。
順序の変更
読みやすく・理解しやすいように順序が多少変更になっている。
「供給者の管理」など、重要な事項を旧版よりは前の箇条に移動させている。また「7.5 製造およびサービスの提供」では、順序が変更になっている。
箇条の詳細化
指摘を出す際に、どの箇条に対するものかが明確になるように要求事項を細分化している。
例えば、マネジメントレビュへのインプットにおいて、「是正処置」と「予防処置」を箇条を分けて記載している。どちらに対する指摘かが明確になるようにするためである。
リスクベースドアプローチの採用
改定版では、いたるところに「リスクに応じて」という記載が見られる。つまり、品質保証にかける資源（ヒト、モノ、金、労力、時間等）は、当該製品のリスクに応じて適切であるように検討しなければならない。
リスクベースドアプローチは、2003年頃からFDAが提唱しているアプローチである。
患者やユーザの安全性を守るためには、規制要件を強化しなければならない。しかしながら、規制要件を強化しすぎると企業においてコンプライアンスコストがかかってしまう。このコストは製品の価格に反映され、医療費が高くなってしまう。つまり、これは規制当局にとってジレンマである。患者のために規制強化したとしても、医療費の高騰を招き、高額所得者しか救われない医療になってしまうのである。
そこで、医療機器企業はリスクに応じた適切な対応が要求されることになったのである。
識別
「7.5.8 識別」において、旧版では「識別」と「製品状態の識別」に分かれていたものが「識別」に統一された。
筆者はコンサルテーションを実施する中で、「識別」と「製品状態の識別」の違いについて明確に説明することが困難であった。やはり、改定版では、統一されている。
時系列別の不適合品管理
「8.3 不適合製品の管理」において、「引渡し前の不適合品における処置」と「引き渡し後に発見された不適合品のおける処置」に区分された。
また旧GQP省令と同様に「通知書」の発行が盛り込まれた。
是正処置・予防処置
CAPA（是正処置・予防処置）にタイムフレームが要求された。つまり、CAPAを起票してからクローズするまでの期限管理を要求している。
その他の新規要求事項
「4.2.5 記録の管理」において「健康機密情報の保護」が追加された。例えば、修理や返却された医療機器のメモリなどに患者の健康状態（検査結果など）に関するデータが記録されている場合などに配慮しなければならない。
「 6.4.2 汚染管理」が「作業環境」から独立した箇条となった。
「7.4.2 購買情報」において、契約書に「変更の事前通知」が要求された。昨今、サプライチェーンが国際化することによって、中国をはじめASEAN諸国から原材料を購買するケースが増えてきた。その際、コスト削減のため、事前予告なく（黙って）原材料を変更したり、製造方法を変更する供給業者が存在し、結果的に最終機器に欠陥が生じ、患者に危害を加えるリスクが高まった。そこで、該当する場合、契約書には「変更の事前通知」を明記しなければならないことになった。これもFDAからの強い要請があったものと思われる。
「顧客とのコミュニケーション」に加えて、「規制当局とのコミュニケーション」が追加された。
GDP（Good Distribution Practice：輸送のバリデーション）が含まれた。医療機器は、適切に製造したとしても、包材の不良や輸送時の振動などにより不具合を起こすことがある。したがって、輸送時における種々の配慮も求められる。
MDSAPとの関連
FDAなどは、MDSAP（Medical Device Single Audit Program：単一監査）を推進させようとしている。
そのため、MDSAPが実施しやすいように箇条が詳細化された。
また、旧版における多くの注記が本文（条文）に組み込まれた。これは、MDSAP実施に向けて各国毎の差異を最小限にしたものと思われる。
【留意事項】
本稿は、ISO FDIS 13485をもとに作成しております。
ISO 13485:2003およびISO FDIS 13485には著作権があります。
また記事の内容には筆者の考えが含まれております。あくまでも参考としてご利用ください。内容等の間違いにつきましては当社は一切の責任を負いません。
【参考文献】
「医療機器の品質マネジメントシステム規格 ISO FDIS 13485説明会 テキスト」 （一社）日本医療機器産業連合会
ISO13485:2016の早期見直しについて
通常、ISO規格は5年サイクルで見直しを実施するが、ISO13485:2016に関しては見直し期間の短縮を検討中。
- 見直し期間を3年とし、2019年2月に見直しを行う予定
- ISOのHLS（High Level Structure）との整合を図るため
- HLS:ISOの全てのマネジメント規格が遵守すべき上位の規格構造。ISO13485:2016は本構造に従っていない。
ISO13485:2016の早期見直しについて、Medical Device Single Audit Program （MDSAP） Regulatory Authority Council （RAC）は懸念を表明
- 医療機器企業にとって、2019年2月はISO13485:2016への移行期間の終わりであり、関係企業の新版への移行が完了する時期であること
- MDSAP Audit ModelはISO13485:2016をベースに作成されており、監査員のトレーニングも当該規格に基づいて行われていること
- 日本、米国等の規制当局がISO13485:2016に準拠した規制要件に移行しようとしていること
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