経営者の責任

【連載】ISO-13485:2016対応の要点

【第3回】経営者の責任

なぜ経営者の責任が重要なのか

ISO-13485:2016の第5章では「経営者の責任」についての要求事項が記載されている。

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

ISO-9001:2015においても同様に品質管理・品質保証における経営者の責任を明記している。

では何故経営者の責任が重要なのであろうか。
これまで各企業では、ISOの認証を受けるために文書や記録の作成を実施してきた。
いつしかその目的が品質の向上ではなく、ISOの認証を受けることとなり、形骸化された文書や記録の作成のみに焦点が変わってしまったのである。
そのため、ISOをしゅとくしている企業であっても品質が一向に高くならないといった事態となってしまった。
これでは本末転倒である。

そこでISO-9001:2015においても、ISO-13485:2016においても経営者の責任により重きを置いている。
つまり、形骸化した文書作成や記録作成を行うのではなく、品質の向上といった目的に対してトップマネジメント(経営者)がコミットし、責任を負わなければならないということとなったのである。

多くの場合、経営者は経済的な利益や損失にのみ責任を負い、品質管理・品質保証に関しては無関心である。
これでは品質は一向に高くはならない。

コミットメントとは

コミットメントとは、「約束」のことである。
ただし、単なる約束ではなく、守れなかった場合具体的に責任をとるといった約束である。
最近、世間を騒がせている多くの品質問題があり、最終的には企業のトップが会見を開き引責辞任をするといった事態にまで及んでいる。
企業のトップは、品質問題に対する責任があるのである。

トップマネジメント(経営者)は、品質マネジメントシステムの構築および実施、並びにその有効性の維持に対するコミットメントの証拠を次の事項によって示さなければならない。

a)適用される規制要求事項を満たすことは当然のこととして、顧客要求事項を満たすことの重要性を組織内に周知する。
b)品質方針を設定する。
c)品質目標が設定されることを確実にする。
d)マネジメントレビュを実施する。
e)資源(リソース)が使用できることを確実にする

トップマネジメントは、適用される規制要求事項に合致するだけでなく、顧客要求事項が決定され、満たされていることを確実にしなければならない。

マネジメントレビュ(経営者による見直し)とは

ISOでは「レビュ」というキーワードが頻繁に登場する。
多くの企業では、「レビュ」を「確認」と訳していないであろうか。
実は「レビュ」を訳す際に2通りの日本語を当てなければならない。
ひとつは「審査・照査」であり、もうひとつは「見直し」である。

例えば「デザインレビュ」は「設計審査」と訳す。決して「設計確認」ではない。
一方で、「マネジメントレビュ」は「経営者による見直し」と訳さなければならない。

ISO-9000によると「レビュ」の定義は以下のとおりである。
「設定された目標を達成するための検討対象の適切性、妥当性、又は有効性の確定」

レビュは確認や単なる打合せ、ヒアリングではない。必ず指導する必要があるのである。
経営者や管理者の責任は「部下の育成にある」のである。

マネジメントレビュ

ISOでは、「経営者が自ら定めた品質方針や品質目標を、体系的に達成するための仕組み」として、引き続き機能しているかを“適切性、妥当性、有効性”に焦点を合わせてレビュすることを要求している。
マネジメントレビュにおいては以下を見直す。

1) QMSの改善および変更の必要性
2) 品質方針の変更の必要性
3) 品質目標の変更の必要性

また結論として次の事項に関する決定および処置を文書化しなければならない。

1) QMSおよびそのプロセスの有効性の維持のために必要な改善
2) 顧客要求事項に関わる製品の改善
3) QMSの妥当性および実効性の維持を確保するために必要な資源

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