重たいQMS

重たいQMSについて

医療機器の製造・販売に関してはISO-13485を基本としなければならない。
筆者はISO-13485に準拠したQMSのひな形を開発し、販売およびコンサルテーションを実施している。
しかしである。いったん制定したQMSがクライアント企業によって改変されるたびにQMSが複雑かつ書類の数が増えてしまう傾向にある。
いわゆる“重たいQMS”になってしまうのである。
その原因は色々あると思われるが、医療機器の専業メーカーではない場合、もともとISO-9001に従ってQMSが構築されているケースが多い。
ISO-9001は、製造業だけではなくサービス業にも適用ができる品質マネジメント規格である。
その目的は、顧客満足度の向上のため日々プロセスを改善することである。
したがって、ISO-9001ではプロセスにフォーカスしている。
一方で、ISO-13485は医療機器の安全性を担保するため、顧客要求を満たすことに加えて、規制要件等を遵守することを要求している。
医療機器は安全でなければならない。
つまりISO-13485は結果主義である。
ISO-9001のようにプロセスを事細かに定義する必要まではない。
製品が安全であることを証明できれば良い訳である。
例えば、ISO-13485は「設計」ではなく「設計管理(Design Control)」を要求している。
多くの企業では、「設計」に関してはプロフェッショナルであっても、「設計管理」が出来ていない。
特に設計審査(Design Review)が重要である。設計審査によってスキルのある要員が徹底的にレビュし、医療機器の安全性を担保しなければならない。
医療機器企業はISO-9001を適用してプロセスを詳細に定義する必要はない。
ISO-9001とISO-13485の違いを理解し、要求に実直に従ったQMS構築が重要である。
“重たいQMS”にするのではなく“有効なQMS”の構築が望まれる。

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