組織とは

ISO-9001やISO-13485では「組織」という用語が使われている。
「組織」とは、同じQMS(Quality Management System:品質管理システム)で活動しているグループのことを指す。法人が同じか異なるかではないことに注意が必要である。

例えば、異業種から参入した医療機器企業などは、民生品はISO-9001を適用し、医療機器ではISO-13485を適用していることだろう。
この場合、同じ法人であっても、QMSが異なれば「組織」は異なる。
一方において、製造所が別法人であっても親会社と同じQMSで活動していれば、同じ「組織」である。

ISO-13485を適用している組織が、ISO-9001を適用している組織に業務を委託する場合は、同じ社内であってもアウトソース扱いとなる。
例えば医療機器製造に必要な部品を、本社の購買部門に依頼して調達してもらう場合などである。

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