2000年版ISO9000での文書化要求
				アメリカのコンサルタントの方が2000年版ISO9000(DIS)の規格文を詳細に調べて文書化が必要な要求事項を以下のようにまとめている。すでに強調しているように、新規格では文書の要求が単純化された。しかし、このように見てみると、現行規格と同じではないかとも受け取れる。いずれにしろ、このような「分析？」は、規格の理解にも、また監査員対策にも役立つ。
			OCUMENTATION EXPLICITLY REQUIRED(明白に要求されている文書化) 1) PROCEDURES REQUIRED ( second level documentatior ) - MANDATORY(強制されている) 5.5.6 DOCUMENT CONTROL: A documented procedure shall be established 5.5.7 CONTROL OF RECORDS:A documented procedure shal be establlished for.... 8.2.2 INTERNAL AUDITING: A documented procedure shall include responsabilities... 8.3 CONTROL OF NONCONFORMITY: These activities shall be defined 　　　　　　　　　　　　　　　　　　　　　　　　　　　in a documented procedure. 8.5.2 CORRECTIVE ACTION: The documented procedure for corrective action shall define requirements... 8.5.3 PREVENTIVE ACTION: The cocumented procedure for preventive action shall define... 2) GENERAL INSTRUCTIONS(一般的な文書) 4.1 The organization shall .... document.......a quality management system QMS )....... 4.2 The QMS documentation shall include: a) documented procedures required in this International Standard ( IS) - see list above b) documents required by the organization to ensure the effective operation and control of its process - So the organisation is free to propose the other required documents. (だから、企業は他の必要な文書を提案することは自由である。) 3) DOCUMENTS TO BE CONTROLLED(管理されるべき文書) 5.3 The qualiy policy shall be controlled ( see 5.5.6 ) 5.5.5 The quality manual shall be controlled 5.5.6 Documents defined as quality records shall be controlled ( see 5.5.7 ) 5.5.7 Records required for the QMS shall be controlled ( the same as above ) 4) ACTIONS TO BE DOCUMENTED ( How? Third level documentation? )(文書化されるべきアクション) 5.4.2 The output of the planning shall be documented. 7.1 Planning of the realization processes..........and shall be documented in a form suitable for the organization's method of operation. 7.3.2 Inputs relating to product requirements shall be defined and documented. 7.3.3 The outputs.....shall be documented. 7.3.4 The results of reviews...shall be recorded. 7.3.5 The results of the verification.......shall be recorded. 7.3.6 The results of the validation.....shall be recorded. 7.3.7 Design and development changes shall be.... documented. The results of the review changes...shall be documented. 7.4.1 The results of evaluations...shall be recorded. 8.2.4 Evidence of conformity with the acceptance criteria shall be documented. 5) QUALITY MANUAL(品質マニュアル) 5.5.5 A quality manual shall be established and maintained..... 6) RECORDS TO BE KEPT(保管されるべき記録) 6.2.2.e) Maintain appropriate records of education..... 7.2.2 The results of the review....shall be recorded. 7) DOCUMENTATION AMMENDMENT(文書の改訂) 7.2.2 Where the product requirements..........that relevant documentation is amended. 8) NEED FOR WORKING INSTRUCTIONS(作業指示書) 7.5.1 b) where necessary, the availability of work instructions.

|トップページ|