Noitol は、保険市場向けの e ラーニング トレーニング マテリアルの設計と制作を専門とする組織です。開発部門の ISO 9001 監査中に、監査員は開発部門の責任者に、最終的なコース設計の検証に使用したプロセスについて質問しました。彼女は、通常は顧客にボランティアで製品を検証するよう依頼していると述べています。受け取ったフィードバックが重要な改善につながることが多いと彼女は言います。
監査人は、247 Insurance 組織の最近完了したコースの設計記録をサンプリングします。
設計検証は実施されましたが、検証レポートはありませんでした。開発責任者は、この顧客は製品を緊急に必要としていたため、検証段階は省略されたと述べています。尋ねたところ、責任者は、これは約 50% の確率で発生すると見積もっています。彼女は、常にフィードバックを求め、頻繁に変更を加えていることを確認しています。コースの設計ファイルにはフィードバックの記録がありません。
監査人は、トレーニング コースの設計プロセスをより詳細にレビューすることを決定します。
このプロセスに意味のある監査証跡を提供する 3 つのオプションを選択します。
正解：B,E,F
According to clause 8.3 of ISO 9001:2015, the organization should establish, implement, and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services. The design and development process should include the following activities:
*Determining the requirements for the products and services to be designed and developed, considering the intended use, the statutory and regulatory requirements, the customer and other relevant interested parties' needs and expectations, and the potential risks and opportunities.
*Defining the design and development objectives, stages, responsibilities, and authorities, and ensuring the availability of adequate resources and competence.
*Implementing design and development controls, such as reviews, verification, and validation, to ensure that the design and development outputs meet the design and development inputs, and to identify and resolve any problems or errors.
*Maintaining documented information on the design and development inputs, outputs, reviews, verification, validation, and changes, and ensuring the traceability and conformity of the products and services to the requirements.
*Managing the design and development changes, by identifying, reviewing, and controlling them, and evaluating their effects on the products and services and the QMS.
In this case, the evidence statements that provide a meaningful audit trail for the design and development process are B, E, and F, because they relate to the design and development controls, the documented information, and the verification activities that are required by the standard. These options can help the auditor to assess the effectiveness and conformity of the design and development process, and to identify any nonconformities or opportunities for improvement. The other options are not directly related to clause 8.3, although they may be relevant for other aspects of the QMS, such as clause 7.2 on competence, clause 7.3 on awareness, clause 7.4 on communication, clause 8.2 on requirements for products and services, clause 8.4 on externally provided processes, products, and services, and clause 8.7 on control of nonconforming outputs.
References: ISO 9001:2015, ISO 9001 Auditing Practices Group Guidance on Design and Development, ISO
9001 Clause 8.3 Design and development of products and services
