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Reference: https://pecb.com/en/education-and-certification-for-individuals/iso-9001/iso-9001-lead-auditor
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監査リスクを軽減し、合理的な保証を得るために監査人が考慮しなければならないことは何ですか?
Correct Answer: B 🗳️
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シナリオ4:
TD Advertising はシカゴに拠点を置く印刷管理会社です。同社はデザイン サービス、デジタル印刷、保管、配布を提供しています。TD が拡大するにつれ、経営陣は成功には新しいテクノロジーの導入と品質の向上が不可欠であることを認識しました。
顧客満足と品質向上を確実にするために、同社は ISO 9001 認証を取得することを決定しました。
QMS を実装した後、TD は監査のために有名な認証機関を雇いました。Anne Key が監査チーム リーダーに任命されました。彼女は、監査チームのメンバー、監査範囲、基準、期間、監査契約の制限を記載した文書を受け取りました。
アンは文書を確認し、監査の委任を承認しました。認証機関と TD の経営陣は認証契約に署名しました。
TD に連絡する前に、Anne は監査範囲を確認し、新しい印刷機器の導入により TD が監査範囲を変更したことに気付きました。しかし、Anne は変更が監査のスケジュールに影響するとして同意しませんでした。彼女は監査から撤退することを検討しました。
シナリオ 4 の最後の段落で示された状況をどのように評価しますか?
Correct Answer: C 🗳️
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組織が行動を起こす前にリスク、結果、影響度を評価する際に、どの品質管理原則を満たすのでしょうか?
Correct Answer: D 🗳️
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初めて ISO 9001 認証を取得しようとしている単一サイトの組織で監査を実施しています。
この組織は大手小売業者向けに化粧品を製造しており、製品を供給している小売業者の名前が製品のパッケージに記載されています。過去 5 年間で売上高は大幅に増加しました。あなたは新しい製品開発マネージャーに面接を行っています。製品開発プロセスの管理に SWIFT と呼ばれるソフトウェア アプリケーションが使用されていることに気付きました。
表に示されているとおりに監査証拠を収集しました。ISO 9001 条項 8.3 の抜粋を監査証拠と一致させます。
Correct Answer:

Explanation:
Audit Evidence and Applicable ISO 9001:2015 Clause 8.3 Extracts
* Half of all new products launched in the past 12 months were late. The Product Development Manager explains he has not got enough people on his team to cope with the demand for new products. # ISO 9001 Clause 8.3.2 e) - "...internal resource needs for the design and development of products and services..."
* The Product Development Manager explains many changes are made to cosmetic formulations during product development owing to retailer feedback. Only when confirmed by the retailer is the agreed formulation documented on SWIFT. # ISO 9001 Clause 8.3.5 - "...retain documented information on design and development changes..."
* The Product Development Manager explains that the customer confirms their approval to proceed with a new formulation by email. These emails are kept on SWIFT. # ISO 9001 Clause
8.3.6 - "...retain documented information on design and development outputs..."
* The Product Development Manager shows you evidence of consumer trials that are carried out for some new products before a full-scale launch. # ISO 9001 Clause 8.3.4 d) - "...conducted to ensure that the resulting products and services meet the requirements..."
* The Product Development Manager explains that an approved external laboratory is used to perform shelf-life stability trials on some formulations during product development. # ISO 9001 Clause 8.3.2 e) - "...external resource needs for the design and development of products and services..." ISO 9001:2015 Clause 8.3 (Design and development of products and services) requires organisations to plan, control, review, verify, validate, and document design and development activities to ensure products meet requirements.
Explanation of clause alignment:
* Clause 8.3.2 e) requires the organisation to determine both internal and external resource needs .
Lack of personnel causing late launches directly evidences internal resource shortfalls, while the use of an external laboratory demonstrates control of external resources.
* Clause 8.3.5 requires organisations to control design and development changes and retain documented information describing those changes, which is demonstrated by controlled updates in SWIFT following retailer confirmation.
* Clause 8.3.6 requires retention of documented information on design and development outputs , including customer approvals, which are evidenced by stored emails in SWIFT.
* Clause 8.3.4 d) requires design and development activities such as verification and validation , ensuring outputs meet requirements. Consumer trials prior to launch clearly meet this requirement.
ISO-aligned conclusion:
The evidence provided demonstrates structured control of product design and development, including planning, resourcing, change management, validation, and retention of documented information, all mapped directly to ISO 9001:2015 Clause 8.3 requirements .
あなたは、複数の拠点を持つ組織のステージ 2 認証監査を主導しており、以下の監査スケジュールを受け取りました。本社および拠点 1 - 1 日目、拠点 2 (本社から 150 km) - 2 日目と 3 日目。監査の 1 日目に、クライアントから、作業員の間で深刻な感染症が発生したため、拠点 2 の実験室で除染のための投薬が行われたとの通知がありました。拠点 2 では、他のすべての機能は計画どおりに監査できます。
監査チームのリーダーとして、あなたは何をしますか?
実行できる最善のアクションを選択してください。
監査プログラム マネージャーに指示を依頼します。
3 日目に監査を完了し、認証機関に報告して認証の決定をもらいます。
2 日目と 3 日目に監査を継続し、後ほどサイト 2 の研究所を監査するために戻ります。
監査計画を完了できないため、直ちに監査をキャンセルします。
監査チームに作業を割り当てる責任は誰にありますか?
Correct Answer: B 🗳️
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