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Reference: https://pecb.com/en/education-and-certification-for-individuals/iso-9001/iso-9001-lead-auditor
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監査チームのリーダーが、認証機関のステージ 2 監査を実行するために印刷会社を訪れます。品質管理マネージャーとの会議で、その会社がコンピューター メーカーからコンピューター ドキュメント パッケージの印刷とコンパイルという最大の契約を獲得したと伝えられます。スペースの関係で隣のユニットを借りていますが、この分野で働いたことはこれまでありませんでした。品質管理マネージャーは、新しい契約をカバーするために ISO 9001 証明書を取得したいと考えています。
監査人の正しい対応はどれですか?
Correct Answer: D 🗳️
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以下は、ISO 9000 シリーズの基盤となる 7 つの原則のうち 4 つです。それぞれの品質管理原則 (QMP) の潜在的な利点を一致させてください。
Correct Answer:
Explanation:
Quality management principles:
Customer focus = Increased revenue and market share
Engagement of people = Enhanced trust and collaboration throughout the organisation Improvement = Enhanced drive for innovation Evidence-based decision-making = Increased ability to demonstrate effectiveness of past actions According to the Quality management principles document published by ISO, each quality management principle has a statement, a rationale, key benefits, and actions you can take to apply it. Based on these descriptions, the potential benefits can be matched to the corresponding principles as follows:
Customer focus: The primary focus of quality management is to meet customer requirements and to strive to exceed customer expectations. The key benefits of this principle include increased customer value, customer satisfaction, customer loyalty, repeat business, reputation, customer base, revenue and market share.
Engagement of people: Competent, empowered and engaged people at all levels throughout the organization are essential to enhance its capability to create and deliver value. The key benefits of this principle include improved understanding of the organization's objectives and values, increased involvement in improvement activities, enhanced personal development, increased motivation and empowerment, enhanced trust and collaboration, and increased recognition and rewards.
Improvement: Successful organizations have an ongoing focus on improvement. The key benefits of this principle include improved organizational capabilities, alignment of improvement activities at all levels, increased ability to anticipate and react to opportunities and threats, enhanced drive for innovation, and increased levels of satisfaction.
Evidence-based decision-making: Decisions based on the analysis and evaluation of data and information are more likely to produce desired results. The key benefits of this principle include improved decision-making processes, increased ability to demonstrate the effectiveness of past decisions, increased ability to review, challenge and change opinions and decisions, and increased ability to improve performance.
複合監査とは何ですか?
Correct Answer: C 🗳️
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監査チームリーダーとして、ISO 9001 認証を取得しようとしている組織で監査を計画しています。監査対象者と監査範囲および監査日を確認し、合意しました。監査チームは、あなたともう 1 人の監査人で構成されます。監査対象者には 2 つのサイトがあり、そのうちの 1 つは経営幹部チームが拠点を置く本社です。
もう1つのサイトはサイト1と呼ばれ、別の国にあります。この点を除けば、両サイトは顧客サービスの提供に関しては基本的に同様です。もう1人の監査人は、サイト1の近くに住んでいるため、サイト1の監査を担当することになりました。
監査計画を文書化する前に確定する必要がある 4 つの問題を選択します。
Correct Answer: C,D,E,F 🗳️
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XYZ 社は 100 人の従業員を抱える組織です。監査チームのリーダーとして、ステージ 1 の認証監査を実施しています。品質管理システム (QMS) のドキュメントを確認すると、上級管理職を除く組織の全従業員に対して品質目標が設定されていることがわかりました。
品質管理者は、これが QMS に対する大きな抵抗を生み出していると不満を述べており、最高経営責任者はコストがいくらかかるかについて疑問を抱いています。彼は、これが目標を設定する正しい方法であるかどうかについてあなたの意見を求めています。
ステージ 1 の 3 か月後、XYZ 社に戻り、監査チーム リーダーとして他の 1 人の監査員とともにステージ 2 の認証監査を実施します。品質管理者が全従業員に対する以前の品質目標を取り消し、自分自身の目標を 1 つ設定したことがわかります。この目標には、「品質管理者は、今後 1 年間で QMS の複数の改善を推進する」と記載されています。品質管理者は、これにより、品質改善が必要な場合に部門管理者に指示を出す権限が与えられると述べています。このアプローチは上級管理職の全面的な支持を得ていると彼は言います。彼は、前回の経営レビューに含まれていた最新の品質改善要求をあなたに示します。
さらに監査を行った結果、以下の問題が見つかりました。「監査証跡」という用語に当てはまる 3 つの文を選択してください。
Correct Answer: A,B,C 🗳️
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