ISO-9001-Lead-Auditor 試験問題 156
化粧品メーカーに規制コンサルティング サービスを提供する組織で ISO 9001 監査を実施しています。
顧客への規制サービス提供を担当する規制専門家のチームを管理するテクニカル ディレクター (TD) に面接します。
あなた:「規制要件に関する規制チームの能力をどのように維持していますか?」 TD:「当社がフルタイムで雇用している2名の規制専門家は、化粧品業界で長年の業務経験を持っています。」 あなた:「彼らの規制能力はどのように維持されていますか?」 TD:「彼らは業界に幅広い人脈を持つ献身的な人材です。」 あなた:「当社は、彼らが最新の規制要件に関する理解を維持できるよう、どのように支援していますか?」 TD:「それは彼らに任せています。」

顧客への規制サービス提供を担当する規制専門家のチームを管理するテクニカル ディレクター (TD) に面接します。
あなた:「規制要件に関する規制チームの能力をどのように維持していますか?」 TD:「当社がフルタイムで雇用している2名の規制専門家は、化粧品業界で長年の業務経験を持っています。」 あなた:「彼らの規制能力はどのように維持されていますか?」 TD:「彼らは業界に幅広い人脈を持つ献身的な人材です。」 あなた:「当社は、彼らが最新の規制要件に関する理解を維持できるよう、どのように支援していますか?」 TD:「それは彼らに任せています。」

ISO-9001-Lead-Auditor 試験問題 157
Which one of the following options is the definition of the context of an organisation?
ISO-9001-Lead-Auditor 試験問題 158
Scenario 6: Davis Clinic (DC) is an American medical center focused on integrated health care. Since its establishment DC was committed to providing qualitative services for its clients, which is the reason why the company decided to implement a quality management system (QMS) based on ISO 9001. After a year of having an active QMS in place, DC applied for a certification audit.
A team of five auditors, from a well-known certification body, was selected to conduct the audit. Eva was appointed as the audit team leader. After three days of auditing, the team gathered to review and examine their findings. They also discussed the audit findings with DC's top management and then drafted the audit conclusions.
In the closing meeting, which was held between the audit team and the top management of DC. Eva presented two nonconformities that were detected during the audit. Eva stated that the company did not retain documented information regarding its outsourced services for an analysis laboratory and regarding the conducted management reviews. During the closing meeting, the audit team required from DCs top management to come up with corrective action plans within two weeks. Although the top management did not agree with the audit findings, the audit team insisted that the auditee must submit corrective actions within the given time frame in order for the audit activities to continue.
Once the action plans were evaluated, the audit team began preparing the audit report. Eva required from the team to provide accurate descriptions of the audit findings and the audit conclusions. The report was then distributed to all the interested parties involved in the audit, including the certification body Based on the report, the certification body together with Eva, as the audit team leader, made the certification decision.
Based on the scenario above, answer the following question:
シナリオ6では、経営陣が監査結果に同意しなかったにもかかわらず、監査チームが監査報告書の作成を開始したことを示しています。これは許容できるでしょうか?
A team of five auditors, from a well-known certification body, was selected to conduct the audit. Eva was appointed as the audit team leader. After three days of auditing, the team gathered to review and examine their findings. They also discussed the audit findings with DC's top management and then drafted the audit conclusions.
In the closing meeting, which was held between the audit team and the top management of DC. Eva presented two nonconformities that were detected during the audit. Eva stated that the company did not retain documented information regarding its outsourced services for an analysis laboratory and regarding the conducted management reviews. During the closing meeting, the audit team required from DCs top management to come up with corrective action plans within two weeks. Although the top management did not agree with the audit findings, the audit team insisted that the auditee must submit corrective actions within the given time frame in order for the audit activities to continue.
Once the action plans were evaluated, the audit team began preparing the audit report. Eva required from the team to provide accurate descriptions of the audit findings and the audit conclusions. The report was then distributed to all the interested parties involved in the audit, including the certification body Based on the report, the certification body together with Eva, as the audit team leader, made the certification decision.
Based on the scenario above, answer the following question:
シナリオ6では、経営陣が監査結果に同意しなかったにもかかわらず、監査チームが監査報告書の作成を開始したことを示しています。これは許容できるでしょうか?
ISO-9001-Lead-Auditor 試験問題 159
監査人が現地監査の前に準備して完了する必要がある文書は次の 2 つのうちどれですか。


