複数拠点を持つ組織のステージ2認証審査を主導しており、以下の審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150km) - 2日目と3日目。審査1日目に、クライアントから、従業員の間で深刻な感染症が発生したため、拠点2の実験室が除染のため閉鎖されたという連絡を受けました。拠点2では、その他のすべての機能は計画通りに審査を受けることができました。
監査チームのリーダーとして、あなたはどうしますか?
実行できる最善のアクションを選択してください。
正解:C
ISO 9001:2015 requires that certification audits be planned, controlled, and conducted in a way that ensures valid and reliable audit conclusions . However, ISO 9001 does not give operational detail on how to manage disrupted audits. For this, ISO 9001 explicitly refers to ISO 19011 and certification schemes require escalation to the audit programme or certification management function .
ISO 9001:2015, Clause 9.2.2 (NOTE) states that guidance on auditing management systems is provided in ISO 19011.
In a Stage 2 certification audit , all applicable processes within the scope must be audited before a certification decision can be made. The laboratory at Site 2 is clearly part of the operational scope and cannot be audited due to circumstances outside the organisation's control (health and safety risk).
Why option C is correct:
* Certification audits operate under a controlled certification programme , not solely at the discretion of the audit team leader.
* ISO 19011 requires auditors to act responsibly when conditions prevent safe or complete auditing and to escalate significant changes or risks .
* Certification bodies require the Audit Programme Manager (or Certification Manager) to decide whether the audit should be paused, partially completed, rescheduled, or split to preserve certification integrity.
Therefore, seeking direction from the audit Programme Manager is the correct and compliant action.