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ます。品質管理システム (QMS) を確認すると、外部コンサルタントが競合他社の目標を参考にして目標を定義しているものの、何も文書化されていない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どれくらいかかるかについて疑問を抱いています。
ISO 9001 の条項 6.2 に対して不適合を指摘できる状況を説明する 2 つのオプションはどれですか。
正解:B,C
According to ISO 9001:2015, clause 6.2.1, the organization is required to establish quality objectives at relevant functions, levels, and processes for the quality management system (QMS). The quality objectives must be consistent with the quality policy, measurable, monitored, communicated, and updated as appropriate.
The organization is also required to maintain documented information on the quality objectives, as per clause
7.5.1.
Therefore, in the scenario given, the quality objectives defined by the external consultant are not in alignment with the organization's quality policy, as they are based on those of a competitor, rather than the organization's own purpose, strategic direction, and customer requirements. This creates a mismatch between the organization's vision and goals, and the quality objectives that are supposed to guide and measure the QMS performance. Moreover, the quality objectives are not maintained as documented information, which makes it difficult to communicate, monitor, and update them, as well as to demonstrate evidence of their implementation and achievement.
Hence, the circumstances in which a nonconformity against clause 6.2 of ISO 9001 could be raised are B and C, as they indicate a failure to comply with the requirements of clause 6.2.1. The other options are either irrelevant or not directly related to clause 6.2, as they do not pertain to the establishment and documentation of quality objectives.
References:
ISO 9001:2015(en), Quality management systems - Requirements, clause 6.2.1 and 7.5.1 ISO 19011:2018(en), Guidelines for auditing management systems, clause 6.4.4 and 6.7.2 ISO 9001 Lead Auditor Training Course | IRCA Certified | BSI, section "Learning objectives" ISO 9001 Lead Auditor Course Material | 3FOLD Education Centre, module 5 and 6