Which two options describe the circumstances in which you could raise a nonconformity against clause 6.2 of ISO 9001?

XYZ Corporation is an organisation that employs 100 people. As the audit team leader, you conduct a certification audit at Stage 1. When reviewing the quality management system (QMS), you find that the objectives have been defined by an external consultant using those of a competitor, but nothing is documented. The Quality Manager complains that this has created a lot of resistance to the QMS, and the Chief Executive is asking questions about how much it will cost.

Which two options describe the circumstances in which you could raise a nonconformity against clause 6.2 of ISO 9001?
A . The consultant has not interpreted ISO 9001 correctly.
B . Quality objectives were not established in alignment with the organisation’s quality policy.
C . Quality objectives are not maintained as documented information.
D . Establishing quality objectives did not include top management.
E . The organisation cannot afford to undertake quality objectives all at once.
F . Quality objectives are not being implemented by the organisations’ personnel.

Answer: B,C

Explanation:

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.

Reference:

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