Câu 24: ISO 9001 Lead Auditor: PECB Certified ISO 9001 Lead Auditor

Noitol is an organization specializing in the design and production of e-learning training materials for the insurance market. During an ISO 9001 audit of the development department, the auditor asks the Head of Development about the process used for validation of the final course design. She states that they usually ask customers to validate the product with volunteers. She says that the feedback received often leads to key improvements. The auditor samples the design records for a recently completed course for the 247 Insurance organization. Design verification was carried out but there was no validation report. The Head of Development advises that this customer required the product on an urgent basis, so the validation stage was omitted. When asked, the Head estimates that this occurs about 50% of the time. She confirms that they always ask for feedback and often make changes. There is no record of feedback in the design file for the course. The auditor raises a nonconformity against ISO 9001. Which one of the following options is the basis for the non-conformity? (Choose one.)

1. A. 8.3.5 – The improvements made the course designs are not documented. Feedback from customers is not always actioned.
2. B. 8.6 – Course materials are released without proper approval. A course for 247 Insurance was released on an urgent basis.
3. C. 8.3.4.d – Design validation is not always conducted. It is omitted about half of the time. — đáp án hiện tại
4. D. 8.3.2.c – Design planning does not include design validation. Design verification is part of the planning process.