You work for an organisation, ' A ' , which provides packaged food to the public. You are asked to lead a team (you as the leader and two other auditors) to audit a supplier, ' B ' , which provides packaging materials to your organisation. It is 4 p.m. and the audit is close to an end; you are having an internal meeting with the team to decide what will be presented to the auditee during the Closing meeting.
The Closing meeting was scheduled
for 5 p.m.
You, as audit team leader, audited top management, the laboratory, and the storage of raw materials.
Auditor 1 audited the two manufacturing lines and dispatch areas.
You to Auditor 1: " What findings would you report? "
Auditor 1: " When reviewing the Dispatch records, I noticed that during the morning two different trucks (Number 011 and 025) delivered the same batch number of the product (Batch 33555). Truck 011 left the plant at 9.15 am and Truck 025 left the plant at
11.30 am. Procedure P-02 Rev.3 says
that trucks should carry a complete batch. The batch number, once on the truck, is captured using a QR device. " You: " OK, what do you think? " Auditor 2: " I think that this is a nonconformity. " You: " OK. How would you describe the evidence on which the nonconformity will be based " ?
Identify which one of the following statements best describes the identified nonconformity.

• A. The batch 33555 was delivered split in two different trucks (011 and 025).
• B. Dispatch personnel do not always carry out its activities in conformance with Procedure P-02 rev 3.
• C. Dispatch personnel are not fully aware of the need to conform to written procedures.
• D. A product delivered to the client was not identified as required in P-02 Rev 3.

Which of the following is correct with regard to the internal audit?

• A. It has no advisory role within the organization for the improvement of the QMS
• B. It may be conducted on an ongoing basis
• C. It considers only the effectiveness of the QMS

An organisation decides to purchase products and services only from ISO 9001 certified suppliers.
Match the four organisational functions to a potential benefit.

Whistlekleen is a national dry cleaning and laundry organization with 50 shops. You are conducting a surveillance audit of the Head Office and are sampling customer complaints. You find that 80% of complaints originate from five shops in the same region. Most of these complaints relate to damage to customer laundry.
The Quality Manager tells you that those are the oldest shops in the organization. The cleaning equipment needs replacing, but the organization cannot afford it now. Complaining customers are offered a financial incentive to close the complaint.
On raising the matter with senior management, you are told that there are plans to replace the equipment in these shops over the next five years.
Select the one option which correctly describes the non-conformity to be raised against ISO 9001.

• A. 8.5.5.d - The organization failed to advise its customers of the potential for damage.
• B. 8.5.3 - Customers were not advised of damage to their property.
• C. 8.5.1.h - Laundry returned to customers with defects.
• D. 10.1 - The organization fails to enhance customer satisfaction.
• E. 8.5.1.d - The organization does not have suitable infrastructure for five shops.
• F. 7.2 - Staff were not competent to handle customers ' laundry.

Noitol is an organisation specialising 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 organisation.
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 nonconformity?

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