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PECB QMS ISO 9001:2015 Lead Auditor Sample Questions:

1. Select the term that best describes the purpose of retaining documented information in a quality management system to ISO 9001.

A) To facilitate auditing for proof of conformity to the standard.
B) To support the operation of the processes of the quality management system.
C) To provide confidence in the effectiveness of the quality management system.
D) To safeguard the integrity of the quality management system.

2. You have been nominated audit team leader of a third-party audit. Which of the following could be the two most relevant objectives of this audit?

A) Evaluate the effectiveness of the management system
B) Identify opportunities for improvement
C) Evaluate the satisfaction interested parties
D) Identify the need of resources
E) Evaluate the capability of the management system to establish and achieve objectives
F) Evaluate the benefits obtained since the implementation of the management system

3. You are conducting an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The organisation manufactures cosmetics for major retailers and the name of the retailer supplied appears on the product packaging. Sales turnover has increased significantly over the past five years You are interviewing the new Product Development Manager. You note that a software application called SWIFT is used to help control the product development process.
You have gathered audit evidence as outlined in the table. Match the ISO 9001 clause 8.3 extracts to the audit evidence.

4. 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) Quality objectives are not being implemented by the organisations' personnel.
B) The organisation cannot afford to undertake quality objectives all at once.
C) Quality objectives are not maintained as documented information.
D) The consultant has not interpreted ISO 9001 correctly.
E) Establishing quality objectives did not include top management.
F) Quality objectives were not established in alignment with the organisation's quality policy.

5. You are an auditor from a construction organisation who is conducting a second party audit to ISO 9001 at a steel rolling mill producing structural steelwork. When auditing the rolling process, you find that the operator who is unloading the furnace does not use the adjacent infrared pyrometer to measure the appropriate product temperature in readiness for the next production stage.
You: "How do you tell when the billet is ready for the rolling stage?"
Operator: "I've done this job for 20 years. I can tell by the bright red colour." You: "What happens if the colour is wrong?" Operator: "The billet goes back into the furnace." You: "Is the pyrometer ever used?" Operator: "Only in borderline cases." You continue to interview the operator and find that around 25% of the billets are sent back to the furnace.
This includes 80% of the borderline cases.
Select three options that would provide evidence of conformance with clause 9.1.1 of ISO 9001.

A) Annual review records for furnace operators.
B) Certification of conformance to national standards from the manufacture of the pyrometer.
C) Maintenance plan for the furnace.
D) Planning for monitoring and measuring the billet temperature.
E) Periodic analysis of the results of temperature checks.
F) A procedure that provides instruction in taking billet temperature.
G) A quality objective to achieve lower recycle rates for billets.
H) An increase in the use of the pyrometer by operators.

Solutions:

Question # 1 Answer: B

Question # 2 Answer: A,E

Question # 3 Answer: Only visible for members

Question # 4 Answer: C,F

Question # 5 Answer: D,E,F