You, as auditor, are in dialogue with the quality lead and managing director of a small business that supplies specialist laboratory equipment and furniture.
You: " I ' d like to look at how you manage change in the organisation. What changes have you made as a
business, say, over the last 12 months? "
Auditee: " We have made some strategic changes, the main one being that we no longer manufacture our
own products in house. "
You: " That sounds like quite a significant change. What has been the impact of that? "
Auditee: " We now mainly sell other manufacturers ' products, under their brand names, and have outsourced
manufacture of our own brand products to one of our suppliers. Unfortunately, we had to make six members
of our staff redundant. This represents about 20% of our workforce, so this has been quite a challenging
time. "
You: " I ' m sure. What were the reasons for making the change? "
Auditee: " Our manufacturing section was a small operation, and we struggled to cope with fluctuations in
demand. During busy periods, we found it hard to meet lead times, and in quiet periods we had staff with
little to do. This was having an impact on customer satisfaction and meant we had to charge premium prices
that made our product uncompetitive. "
You: " How did you go about the change? "
The auditor asks to speak to the purchasing manager about the selection of the subcontractor to
manufacture the company ' s own brand products.
You: " How did you choose a supplier to manufacture your products? "
Auditee: " We have had a long-term relationship with a supplier ABC Ltd - we gave them our design
drawings, got them to complete a supplier questionnaire and run a couple of trial batches for us. We were
happy with the result and we have used them ever since. "
ISO 9001:2015, clause 8.4.1 outlines situations when controls need to be applied to externally provided processes, products and services. Which one of the following situations is applicable to this scenario?
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.
' XYZ ' has already sent to you a list with all documented procedures and work instructions related to the services provided to ' ABC ' (a quality manual is not included in the list).
To complete the audit planning which additional information would you ask to XYZ to submit? Select four.
ABC is a car washing company with 25 stations in the city. A national taxi chain (CAR XX) decided to audit ABC’s ISO 9001 management system.
You, as CAR XX audit team leader, are interviewing the ABC Quality Manager (QM) at their central office.
You: “How do you measure customer satisfaction?”
QM: “When we give the keys back to the owners, we always ask them two questions about their needs and expectations, and once per month, we discuss a summary of the answers to those questions and the complaints we receive in a box located in the waiting room.”
You: “Did you take any action based on these responses?”
QM: “We installed cameras to monitor the process and a coffee machine in the waiting room. These actions reduced the complaints by 90%.”
Based on the scenario, select which three statements are true:
What is the responsibility of the audit committee during an internal audit?
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.
What are the criteria for reviewing documented information?
You work for an organisation which provides packaged food to the public. You are asked to lead a team (you as the leader and two other auditors) of a one-day audit of HMB, a supplier of hamburgers. It is 4 pm, and the audit is coming 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 is scheduled for 5 pm.
You, as the audit team leader, audited HMB’s Top Management and the two production lines of hamburger production (PL1 and PL2).
Auditor 1 audited the laboratory.
You to Auditor 1: “What findings would you report?”
Auditor 1: “When reviewing the laboratory records, I noticed that during the whole morning, HMB’s supervisors of each production line sent samples to be analysed by the laboratory. The samples from PL1 included the reference to the raw meat batch being used and the name of the sub-supplier, while the reports from PL2 referred only to the name of the sub-supplier. HMB’s Procedure P-02 Rev.3 says that samples sent to the laboratory have to include reference to the raw meat batch being used, to ensure traceability of the products.”
You to Auditor 2: “OK, what do you think?”
Auditor 2: “I think that this is a non-conformity.”
You to Auditor 1: “OK. How would you describe the evidence on which the non-conformity will be based?”
Identify which one of the following statements best describes the identified evidence.
When should the certification body accept the audit?
What should the auditor document during the Stage 1 audit?
