ISO-9001-Lead-Auditor Practice Exam Questions | ISO 9001

During an internal audit, a manufacturer of polystyrene packaging products for the electronics industry found that six per cent of finished products being ejected from the moulding machines fell onto the factory floor instead of into collection baskets. The factory floor was wet and dirty in places, so a lot of products were rejected at inspection. Auditors raised a non-conformity to the Maintenance Manager.

Select three options for the corrective action to be taken by the Maintenance Manager that could be needed to prevent rejects from recurring.

You will perform a third-party initial audit of ABC, a car manufacturer located on the outskirts of São Paulo, Brazil.

ABC is a local branch of an American car manufacturer that wants to introduce a new model, the GX-1, into the Brazilian market. In your audit plan, you included a two-hour interview with the Production Engineering department to audit clause 8.3 of ISO 9001.

When you sent the audit plan to ABC for their review, ABC said, “There is no need for that interview because the design of the model GX-1 was made in the USA, and we did not participate in that process.”

Millions of cars have already been sold in the USA and the Far East with fantastic success.

Which one of these potential actions is acceptable?

You are carrying out 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. The organisation uses a software programme called SWIFT, which is used to record sales, plan production, purchase supplies, print despatch notes, track new product development, perform traceability exercises, carry out mass balance checks, raise invoices, create budgets, and support financial control.

You are nearing the end of the audit and you are reviewing your audit notes. You notice a recurring trend concerning the SWIFT database as shown below:

You ask the Quality Manager to explain how the SWIFT database is controlled. You learn that the Operations Director is

responsible for determining and progressing SWIFT software updates. You decide to meet the Operations Director (OD).

You: " Good afternoon. "

OD: " Good afternoon. "

You: " What responsibility do you have concerning the SWIFT database? "

OD: " I maintain it. If anyone wishes to propose an update to the database, they send me an email with

details of their proposal. I then either process the database update myself, or I send the request to the

consultant who designed the database 20 years ago. The necessary software changes are made, and the

amended software is immediately released to users. "

You: " Would you explain how the software amendments are controlled? "

OD: " Of course. I personally update every computer myself. "

You: " Do you inform the database users of the changes? "

OD: " No I don ' t. They find out for themselves by using the software, or they come to see me if they have

any questions. "

You: " How do you ensure that the database users use the latest version? "

OD: " That ' s easy, I update every computer myself. "

You: " During the audit, I noted there were several versions of SWIFT in use (you refer to your audit

notes). "

OD: " I know. That ' s because some versions work better than others, and depending on user needs and

experiences, we allow users to revert to using an earlier version if they find it works better for them. "

Based on the scenario, which two of the following statements are true? There is evidence of

nonconformity with a requirement defined in ...