ISO 9001 Lead Auditor

ISO 9001 Lead Auditor practice questions, page 4 of 5, with answer review and explanations.

Question 16

An audit team leader arrives at a printing organization to carry out a Stage 2 audit for a certification body. At a meeting with the Quality Manager, she is told that they have won their biggest contract from a computer manufacturer to print and compile computer documentation packages. They have leased the unit next door for space reasons but have never worked in this sector before. The Quality Manager wants the ISO 9001 certificate to cover the new contract. During the audit, a team member finds that a number of print jobs have been rejected by several clients over a number of months due to spelling errors in the print run. The Print Manager blames the new employees they have had to take on because of a big contract. The auditor raises a nonconformance against clause 10.2.1.b of ISO 9001. Which one of the evidence statements would support this finding? (Choose one.)

  1. There was no record that the organization evaluated the effectiveness of the training given to new employees.
  2. The action taken to deal with customer complaints did not prevent recurrence of the problem.
  3. There was no evidence that a check of spelling took place before the release of printing to the client.
  4. The organization did not provide the correct resources to prevent nonconformity.

Question 17

You are carrying out an audit at a single-site organization seeking certification to ISO 9001 for the first time. The organization 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 organization 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 mode, 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. Thet 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 …(Choose two.)

  1. …clause 7.1.4 Environment for the operation of processes
  2. … clause 7.5.1 Documented information - General
  3. …clause 7.5.2 Documented information – Creating and updating
  4. …clause 7.1.3 Infrastructure
  5. …clause 7.5.3 Control of documented information

Question 18

During a third-party surveillance audit, the auditor finds that the management review meeting minutes record that the improvement actions set by the previous reviewer have not been completed for a second year running. It states that a new Quality Manager has been brought in at the middle management level to rectify the situation. You learn that top management is not involved in the QMS other than being copied into the minutes of the management review meeting. The audit reveals that the new Quality Manager was given responsibility by top management to a) take accountability for the effectiveness of the QMS, b) select, approve, and monitor improvement actions without involving and reporting to top management, c) promote the improvement of the QMS and d) make efficient use of the limited financial and personnel resources allocated for the QMS by top management. The auditor considers whether there is a nonconformity against clause 5.1.1 of ISO 9001. Select two options of the evidence required for such a nonconformity. (Choose two.)

  1. Top management is not accountable for the effectiveness of the QMS.
  2. The Quality Manager avoids giving improvement actions to the Chief Executive.
  3. The Chief Executive never attends the management review meetings in person.
  4. The Quality Manager is on target to complete only half of the improvement actions.
  5. The Quality Manager only reports to one designated senior manager.
  6. The Quality Manager does not have access to the resources needed for the QMS.

Question 19

You are carrying out an audit at an organization seeking certification to ISO 9001 for the first time. The organization offers regulatory consultancy services to manufacturers of cosmetics. The business operates from ten regional offices. You are nearing the end of the audit and need to decide if sufficient evidence of top management leadership and commitment with respect to the quality management system has been gathered. Which four of the following would demonstrate top management leadership and commitment with respect to the quality management system? (Choose four.)

  1. Promoting the importance of following procedures
  2. Chairing management review meetings
  3. Investing time and money in corrective actions arising from nonconformities
  4. Briefing staff on the development of an improvement culture
  5. Not attending audit closing meeting
  6. Approving company car budgets for the fiscal year
  7. Conducting staff disciplinary meetings

Question 20

XYZ Corporation is an organization that employs 100 people. As the audit team leader, you are conducting a certification audit at Stage 1. When reviewing the quality management system (QMS) documentation, you find that quality objectives have been set for every employee in the organization except top management. The Quality Manager complaints that this has created a lot of resistance to the QMS, and the Chief Executive is asking questions about how much it will cost. He asks for your opinion on whether this is the correct method of setting objectives. How would you respond with the following options? (Choose three.)

  1. Inform the Quality Manager that you will comment on the subject in your audit report.
  2. Suggest asking the certification body for guidance on this matter.
  3. Suggest the all employees undertake a training course on ISO 9001.
  4. Indicate that ISO 9001 requires a minimum of two quality objectives.
  5. Suggest that the Quality Manager obtains external consultancy on the use of quality objectives.
  6. Advise the Quality Manager that you will raise an opportunity for improvement if the quality objectives are not addressed properly.
  7. Advise the Quality Manager to read the ISO 9001 standard and interpret in relation to the organization’s requirements.
  8. Advise the Quality Manager that, as an auditor, you cannot provide advice to the organization on how it should operate its QMS.