PECB ISO-9001-Lead-Auditor Exam : QMS ISO 9001:2015 Lead Auditor Exam

You are conducting an ISO 9001 audit of a Materials Recycling Facility (MRF). The company processes waste plastics into raw material for plastic bottle manufacturers. You reach the manual picking line where operators are removing contaminant materials from incoming products, such as plastic bags, plastic film and badly contaminated items that would compromise the recycling process.
You interview the line supervisor.
You: " Why are these plastic items being rejected at this stage? "
Auditee: " They do not meet our processing standards. "
You: " What is the reason for that? "
Auditee: " These items are likely to damage the machinery down the line. They can also compromise our quality standards. We need to protect our reputation for good quality output materials. " You: " What happens to the rejected items? " Auditee: " Some get melted down in another process later on and some are disposed of as waste products that cannot be recycled. " You: " What happens to the waste products? " Auditee: " I ' m not sure. I suppose they go to landfill. " After further auditing, you have gathered additional evidence.

XYZ Corporation is an organisation that employs 100 people. As 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 organisation except top management.
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. He asks for your opinion on whether this is the correct method of setting objectives.
Three months after Stage 1, you return to XYZ Corporation to conduct a Stage 2 certification audit as Audit Team Leader with one other auditor. You find that the Quality Manager has cancelled the previous quality objectives for all employees and replaced them with a single objective for himself. This states that " The Quality Manager will drive multiple improvements in the QMS in the next year " . The Quality Manager indicates that this gives him the authority to issue instructions to department managers when quality improvement is needed. He says that this approach has the full backing of senior management. He shows you the latest Quality Improvement Request that was included in the last management review.

After further auditing, the issues below were found. Select three statements that apply to the term ' audit trail '

• A. Decisions on improvement action timescales not involving departmental managers.
• B. Limited knowledge of the content of Quality Improvement Requests by departmental staff.
• C. Top management claim not to be aware of the improvement request (QI/12/20/HR-3) initiated by the Quality Manager.
• D. Quality improvements not aligning with the quality policy.
• E. The single quality objective set for the organisation by the Quality Manager.
• F. Evaluation of the results of the improvement action not always documented by the Quality Manager.

Scenario 4:
TD Advertising is a print management company based in Chicago. The company offers design services, digital printing, storage, and distribution. As TD expanded, its management recognized that success depended on adopting new technologies and improving quality.
To ensure customer satisfaction and quality improvement, the company decided to pursue ISO 9001 certification.
After implementing the QMS, TD hired a well-known certification body for an audit. Anne Key was appointed as the audit team leader. She received a document listing the audit team members, audit scope, criteria, duration, and audit engagement limits.
Anne reviewed the document and approved the audit mandate. The certification body and TD's top management signed the certification agreement.
Before contacting TD, Anne reviewed the audit scope and noticed that TD made changes to it due to the adoption of new printing equipment. However, Anne disagreed with the changes, stating they would affect the audit timeline. She considered withdrawing from the audit.
The audit team members were selected based on their knowledge of the legal and other regulations that TD is subject to. Is this acceptable?

• A. Yes, to ensure effective conduct of the audit, each audit team member should have knowledge of legal and other requirements that TD is subject to.
• B. No, because only one audit team member is required to have knowledge of legal and other regulatory requirements that TD is subject to.
• C. Yes, but only the lead auditor needs to have knowledge of legal and other regulatory requirements.
• D. No, because there is no need to have knowledge of the legal and other requirements that TD is subject to.

A small cleaning services organisation is about to start work on a hospital cleaning contract for the local Health Trust. You, as auditor, are conducting a Stage 2 audit to ISO 9001 and review the contract with the Service Manager. The contract requires that a cleaning plan is produced.
You: " How was the cleaning plan for the contract developed? "
Service Manager: " We have a basic template that covers the materials, labour requirements and cleaning methods to be employed. Some of that is specified by the customer. " You: " How does the plan deal with locations like the intensive care wards and the operating theatres, which are included in the contract? " Service Manager: " The basic plan covers general wards, but we will do more frequent cleaning in those areas if the hospital requests it. " You: " Are you aware of the regulatory requirements for cleaning standards in hospitals? " Service Manager: " No. We depend on the hospital to look after that side of things in the contract. " You decide to raise a non-conformity against section 8.2.2.a.1 of ISO 9001.
You decide to raise another non-conformity against section 8.2.4 of ISO 9001 when finding that the cleaning plan was amended without the agreement of the Health Trust. A different cleaning chemical was substituted to that specified in the contract. At the follow-up audit, the corrective action proposed was to
" obtain a concession from the Health Trust for use of the new chemical. " Which one of the following options is the reason why you did not accept this action taken?

• A. The process for making changes to the contract has not been addressed.
• B. The substitute chemical has not been used before in the Health Trust.
• C. Staff have not been trained in the use of the new chemical.
• D. The action assumes that the Health Trust will agree to the change.
• E. The substitute chemical may not be as effective as the original.

In the context of a third-party management system certification audit, which two of the following statements are correct?

• A. The Stage 2 audit must be conducted by auditors who have never worked for the auditee
• B. The Stage 2 audit should include an opening meeting at the start of the audit and a closing meeting at the conclusion of the audit.
• C. The purpose of a Stage 2 audit is to evaluate the implementation of the auditee ' s management system.
• D. The purpose of a Stage 2 audit is to certify an organisation to ISO 9001.
• E. A Stage 2 audit evaluates how efficiently the organisation is implementing its management system
• F. The Stage 2 audit cannot include remote access to electronic site(s) that contain information relevant to the audit of the management system.