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| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Conducting an ISO 9001 Audit | 15–20% | - Opening meeting, on-site activities, evidence collection - Team meetings, audit observations - Evaluating conformity, identifying nonconformities |
| Topic 2: Fundamental Audit Concepts and Principles | 10–15% | - Audit principles, types, roles and responsibilities - ISO 19011 and ISO/IEC 17021-1 requirements - Independence, evidence-based approach |
| Topic 3: Preparation of an ISO 9001 Audit | 10–15% | - Document review and communication - Selecting audit team, preparing plan and checklist - Initiating audit, defining objectives and scope |
| Topic 4: Fundamental Principles and Concepts of Quality Management System | 10–15% | - Concepts of QMS, risk, process approach - Quality management principles - Relationship between ISO 9001 and other standards |
| Topic 5: Closing an ISO 9001 Audit | 5–10% | - Preparing conclusions, closing meeting - Audit report, follow-up actions |
| Topic 6: Managing an ISO 9001 Audit Program | 5–10% | - Competence and evaluation of auditors - Establishing, implementing and monitoring audit program |
| Topic 7: Quality Management System (QMS) Requirements | 25–30% | - Scope, normative references, terms and definitions - Support, operation, performance evaluation, improvement - Context of the organization, leadership, planning |
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NEW QUESTION # 219
You are auditing an organisation that has been certificated to ISO 9001 for ten years. The organisation is a privately-owned, multi-site car tyre fitting organisation. You are auditing one of the sites. You are auditing the car tyre fitting service. You are interviewing the Site Manager (SM).
You: "Would you explain the car tyre fitting service?"
SM: "Of course. Customers typically call us by phone with their requirements. We ask them what they want.
We check whether we have the tyres
they need in stock. If we don't have the tyres in stock, we contact our supplier to confirm when they would be able to supply the tyres. We then determine the cost. We then check what availability we have in our busy schedule to fit the new tyres. We then inform the customer with details of cost and when we can fit the tyres. If the customer is happy to proceed with the booking, we update our Work Schedule. The same process applies for customers who walk into our office and for online requests." You: "What information do you retain should there be a defect reported by a manufacturer of tyres that you have fitted?" SM: "We maintain records of customer names, addresses and contact phone numbers. We maintain a record of the type of tyre fitted and the tyre manufacturers batch information. We also maintain a record of the registration numbers of the vehicles we have fitted tyres to. All records are in our Work Schedule." Which two of the following options you would take to enable you to gather further audit evidence to validate what the Site Manager has told you?
Answer: E,F
NEW QUESTION # 220
(A third-party audit has been planned at a single-site organisation. The audit team comprises one audit team leader, one auditor and one auditor who is undertaking his first third-party audit.
During the on-site audit, the auditor who is undertaking his first third-party audit shall...)
Answer: C,E
Explanation:
An auditor undertaking their first third-party audit is normally treated as an auditor under supervision. They may participate in audit activities, but should be monitored and supported by the audit team leader.
They should therefore review their auditing performance with the audit team leader and conduct interviews only with the audit team leader present.
They should not lead the closing meeting, independently interview auditees, or decide nonconformity grading alone. ISO 9001:2015 requires audits to be conducted objectively and by competent auditors, and ISO 9001 refers to ISO 19011 for audit guidance.
NEW QUESTION # 221
What is a horizontal audit?
Answer: C
Explanation:
Comprehensive and Detailed In-Depth Explanation:A horizontal audit examines one process across multiple departments to assess consistency.
Thus, A is the correct answer.
NEW QUESTION # 222
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.
Answer:
Explanation:
Explanation:
The table below shows the possible matching of the ISO 9001 Clause 8.3 extract to the audit evidence.
Table
Audit evidence
ISO 9001 Clause 8.3 extract
Half of all new products launched in the past 12 months were late. The NPD Manager explains he has not got enough people on his team to cope with the demand for new products.
"8.3.2 e) ... internal ... resource needs for the design and development of products ..." The NPD Manager explains many changes are made to cosmetic formulations during product development owing to retailer feedback. Only when confirmed by the retailer is the agreed formulation documented on SWIFT.
"8.3.5 ... retain documented information ..."
The NPD Manager explains that the customer confirms their approval to proceed with a new formulation by email. These emails are kept on SWIFT.
"8.3.6 ... retain documented information ..."
The NPD Manager shows you evidence of consumer trials that are carried out for some new products prior to full-scale launch.
"8.3.4 d) ... conducted to ensure that the resulting products and services meet the requirements ..." The NPD Manager explains that an approved external laboratory is used to perform shelf-life stability trials on some formulations during product development.
"8.3.2 e) ... external ... resource needs for the design and development of products ..."
NEW QUESTION # 223
Knowledge and skills are requirements of the auditor's competence. Select two from the following topics of knowledge that apply to every member of an audit team auditing an ISO 9001 quality management system.
Answer: B,F
Explanation:
According to ISO 9001:2015, clause 7.2, an auditor shall have the competence to:
Understand the requirements of ISO 9001 and how they relate to the audit Understand the organization's quality management system and its processes Understand the applicable legal, regulatory, contractual and other requirements that affect the audit Understand the needs and expectations of interested parties other than customers Plan and conduct audits in accordance with ISO 19011 Evaluate audit evidence and draw appropriate conclusions Communicate audit findings effectively1 Therefore, knowledge of ISO 9001 requirements and ISO 19011 audit principles are essential for every member of an audit team auditing an ISO 9001 quality management system.
References:
ISO 9001:2015 - Quality management systems - Requirements
ISO 19011:2018 - Guidelines for auditing management systems
NEW QUESTION # 224
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