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NEW QUESTION # 252
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?
Answer: D
Explanation:
Comprehensive and Detailed In-Depth Explanation:
ISO 9001:2015 requires organizations to ensure that auditors have the necessary competence and knowledge to conduct audits effectively.
Clause References:
* ISO 19011:2018, Clause 7.2.1 - Determining Competence of Auditors: Auditors must have knowledge of applicable legal and regulatory requirements that affect the scope of the audit.
* ISO/IEC 17021-1:2015, Clause 7.1.2 - Competence Requirements: Certification bodies must ensure that auditors assigned to the audit team possess relevant knowledge in areas such as legal and regulatory compliance.
Why is the Correct Answer C?
* Each audit team member should have sufficient knowledge of relevant legal and regulatory requirements to ensure compliance.
* This helps auditors identify gaps or nonconformities related to compliance obligations.
* Having multiple team members with knowledge reduces reliance on a single expert and ensures a comprehensive assessment.
Why are the Other Options Incorrect?
* A (Only one team member needs knowledge) # Incorrect because audits involve various aspects, and all auditors should have basic awareness of legal and regulatory requirements.
* B (Legal knowledge is not necessary) # Incorrect because compliance is essential for QMS effectiveness.
* D (Only the lead auditor needs legal knowledge) # Incorrect because ISO requires all auditors to be competent in applicable laws, not just the leader.
NEW QUESTION # 253
You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The organization manufactures cosmetics for major retailers.
You are interviewing the Manufacturing Manager (MM).
You: "I would like to begin by looking at the cleaning controls."
MM: "We record the cleaning of the equipment at the end of every batch. This document details the minimum cleaning frequency and the procedures to follow for all areas and each item of equipment. The person who carries out the cleaning puts their initial on the document and records the time and date alongside." Narrative: You sample production records over 3-days and note down evidence of nonconformity as per the table below.
Answer:
Explanation:
Explanation:
Nonconformity report
ISO 9001 Clause Number: 8.5.4 Nature of problem: Cleaning and sanitising records are not available for every batch. ISO 9001 requirement that has not been fulfilled: ISO 9001 - "The organization shall implement planned arrangements, at appropriate stages, to verify that the product requirements have been met." Evidence: 40 cleaning records are available for 63 batches.
NEW QUESTION # 254
In the context of a third-party audit, match the activity with the party responsible in relation to the audit process.
Answer:
Explanation:
Explanation:
In the context of a third-party audit, the activities and the parties responsible can be matched as follows:
Review the organization's processes: This is typically the responsibility of the audit team. They examine the processes to ensure they comply with the specified standards1.
Review the audit results: The audit team leader usually reviews the audit findings to ensure accuracy and completeness before they are finalized1.
Issue the certificate: The certification body is responsible for issuing the certificate if the audit is successful and the organization meets the required standards1.
Select the audit team: The individual(s) managing the audit programme are responsible for selecting the audit team. This ensures that the team has the appropriate skills and knowledge for the audit1.
These roles are essential to maintain the integrity and effectiveness of the audit process. The audit team conducts the actual audit, the team leader oversees the audit process, the certification body grants the certification, and the management of the audit program ensures that the right team is in place to conduct the audit1.
Based on the description of the image you've provided, here's how the activities match with the responsible parties in the context of a third-party audit:
Review the organization's processes: This activity is typically the responsibility of the Audit Team. They are tasked with examining the processes to ensure they meet the requirements of the standard being audited.
Review the audit results: The Audit Team Leader is usually responsible for this activity. They oversee the audit process and are in charge of reviewing the findings and ensuring that the audit objectives are met.
Issue the certificate: The Certification Body is responsible for issuing the certificate if the organization's management system is found to be in compliance with the standard.
Select the audit team: The Individual(s) managing the audit programme are responsible for selecting the audit team. They ensure that the team has the appropriate competence and resources to effectively conduct the audit.
These roles are defined within the framework of ISO 9001:2015 and are essential for the proper conduct of a third-party audit. The audit team and its leader play a critical role in the operational aspects of the audit, while the certification body and those managing the audit programme have overarching responsibilities for the audit' s governance and integrity.
NEW QUESTION # 255
Which two of the following statements related to Stage 1 of an initial certification audit against ISO 9001:2015 are true?
Answer: A,E
Explanation:
* Reviews the client's management system documented information: This activity involves checking the documentation of the quality management system, such as the quality policy, the quality objectives, the scope, the processes, and the procedures, to ensure that they meet the requirements of ISO 9001:2015123. The audit team also evaluates the client's understanding and implementation of the standard, and identifies any gaps or nonconformities that need to be addressed before the Stage 2 audit123.
*Reviews the processes with high level of risk: This activity involves assessing the processes that have a significant impact on the quality of the products or services, or that pose a high risk of nonconformity or customer dissatisfaction123. The audit team also verifies the client's risk management approach, and evaluates the effectiveness of the controls and actions taken to mitigate the risks123.
The other options are not statements that are true for the Stage 1 audit, according to the web search results from my internal tool. They may be related to other stages or types of audits, but they are not the focus of the Stage 1 audit.
Therefore, the correct answer is D and G.
References: 1: ISO 9001 Certification Audits | Stage 1 and Stage 2 - 9001. Simplified 2: Stage 1 of your Audit
| NQA Blog 3: Getting Certified to ISO 9001 - the Stage 1 Audit
NEW QUESTION # 256
You are auditing an organisation that has been certified to ISO 9001 for 10 years. The organisation is a privately owned, multi-site car tyre fitting company. You are auditing one of the sites.
You have confirmed with the Workshop Supervisor that tyre batch numbers shall be recorded in the Work Schedule. You have sampled recent Work Schedule records and written the following in your audit notes:
No batch numbers for tyres fitted to customers' cars were recorded in the Work Schedule for job numbers 1/5,
1/16, 2/2, 2/7, 3/2, 3/5, 3/7 and 3/9. 15 jobs completed over the past five days were sampled. The Workshop Supervisor and the Tyre Fitter were aware of this missing information in the records, but no action had been taken.
You decide to raise a non-conformity.
Answer:
Explanation:
Explanation:
ISO 9001 Clause Number:
8.5.2
Nature of problem:
Tyre batch numbers have not been recorded in the Work Schedule.
ISO 9001 requirement that has not been fulfilled:
ISO 9001 - "The organization shall retain the documented information necessary to enable traceability." This is a traceability issue. The organisation requires tyre batch numbers to be recorded in the Work Schedule, but sampled records showed that batch numbers were missing for multiple completed jobs.
ISO 9001 clause 8.5.2 Identification and traceability requires the organisation to control unique identification when traceability is required and retain the documented information necessary to enable traceability.
Clause 7.2 competence and clause 7.3 awareness are not the best fit because the evidence shows the Workshop Supervisor and Tyre Fitter were aware of the missing records. The issue is the failure to retain required traceability information.
NEW QUESTION # 257
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