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NEW QUESTION # 239
Below are four of the seven principles on which ISO 9000 series are based. Match a potential benefit to each of the quality management principles (QMP).
Answer:
Explanation:
Explanation:
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According to the ISO 9000:2015 document, the seven quality management principles are:
Customer focus
Leadership
Engagement of people
Process approach
Improvement
Evidence-based decision making
Relationship management
For each principle, the document provides a statement, a rationale, key benefits, and actions you can take to apply the principle in your organization.
Based on the document, here is a possible way to match a potential benefit to each of the four quality management principles you mentioned:
Table
Quality management principle
Potential benefit
Customer focus
Increased revenue and market share
Engagement of people
Enhanced trust and collaboration throughout the organization
Improvement
Enhanced drive for innovation
Evidence-based decision making
Increased ability to demonstrate effectiveness of past actions
NEW QUESTION # 240
What does the application of the process approach in a QMS enable?
Answer: C
NEW QUESTION # 241
Who maintains ownership of the audit report?
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:
According to ISO 17021-1:2015, Clause 9.4.8 (Audit Reporting):
* The certification body retains ownership of the audit report as it is responsible for the certification decision.
* The auditee may receive a copy, but it does not own the report.
* The audit team leader compiles the report but does not own it.
Thus, C is the correct answer.
Reference:
ISO 17021-1:2015, Clause 9.4.8 (Audit Reporting)
NEW QUESTION # 242
Select six of the activities that are specifically required by ISO 17021-1 as part third-party (Certification Body) surveillance audit processes.
Answer: A,B,C,F,I,J
Explanation:
The activities that are specifically required by ISO 17021-1 as part of third-party (Certification Body) surveillance audit processes are:
*Option A: Audit use of certification marks on marketing materials. This option is correct because ISO
17021-1:2015 clause 9.6.2.2 requires the certification body to audit the client's use of marks and/or any other reference to certification, as applicable, to ensure conformity with the certification requirements.
*Option B: Review changes to the QMS since last visit. This option is correct because ISO 17021-1:2015 clause 9.6.2.2 requires the certification body to review any changes affecting the client's quality management system and its ability to continue to fulfil the requirements of the standard used for certification.
*Option C: Confirm effectiveness of internal audit and management review. This option is correct because ISO
17021-1:2015 clause 9.6.2.2 requires the certification body to confirm the continuing effectiveness of the client's quality management system, including the effectiveness of the internal audit and management review processes.
*Option F: Review the status of previously raised findings and audit effectiveness of any outstanding findings.
This option is correct because ISO 17021-1:2015 clause 9.6.2.2 requires the certification body to review the status of findings and any corrective actions taken by the client in response to previous audits, and to verify the effectiveness of the implemented corrective actions.
*Option H: Verify legal compliance. This option is correct because ISO 17021-1:2015 clause 9.6.2.2 requires the certification body to verify the client's compliance with applicable statutory and regulatory requirements related to the scope of certification.
*Option I: Handling of customer complaints since last visit. This option is correct because ISO 17021-1:2015 clause 9.6.2.2 requires the certification body to review the client's handling of customer complaints related to the certified activities since the last audit.
The following options are not correct:
*Option D: Complete a full document review of the quality management system. This option is not correct because ISO 17021-1:2015 clause 9.6.2.2 does not require the certification body to complete a full document review of the quality management system during surveillance audits. A full document review is only required during the initial certification audit or when there are significant changes to the quality management system or the certification requirements.
*Option E: Failing to meet financial responsibilities. This option is not correct because ISO 17021-1:2015 clause 9.6.2.2 does not require the certification body to audit the client's financial responsibilities during surveillance audits. The certification body may have contractual arrangements with the client regarding the payment of fees, but this is not part of the surveillance audit process.
*Option G: Review the calibration status of the instrumentation. This option is not correct because ISO
17021-1:2015 clause 9.6.2.2 does not require the certification body to review the calibration status of the instrumentation during surveillance audits. The certification body may audit the client's monitoring and measuring resources as part of the quality management system requirements, but this is not a specific activity required by ISO 17021-1.
*Option J: Conduct a minimum number of annual surveillance audits during the certification period. This option is not correct because ISO 17021-1:2015 clause 9.6.2.2 does not require the certification body to conduct a minimum number of annual surveillance audits during the certification period. The certification body may determine the frequency and duration of surveillance audits based on the risk and performance of the client, but this is not a specific activity required by ISO 17021-1.
References:
*ISO 17021-1:2015 Conformity assessment - Requirements for bodies providing audit and certification of management systems - Part 1: Requirements
*ISO 9001 Lead Auditor Course Material, Module 7: Audit Follow-up and Surveillance, Slide 8: Surveillance Audit
*ISO 9001 Lead Auditor Training Course - IRCA Certified, Section 7.2: Audit Follow-up and Surveillance
*Lead Auditor Exam Preparation Guide (EPG) Template - PECB, Section 3.2: Exam Content Outline, Subsection 3.2.1: Section 1 - Audit Fundamentals, Subsection 3.2.2: Section 2 - Audit Principles, Subsection
3.2.3: Section 3 - Audit Process, Subsection 3.2.4: Section 4 - Audit Competencies
NEW QUESTION # 243
Scenario 5: Mechanical-Electro (ME) Audit Stages
Mechanical-Electro, better known as ME, is an American company that provides mechanical and electrical services in China. Their services range from air-conditioning systems, ventilation systems, plumbing, to installation of electrical equipment in automobile plants, electronic manufacturing facilities, and food processing plants.
Due to the fierce competition from local Chinese companies and failing to meet customer requirements, ME's revenue dropped significantly. In addition, customers' trust and confidence in the company decreased, and the reputation of the company was damaged.
In light of these developments, the top management of ME decided to implement a quality management system (QMS) based on ISO 9001. After having an effective QMS in place for over a year, they applied for a certification audit.
A team of four auditors was appointed for the audit, including Li Na as the audit team leader. Initially, the audit team conducted a general review of ME's documents, including the quality policy, operational procedures, inventory lists, QMS scope, process documentation, training records, and previous audit reports.
Li Na stated that this would allow the team to maintain a systematic and structured approach to gathering documents for all audit stages. While reviewing the documented information, the team observed some minor issues but did not identify any major nonconformities. Therefore, Li Na claimed that it was not necessary to prepare a report or conduct a meeting with ME's representatives at that stage of the audit. She stated that all areas of concern would be discussed in the next phase of the audit.
Following the on-site activities and the opening meeting with ME's top management, the audit team structured an audit test plan to verify whether ME's QMS conformed to Clause 8.2.1 (Customer Communication) of ISO
9001.
To do so, they gathered information through group interviews and sampling. Li Na conducted interviews with departmental managers in the first group and then with top management. In addition, she chose a sampling method that sufficiently represented customer complaints from both areas of ME's operations.
The team members were responsible for the sampling procedure. They selected a sample size of 4 out of 45 customer complaints received weekly for electrical services and 2 out of 10 complaints for mechanical services.
Afterward, the audit team evaluated the evidence against the audit criteria and generated the audit findings.
According to general principles of sampling procedure, did the audit team select a valid sample for electrical services?
Answer: A
Explanation:
Comprehensive and Detailed In-Depth Explanation:
The audit team selected 4 out of 45 customer complaints for electrical services, which is too low based on standard statistical sampling methods. According to ISO 19011:2018 (Guidelines for Auditing Management Systems), for a population size between 13 and 52, a minimum sample size should be 5 to achieve a reasonable level of confidence.
This means the selected sample (4 complaints) was insufficient and did not align with standard sampling procedures. Therefore, the correct answer is A.
Reference:
ISO 19011:2018, Clause 6.4.5 (Sampling Methods in Auditing)
NEW QUESTION # 244
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