BTW, DOWNLOAD part of ITexamReview ISO-9001-Lead-Auditor dumps from Cloud Storage: https://drive.google.com/open?id=1eFkqWNK84DvL_wlhyrIp30geX8sWGnxT
As the employment situation becoming more and more rigorous, it’s necessary for people to acquire more ISO-9001-Lead-Auditor skills and knowledge when they are looking for a job. Enterprises and institutions often raise high acquirement for massive candidates, and aim to get the best quality talents. Thus a high-quality ISO-9001-Lead-Auditor Certification will be an outstanding advantage, especially for the employees, which may double your salary, get you a promotion. So choose us, choose a brighter future.
| Certification Vendor: | PECB |
|---|---|
| Exam Name: | PECB Certified ISO 9001 Lead Auditor |
| Exam Number: | ISO-9001-Lead-Auditor |
| Related Certifications: | PECB Certified ISO 9001 Lead Implementer PECB Master in Quality Management |
| Exam Price: | USD 1000 |
| Exam Format: | Open Book, Multiple Choice |
| Certificate Validity Period: | 3 Years |
| Real Exam Qty: | 80 |
| Exam Duration: | 180 minutes |
| Passing Score: | 70% |
| Available Languages: | English |
| Sample Questions: | PECB ISO-9001-Lead-Auditor Sample Questions |
| Exam Way: | Online (PECB Exams application) or Paper-based (at training centers) |
| Pre Condition: | None (Recommended: Training course and experience in Quality Management) |
| Official Syllabus URL: | https://pecb.com/en/education-and-certification-for-individuals/iso-9001-lead-auditor |
>> ISO-9001-Lead-Auditor New Guide Files <<
The industry experts hired by ISO-9001-Lead-Auditor study materials explain all the difficult-to-understand professional vocabularies easily. All the languages used in ISO-9001-Lead-Auditor real exam were very simple and easy to understand. With our ISO-9001-Lead-Auditor study guide, you don't have to worry about that you don't understand the content of professional books. You also don't need to spend expensive tuition to go to tutoring class. ISO-9001-Lead-Auditor Practice Engine can help you solve all the problems in your study.
| Topic | Details |
|---|---|
| Topic 1 |
|
| Topic 2 |
|
| Topic 3 |
|
NEW QUESTION # 167
You are carrying out 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. The organisation 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 made, 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. They 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 ...
Answer: A,C
Explanation:
Based on the scenario provided, there is evidence of nonconformity with the requirements defined in:
C: Clause 7.5.1 Documented information - General: The scenario indicates that there is no formal process for informing users about updates to the SWIFT database, which suggests a lack of control over documented information. This could lead to users being unaware of important changes and not using the latest version of the software, which is required by the quality management system1.
E: Clause 7.5.3 Control of documented information: The Operations Director's approach to updating the SWIFT database and the lack of communication to users about these updates indicate that the documented information is not adequately controlled. Allowing users to revert to earlier versions of the software at their discretion further suggests that the organization does not have a proper mechanism in place to ensure the integrity and suitability of documented information2.
These clauses are part of the ISO 9001:2015 standard, which requires organizations to have a systematic approach to controlling and managing documented information as part of their quality management system.
The scenario described shows a casual approach to managing critical software updates, which could affect the organization's ability to consistently meet customer and regulatory requirements.
NEW QUESTION # 168
Noitol is an organisation specialising in the design and production of e-learning training materials for the insurance market. During an ISO 9001 audit of the development department, the auditor asks the Head of Development about the process used for validation of the final course design. She states that they usually ask customers to validate the product with volunteers. She says that the feedback received often leads to key improvements.
The auditor samples the design records for a recently completed course for the 247 Insurance organisation.
Design verification was carried out but there was no validation report. The Head of Development advises that this customer required the product on an urgent basis, so the validation stage was omitted. When asked, the Head estimates that this occurs about 50% of the time. She confirms that they always ask for feedback and often make changes. There is no record of feedback in the design file for the course.
The auditor raises a nonconformity against ISO 9001. Which one of the following options is the basis for the nonconformity?
Answer: B
Explanation:
Clause 8.3.4.d of ISO 9001:2015 requires that design and development validation be performed to ensure that the resulting products or services meet the requirements for their specified application or intended use.
Validation is critical to confirm that the product works as intended in real-world conditions.
In this case, Noitol omitted the design validation step approximately 50% of the time, which is a direct violation of Clause 8.3.4.d. Although they collect feedback after the fact, this is not a substitute for formal validation before the product is released. The nonconformity arises because the process of validation was neglected, not the recording of improvements or feedback.
Other options, such as documenting improvements (A) or issues with planning verification (B), are important but do not directly address the primary concern: the lack of consistent design validation before product release. Option D (8.6) concerns product release, but this nonconformity focuses on the validation stage, not just approval for release.
NEW QUESTION # 169
Which two of the following may be changed once a Stage 2 certification audit has commenced?
Answer: C,D
Explanation:
Comprehensive and Detailed In-Depth Explanation:
Once a Stage 2 certification audit has commenced, certain logistical or planning-related elements may still be adjusted, while others are fixed by prior agreement and cannot be changed.
# C. Audit Plan:
The audit plan is a document that outlines the scope, objectives, criteria, and logistics of the audit. According to ISO/IEC 17021-1:2015 (the standard for bodies providing audit and certification of management systems), clause 9.2.3.3 allows for modification of the audit plan based on real-time conditions during the audit - such as availability of auditees or changes in process access.
# F. Increase of Audit Duration:
Audit duration is generally determined during audit planning based on factors like employee count, risk, complexity, etc. However, if during Stage 2 it is found that more time is needed (e.g., due to additional processes, scope not fully covered, or significant findings), auditors are permitted to extend the audit. This ensures full coverage of all required areas as per ISO/IEC 17021-1 clause 9.1.4 and IAF MD 5.
# A. Agreed Language of the Audit:
This is determined and agreed upon in the contract and audit planning stages. Changing it during Stage 2 would create communication and documentation issues, especially in multi-site or multi-national audits.
# B. Audit Scope:
The audit scope is defined in the contract and certification agreement based on clause 4.3 of ISO 9001:2015.
Changing it mid-audit would invalidate planning, required competencies, and potentially even the certification basis.
# D. Agreed Standard for the Audit Criteria:
Changing the standard (e.g., from ISO 9001 to ISO 13485) is fundamentally altering the purpose and contractual basis of the audit and is not permissible once Stage 2 has started.
# E. Audit Checklist:
The checklist is a tool prepared by the auditor as part of audit preparation and is based on the audit plan and standard requirements. While it may be adapted during the audit (e.g., if new risks arise), it does not constitute a formal change like duration or scope.
Relevant References:
* ISO/IEC 17021-1:2015 Clause 9.2.3.3 (Audit Plan Modification)
* IAF MD 5:2019 (Duration of QMS Audits)
* ISO 9001:2015 Clause 4.3 (Scope of the QMS)
* ISO/IEC 17021-1:2015 Clause 9.1.4 (Audit Duration)
NEW QUESTION # 170
In the context of a third-party certification audit, match the roles with the following responsibilities:
Answer:
Explanation:
Explanation:
In the context of a third-party certification audit, match the roles with the following responsibilities:
Responsibilities:
Conduct the audit to the assigned area.= Auditors
Assist the auditors in identifying personnel to participate in the audit.= Guide Assign each team member's responsibility for the audit.= Audit team leader Respond to questions and provide evidence to the auditor.= Auditee According to ISO 19011:2018, clause 3, the definitions of the roles are as follows1:
Auditors: persons with the competence to conduct an audit
Guide: person appointed by the auditee to assist the audit team
Auditee: organization being audited
Audit team leader: member of an audit team appointed to manage the audit or an audit team Therefore, the roles can be matched to the responsibilities based on these definitions and the description of the audit process in clause 6 of the standard1.
References: ISO 19011:2018(en), Guidelines for auditing management systems
NEW QUESTION # 171
You are carrying out an annual audit at an organisation that offers home security services. You are interviewing the Quality Manager (QM) You: "Would you tell me about your management review process?" QM: "The senior management team plans to review the management system every six months. The review follows a set agenda and records are maintained." You: "May I see the records from the last two management reviews?" Narrative: The Quality Manager gives you the latest record, which shows the last management review took place nine months ago.
The Quality Manager then gives you the previous management review record, which took place one year before the latest review.
You: "Are there any other review reports in the last two years?
QM: "No, these are the only ones."
Answer:
Explanation:
Explanation:
Nonconformity report
ISO 9001 Clause Number: 9.3.1 Nature of problem: Management review has not been conducted at the defined frequency. ISO 9001 requirement that has not been fulfilled: ISO 9001 - "Top management shall review the organization's quality management system at planned intervals." Evidence: The last management review took place nine months ago, and the previous one took place one year before the latest review. The planned interval is six months.
NEW QUESTION # 172
......
Reliable ISO-9001-Lead-Auditor Test Materials: https://www.itexamreview.com/ISO-9001-Lead-Auditor-exam-dumps.html
What's more, part of that ITexamReview ISO-9001-Lead-Auditor dumps now are free: https://drive.google.com/open?id=1eFkqWNK84DvL_wlhyrIp30geX8sWGnxT