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>> PECB ISO-9001-Lead-Auditor Vorbereitungsfragen <<
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201. Frage
(Which one of the following characteristics of documented information does not need to demonstrate conformity to the requirements of clause 7.5 of ISO 9001?)
Antwort: A
Begründung:
ISO 9001:2015 Clause 7.5 - Documented Information establishes requirements for the creation, updating, and control of documented information within the Quality Management System (QMS).
Relevant ISO 9001 Requirements
Clause 7.5.2 - Creating and Updating
When creating and updating documented information, the organization shall ensure appropriate:
* Identification and description (e.g., title, date, author, reference number)
* Format and media
* Review and approval for suitability and adequacy
This supports the requirement that documented information be identifiable .
Clause 7.5.3 - Control of Documented Information
Documented information required by the QMS and by ISO 9001 shall be controlled to ensure:
* It is available and suitable for use where and when it is needed
* It is adequately protected
Control activities include:
* Distribution, access, retrieval and use
* Storage and preservation
* Control of changes (version control)
* Retention and disposition
These requirements support:
* Retrievable # Required by Clause 7.5.3
* Under change control # Required by Clause 7.5.3
* Identifiable # Required by Clause 7.5.2
Why " Translatable to Other Languages " is Incorrect
ISO 9001:2015 does not require documented information to be translated into other languages.
An organization may choose to translate documents where necessary for operational effectiveness, multinational operations, or legal requirements, but this is not a requirement of Clause 7.5 .
Therefore, being translatable to other languages is not a characteristic that documented information must demonstrate to conform to ISO 9001.
Evaluation of Each Option
Option
Required by ISO 9001 Clause 7.5?
Retrievable
Yes
Under change control
Yes
Translatable to other languages
No
Identifiable
Yes
ISO-Aligned Conclusion
Clause 7.5 requires documented information to be identifiable , retrievable , and controlled against unauthorized or uncontrolled changes . There is no ISO 9001 requirement that documented information be translatable into other languages .
202. Frage
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 two statements that apply to the term
`nonconformity'.
Antwort: B,C
Begründung:
According to the ISO 9001:2015 standard, clause 10.2.1 defines nonconformity as the non-fulfilment of a requirement. A requirement can be related to the quality management system, the products and services, the customer expectations, or the applicable statutory and regulatory requirements. Nonconformities can be detected through various sources, such as audits, inspections, tests, customer complaints, or internal reviews.
Nonconformities must be addressed by taking appropriate actions to correct them and prevent their recurrence.
In this scenario, the auditee has shown several issues that indicate nonconformities in their quality management system. Two statements that apply to the term nonconformity are:
A: No quality objectives planned for the top management team: According to ISO 9001, clause 6.2.1, the organization must establish quality objectives at relevant functions, levels, and processes. The quality objectives must be consistent with the quality policy and the strategic direction of the organization. The top management team is responsible for providing leadership and direction for the quality management system and ensuring its alignment with the organization's purpose and context. Therefore, the absence of quality objectives for the top management team is a nonconformity as it violates the requirement of clause 6.2.1.
E: Quality improvements not aligning with the quality policy: According to ISO 9001, clause 5.2.1, the quality policy is a statement of the organization's intentions and direction regarding quality, as formally expressed by top management. The quality policy must provide a framework for setting quality objectives and be compatible with the context and strategic direction of the organization. The quality policy must also be communicated, understood, and applied within the organization. Therefore, if the quality improvements are not aligned with the quality policy, it is a nonconformity as it violates the requirement of clause 5.2.1.
203. Frage
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.
Antwort:
Begründung:
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 ..."
204. Frage
What are the objectives of the Stage 2 audit?
Antwort: A
Begründung:
Comprehensive and Detailed In-Depth Explanation:
The Stage 2 audit (ISO 17021-1:2015, Clause 9.3.1.3) is conducted to:
* Verify whether the QMS is effectively implemented and operational.
* Ensure compliance with ISO 9001 requirements in actual practice.
* Identify nonconformities that may impact certification.
Reviewing documented information (Answer B) is part of Stage 1, and gathering scope information (Answer C) is done before the certification audit.
Reference:
ISO 17021-1:2015, Clause 9.3.1.3 (Stage 2 Audit)
205. Frage
A person who provides specific knowledge or expertise to the audit team during the audit is known as a
/an:
Antwort: C
Begründung:
Comprehensive and Detailed In-Depth Explanation:
A technical expert is someone with specialized knowledge that helps the audit team understand specific technical aspects of the auditee's processes.
Clause References:
* ISO 19011:2018, Clause 7.3.4 - Use of Technical Experts:
* Technical experts support the audit team with specialized knowledge but do not perform the audit themselves.
Why is the Correct Answer B?
* A technical expert is needed when auditors lack deep expertise in specific areas, such as engineering, software, or medical devices.
* They assist in interpreting complex technical requirements but do not act as auditors.
Why are the Other Options Incorrect?
* A (Observer) # Observers do not contribute expertise; they only watch the audit (e.g., trainees).
* C (Guide) # Guides help with logistics but do not provide technical expertise.
Reference:
ISO 19011:2018, Clause 7.3.4 - Use of Technical Experts
206. Frage
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