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Free ISO-9001-Lead-Auditor Exam Braindumps (page: 13)

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QUESTION: 49

DRAG DROP (Drag and Drop is not supported)
You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time. The organisation offers warehousing and export services to customers. Customers are invoiced for the time stock items are stored in the warehouse. Transport to and from the warehouse is controlled by the organisation and approved subcontract transport services are used. The organization does not have its own transport vehicles. Stock items are not purchased by the organisation.

You have gathered audit evidence as outlined in the table. Match the ISO 9001 Clause 8 extract to the audit evidence.

See Explanation section for answer.

Answer(s): A

Explanation:

The table below shows the possible matching of the ISO 9001 Clause 8 extract to the audit evidence.

Table
Audit evidence ISO 9001 Clause 8 extract

Four of the 10 pallets of stock sampled in the warehouse were not labelled. "8.5.2 ... shall use suitable means to identify outputs ..."

A damaged pallet of stock seen in the quarantine area was "8.7.1 ... shall ensure that outputs that do not conform to leaking liquid onto the floor. their requirements are identified and controlled ..."

One of the fork-lift truck drivers had no fork-lift truck driving "8.5.1 e ... shall include, as applicable ... the appointment licence. of competent persons ..."

"8.5.4 ... shall preserve the outputs during production and
There was no pest control provision in the warehouse. service provision ..."

Two pallets of temperature-sensitive stock items were being stored at ambient as the chilled storage facility was full. "8.1 ... shall plan, implement and control the processes ..."

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QUESTION: 50

DRAG DROP (Drag and Drop is not supported)
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.

See Explanation section for answer.

Answer(s): A

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 "8.3.2 e) ... internal ... resource needs for Manager explains he has not got enough people on his team to cope with the the design and development of products demand for new products. ..."

The NPD Manager explains many changes are made to cosmetic formulations during product development owing to retailer feedback. Only when confirmed "8.3.5 ... retain documented information by the retailer is the agreed formulation documented on SWIFT. ..."

The NPD Manager explains that the customer confirms their approval to "8.3.6 ... retain documented information proceed with a new formulation by email. These emails are kept on SWIFT. ..."

"8.3.4 d) ... conducted to ensure that the
The NPD Manager shows you evidence of consumer trials that are carried out resulting products and services meet the for some new products prior to full-scale launch. requirements ..."

The NPD Manager explains that an approved external laboratory is used to "8.3.2 e) ... external ... resource needs for perform shelf-life stability trials on some formulations during product the design and development of products development. ..."

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QUESTION: 51

DRAG DROP (Drag and Drop is not supported)
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.
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.

See Explanation section for answer.

Answer(s): A

Explanation:

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QUESTION: 52

DRAG DROP (Drag and Drop is not supported)
You are carrying out an audit to ISO 9001 at an organisation which offers regulatory consultancy services to manufacturers of cosmetics.

You are interviewing the Technical Director (TD), who manages a team of regulatory experts responsible for providing regulatory services to customers.

You: "How do you ensure your regulatory team's competence concerning regulatory requirements is maintained?"

TD: "The two Regulatory Experts we employ full-time have years of experience of working in the cosmetics industry."

You: "How is their regulatory competence maintained?"

TD: "They are dedicated individuals with lots of contacts in the sector."

You: "How does the business enable them to maintain their understanding of current regulatory requirements?"

TD: "We leave that up to them."

See Explanation section for answer.

Answer(s): A

Explanation:

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Inbarajan commented on January 02, 2025
Very useful
Anonymous
upvote

Faith Egwuenu commented on December 09, 2024
The case studies/questions were very helpful.
Anonymous
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Md. Jakir Hossain commented on November 17, 2024
pls help me given total question
BANGLADESH
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Joseph commented on November 08, 2024
The questions and answers/explanations are very helpful and professional, thank you
Anonymous
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Tadele commented on November 02, 2024
Help full to next exam
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Arvind Sharma commented on October 27, 2024
Helpful questions for preparation foe LA exam
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Rajesh Kumar M - commented on October 26, 2024
For the question 6- the continual improvement , the organization shall continually improve the suitability, adequacy and effectiveness of the QMS. Not Efficiency, Refer Clause 10.3 continual improvement in ISO 9001 :2015
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jakir commented on October 24, 2024
its really more help full.
BANGLADESH
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Apvj commented on October 17, 2024
Need to update section 5 questions,it was all new question today in exam , unitl section 4 it was fine even though pattern of question changed
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vaibgav commented on October 13, 2024
nice paper for practise
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Md Nur Hosen commented on September 21, 2024
Preparing for exam
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SRILANKA commented on September 04, 2024
PREPARING FOR EXAM
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