Which two of the following are the key expected results of a quality management system that conforms to the requirements of ISO 9001:2015?

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DRAG DROP

Whistlekleen is a national dry cleaning and laundry company with 50 shops. You are conducting a surveillance audit of the Head Office and are sampling customer complaints. You find that 80% of complaints originate from five shops in the same region. Most of these complaints relate to damage to customer laundry. The Quality Manager tells you that these are the oldest shops in the company. The cleaning equipment needs replacing but the company cannot afford it at the moment. You learn that the shop managers were told to dismiss most of the claims on the basis of the poor quality of the laundered materials.

On raising the matter with senior management, you are told that there are plans to replace the equipment in these shops over the next five years.

You raised a nonconformity against clause 8.5.1 of 150 9001. Select the words that best complete the sentence;

To complete the sentence click on the blank section you want to complete so it is highlighted in red and then dick on the applicable text from the options below., Alternatively, drag and drop the options to the appropriate blank section.

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Correct Answer:

Explanation:

The quality system failed to control the laundry services provided for customers in five shops.

The equipment used was not capable of consistently producing the required service.

ABC is a service organisation that cleans and irons bed and table linen for four large hospitals in the city centre. It claims to meet ISO 9001:2015 requirements. During an internal audit, an auditor observes that machine No. 4 is being operated with the three variables outside the limits established in the applicable documented procedure SP-701. The auditor has decided to raise a nonconformity.

Which six elements should be included in the nonconformity report?

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XYZ Corporation employs 100 people, and during a Stage 1 certification audit, certain issues are identified with the Quality Management System (QMS).

Which two options describe the circumstances in which you could raise a nonconformity against Clause 6.2 of ISO 9001:2015?

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Which one of the following options is the definition of the context of an organisation?

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DRAG DROP

Select the word that best completes the sentence:

To complete the sentence with the best word, click on the blank section you want to complete so it is highlighted in red and then click on the applicable text from the option(s) below. Alternatively drag and drop the option(s) to the appropriate blank section.

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Correct Answer:

Explanation:

According to the ISO – Management system standards page, the key benefits of an effective management system include improved operational effectiveness and efficiency, improved risk management and protection of people and the environment, and enhanced drive for innovation.

The Integrated Use of Management System Standards (IUMSS) handbook also states that the purpose and objectives of management system standards are to help organizations improve their performance by specifying repeatable steps that organizations consciously implement to achieve their goals and objectives.

Therefore, the complete sentence is:

“The purpose of a management system standard is to improve the performance of an organization.”

DRAG DROP

State the correct sequence of events in the certification process for an organisation to obtain third-party accredited certification to ISO 9001.

To complete the sentences click an the blank section you want to compete so itis highlighted in red and then click on the applicable text from the options below. Alliteratively, drag and drop the options to the appropriate blank section.

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Correct Answer:

Explanation:

Step 1: Programme Initial Certification Audit

Before conducting an ISO 9001 audit, organizations must arrange and plan the initial certification audit with the selected accredited certification body. This step involves scheduling the audit stages and ensuring readiness for the audit process.

Reference: ISO 9001:2015 Clause 9.2 emphasizes the planning of audits and their scheduling to achieve desired results.

Step 2: Conduct Certification Audit Stages

The certification process includes a two-stage audit.

Stage 1 Audit: Review of documentation to verify readiness and understanding of the Quality Management System (QMS).

Stage 2 Audit: A detailed evaluation of the implementation and effectiveness of the QMS against ISO 9001 requirements.

Reference: Clause 8.1 of ISO 9001:2015 discusses operational planning and control, which includes

the preparation for audit activities.

Step 3: Award ISO 9001 Certificate

After successfully completing the certification audits and resolving any identified non-conformities, the certification body awards the ISO 9001 certificate. This certificate demonstrates that the organization’s QMS meets the ISO 9001 standard.

Reference: Clause 10 of ISO 9001:2015 focuses on continual improvement and conformity, which

leads to the certification issuance.

Step 4: Accredit Certification Body

Certification bodies must be accredited to ensure they meet international standards for certification. Accreditation is conducted by bodies like UKAS (United Kingdom Accreditation Service) or ANAB (ANSI National Accreditation Board), ensuring the credibility and global acceptance of the certification process.

Reference: Clause 7.1.5 of ISO 9001 covers resource monitoring, which supports the integrity of the certification process.

By following these steps, organizations can ensure an effective and compliant certification process, achieving ISO 9001 certification.

DRAG DROP

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).

To complete the table click on the blank section you want to complete so it is highlighted in red and then click on the applicable text from the options below. Alternatively, drag and drop each of the following potential benefits to a QMP.

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Correct Answer:

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

During a third-party audit of a pharmaceutical organisation (CD9000) site of seven COVID-19 testing laboratories in various terminals at a major international airport, you interview the CD 9000’s General Manager (GM), who was accompanied by Jack, the legal compliance expert. Jack is acting as the guide in the absence of the Technical Manager due to him contracting COVID-19.

You: "What external and internal issues have been identified that could affect CD9000 and its quality management system?"

GM: "Jack guided us on this. We identified issues like probable competition of another laboratory organisation in the airport, legal requirements on COVID-19 continuously changing, the shortage of competent laboratory analysists, the epidemic declining soon, shortage of chemicals for the analysis. It was quite a good experience."

You: "Did you document these issues?"

GM: "No. Jack said that ISO 9001 does not require us to document these issues."

You: "How did you determine the risks associated with the issues and did you plan actions to address them?"

GM: "I am not sure. The Technical Manager is responsible for this process. Jack may be able to answer this question in his absence."

Select two options for how you would respond to the General Manager’s suggestion:

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DRAG DROP

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."

You decide to raise a nonconformity.

To complete the nonconformity report click on the blank section you want to complete so itis highlighted in red and then did on the applicable text from the options below. Alternatively, drag and drop the options to the appropriate blank section.

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Correct Answer:

Explanation:

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