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ISO $9001$:$2015$ Requirements Exam

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$1.$ What is the intent of the standard ISO $9001$:$2015?$

To provide the requirements for a QMS with the ability to consistently provide products and services that meet customer and statutory requirements

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$2.$ What is the correct definition of effectiveness?

Extent to which planned activities are realized and planned results achieved

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$3.$ What is risk$-$based thinking as per the standard ISO $9001$:$2015?$

Developing a formal risk assessment process to ensure statutory and regulatory compliance

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$4.$ Which of the following statements is incorrect with regards to the application of the process approach?

It aids the consideration of processes in terms of added value.

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$5.$ What do you understand from the term PDCA?

Deming $-$ Plan, Do$,$ Check, Act cycle

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$6.$ What is meant by the quality management principle of customer focus?

The primary focus of quality management is to meet customer requirements and to strive to exceed customer expectations.

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$7.$ What is the purpose of the High$-$Level Structure Annex SL followed in the ISO $9001$:$2015$ standard?

To provide a structure and common text for all management system standards

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$8.$ Within the introduction to ISO $9001,$ which of the following statement is incorrect?

Assurance of conformity to customer and all statutory and regulatory requirements

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$9.$ The standard requires the organization to determine the external and internal issues. Which issues is it referring to$?$

Those that are within the scope of the organization's QMS but will not affect the intended results of the QMS

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$10.$ What is the purpose of identifying possible controls of a process?

To evaluate conformance to the PDCA cycle in line with continual improvement principles

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$11.$ How does the top management of an organization demonstrate leadership and commitment with respect to the quality management system as required by the standard?

By taking accountability for the effectiveness of the QMS

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$12.$ From the following, what does top management need to demonstrate within the QMS$?$

Ensure a quality policy and objectives are established and compatible with the strategic direction of the organization

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$13.$ Who must assign the responsibility and authority for reporting on the performance of the QMS and on opportunities for improvement?

Top management

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$14.$ What is the link between Clause $4\mathrm{.}1$ and Clause $6\mathrm{.}1$ of ISO $9001$:$2015?$

The output of Clause $4\mathrm{.}1$ and of Clause $6\mathrm{.}1$ are both considered in determining the risk and opportunities.

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$15.$ Which one of the following is not a requirement of change management according to ISO $9001$:$2015,$ Clause $6\mathrm{.}3?$

Reviewing risks to the intended outcomes of the QMS once changes have been implemented

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$16.$ Which of the following regarding quality objectives is not required according to Clause $6\mathrm{.}2?$

Objectives are relevant to functions and levels

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$17.$ Which of the following related to monitoring and measurement resources is a requirement?

Measuring traceability is applicable to all resources and need to be determined$/$provided to ensure valid and reliable results.

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$18.$ Which statement regarding organizational knowledge is true?

It was introduced for the purpose of safeguarding the organization from loss of knowledge.

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$19.$ Which of the following is not considered part of Clause $7\mathrm{.}1\mathrm{.}4$ Environment for the operation of processes?

Political

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$20.$ Which of the following is a mandatory requirement of the standard?

Establishing a documented procedure for monitoring and measurement resources

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$21.$ What mandatory documented information is required to be maintained for the QMS of an organization?

Quality policy and objectives

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$22.$ What documented information must be retained by the organization as required by the ISO $9001$:$2015$ standard?

Audit programme$($s$)$ audit results

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$23.$ Which of the following is not part of Clause $7\mathrm{.}5\mathrm{.}3$ Control of documented information?

Creating and updating

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$24.$ Which of the following is not a requirement of Clause $8\mathrm{.}1$ of the standard?

Ensuring the control of outsourced processes within the QMS

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$25.$ Which of the following is part of the requirements of Clause $8\mathrm{.}2\mathrm{.}1?$

To require communication with customers on complaints

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$26.$ Which of the following best explains the requirements of Clause $8\mathrm{.}2\mathrm{.}3?$

Requires reviews $($before committing to supply products or serv