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Bayer LSS Black Belt Survey
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Training Survey
How relevant was the training to your function and role?
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How useful was the training to your function and role?
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How satisfied are you with the training?
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Satisfied Enough
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What did you appreciate most (or least) about the training?
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Learning Check
1. The QMS Approach based on ISO 9001 involves the following except? Choose the correct answer.
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Prevent non-conformities and eliminate their causes
Establish the quality policy and quality objectives
Ensure customer expectations are exceeded
Apply a process for continually improving the QMS
2. ISO 9001 specifies requirements that are intended to create confidence in an organization's products and services, which ultimately? Choose the best option.
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Improves process efficiency
Enhances customer satisfaction
Satisfies legal requirements
Reduces statutory penalties
3. In understanding our organizational context of our QMS, we need to determine the internal and ( ) that are relevant to our company's purpose and strategic direction. Type your response.
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4. We need to determine the ( ) of interested parties that are relevant to our QMS. Type your response.
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5. What is NOT considered in establishing the scope of our QMS? Choose the least required.
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Our products and services
Requirements of interested parties
Exclusions in ISO 9001 requirements
Risks and Opportunities
6. What conditions are TRUE about QMS Processes? Choose all that apply.
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Responsibilities and authorities for QMS processes are assigned
Resources to ensure the availability of QMS processes are determined
Processes and the QMS are continually improved
Inputs, outputs, sequences and interactions of QMS processes are determined
7. Top Management is ( ) for the effectiveness of our QMS. Choose the best option.
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Responsible
Accountable
Consulted
Informed
8. What is NOT TRUE about a Quality Policy. Choose the least applicable.
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It provides a framework for setting the Quality Objectives
It provides a framework for setting the Quality Plan
It includes our commitment to satisfy applicable requirements
It includes our commitment to to continually improve our QMS
9. The following roles are identified by Top Management except? Choose the least required.
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Role that ensures that the QMS conforms to ISO 9001
Role that reports QMS performance
Role responsible for promoting customer focus
Role for addressing risks and opportunities
10. Which of the following are reasons why risks and opportunities need to be addressed. Choose all that applies.
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To provide assurance that our QMS will deliver its intended results
To guarantee customer satisfaction will be enhanced
So desirable effects are enhanced while the undesirable ones are prevented or reduced
So statutory and regulatory requirements are satisfied
11. Which of the following is NOT TRUE about Quality Objectives? Choose the right option.
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Quality Objectives take into account applicable requirements
Quality Objectives are established to achieve the Quality Plan
Quality Objectives are measurable and maintained as documented information
Quality Objectives are communicated, monitored and updated, as appropriate.
12. Which among the following are considered when planning to implement changes in the QMS? Choose all that apply.
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Purpose and consequences of the change
Integrity of the QMS
Availability of resources
Allocation of responsibilities and accountabilities
13. Resources needed for the effective operation of our QMS processes include the following except? Choose the least required.
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People
Infrastructure and environment
Documented Information
Organizational knowledge
14. People who influence the performance and effectiveness of our QMS are competent based on their education, training or ( ). Type your response.
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15. Which among the following should our employees be aware of? Choose all that apply.
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Quality policy and quality objectives
Their contribution in keeping our QMS effective
Benefits of improving our QMS
Implications of not conforming to QMS requirements
16. Internal and External Communications should include the following except? Choose all that apply.
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What we will communicate
Who will communicate
When will we communication
Why should we communicate
17. Which of the following is true about managing documented information? Choose all that apply.
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They are available for use when and where they are required
They are reviewed and approved for suitability and adequacy
They are protected from unintended alterations
They have appropriate identification and description
18. The consequence of unintended changes must be reviewed and corrected to mitigate their negative effects. True or False?
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True
False
19. We must ( ) the requirements of our clients before we accept them especially when they do not provide any documented information about their requirements? Choose the best option.
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Review
Confirm
Fulfill
Document
20. Which documented information about the Design and Development of products and services do we need to maintain? Choose all that apply.
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Design and Development inputs
Design and Development Outputs
Design and Development Changes
Review, verification and validation activities
21. What are the 2 criteria must be established for Operational Planning and Control? Choose all that apply.
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Evaluation Criteria
Selection Criteria
Acceptance Criteria
Product Criteria
22. Which among the following must be reviewed before committing to provide our products and services? Choose all that apply.
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Applicable statutory or regulatory requirements applicable to our products and services
requirements specified by our clients including those that they do not state but are necessary for their intended use, when known
External provider requirements
Contract or order requirements that differ from what clients’ previous express
23. Below are common requirements that must be considered in the Design and Development of products and services, except? Choose the right option.
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Performance Requirements
Technology Requirements
Functional Requirements
Applicable Statutory Requirements
24. Externally provided processes, products and services must not adversely affect our ability to consistently deliver our commitments to customers. True or False?
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True
False
25. Which among the following do we prevent when providing our products and services under controlled conditions? Choose the right option.
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We prevent infrastructure and environments from operating our processes.
We prevent competent people with required qualifications
We prevent human errors
We prevent release, delivery and post-delivery activities
26. When releasing products and services to customers, which documented information must we maintain? Choose all that apply.
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Evidence of conformity with the acceptance criteria
Traceability to the person authorizing the release
Description of the nonconformity
Authority deciding the actions related to the nonconformity
27. Our outputs that do not conform to client requirements are released to allow their unintended use or delivery. True or False?
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False
True
28. Which among must we actively monitor and measure? Choose all that apply.
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The conformity of our products and services
The degree of customer satisfaction
The performance and effectiveness of our QMS
The performance of external providers
29. Which among the following are NOT performed when managing Internal Audits? Choose the right option.
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We define an audit program, audit criteria and audit scope
We select auditors and conduct audits with objectivity and impartiality
We perform Internal Audit at planned intervals
We report audit results only to top management
30. Outputs of Management Reviews must include decision and actions about which of the following, except? Choose the right option.
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Improvement opportunities
Changes to our QMS
QMS resource requirements
Customer satisfaction
31. We identify and select improvement opportunities and implement actions needed to meet customer requirements and lessen customer dissatisfaction. True or False?
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False
True
32. Which among the following are required when managing non conformities? Choose all that apply.
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Our corrective actions are appropriate to the effects of the nonconformities
we implement the needed corrective actions and review their effectiveness
We evaluate the need to eliminate the causes of a nonconformity
We retain documented information about the nature of nonconformities
33. We continually improve the ( ), adequacy and effectiveness of our QMS. Type your response.
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Bayer LSS Black Belt Survey
UA-230143155-1