All of the following factors are included in identification and traceability, EXCEPT:

• A) Contract Requirement
• B) Problem Prevention
• C) Status of Products
• D) Risk Mitigation

All of the following are included in inputs to management review, EXCEPT:

• A) Planning for future resources
• B) Recommendations for improvement
• C) Results of audits
• D) Customer feedback

Which of the following is an answer to the Third Absolute of Quality Management as summarized by Crosby; what performance standard should be used?

• A) Price of nonconformance
• B) Conformance to requirements
• C) Zero defects
• D) Prevention

Which of the following will NOT be included in the process of validation?

• A) Approval of equipment and qualification of personnel
• B) Use of vague methods and procedures
• C) Requirements for records
• D) Defined criteria for review and approval of the processes

According to John Kotter, which one of the following begins with planning for budgeting?

• A) Management
• B) Leadership
• C) Teamwork
• D) Performance

What is required after taking corrective action in the process of acquiring the certificate of ISO 9000?

• A) Selecting a third party registrar
• B) Selecting the appropriate standards
• C) Submitting quality manual for approval
• D) Final assessment by registrar

Which of the following is the primary purpose of quality documentation?

• A) To be recognized for mastery of scientific principles, as well as an ongoing commitment to quality patient care
• B) To express the quality policy and to describe the quality management system
• C) To notify the specific information that permits adequate review, approval and recording of plans
• D) To assure that software products are safe and reliable without placing an undue burden on manufacturers

Crosby’s program calls for measuring and publicizing which of the following options?

• A) Cost of quality product
• B) Quality of specification
• C) Quality of design
• D) Cost of poor quality

Which of the following can be used as a benchmark for assessing different organizations for equivalent comparison?

• A) Black Widow Model
• B) Organizational Model
• C) Maturity Model
• D) Locust Model

All of the following are the agreed generic product categories as per ISO-9000, EXCEPT:

• A) Services
• B) Processed materials
• C) Employees
• D) Software

Which of the following statements is TRUE for ISO 9001?

• A) Describes the principles of a quality management system and defines the terminology
• B) Intended for internal use and not for contractual purposes, focuses particularly on continually improving performance
• C) Contains the guidelines for auditing quality management and/or environmental management systems
• D) Describes the requirements relative to a quality management system either for internal use or for contractual or certification purposes

How many maturity levels are there in the Capability Maturity Model?

• A) Four
• B) Five
• C) Seven
• D) Six

Which one of the following options is included in ISO 9000 QMS manual?

• A) Quality work instructions
• B) Quality literature
• C) Quality audit
• D) Quality description

How should the benchmarking of individual processes as well as customer satisfaction be employed?

• A) As an improvement tool
• B) As a defective tool
• C) As a standard tool
• D) As an instrumental tool

All of the following are sources of information for corrective action, EXCEPT:

• A) Supplier contribution
• B) Internal audit reports
• C) Customer complaints
• D) Non-Conformance reports

Which one of the following nationals defines quality as doing things right the first time is cheaper than correcting errors?

• A) Pakistani
• B) Americans
• C) Europeans
• D) Japanese

Which of the following is an accurate statement about preservation of conformity of product?

• A) It implements release, delivery and post-delivery activities
• B) It defines criteria for review and approval of the processes
• C) It makes work instructions available, as necessary
• D) It includes identification, packaging, storage and protection

Which one of the following actions organization should take to remove the potential non conformances?

• A) Preventive
• B) Centralized
• C) Decentralized
• D) Corrective

Which one of the following levels of ISO 9001,9004 (2000) describes about “continual improvement”?

• A) Level 4
• B) Level 3
• C) Level 2
• D) Level 1

All of the following are included in general requirement of QMS, EXCEPT:

• A) Identify the processes needed for the quality management system
• B) Ensure availability of resources and information
• C) Implement action necessary to achieve result
• D) Performance standard will be zero defects