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Pre course handout Pre-course self assessment test on ISO 9001:2015
Bureau Veritas Certification
QMS Auditor/ Lead Auditor Training Course Pre- course self assessment test Delegate’s name: Company name: Position: Date of the course:
Hafiz M. Arshad Veolia Saudi Western Region QHSE Coordinator 27 Jan, 2019 – 31 Jan, 2019
Note: 1. This quiz has to be attempted on a hard copy and brought to the training venue on the Day 1 2. Before you attempt the test, please complete the following: 2.1 Thoroughly read the pre-course reading material including the extracts of ISO 9001:2015 standard 2.2 Complete the Pre- course assignments. 3. Attempt this test on your own ( The test will be evaluated during the training course) A. State whether the following statements are ‘TRUE’ or ‘FALSE’ - 1 mark each Sr No
Statement
True
A.1
The retention time of all records must be the same
A.2
Quality policy must be documented (5.2)
A.3
Persons whose work affects quality must be competent. (7.2 d)
A.4 A.5
Documented work instructions are necessary for each and every person Capturing customer perception is mandatory. (9.1.2)
False
B. Write answers in few words - 1 mark each B.1 Which clause of ISO 9001 covers equipment maintenance? 7.1.5 (Monitoring & Measuring Resources) 7.1.3 (Infrastructure)
B.2 The output of analysis and evaluation shall be used to : According to clause (9.1.3); it shall be used for the evaluation of following: a) conformity of products & services b) degree of customer satisfaction c) performance & effectiveness of QMS d) planning has been implemented effectively e) effectiveness of actions taken f) performance of external providers g) need of improvement to QMS
Oct 2015
QMS Auditor / Lead Auditor Training Course (A 17929)
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Pre course handout Pre-course self assessment test on ISO 9001:2015
Bureau Veritas Certification
B.3 State the difference between ‘documents’ and ‘ records’ as part of Documented Information Whenever it is stated in the standard that “documented information shall be maintained”, it is a document, & when it is “documented information shall be retained”, it is a record.
B4. Why Management reviews are required to be conducted? To ensure the continuing stability, adequacy, effectiveness & alignment with the strategic direction of the organization. (9.3.1)
B.5 State at least 2 clauses of the standard that requires records to be maintained. 4.3 (scope of organization) 5.2.2 (Quality Policy) 8.5.1 (Control of production & service provision)
B.6 ISO 9001:2015 does not address exclusion of any requirement. Please state “true” or “false”. Justify your decision
False; ISO 9001:2015 addresses exclusion of any requirement as stated in clause 4.3; “justification for any requirement of this international may only be claimed if the requirements determined as not being applicable to the scope of its quality management system”
B.7 Responsibilities and Authorities need to be documented. State “true” or “false” and justify your decision
False. Standard does not define this requirement.
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QMS Auditor / Lead Auditor Training Course (A 17929)
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Pre course handout Pre-course self assessment test on ISO 9001:2015
Bureau Veritas Certification
B.8 All records need to be maintained in Hard copy – state “true” or “false” and justify your decision
False
B.9. Process Environment must include those required for human comfort of the personnel working in the process . State true or false and justify.
7.1.4
B.10 State the difference between ‘Corrective action’ and ‘Preventive Action’.
B.12 Explain briefly PDCA cycle.
Oct 2015
QMS Auditor / Lead Auditor Training Course (A 17929)
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Pre course handout Pre-course self assessment test on ISO 9001:2015
Bureau Veritas Certification
B.13 List down the Quality Management Principles on which ISO 9001:2015 standard is based.
B.14 List two ISO 9001 clauses (number and title) that support the quality management principle, ‘Evidence based decision making’.
Any standard clause with documented information is covered in this.
B.15 Explain in your words the concept of “Change Management”
C. Match the associated term/ terminology with the definition given below – 1 mark each Sr. No.
Oct 2015
Definition (from ISO 9000:2015)
Answers
QMS Auditor / Lead Auditor Training Course (A 17929)
Associated Term/ Terminology:
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Pre course handout Pre-course self assessment test on ISO 9001:2015 C.1.
C.2.
C.3.
C.4. C.5.
C.6.
C.7.
C.8. C.9.
C.10.
Bureau Veritas Certification
Part of quality management focused on setting quality objectives and specifying necessary operational processes and related resources to fulfill the quality objectives Degree to which a set of inherent characteristics fulfils requirements
QUALITY AUDIT
Part of quality management focused on increasing the ability to fulfill quality requirements Part of quality management focused on fulfilling quality requirements Category or rank given to different quality requirements for products, processes or systems having the same functional use Part of quality management focused on providing confidence that quality requirements will be fulfilled Coordinated activities to direct and control an organization with regard to quality
CUSTOMER SATISFACTION
Need or expectation that is stated, generally implied or obligatory Something sought, or aimed for, related to quality
QUALITY PLANNING
Customer’s perception of the degree to which the customer’s requirements have been fulfilled
QUALITY MANAGEMENT SYSTEM
GRADE
EFFECTIVENESS QUALITY MANAGEMENT
CONTINUAL IMPROVEMENT QUALITY
QUALITY IMPROVEMENT
REQUIREMENT QUALITY ASSURANCE EFFICIENCY QUALITY OBJECTIVE QUALITY CONTROL ********End of Quiz******
Oct 2015
QMS Auditor / Lead Auditor Training Course (A 17929)
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