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WorksheetsISO Internal Auditor Assessment
Total questions: 21
Worksheet time: 21mins
What is ISO Quality Audit?
Audit the Quality Manual, Standard Operating Procedures
Audit the Quality Management System
Audit the quality of the products and services
Audit the quality of the organisation and people
All of above
Quality Audit needs to be conducted
Only once a year
Whenever QMR feels there is a need to audit based on existing performance
According to the numbers indicated in quality manual
According to the numbers indicated in SOP
All of above
Who can be a qualified quality Auditor?
Director
Head of Department/ Manager
Executive/ Engineer
Accountant
None of above
Auditor shall check the following documents during quality audit, EXCEPT
Quality Manual
Standard Operating Procedure (SOP)
Work Instruction (WI)
All Forms
All of above
Corrective Action (CA) may be raised as a result of:
Quality System noncompliance (e.g. detected during internal audits)
Serious and/or recurring non-conforming product or service
Supplier Product Inspection
Customer complaint
All of above
The NCAR Register shall detail the Running number, Date issued, Person issued, Deficiency, and close out dates. The deficiency section to detail the Non-conformity e.g.:
Problem
Evidence of the problem
Requirements in the standard or procedure
Location where the non-conformity was found
All of above
What is the new emphasis in the latest version of ISO9001:2015?
System approach
Process approach
Risk-based thinking
Preventive action
Customer Focus
The clauses and requirements of the standard are all based on the Plan-Do-Check-Act (PDCA) cycle. Which is NOT TRUE?
PDCA is integral and operate at the process level
PDCA is integral and operate at the overall system level
The PDCA cycle never ends. It is a continual improvement process.
The PDCA cycle is one of the best practices to commonly adopted in ISO 9001 standard
None of above
Risks and Opportunities can be derived from
Internal issue of an organisation
External issues of an organisation
The needs and expectation of the interested parties of an organisation
Process within an organisation
All of above
Prior to the audit, what are the activities covered in preparation for Quality Audit?
The Auditor shall advise the Auditee (HOD, or personnel responsible for executing the processes) in advance of the intent to audit.
The Auditor shall organise for the audit by preparing a checklist of questions and possible analysis of data on the Audit Check Sheet
Cross check the latest SOP, WI and Forms. Review last year NCAR, OFI, Risk assessment and external document registration
Request for supporting documents like Organisation Chart, Infrastructure list, Skill Matrix, PDCA
All of above
Which statements below are TRUE?
A QMS is a tool to help an organisation to manage quality
QMS means quality manual
The quality manual means of recording how quality is managed within the organisation so everyone does their job in a consistent way, delivering a consistent and quality product or service
The quality manual reflects the business and the quality management system
Clause 4.2 Understanding the needs and expectation of interested parties. In IME, these interested parties include:
Employees
Suppliers
Direct Customer
Corporate Partners
Clause 4.2 Understanding the needs and expectation of interested parties and effective QMS.
These parties add direct value to the organisation and/or are affected by the activities within the organisation
Identifying their needs and expectations lays the foundation of implementing an efficient QMS
Their needs and expectations shall be audited in quality audit
All above are False
Which statements are TRUE below?
An Auditor shall be independent and unbiased as possible, and shall not audit his own Department or in functions where he/she has responsibilities
HOD shall presence during the audit
Auditor shall brief the Auditee the purpose and scope of audit; method for recording noncompliance and follow-up arrangement
The Auditor shall seek evidence of compliance with the requirements of procedures, and such evidence shall be stated against the prepared Audit Checklist. Compliance checks shall be sought by sampling records and observation of activity. The results of the sampling and observation shall be recorded on the Audit Checklist.
Kindly confirm the sequence of audit below:
I. Questionnaires
II. NCAR follow up and Closing
III. Identify NCAR/ OFI, confirm with HOD or process owner
IV. Prepare IA Report
I, II, III, IV
I, III, IV, II
III, I, IV, II
I, III, II, IV
What is classification available for IQA finding:
Non-Conformance (NC)
Acceptable (A)
Observation (O)
Opportunity for Improvement (OFI)
When non-conformities are found, the Auditor shall issue a NCAR as detailed in procedure for Corrective Action. Which statements are TRUE below?
At the close out meeting, the Auditor shall present an overview of the audit results. Non-complying aspects of the audit shall be presented in NCAR.
The CA shall be completed as far as practical during the meeting, copied for information to the audited department and the original retained by the responsible parties/ Auditors for follow-up.
The Auditor shall prepare a formal audit report (IA Report). The Audit Check Sheet and any NCAR may be listed and/or attached. The results of the audit shall be analysed to provide an indication of the effectiveness of the QMS.
When the follow-up audit indicates that the nominated actions taken have been implemented and are effective, the QMR shall close out the NCAR as defined in the relevant procedure.
Who are the potential Auditees to be audited in QMS?
Top management
Managers
Workers
Suppliers
Customers
Which one is TRUE?
Risk Assessment to be conducted at company Level
Risk Assessment to be conducted at process Level
Risk Assessment required in ISO9001:2008
Risk Assessment required in ISO9001:2015
Which one is NOT TRUE on infrastructure?
Infrastructure include of Process equipment, Building and associated M&E infrastructure, Logistic and telecommunication system
Infrastructure include of computer software and hardware and networking system
Audit on Infrastructure shall be performed at company level
Audit on Infrastructure shall be performed at process level
Who shall determine the criteria of maintenance for the Infrastructure based on existing infrastructure performance and machine operating manuals?
CEO
HODs
Managers
HR custodian
