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WorksheetsBengkel Audit Dalaman
Total questions: 25
Worksheet time: 13mins
Which clause explain about internal audit?
Clause 8.8.3
Clause 7.3.3
Clause 8.9.3
Clause 6.8.3
What is MS ISO 15189
Specific requirements for quality of laboratories
Specific requirements for quality management system
Specific requirements for quality and competence for medical laboratories
Specific requirements for quality to medical laboratories
Auditors and person managing auditing program should..
Consider the auditee feelings during the audit
Help to hide the significant audit findings
Be honest and unbiases in reporting audit findings.
Share any sensitive or confidential information with other non related personal.
Which statement is FALSE?
Evidence based approach audit should have verifiable data
Risk based approach influence the planning, conducting and reporting of audit focus on auditee interest and audit program objectives.
Risk evidence based approach audit is the rational method for reaching reliable audit conclusion.
Appropriate sampling should be use in evidence based approach.
What NOT to be consider for the auditee before audit program?
Information security and confidentiality requirements.
The need and expectations of relevant interested parties
The interpersonal issues of the auditee.
Organizational objectives
The statements are true, EXCEPT?
The quality manager delegate the internal audit task
Internal audit is done by laboratory personal to determine the extend of the laboratory's conformity.
Internal auditors are independent from operations that are being evaluated,
Internal audit will be conducted if there is incident reporting made.
These are responsibilities of Internal Auditor EXCEPT?
Follow up on adequacy of corrective action.
Assess the fundamental issues of the organization
Delegate the audit task.
Determine level of compliance
Audit method in conducting internal audit
Interview, observe and examine
Observe and examine
Interview only
Examine only
Which of these is NOT 5 C's of internal audit.
Criteria
Clause
Corrective action plan
Consequences
Cheques
The audit cycle consists of the following four steps;
Planning, conducting, review and close out
Planning, program, conducting and close out
Program, conducting, close out and review
Planning, program, close out and review
Internal audit is:
First party audit
Third party audit
Second party audit
A non-conformance is define as;
Not meeting the requirements of the standard.
Non fulfilment of specified requirement.
Not meeting the requirement of the quality system
The root cause of an inability to produce competent result
Agreement is NOT necessary in planning internal audits. Once told, people will know what is expected.
True
False
Internal audit program is:
Formal/scheduled audit
Surprise/informal
Both of the above
Types of NON CONFORMITIES. Which of this is NOT true?
Minor non conformity Cat 3
Any non conformities that does not adversely affect the performance
Major non conformity Cat 2
Multiple minor non conformities when considered collectively may raise the category to major or critical non conformity
Critical non conformity Cat 1
Any conformities that cause hazardous or unsafe condition and require immediate suspension.
Confidentiality during an internal audit is the responsibility of:
The accreditation body
Auditee(s)
ISO
Auditor(s)
Observation is area of concern but insufficient objective evidence that could lead to potential non conformity if not tackled,
True
False
Auditors need to take good notes to:
Look thorough
Record evidence to support findings
Record evidence to support requirements
Identify who has made the mistake
Audit findings MUST:
Be written in pen
Have the agreement of the quality manager
Have the agreement of the accreditation body
Be supported by audit evidence
What does an internal audit plan normally contain?
Areas, objectives, timing and location of record.
Audit team names, date, objectives and timing
List of staff participants, scope, objectives and logistic details
Timing, scopes,locations and audit referrence documents
Agreement is NOT necessary in planning internal audits. Once told, people will know what to expect.
True
False
Closing meeting are generally
Shorter than opening meeting because everyone already acquainted
A formal discussion to discuss the process flow of an audit before the audit takes place
A formal meeting to present the outcomes of the audit
Longer than opening meeting because of argumentations and fighting
The following people are responsible for the content and format of the audit report
Top management, the accreditation body, and auditees
The auditors
The auditees
Admin staff
What to do after an audit?
Argue with auditor regarding the findings
Continue work as usual
Improve and try to find corrective action
SAMM stands for:
Standard Malaysia
Standard Akreditasi Makmal Malaysia
Skim Akreditasi Makmal-Makmal
Skim Akreditasi Makmal Malaysia
