WorksheetsISO 9001:2015 Awareness
Total questions: 20
Worksheet time: 10mins
"The organization shall determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system." Which of the following is true about this statement?
It is a requirement
It is a recommendation
It is a suggestion
None of the above
ISO 9001 requires that organizations conduct internal audits at planned intervals. What intervals are recommended?
Every 6 months
Once a year
Every 3-4 months
The Standard does not recommended a specific interval
The organization shall conduct the Management Review at least twice a year.
True
False
Extent and boundaries of an audit are defined as
Audit scope
Audit criteria
Audit evidence
Audit schedule
Which of the following DOES NOT comply with the good storage requirements?
Store on pallet or racking
Mixed raw materials and finished product as long as all items are packed properly
Label raw material
Store room is clean and well ventilated
Auditor shall not audit their own works or area of responsibilities.
True
False
Which of the following tools can best be used to visually represent the interrelationship of processes?
Work Instructions
SOP
Procedures
Business process mapping
P-D-C-A stands for
Plan-Do-check-Act
Plan-Do-correct-Act
Proceed-Do-check-Act
Proceed-Do-correct-Act
Clause 4.4 Quality management system and its processes, requires the determination of:
inputs and outputs of processes
sequence and interaction of processes
criteria and methods needed to control processes
resources needed
All of the above.
Clause 7.1 Resources, requires the determination of following resources.
People, Infrastructure, Environment for operation, monitoring and measuring resources, and organization knowledge.
People and infrastructure needed only.
Infrastructure and knowledge only.
Clause 7.2 Competence, requires the following as the basis:
education, training or experience.
education and experience only
skill only
experience only
Clause 7.5.3 Control of documented information, requires to address the following:.
distribution, access, retrieval and use, storage, preservation, control of changes, retention and disposition of documented information.
storage and preservation only.
retention and disposition only.
obselete document control only.
Clause 8.4 Control of externally provided processes, products and services, requires the determination and apply criteria for the evaluation, selection, monitoring of performance and re-evaluation of non-performing approved external providers only.
True
False
What is a standard?
A document that provides
requirements
guidelines
specifications
All of the above.
Management review inputs consist of:
the status of actions from previous management reviews;
changes in external and internal issues that are relevant to the quality management system;
information on the performance and effectiveness of the quality management system
all of above
none of above
The Medical Certificates for staff S001, S90 and S71 show that they have high blood pressure and it was found that the workers recorded a very high number of sick leaves. From the interview with Human Resources Officer, he told that they never have high blood pressure before but due to excessive production pressure , they were ordered to work late into the night for 3 consecutive months due to insufficient of manpower. The objective evidence is against clause:
7.1.5
7.1.2
7.2
7.1.3
During visiting the production location of Line A, it was found that the employee were working in very dim lighting conditions and floor filled with black oil spillage and very slippery. The objective evidence is against clause:
7.1.2
7.1.4
7.1.5.2
7.3
Inspection result during inspection by QC inspector is recorded in the system. However, the QC supervisor had changed the result after detecting the result recorded by QC inspector is out of specification in order to prevent delay in delivery to customer. The objective evidence is against clause:
7.5.2a
7.5.2c
7.5.3.1b
7.5.3.2
QMS records stored in the filing room had deteriorated and damaged to such an extent that they could not be identified. The objective evidence is against clause:
7.2
7.5
6.3
7.1.2
Risk-based thinking has inbuilt provision for preventive action
True
False
