The examination paper has four parts

The examination paper has four parts, all questions must be answered.

Time allowed: 1 and half hours

Total mark is 100. Each part must have 10 marks or above.

You answer must write on the space on the examination paper. Additional sheet of paper is not

accepted.

In this examination paper

“

ISO13485< /p>

”

and

“

the standard

”

is refers to ISO 13485:2003

Part 1: 15 True/False questions, 2 marks each.

Please write T=True or F= False in the blank.

Part 2: 10 multiple choice questions, 2 marks each.

Please circle the most suitable answer(A, B, C, D, or E)

Part 3: 3 short questions, 10 marks each

Please write the answer in the blank.

Part 4: 1 Case study, 20 marks

Please write the answer in the blank

Part 1: 15 True/False Questions; 2 Marks Each

Please write T=True or F=False in the blank

1.

( ) All requirements of ISO13485 standard are specific to manufacturing organizations.

2.

(

)

Same

as

ISO9001:2008

standard,

only

6

documented

procedures

required

in

ISO13485

requirements.

3.

( )The organization can determine exclude any clause(s) of ISO 13485, and just need to detail

the justification in its quality manual.

4.

( )It is necessary to maintain the record from management reviews.

5.

( ) While ISO 13485 is a stand-alone standard, it is based on ISO9001:2008.

6.

(

)

The

organization

shall

establish

documented

requirements

for

maintenance

activities,

including their frequency, when activities or lack thereof can affect product quality, but the

records of such maintenance do not be necessarily maintained.

7.

( ) The organization does not need to determine the requirement not stated by the customer

but necessary for specified or intended use.

8.

(

)

The

organization

shall

establish

documented

requirements

for

risk

management

throughout product realization. Records arising from risk management shall be maintained.

9.

( ) Validation not yet completed still can delivery or implementation of the medical device.

10.

(

)

The

organization

shall

evaluate

and

select

suppliers

based

on

their

ability

to

supply

product in accordance with the organization

’

s requirements. Criteria for selection, evaluation

and re-evaluation are not necessarily established.

11.

( )The organization shall establish and maintain a record for each batch of medical device that

provides traceability to the extent specified and indentifies the amount manufactured and

amount approved for distribution. The batch record shall be verified only.

12.

() In 7.5.1.2.2 clause of ISO 13485, the installation activities mean the assembly process in

manufacturing workshops by the workers.

13.

( ) Sterilization Process is necessarily validated prior to initial use.

14.

( ) For Internal audit, the auditors can audit their own work.

15.

( ) If product needs to be reworked, the organization shall document the rework process in a

work instruction that has undergone the same authorization and approval procedure as the

original work instruction.

Part 2: 10 multiple choice questions, 2 marks each

Please circle the most suitable answer(A, B,C, D, or E) on the letter, each question should only

circle one answer.

2.1

The non-fulfillment of a requirement is called:

A

a concession

B

a nonconformity

C

a corrective action D

All of the above

E None of the above

2.2

Auditors can gather audit evidence by

A

Interview Staff

B

Observing activities

C

Review the documents, including the quality records

D All of the above

E None of the above

2.3 The action to eliminate the cause of nonconformities in order to prevent recurrence is

called

A

Correction

B Corrective action

C Preventive action

D

All of the above

E None of the above

2.4 Which of the following documents need to be controlled in ISO 13485 requirements?

A Instruction for use for the medical device

B Assemble drawing for the medical device

C ISO14971 Standard

D A&B

E A,B&C

2.5 Advisory notice issued by the organization, subsequent to delivery of the medical device,

to provide supplementary information and /or to advise what action should be taken in

A The use of a medical device

B

The modification of a medical device

C The destruction of a medical device

D all of the above

E none of the above

2.6 The retention period of the records should consider

A The lifetime of the medical device

B

The relevant regulatory requirements

C Not less than 2 years from the date of product release by the organization(4.2.4 clause in

ISO13485)

D All of the above

E None of the above

2.7

The input of management review shall include information on

A

Results of audits

B

New or revised regulatory requirements

C

Corrective and Preventive Action Status

D all of the above

E

none of the above

2.8

The

extent

of

the

quality

management

system

documentation

can

differ

from

one

organization to another due to

A

The size of the organization and type of activities

B

The complexity of processes and their interactions

C

The competence of personnel

D

All of the above

E None of the above