ISO 14971 2007


1.
2.ISO 14971 2007
3.

ISO 14971



ISO 13485 2003 7.1 The organization shall establish
documented requirements for risk management
throughout production realization. Records arising from
risk management shall be maintained.

ISO14971


MDD 93/42
It(the quality syatem)shall include in particular an
adequate description of:
.the procedures for monitoring and verifying the design
of the procedures and in particulars:
..the result of the risk analysis

ISO 13485
QS

ISO 14971
Requirements


Risk management
Systematic application of management
policies,precedures and practices to the tasks of
analysing ,evaluating,controling and monitoring
risk(ISO:14971 2007 2.22)

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ISO 14971 2007

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ISO 14971 2007

1.
2.
3.
4.
5.
6.
7.
8.
9.
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Section 1

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Section 2

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Section 3

3.1

3.3 3.4
3.2

1.
2.
3.
4.

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Section 3

3.1

3.3 3.4
3.2

1.
2.
3.
4.

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Section 3
3.3

a.
b.
c. : , ,

d. ,
.
,
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Section 3

3.4

3.5
,
a. ,

b.
c.
d.
e.

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Section 3

3.5

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Section 4
4.1
4.2 4.4
4.2 4.4

a.
b.
c.
: ,
.
.
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Section 4
4.2
.

.

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Section 4
4.3
.
4.4
a.

b. ,
, .
c.
1. 2. 3.
.4. 5.
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Section 5
,

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Section 6
6.1
1. , 6.2 6.7
2.
6.2
, . :
a.
b. .
c.
,
, /
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Section 6
6.3
6.2 ,
.

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Section 6
6.4

,
,
6.2
,
, ,

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Section 6
6.5
a. ,

b. ,
.
c.

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Section 6
6.6
:
a.
b. ,

6.7

. .

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Section 7
,
, ,

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Section 8
.

a. , ,
.
b. .

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Section 9

, , (
) ,
a. , , ,

b.
c.
, ,
a.
b.

a. ,
.
b.
c.
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. (RM Plan),
, ( ,
, )
. , ,
, ,

. ,

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a. ( )
b.
c.
d.

e.

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a. HAZOP
b. FAT
c.FMEA
d.

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What
Who
Where
When
How

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2
3
a. 3-5
b. 3-6
c.

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4 D4

Manufactuers defined
Accetable risk
Increasing
Probability of
occurrence

Increasing severity of harm

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6.

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Thank You

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