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Table of Contents
General Requirements........................................................................................................................................................................................................2
Quality Management System.............................................................................................................................................................................................2
Management Responsibility...............................................................................................................................................................................................4
Resource Management.......................................................................................................................................................................................................6
Product Realization............................................................................................................................................................................................................7
Measurement, analysis and improvement.......................................................................................................................................................................15
259170020.doc
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General Requirements
1.
Q1 Section 1.2
3.
Organization shall:
a) Determine processes needed for QMS
b) Determine sequence and interaction of processes
c) Determine criteria & methods needed to ensure
operation and control of processes are effective
d) Ensure the availability of resources necessary to
support the operation
e) Monitor, Measure, where applicable, and analyze
processes
f) Implement actions necessary to achieve results and
continual improvement of processes
Organization shall control all processes that are outsourced
259170020.doc
Q1 Section 4.1
Q1 Section 4.1
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4.
5.
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Documentation includes:
a) Statement of quality policy and quality objectives
b) Quality Manual
c) Documented procedures and records
d) Documents, including records, determined to be
necessary to ensure effective planning, operation
and control of its processes
Quality Manual includes:
a) Scope of QMS and exclusions (with justifications)
b) Documented procedures or reference to them
c) A description of interaction between the processes
of the QMS
OK
Y/N
Y
Q1 Section 4.2.1
Q1 Section 4.2.2
requirement
of
the
Technical
Q1 Section 4.2.2.1
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6.
7.
8.
9.
10.
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259170020.doc
Q1 Section 4.2.3
Q1 Section 4.2.3.1
Q1 Section 4.2.3.2
Q1 Section 4.2.4
Q1 Section 4.2.4.1
OK
Y/N
Y
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Management Responsibility
11.
12.
13.
14.
15.
16.
259170020.doc
Q1 Section 5.1
Q1 Section 5.2
Q1 Section 5.4.1
Q1 Section 5.4.2
Q1 Section 5.5.1
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17.
18.
19.
20.
21.
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259170020.doc
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Q1 Section 5.5.2
Q1 Section 5.5.3
Q1 Section 5.6.1
& 5.6.1.1
Q1 Section 5.6.2
Q1 Section 5.6.3
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Resource Management
22.
23.
24.
Q1 Section 6.2.1
Q1 Section 6.2.2
Q1 Section 6.2.2.1
26.
Provide
and
259170020.doc
Q1 Section 6.3
Q1 Section 6.4
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Product Realization
27.
28.
29.
30.
31.
32.
33.
34.
35.
259170020.doc
Q1 Section 7.1a
Q1 Section 7.1 c
Q1 Section 7.2.2
Section 7.2.2
Section 7.2.2
Q1 Section 7.2.2.1
Section 7.2.3
Section 7.3.1
Section 7.3.1
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36.
37.
38.
39.
40.
41.
42.
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Output shall:
a) Meet the input requirements.
b) Provide information for purchasing, production and
service
c) Contain or reference product acceptance criteria
a) Specify the characteristics of the product that are
essential for the safe and proper use
Design and development outputs are documented
Review shall occur at suitable stages to evaluate design as
it meets requirements
259170020.doc
OK
Y/N
Q1 Section 7.3.1.1
Q1 Section 7.3.1.2
Section 7.3.2
Q1 Section 7.3.2.1
Section 7.3.3
Q1 Section 7.3.3.1
Section 7.3.4
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43.
44.
45.
46.
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Section 7.3.4
Section 7.3.4
Q1 Section 7.3.4.1
Section 7.3.5
Section 7.3.6
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49.
50.
51.
52.
53.
54.
55.
56.
AUDIT REF:
DOC. REFERENCE
259170020.doc
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Y/N
Section 7.3.7
Q1 Section 7.3.7.1
Section 7.4.1
Section 7.4.1
Q1 Section 7.4.1.1
Q1 Section 7.4.1.2
Section 7.4.2
Section 7.4.2.
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57.
58.
59.
60.
61.
62.
63.
AUDIT REF:
DOC. REFERENCE
259170020.doc
OK
Y/N
Q1 Section 7.4.2.1
Section 7.4.3
Section 7.4.3
Q1 Section 7.4.3.1
Section 7.5.1
Q1 Section 7.5.1.1
Q1 Section 7.5.1.2
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64.
65.
AUDIT REF:
DOC. REFERENCE
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Y/N
Q1 Section 7.5.1.2
Section 7.5.2
68.
259170020.doc
Q1 Section 7.5.2.1
Section 7.5.3
Section 7.5.3
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69.
70.
71.
72.
73.
74.
AUDIT REF:
DOC. REFERENCE
259170020.doc
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Y/N
Section 7.5.3
Q1 Section 7.5.3.1
Q1 Section 7.5.3.2
Q1 Section 7.5.3.3
Section 7.5.4
Q1 Section 7.5.4.1
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75.
76.
77.
78.
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Section 7.5.5
Pre
servation
of product
during
handling
Pre
servation
of product
during
packagin
g
Pre
servation
of product
during
storage
Pre
servation
of product
during
delivery
259170020.doc
OK
Q1 Section 7.5.5.1
Q1 Section 7.5.5.2
Section 7.6
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79.
Section 7.6
80.
Section 7.6
OK
Y/N
Y
a) Calibrated
against
standards
traceable
to
international or national standards
b) Adjusted or re-adjusted as necessary
c) Identified to enable calibration status to be
determined
d) Safeguarded from adjustments that would invalidate
the measurement results
e) Protected from damage and deterioration during
handling, maintenance and storage
81.
Section 7.6
82.
Section 7.6
83.
84.
Q1 Section 7.6.1
85.
Environmental
Q1 Section 7.6.2
259170020.doc
Q1 Section 7.6
inspection
and
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Section 8.2.1
87.
Section 8.2.2
88.
Internal audits:
Section 8.2.2
90.
The
259170020.doc
Q1 Section 8.2.2.1
for
Q1 Section 8.2.2.2
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91.
Section 8.2.3
92.
Section 8.2.4
93.
Section 8.2.4
94.
Section 8.2.4
95.
Section 8.2.4
96.
Section 8.2.4
97.
Q1 Section 8.2.4.1
98.
Final
Q1 Section 8.2.4.2
99.
Section 8.3
100.
Section 8.3
101.
Section 8.3
259170020.doc
(acceptance) inspection/testing
independent personnel
is
controlled
by
OK
Y/N
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102.
Section 8.3
103.
Section 8.3
104.
Section 8.3
105.
Q1 Section 8.3.2
106.
Controls
for
evaluation/disposition
of
accepting
nonconforming product that does not meet
original design acceptance
Q1 Section 8.3.2
107.
Q1 Section 8.3.3
108.
Section 8.4
109.
Section 8.4
110.
Q1 Section 8.4.1
111.
259170020.doc
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Y/N
Section 8.5.1
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112.
Section 8.5.2
113.
Section 8.5.2
OK
Y/N
Q1 Section 8.5.2.1
115.
Q1 Section 8.5.2.2
116.
259170020.doc
Section 8.5.3
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117.
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Section 8.5.3
Q1 Section 8.5.3.1
Form Q-002
259170020.doc
Date: ________________________
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