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1
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21 CFR 820 - ISO 13485:2003 Correspondence Matrix, .pdf file
(free
download - not included in the set)
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2
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Approved Supplier List
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3
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Audit Checklist ISO 13485-2003
/ 9001-2000
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4
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Audit
Confidentiality Agreement
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5
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Audit
Certificate
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6
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Audit
Procedure ISO 13485:2003
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7
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Audit
Record
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8
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Audit
Report
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9
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Audit
Schedule
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10
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Audit
Strategic Plan ISO 13485:2003
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11
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Calibration
Master List
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12
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Communication
Log
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13
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Communication
Procedure
ISO 13485:2003
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14
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Confidentiality
Agreement
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15
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Contract
Review Procedure
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16
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Customer
Satisfaction Analysis Procedure
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17
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Controlled
Environment Procedure
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18
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Counsil Directive93/42/EEC Index, xls
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19
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Customer
Satisfaction Analysis Procedure
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20
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Customer
Satisfaction Survey
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21
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Data
Analysis Procedure
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22
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DCR
Form
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23
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DCR
Log
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24
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Design
Management Procedure
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25
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Design
Project Plan
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26
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Design
Input Output
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27
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Design
History File ToC
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28
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Device
History Record ToC
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29
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Device
Master Record ToC
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30
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Documentation
Management Procedure
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31
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Documentation
Master list
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32
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FMEA
Table
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33
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Infrastructure
Procedure
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34
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Inspection
and Testing Procedure
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35
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Job
Description Template
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36
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Maintenance Record Master Log
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37
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Management
Review Procedure
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38
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Management
Review Record Template
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39
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Master Maintenance Schedule
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40
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MDD
93/42/EEC ER Checklist
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41
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Measuring
Equipment Procedure
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42
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NC-CAPA
Log
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43
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NC-CAPA
Procedure ISO 13485:2003
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44
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NC-CAPA
Record ISO 13485:2003
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45
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Organizational
Chart
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46
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Product
Identification Procedure
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47
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Process
Interaction Matrix
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48
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Product
Order Record
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49
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Product
Realization Procedure
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50
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Purchase
Requisition Form
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51
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Purchasing
Procedure
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52
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Quality
Manual ISO 13485:2003 / ISO 9001:2000
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53
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Quality
Manual ISO 13485:2003 / ISO 9001:2000
Review Checklist
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54
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Quality
Policy ISO 13485:2003
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55
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Records
Procedure
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56
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Resource
Management and Infrastructure Procedure
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57
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Risk
Analysis Procedure
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58
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Servicing
Procedure
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59
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Supplier
Certification Form
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60
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Technical
File ToC
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61
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Template
Procedure
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62
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The
Balanced Scorecard
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63
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Training
Procedure
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64
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Training
Record
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65
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Validation
Procedure
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66
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Validation
Record
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