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INDIVIDUAL DOCUMENTS & DOCUMENTATION PACKAGES |
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ISO 9001 Compliant |
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ISO 13485 Compliant |
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Primary Sections
Supported |
Product Code |
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Primary Sections
Supported |
Product Code |
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QUALITY
POLICY MANUAL DOCUMENT |
4.2.1b & 4.2.2 |
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4.2.1b & 4.2.2 + Notes |
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CONTROL OF
QUALITY SYSTEM DOCUMENTS |
4.2.3 |
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4.2.3 + Notes |
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CONTROL OF
QUALITY SYSTEM RECORDS |
4.2.4 |
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4.2.4 + Notes |
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MANAGEMENT
REVIEW |
5.6 |
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5.6 + Notes |
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COMPETENCE,
TRAINING AND AWARENESS |
6.2.2 |
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6.2.2 + Notes |
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REQUIREMENTS
REVIEW |
7.2.1 & 7.2.3 |
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7.2.1 & 7.2.3 + Notes |
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DESIGN &
DEVELOPMENT |
7.3 |
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7.3 + Notes |
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CONTROL OF
MONITORING & MEASUREMENT EQUIPMENT & CALIBRATION |
7.6 |
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7.6 + Notes |
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QUALITY
SYSTEM MEASUREMENT, ANALYSIS & IMPROVEMENT |
4.1e, 8.1, 8.2.3 & 8.4 |
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4.1e, 8.1, 8.2.1, 8.4 + N |
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INTERNAL
AUDIT PROCESS |
8.2.2 |
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8.2.2 |
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CONTROL OF
NONCONFORMING PRODUCT |
8.3 |
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8.3 + Notes |
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CORRECTIVE &
PREVENTIVE ACTIONS |
8.5.2 & 8.5.3 |
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8.5.2 & 8.5.3 + Notes |
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RISK
MANAGEMENT |
(TBD) |
(Avail. 2014) |
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7.1 + Notes |
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BATCH
RECORDS, IDENTIFICATION, TRACEABILITY & PRESERVATION |
n/a |
Not Reqd |
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7.5.1.1, 7.5.3.2, 7.5.3.3 |
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ISO 9001 Compliant |
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ISO 13485 Compliant |
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100% COMPLETE
BOILERPLATE DOCUMENTATION PACKAGE WITH TRAINING, IMPLEMENTATION
TIPS & QMS ‘OWNER’S MANUAL’ |
(All ISO 9001) |
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(All ISO 13485) |
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ISO 9001 Compliant |
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ISO 13485 Compliant |
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CONTROL OF
MONITORING & MEASUREMENT EQUIPMENT & CALIBRATION PROGRAM WITH
DATABASE |
7.6 |
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7.6 |
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COMPLIANT
‘QUALITY SUITE’ WITH SUPPORTING DATABASE |
4.2.3, 6.2.2, 8.2.2, 8.3, 8.5.2 &
8.5.3. |
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(Avail. 2014) |
(TBD) |
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COMPLIANT
QUALITY MANAGEMENT SYSTEM WITH DATABASE |
(All ISO 9001) |
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(Avail. 2014) |
(TBD) |
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