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INDIVIDUAL DOCUMENTS & DOCUMENTATION PACKAGES

 

ISO 9001 Compliant

 

ISO 13485 Compliant

 

Primary Sections Supported

Product Code

 

Primary Sections Supported

Product Code

QUALITY POLICY MANUAL DOCUMENT

4.2.1b & 4.2.2

AFC-9001-1

 

4.2.1b & 4.2.2 + Notes

AFC-13485-1

CONTROL OF QUALITY SYSTEM DOCUMENTS

4.2.3

AFC-9001-2

 

4.2.3 + Notes

AFC-13485-2

CONTROL OF QUALITY SYSTEM RECORDS

4.2.4

AFC-9001-3

 

4.2.4 + Notes

AFC-13485-3

MANAGEMENT REVIEW

5.6

AFC-9001-4

 

5.6 + Notes

AFC-13485-4

COMPETENCE, TRAINING AND AWARENESS

6.2.2

AFC-9001-5

 

6.2.2 + Notes

AFC-13485-5

REQUIREMENTS REVIEW

7.2.1 & 7.2.3

AFC-9001-6

 

7.2.1 & 7.2.3 + Notes

AFC-13485-6

DESIGN & DEVELOPMENT

7.3

AFC-9001-7

 

7.3 + Notes

AFC-13485-7

CONTROL OF MONITORING & MEASUREMENT EQUIPMENT & CALIBRATION

7.6

AFC-9001-8

 

7.6 + Notes

AFC-13485-8

QUALITY SYSTEM MEASUREMENT, ANALYSIS & IMPROVEMENT

4.1e, 8.1, 8.2.3 & 8.4

AFC-9001-9

 

4.1e, 8.1, 8.2.1, 8.4 + N

AFC-13485-9

INTERNAL AUDIT PROCESS

8.2.2

AFC-9001-10

 

8.2.2

AFC-13485-10

CONTROL OF NONCONFORMING PRODUCT

8.3

AFC-9001-11

 

8.3 + Notes

AFC-13485-11

CORRECTIVE & PREVENTIVE ACTIONS

8.5.2 & 8.5.3

AFC-9001-12

 

8.5.2 & 8.5.3 + Notes

AFC-13485-12

RISK MANAGEMENT

(TBD)

(Avail. 2014)

 

7.1 + Notes

AFC-13485-13

BATCH RECORDS, IDENTIFICATION, TRACEABILITY & PRESERVATION

n/a

Not Reqd

 

7.5.1.1, 7.5.3.2, 7.5.3.3

AFC-13485-14

 

 

 

 

 

 

 COMPLETE QUALITY SYSTEM (BOILERPLATE) DOCUMENTATION PACKAGES

 

ISO 9001 Compliant

 

ISO 13485 Compliant

 

 

 

 

 

 

100% COMPLETE BOILERPLATE DOCUMENTATION PACKAGE WITH TRAINING, IMPLEMENTATION TIPS & QMS ‘OWNER’S MANUAL’

(All ISO 9001)

AFC-9001-13

 

(All ISO 13485)

AFC-13485-15

 

 

 

 

 

 

 
QUALITY MANAGEMENT SYSTEM (BOILERPLATE) PROCESSES WITH DOCUMENTATION & DATABASE

 

ISO 9001 Compliant

 

ISO 13485 Compliant

 

 

 

 

 

 

CONTROL OF MONITORING & MEASUREMENT EQUIPMENT & CALIBRATION PROGRAM WITH DATABASE

7.6

AFC-9001-14

 

7.6

AFC-13485-16

COMPLIANT ‘QUALITY SUITE’ WITH SUPPORTING DATABASE

4.2.3, 6.2.2, 8.2.2, 8.3, 8.5.2 & 8.5.3.

AFC-9001-15

 

(Avail. 2014)

(TBD)

COMPLIANT QUALITY MANAGEMENT SYSTEM WITH DATABASE

(All ISO 9001)

AFC-9001-16

 

(Avail. 2014)

(TBD)


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