Iso 13485 Manual Documents
Iso 13485 Manual Documents
Iso 13485 Manual Documents
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Chapter-1.0 CONTENTS OF ISO 13485:2016 DOCUMENT KIT
(More than 125 document files)
Formats / Templates
61 formats in Ms. Word & Ms. Excel
Name of departments
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B. ISO 13485:2016 requirementwise documents list:
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6.2 Human Resource
PRO/SYS/05 Procedure for Training (Ref Clause 6.2.2)
E/SYS/02/HRD Process approach for Training
E/HRD/01 Exhibits for Skill requirements
F/TRG/01 Training Calendar
F/TRG/02 Training Need Cum Records Sheet
F/TRG/03 Induction Training Report
F/TRG/04 Job Description and Specification
F/TRG/05 Skill Matrix
F/TRG/06 Training Report
F/TRG/07 Skill Matrix for QC Personnel
F/SYS/15 Risk analysis sheet
F/SYS/16 Risk identification sheet
6.3 Infrastructure
E/SYS/02/ENG Process approach for Engineering
F/ENG/01 Breakdown History Card
F/ENG/02 Preventive Maintenance Schedule
F/ENG/03 Equipment Wise preventive maintenance checkpoints
6.4 Work Environment and contamination control
PRO/SYS/08 Procedure for control of monitoring of work environment (Ref Clause 6.4)
F/OPN/01 Temperature Record
F/OPN/02 Validation Of Autoclave By Biological Indicator
F/OPN/03 Temperature And Relative Humidity Record (Parentral)
F/OPN/04 Temperature And Relative Humidity Record (Washing & Sterilization)
F/OPN/05 Temperature And Relative Humidity Record (Filling and Manufacturing)
F/OPN/06 Differential Pressure Monitoring Record (Parentral)
F/OPN/07 Differential Pressure Monitoring Record (Washing & Sterilization)
F/OPN/08 Differential Pressure Monitoring Record (Ointment)
F/OPN/09 Temperature & Humidity Monitoring Record – General area
F/OPN/10 Microbial Monitoring Of Production Area By Settling Plate Method
F/OPN/11 Microbial Monitoring Of Production Area By Settling Plate Method – Ointment preparation
F/OPN/12 Microbial Monitoring By Swab /Surface Contact Technique – Parenteral in preparation.
F/OPN/13 Microbial Monitoring – Microbial Testing Of Sterile Garments
F/OPN/14 Testing Of Personnel By Finger Dab
F/OPN/15 Microbial Monitoring By Swab /Surface Contact Technique
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Clause No. 07 Product realization and implementation and operation
7.1 Planning Of Product Realization
E/QCD/01 Quality Plan
7.2 Customer Related processes
E/SYS/02/MKT Process approach for Marketing
F/MKT/01 Order form/ confirmation
F/MKT/02 Customer Complaint report
F/MKT/03 Customer Feed Back Form
F/MKT/04 Medical Practitioner Feedback Form
F/MKT/05 Customer Property Monitoring Register
F/SYS/17 Communication report
7.3 Design and Development
E/SYS/02/DND Process Approach for Design and Development
F/DND/01 Design and Development Plan
F/DND/02 Design review meeting
F/DND/03 Design Verification report
F/DND/04 Design Validation report
7.4 Purchasing
PRO/PUR/01 Procedure for purchasing (Ref Clause 7.4)
F/SYS/13 Vendor Rating
E/SYS/02/PUR Process approach for Purchase
F/PUR/01 Purchase Order
F/PUR/02 Indent cum Incoming inspection report
F/PUR/03 Approved Vendor list cum open purchase order
F/PUR/04 Supplier Registration form
F/PUR/05 Open Purchase Order
7.5 Production and Service Provision
7.5.1 Control of Production and Service Provision
E/SYS/02/PRD Process approach for Production
E/SYS/02/QCD Process approach for Quality Control
E/QCD/01 Quality Plan
E/SYS/02/STR Process approach for Stores
7.5.2 Cleanliness of the product
QM 01 Quality manual
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7.5.3 Installation activities
E/SYS/02/INS Process approach for Installation and commissioning
F/SER/03 Installation and commissioning record
7.5.4 Service activities
E/SYS/02/SER Process approach for Servicing
F/SER/01 Service Report
F/SER/02 Repairing card
7.5.5 Particular requirements for sterile medical devices
PRO/SYS/09 Procedure for validation of sterilization process (Ref Clause 7.5.2)
7.5.6 Validation of Processes for Production and Service Provision
PRO/SYS/09 Procedure for validation of sterilization process (Ref Clause 7.5.2)
Particular requirements for validation of processes for sterilization and sterile
7.5.7 barrier systems
PRO/SYS/09 Procedure for validation of sterilization process (Ref Clause 7.5.2)
7.5.8 Identification
PRO/STR/01 Procedure for identification of products(Ref Clause 7.5.3.1)
7.5.9 Identification and Traceability
PRO/STR/02 Procedure for traceability (Ref Clause 7.5.3.2)
7.5.10 Customer Property
F/MKT/05 Customer Property Monitoring Register
7.5.11 Preservation of Products
E/SYS/02/STR Process approach for Stores
7.6 Control of Measuring and Monitoring Equipment
PRO/SYS/07 Procedure for control of monitoring and measuring equipments (Ref Clause 7.6)
F/SYS/03 Calibration Status Of Instrument / Equipment
Clause No. 08 à Measurement, Analysis and improvement
8.1 General
QM 01 Quality manual
8.2 Monitoring And Measurement
8.2.1 Feedback
8.2.2 Customer complaint
8.2.3 Reporting to regulatory authorities
PRO/MKT/01 Procedure for customer feedback
F/MKT/02 Customer Complaint report
F/MKT/03 Customer Feed Back Form
F/MKT/04 Medical Practitioner Feedback Form
F/SYS/17 Communication report
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8.2.4 Internal Audit
PRO/SYS/04 Procedure for internal audit (Ref Clause 8.2.2)
E/SYS/02/QCD Process approach for Quality Control
F/SYS/06 Audit Plan / Schedule
F/SYS/07 Internal Audit Non–Conformity Report
F/SYS/08 Clausewise Document wise Audit Review Report
8.2.5 Monitoring and measurement of product
E/QCD/01 Quality Plan
8.2.6 Monitoring and measurement of processes
PRO/SYS/10 Procedure for monitoring and measurement of process (Ref Clause 8.2.3)
F/SYS/05 Quality objective monitoring report
F/SYS/12 Qualitative process monitoring report
8.3 Control of Non confirming products
PRO/PRD/01 Procedure for control of non confirming products (Ref Clause 8.3)
E/PRD/01 Exhibit for disposal of non confirming products
8.4 Analysis of Data
PRO/SYS/11 Procedure for Analysis of data
8.5 Improvement
PRO/SYS/12 Procedure for issue and implementation of advisory notice (Ref Clause 8.5.1)
PRO/SYS/06 Procedure for corrective and preventive actions (Ref Clause 8.5.2 and 8.5.3)
F/SYS/10 Corrective Action Report
F/SYS/11 Preventive Action Report
Master Reference Guideline
PRO/SYS/13 Procedure for Hazard Analysis
F/SYS/14 Hazard Analysis
F/SYS/15 Risk analysis sheet
F/SYS/16 Risk indemnification sheet
Clause wise audit questionnaire
Department wise audit questionnaires
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Part: C Documentation:-
Our document kit is having sample documents required for implementation of ISO 13485:2016. The
documents are prepared by the highly experienced team of people with rich experience of process
improvement and process enhancement and many companies are certified successfully under ISO
13485:2016 with our help. You need to study the document kit and do necessary changes as per
your company need and within 1 week your entire documents are ready as well as your team will
got many ideas for system establishment to reduce the cost and effort with all necessary controls
and your total documents are ready. We had given all type of templates and organization use it as
per their need and many organization are certified globally in 1st trial with the help of our
documents from any kind of stringent lead appraisal audit.
Under this directory many files are made in word Document as per the details listed below. All the
documents are related to ISO 13485:2016 for and user can edit it in line with their own processes.
1. Quality Manual:
It covers sample copy of quality manual and requirement wise details for how ISO 13485:2016 is
implemented. It covers sample policy for all process areas, Quality policy and organization structure and
st
covers 1 tier of ISO 13485:2016 documents.
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List of Procedures (19 procedures)
Sr. Procedure
Name of Procedure Total Page
No. No.
1. PRO/SYS/01 Procedure for Management review 03
2. PRO/SYS/02 Procedure for Document and Data Control 07
3. PRO/SYS/03 Procedure for Control of records 03
4. PRO/SYS/04 Procedure for Internal Audit 03
5. PRO/SYS/05 Procedure for Training 03
6. PRO/SYS/06 Procedure For Corrective And Preventive Action 04
7. PRO/SYS/07 Procedure For Control of Monitoring And Measuring Equipments 04
8. PRO/SYS/08 Procedure for Control of Monitoring of work environment 02
9. PRO/SYS/09 Procedure for validation of sterilization process 03
10. PRO/SYS/10 Procedure For Monitoring And Measurement of Processes 03
11. PRO/SYS/11 Procedure For Analysis of Data 02
12. PRO/SYS/12 Procedure For Issue And Implementation of Advisory Notices 02
13. PRO/SYS/13 Procedure For Hazard Identification 01
14. PRO/MKT/01 Procedure for customer satisfaction survey 02
15. PRO/PUR/01 Procedure for Purchasing 05
16. PRO/PRD/01 Procedure for Control of Non–Conforming Products 02
17. PRO/STR/01 Procedure for identification of products 02
18. PRO/STR/02 Procedure for traceability 02
19. PRO/STR/03 Procedure for preservation 02
Total Pages 55
3. Exhibits (04 Exhibits):
It covers sample copy of guidelines covering all the details and for training to the user to
implement the processes and get detail ideas for process implementation and improvement.
List of Exhibits (04 Exhibits)
Sr. No. Guideline No. Name of Guidelines Total Pages
1. E/HRD/01 Skill Requirements 01
2. E/PRD/01 Disposal of Non–conforming Products 01
3. E/QCD/01 Quality Plan 01
4. E/SYS/01 Document codification system 01
Total Pages 04
4. Formats (61 Formats)
It covers sample copy of forms required to maintain records as well as establish control and make system in
the organization. The samples given are as a guide and not compulsory to follow and organization is free to
change the same to suit own requirements.
List of Formats (61 Formats)
Sr. No. Format No. Name of Format
1. F/PUR/01 Purchase Order
2. F/PUR/02 Indent cum Incoming inspection report
3. F/PUR/03 Approved Vendor list cum open purchase order
4. F/PUR/04 Supplier Registration form
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5. F/PUR/05 Open Purchase Order
6. F/ST/01 Daily Stock Statement
7. F/ST/02 Gate Pass
8. F/DND/01 Design And Development Plan
9. F/DND/02 Design Review Minutes Of Meeting
10. F/DND/03 Design Verification Report
11. F/DND/04 Design Validation Report
12. F/ENG/01 Breakdown History Card
13. F/ENG/02 Preventive Maintenance Schedule
14. F/ENG/03 Equipment Wise preventive maintenance checkpoints
15. F/MKT/01 Order form/ confirmation
16. F/MKT/02 Customer Complaint report
17. F/MKT/03 Customer Feed Back Form
18. F/MKT/04 Medical Practitioner Feedback Form
19. F/MKT/05 Customer Property Monitoring Register
20. F/OPN/01 Temperature Record
21. F/OPN/02 Validation Of Autoclave By Biological Indicator
22. F/OPN/03 Temperature And Relative Humidity Record (Parentral)
23. F/OPN/04 Temperature And Relative Humidity Record (Washing & Sterilization)
24. F/OPN/05 Temperature And Relative Humidity Record (Filling and Manufacturing)
25. F/OPN/06 Differential Pressure Monitoring Record (Parentral)
26. F/OPN/07 Differential Pressure Monitoring Record (Washing & Sterilization)
27. F/OPN/08 Differential Pressure Monitoring Record (Ointment)
28. F/OPN/09 Temperature & Humidity Monitoring Record – General area
29. F/OPN/10 Microbial Monitoring Of Production Area By Settling Plate Method
Microbial Monitoring Of Production Area By Settling Plate Method – Ointment
30. F/OPN/11
preparation
Microbial Monitoring By Swab /Surface Contact Technique – Parenteral in
31. F/OPN/12
preparation.
32. F/OPN/13 Microbial Monitoring – Microbial Testing Of Sterile Garments
33. F/OPN/14 Testing Of Personnel By Finger Dab
34. F/OPN/15 Microbial Monitoring By Swab /Surface Contact Technique
35. F/SER/01 Service report
36. F/SER/02 Repairing card
37. F/SER/03 Installation commissioning report
38. F/SYS/01 Master List Cum Distribution List Of Documents
39. F/SYS/02 Change Note
40. F/SYS/03 Calibration Status Of Instrument / Equipment
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41. F/SYS/04 Master list of records
42. F/SYS/05 Quality Objective Monitoring Report
43. F/SYS/06 Audit Plan / Schedule
44. F/SYS/07 Internal Audit Non–Conformity Report
45. F/SYS/08 Clausewise Documentwise Audit Review Report
46. F/SYS/09 Continual Improvement Plan
47. F/SYS/10 Corrective Action Report
48. F/SYS/11 Preventive Action Report
49. F/SYS/12 Qualitative Process Monitoring Report
50. F/SYS/13 Vendor Rating
51. F/SYS/14 Hazard Analysis Report
52. F/SYS/15 Risk analysis sheet
53. F/SYS/16 Risk indemnification sheet
54. F/SYS/17 Communication report
55. F/TRG/01 Training Calendar
56. F/TRG/02 Training Need Cum Records Sheet
57. F/TRG/03 Induction Training Report
58. F/TRG/04 Job Description and Specification
59. F/TRG/05 Skill Matrix
60. F/TRG/06 Training Report
61. F/TRG/07 Skill Matrix for QC Personnel
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7. ISO 13485:2016 audit questionnaire (02 files of more than 900 Questions)
There covers audit questions based on ISO 13485:2016 requirements as well as for Clausewise
questions and department wise question. It will be very good tool for the auditors to make audit
Questionnaire / clause wise audit Questionnaire while auditing and make effectiveness in
auditing.
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Chapter-2.0 ABOUT COMPANY
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A. Hardware:-
Our document kit can be better performed with the help of P3 and above computers
with a minimum 10 GB hard disk space.
For better visual impact of the power point Document you may keep the setting of
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Documents written in Ms Office 2003 and window xp programs. You are therefore
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Chapter-4.0 BENEFITS OF USING OUR DOCUMENT KIT
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13485:2016 documents for their organization
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6. The audit questions helps in making perfect audit checklist
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