Description
Our documentation kit (Technical file) contains sample documents required for CE certification as listed below. All documents are in MS Word files and you can edit them. You can make changes as per your organization’s need and within few days your entire Technical File with all necessary controls will be ready.
Content of Medical Devices – Quality Management System ISO 13485 :2016 Documentation Kit
Our ISO 13485:2016 manual documentation kit consists of the following documents in editable .doc format.
- ISO 13485 2016 Manual: An ISO 13485 2016 manual to establish a quality system in accordance with the clause wise requirements for system implementation (40 pages in MS-word format)
- ISO 13485 Procedures: A list of mandatory iso 13485 procedures to follow during ISO 13485 certification procedure (19 procedures – 54 pages in MS-word format)
- Exhibits: Sample copies of mandatory exhibits (04 exhibits – 4 pages in MS-Word format)
- Sample Formats / Templates: Ready-to-use verified QMS forms for quick documentation (61 blank formats in MS-Word and MS-Excel format)
- Quality SOP: A set of sample standard operating procedures (06 SOPs – 19 pages in MS-word format)
- Filled forms: Asset register, risk assessment, risk treatment, scope document for quick record keeping.
- ISO 13485 Audit Checklist: It covers more than 900 ISO 13485 audit checklists based on ISO 13485:2016 clause wise and department wise requirements. You can customize this iso 13485 checklist to make your own internal audit checklist.
- Medical Device File: A set of sample technical documents for medical devices in accordance with ISO 134852016 certification requirements (21 files in MS-Word format)
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 covers 1st tier of ISO 13485:2016 documents.
(A) Table Of Contents
Section–1
1. Cover page, table of contents and authorization statement
2. Company profile
3. Control and distribution
Section–2
4. Quality Management System
5. Management Responsibility
6. Resource Management
7. Product Realization
8. Measurement, Analysis And Improvement
Annexure
ANX–I List of procedures
ANX–II Glossary of terms
ANX–III Process flow chart
ANX–IV Quality Policy
ANX–V Organization structure
2. Procedures (19 Procedures):
It covers sample copy of procedures covering all the specific practice areas of 19 processes. Our procedures help the organization to make the best system and quick process improvements. All procedures are as listed below.
List of Procedures (19 procedures)
Sr. No. Procedure No. Name of Procedure Total Page
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
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
30. F/OPN/11 Microbial Monitoring Of Production Area By Settling Plate Method – Ointment preparation
31. F/OPN/12 Microbial Monitoring By Swab /Surface Contact Technique – Parenteral in 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
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
5. Standard Operating Procedures (06 SOPs)
It covers sample copy of work instructions to link with significant aspects issues in the organization. It takes care of all such issues and used as a training guide as well as to 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 SOPs
Sr. No. SOP No. Name of SOP Total Page
1. W/OPN/01 Measurement Of Temperature And Humidity 02
2. W/OPN/02 Validation of Autoclave 03
3. W/OPN/03 Microbial Monitoring of Production Area 07
4. W/OPN/04 Temperature Monitoring of Sterility Room and Microbiology Laboratory 02
5. W/OPN/05 Temperature & Humidity Monitoring 02
6. W/OPN/06 Clean Room Condition Monitoring 03
Total Pages 19
6. Process Flow Chart
List of Process flow charts
Sr. No. Process flow chart No. Name of SOP Total Page
1. E/SYS/02/DES Process approach for Despatch 02
2. E/SYS/02/DND Process approach for Design and Development 04
3. E/SYS/02/ENG Process approach for Engineering 03
4. E/SYS/02/HRD Process approach for Training 03
5. E/SYS/02/MKT Process approach for Marketing 05
6. E/SYS/02/MR Process approach for Management Representative 02
7. E/SYS/02/PRD Process approach for Production 02
8. E/SYS/02/PUR Process approach for Purchase 04
9. E/SYS/02/QCD Process approach for Quality Control 04
10. E/SYS/02/STR Process approach for Stores 04
11. E/SYS/02/INS Process approach for Installation and Commissioning 03
12. E/SYS/02/STR Process approach for Servicing 03
Total Pages 39
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.
8. ISO 13485:2016 medical devices file (21 files)
There covers medical devices technical files for ISO 13485:2016.
How useful?
- Our documents kit contains ISO 13485 manual, procedures, SOPs, sample templates and formats that comply with system requirements.
- Our ISO 13485 2016 documentation kit is ideal for individual learning as well as group training to ensure the successful implementation of the quality management system for medical devices.
- This set of readymade documents is extremely useful to ISO 13485 consultants for complying with requirements.
- This documentation kit provides you with sample templates and ISO 13485 2016 audit checklist that you need for effective quality documentation and system implementation.
- By using our globally used editable ISO 13485 2016 documents, you can save a lot of your precious time and money while preparing the course materials for in-house documents and SOPs to create cultural change in the organization.
- It is a perfect tool to educate all employees to achieve better performance of Medical devices in the pharma sector.
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