ISO 14155:2020 Documentation and Awareness Training Kit

The ISO 14155 Documentation and Training kit for clinical investigation of medical devices contains a set of a total of more than 85 editable files, which are based on requirements of ISO 14155:2020 standard requirements. Documentation: The documentation part covers the following readymade templates that can be used as a ready reference tool to accelerate the documentation process for ISO 14155:2020 Certification.

1. ISO 14155 Manual – Editable medical device quality manual with 10 chapters and 01 annexure for ISO 14155:2020 requirements.
2. Procedures – There are 21 mandatory procedures in word format for various requirements.
3. Exhibits – sample copy of 06 exhibits that cover all the details in MS Word/excel.
4. Standard Operating Procedures – 05 SOPs given with this documentation kit that can use to define safety and care precaution, etc.
5. Readymade Formats/ Templates – 49 blank editable sample forms to maintain records as well as establish control and create an effective quality management system in the organization.
6. ISO 14155 Audit Checklist – More than 180 audit questions based on the clinical investigation management system for medical devices.
7. ISO 14155 Compliance Matrix: 01 Excel has given to understand how the system is made.

Presentation: It includes more than 100 ppt presentation slides as bellow:

1. Awareness on ISO 14155:2020 – 16 ppt slides
2. ISO 14155:2020 requirements – 113 ppt slides
3. ISO 14155:2020 document control and records – 14 ppt slides
4. Step for ISO 14155:2020 certification – 06 ppt slides

Literature: A literature to understand ISO 14155:2020 subject well in 04 chapters, 02 workshops, and 01 case study. (Total 60 pages in Ms. Word file)To guide organizations for ISO 14155:2020 certification as per ISO 14155:2020 requirements, GMG is developed this ISO 14155:2020 documentation and training kit. The ISO 14155:2020 standard is required a specific set of documents for its effective implementation and certification.

Part-1: Documentation:

Our documentation kit contains sample documents required for ISO 14155:2020 certification as listed below. All documents are in MS-Word/Excel files and you can edit them. You can make changes as per your organization’s need and within few days your entire documents with all necessary controls will be ready. In the ISO 14155:2020, documented information (procedures, SOPs, etc.) are required a few places only. But for making the system better, we have provided many editable templates from which a user can select templates as per their own requirement and make some minor changes in them to make own system. Two types of documented information are provided in this kit, as listed below:

1. Maintain documented information (Scope, Manual, etc.)
2. Retain documented information (Forms / Templates)

Under the main directories, further files are provided in MS Word document as per the details given below.

1. Quality Manual:

It is a sample copy of quality manual having clause-wise details of how ISO 14155 system is implemented. The quality manual is tier-1 of ISO 14155 documents and covers list of procedures as well as overview of organization. This manual has total 10 chapters covering company profile, amendment sheet, index, clause-wise details as per ISO 14155 for implementation, sample quality policy and organization chart.

ISO 14155:2020 Manual

1. Cover page, Table of contents, amendment record sheet and glossary of terms (abbreviation)
2. Authorization statement and profile and context of organization
3. Control and distribution
4. Summary of good clinical practice (GCP) principles
5. Ethical Consideration
   5.1 General
   5.2 Improper Influence or Inducement
   5.3 Compensation and additional health care
   5.4 Registration in publicly accessible database
   5.5 Responsibilities
   5.6 Communication with the ethics committee (EC)
   5.7 Vulnerable populations
   5.8 Informed consent
6. Clinical investigation planning
   6.1 General
   6.2 Risk management
   6.3 Justification for the design of the clinical investigation
   6.4 Clinical investigation plan (CIP)
   6.5 Investigator’s brochure (IB)
   6.6 Case report forms (CRFs)
   6.7 Monitoring plan
   6.8 Investigation site selection
   6.9 Agreement(s)
   6.10 Labelling
   6.11 Data monitoring committee (DMC)
7. Clinical investigation conduct
   7.1 General 00 27
   7.2 Investigation site initiation
   7.3 Investigation site monitoring
   7.4 Adverse events and device deficiencies
   7.5 Clinical investigation documents and documentation
   7.6 Additional members of the investigation site team
   7.7 Subject privacy and confidentiality of data
   7.8 Document and data control
   7.9 Investigational device accountability
   7.10 Accounting for subjects
   7.11 Auditing
8. Suspension, termination, and close-out of the clinical investigation
   8.1 Completion of the clinical investigation
   8.2 Suspension or premature termination of the clinical investigation
   8.3 Routine close-out
   8.4 Clinical investigation report
   8.5 Risk assessment and conclusions
   8.6 Document retention
9. Responsibilities of the Punyam
   9.1 Clinical quality management
   9.2 Clinical investigation planning and conduct
   9.3 Outsourcing of duties and functions
   9.4 Communication with regulatory authorities
10. Responsibilities of the principal investigator
    10.1 General
    10.2 Qualification of the principal investigator
    10.3 Qualification of investigation site
    10.4 Communication with the EC
    10.5 Informed consent process
    10.6 Compliance with the CIP
    10.7 Medical care of subjects
    10.8 Safety reporting

2. Quality Procedures (21 Procedures):

Sample copies of mandatory procedures as per ISO 14155 are provided, which cover all the details like purpose, scope, responsibility, how procedure is followed as well as the list of exhibits, reference documents and formats. The list of sample procedures provided in the kit is given below.

List of procedure

1. Procedure for recruiting subjects and advertising materials
2. Procedure for clinical investigations on vulnerable populations
3. Procedure for risk assessment
4. Procedure for preparation, review and changes or corrections in case report forms
5. Procedure for the control of documents and document changes
6. Procedure for decoding blinded/masked clinical investigations
7. Procedure for electronic clinical data system
8. Procedure for Investigational device accountability
9. Procedure for audit
10. Procedure for suspension or premature termination and resuming the clinical investigation after temporary suspension
11. Procedure for assuring and maintain clinical quality
12. Procedure for identification and access to the regulatory requirements
13. Procedure for training and competence assessment of personnel
14. Procedure for the control of suppliers
15. Procedure for possible emergency situations
16. Procedure for verification, validation, and securing of electronic clinical data systems
17. Procedure to maintain and protect subject privacy
18. Procedure for data retention
19. Procedure for recording, reporting, and analyzing CIP deviations
20. Procedure for cleaning, disinfection, or sterilization
21. Procedure for appeal of its decisions/opinions

3. Exhibits (06 exhibits)

It covers sample copy of exhibits covering all the details of ISO 14155:2020.

List of exhibits

1. Exhibit for codification system
2. Exhibit for skill requirement
3. Exhibit for secrecy rules
4. Exhibit for communication process
5. Exhibit for clinical investigation plan
6. Exhibit for employee competence requirement

4. Standard operating procedures (05 SOPs):

It covers sample copy of SOPs 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. The list of standard operating procedures provided in the kit is given below.

List of SOPs

1. SOP for Needle Stick Injury – Care & Precaution
2. SOP for Housekeeping Procedure
3. SOP for Personnel Safety Procedure
4. SOP for Data backup plan
5. SOP for Treatment and Disposal of Biomedical Waste

5. Blank Formats (49 Formats):

This directory includes sample copy of blank forms that are required to maintain records as well as establish control and create system in the organization. The samples are given for the users as a guide to follow. The organization is free to change the same to suit their own requirements. The blank formats can be used as templates. A total of 49 blank formats are provided as per the list given below.

List of Formats

1. Case Report Form
2. Informed Consent form
3. Subject Recruitment Log
4. Site Monitoring Report
5. Checklist for Assent Form for vulnerable population
6. Checklist for participants with special consideration
7. Assent Form vulnerable population
8. Unbinding form
9. Monitoring Plan
10. Investigator / Investigation Agreement
11. Site Delegation Log
12. Sub–contractors / External service provider’s agreement
13. Supplier Evaluation Report
14. Inspection report
15. Master List and Distribution List of Documents
16. Corrective Action Report
17. Change Note
18. Objective Monitoring Report
19. Master List of Records
20. Adverse Event Reporting Form
21. Audit plan / schedule
22. Internal Audit Non–Conformity Report
23. Log of Adverse Event
24. Subject Identification Log
25. Investigational device accountability / inventory log
26. Monitoring Feedback Form
27. Complaint Report
28. Housekeeping Checklist
29. Information Brochure
30. Sterilization Report
31. Safety Evaluation Checklist
32. Purchase Order
33. Indent
34. Approved External Providers List
35. Supplier Registration Form
36. Clause-wise Document-wise Audit Review Report
37. Risk Assessment sheet
38. Clause-wise audit report
39. Circular – MRM Agenda
40. Minutes of management review meeting
41. Periodic document review report
42. Training Calendar
43. Register of rules and Regulation
44. Job Description And Specification
45. Training Report
46. Induction Training Report
47. Employees Competence Report
48. Handover Form
49. Appointment Letter

6. ISO 14155:2020 Audit Checklist (more than 180 questions)

This covers audit questions based on the ISO 14155:2020 requirements. It will be a very good tool for the auditors to make audit questionnaire for auditing. It will bring effectiveness in auditing. A total of more than 180 questions are prepared on the basis of ISO 14155:2020.

7. ISO 14155:2020 Compliance Matrix

This compliance matrix contains ISO 14155:2020 requirement wise list of documented information for easy reference of users and to understand how this system is made.

Part-2: Training: ISO 14155:2020 awareness training:

A. Presentation:-

Under this directory further files are made in power point presentation as per the chapter listed below.
• Topic wise power point presentation in 4 modules as listed below.

1. Awareness of ISO 14155:2020

It covers awareness of Clinical investigation of medical devices for human subjects – Good clinical practice system, benefits and summary of overall system.

2. ISO 14155:2020 requirements

It covers ISO 14155:2020 systems, Requirements, to establish the systems, It gives explanation for many concepts and given in plain English.

3. Control of Documents and Records

It covers ISO 14155:2020 documented information details and list of areas where standard demands for documented information. Such documented information with list against the requirements is given.

4. Step for ISO 14155:2020 Installation & Certification

It covers implementation methodology, steps for ISO 14155:2020 certification, the non conformances, process, what happens during a certification audit.

B. A literature to understand ISO 14155:2020 subject well:-

This topic covers write up for the ready reference to the participant for understanding and reading the subject to get in depth knowledge on the subject.
It is given in word. You may also use it for further reading and circulations within audience.
Chapter No.           Name of chapter
1.                 Awareness of ISO 14155:2020
2.                 ISO 14155:2020 requirements
3.                Control of Documents and Records
4.                Step for ISO 14155:2020 Installation & Certification

C. Total 02 workshops and 01 case study to understand ISO 14155:2020 requirements:-

This topic covers 2 workshops and 1 case study questions with details to find out the ISO 14155:2020 applicable clause number to check effectiveness of training gained by students.

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