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Welcome and Study Instruction
Intro to Quality HUB India
Course Instructions & Study Guidelines(English)
Mr. Aryan Viswakarma (Founder CEO QHI & NAPL) Introduction (English)
QHI Awards and Recognitions (English)
Internal Auditor Course (English)
Important Instructions For Learners 01.08.24
Introduction to ISO13485
(P1) Introduction to ISO13485 (English)
(P2) ISO13485-Benefits, Exclusion and Non-Applicability(English)
(P3)Introduction to Standard ISO13485 (English)
(P4.1)Clarification of the concept-Section 0.2 (English)
(P4.2) Process and Process Approach (English)
(P4.3)ISO13485(Clause 0.5)-Compatibility with other management systems
ISO13485 Standard and Clauses
Introduction to ISO13485 Standard and Clauses (English)
Scope (Clause 1) and Normative Reference (Clause 2) (English)
Clause 3.0 Terms and Definition
Clause 3.0 (P1)3.1 to 3.6 (English)
Clause 3.0 (P2) 3.7 to 3.14 (English)
Clause 3.0 (P3) 3.15 to 3.20 (English)
Clause 4.0 Quality Management System
(P4.1) Clause 4.1 General Requirements (English)
(P4.2)Clause 4.1.3 to 4.1.5 Clause (English)
(P4.3)Clause 4.1.16 to 4.2.2 (English)
(P4.4) QMS Clause 4.2.3 to 4.2.4 (English)
(P4.5) Clause 4.2.5 Control of Records (English)
Clause 5.0 Management Responsibility
(P5.1) Clause 5.0 -Clause 5.3 (English)
(P5.2) Clause 5.4 -Clause 5.5.2(English)
(P5.3)Clause 5.5.3- Clause 5.6.3 (English)
Clause 6.0 Resource Management
(P6.1) Clause 6.1- Clause 6.3 (English)
(P6.2) Clause 6.4.1- Clause 6.4.2 (English)
Clause 7.0 Product Realization
(P7.1) Product Realization -Clause 7.1 (English)
(P7.2) Product Realization -Clause 7.2.1 to 7.2.2 (English)
(P7.3) Product Realization -Clause 7.2.3 to 7.3.2 (English)
(P7.4) Product Realization -Clause 7.3.3 to 7.3.4 (English)
(P7.5) Product Realization -Clause 7.3.5 to 7.3.7 (English)
(P7.6) Product Realization -Clause 7.3.8 to 7.3.10 (English)
(P7.7)Product Realization -Clause 7.4 to 7.4.2 (English)
(P7.8) Product Realization -Clause 7.4.3 to 7.5.1 (English)
(P7.9)Product Realization -Clause 7.5.2 to 7.5.4 (English)
(P7.10)Product Realization -Clause 7.5.5 to 7.5.7 (English)
(P7.11)Product Realization -Clause 7.5.8 to 7.5.11 (English)
(P7.12) Clause 7.6 (Control of Monitoring & Measuring Equipment)
Clause 8.0 Measurement, Analysis and Improvement
(P8.1) Clause 8.1- Clause 8.2.2 (English)
(P8.2) Clause 8.2.3- Clause 8.2.5 (English)
(P8.3) Clause 8.2.6- Clause 8.3.3 (English)
(P8.4)P1-Clause 8.3.4-Clause 8.5.1(English)
(P8.4)P2-Clause 8.5.2-Clause 8.5.3 (English)
Various aspects pertaining to Management Representative (MR)
(P1) Roles and Responsibilities of an Management Representative(MR) (English)
(P2) Skill, Exp, Challenges for Management Representative(MR) (English)
Management Review Meeting (MRM)
(P1) Management Review Meeting(English)
(P2) Management Review Meeting(English)
ISO19011:2018 - Guideline for Conducting Audit
ISO19011 - Clause 1 (SCOPE) and 2 (NORMATIVE REFERENCE)-(English)
ISO19011- Clause 3 (Terms and Definitions) - (Part1) - (English)
ISO19011- Clause 3 (Terms and Definitions) - (Part2) (English)
ISO19011- Clause 4 (Principles of Auditing)-(English)
ISO19011- Clause 5 (Managing an Audit Program)-(English)
Internal Audit Schedule-(English)
ISO19011- Clause6(Part1) - Performing an Audit -(English)
ISO19011- Clause 6 (Part2)- Audit Check List -(English)
ISO19011- Clause6(Part1) - Performing an Audit -(English)
ISO19011-Clause 6- Interviewing Technique -(English)
ISO19011-Clause6 -Conducting the audit-(English)
ISO19011- Clause 6.4.2- Third Party Opening Meeting -(English)
ISO19011-Clause 6.4.7-Collecting Information -(English)
ISO19011- Clause 6.4.8 (Generating Audit Findings)-(English)
ISO19011- Clause 6 (Audit Reporting) -(English)
ISO19011- Clause 6 ( NC Reports) -(English)
ISO19011- Clause 6 - Closing of Audit-(English)
ISO19011- Clause 7 (Part1)-(English)
ISO19011- Clause 7 (Control of Audit)-(English)
ISO19011- Clause 7.2.4 (Auditor Competency) -(English)
Skills and Traits of Auditor (English)
Clause Identification Exercise for Learners:
Clause Identification Questions (ISO13485)-V0
Clause Identification Answers (ISO13485)-V0
Non Conformity(NC) Report Writing
Content of NC Report (English)
(P1) Non Conformity Report Format (English)
(P2) NC Report ISO13485 (Case 01 to 03) English
(P3)NC Report ISO13485 (Case 4 and 5) English
(P4)NC Report ISO13485 (Case 6 to 8) English
(P5)NC Report ISO13485 (Case 9 to 10) English
Most Common NCRs observed during ISO13485 Audit (English)
Major NC Vs Minor NC VS OFI (English)
10 Steps for Non Conformity Closure in an Audit (English)
Flow of Non Conformity Closure in an Audit (English)
Other Support Modules
Levels of Documents (English)
Types of Processes: COP, MOP and SOP (English)
Quality Objective Tracker System - English
Important Audit Terms and Definitions (English)
What is an Audit? Types of System Audits (English)
Difference between 'System' and 'Process' (English)
Document VS Record (English)
PDF, Formats etc
MDR17- Regulations of Medical Devices in India (Dept. of Pharmaceuticals)
MEDICAL DEVICE REGULATIONS Global overview and guiding principles (WHO)
FAQ on Medical Devices (India)-CDSCO
FAQ on Medical Devices (USA)-V0
Gazzette Notifications Link
Classification of Non Medical Devices
List of Medical Devices in India
Doc Control Matrix_QHI
Standard and Format
ISO13485:2016 standard pdf File
ISO 13485 Internal Audit Checklist
Mandatory Procedure MDQMS(ISO13485-2016)
Mandatory Procedure & Records (ISO13485-2016)
Practice Test
Section A - Multiple Choice Questions
Section B: Descriptive (Short answer type questions)
Section C: Descriptive answer type questions
Section D: Descriptive answer type questions
Section E: NC Report Writing
Related Articles / Blogs for Study
Confirmation for Final Test
For Requirement of Hard Copy of Certificate
Learner Registration Form