Preview Certified Internal Auditor ISO13485:2016 (English)

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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 Learner

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

Preview - Certified Internal Auditor ISO13485:2016 (English)