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| Item Details | Price | ||
|---|---|---|---|
Become a Globally Recognized Exemplar Global Certified Lead Auditor | Audit with Confidence | Lead with Impact | Become More Valuable
Language: English
Instructor: SubMastery | Exemplar Global Certified
Validity Period: 240 days
10% Cashback as Points
ISO 13485:2016 Lead Auditor Training (Exemplar Global Accredited)
π Special Dicount Offer β Limited Time Only! π
π₯ Get 10% OFF on your course enrollment!
π Use Promo Code: SM10 (for Indian users)
π For International users, apply code: SM10INT
π Offer Valid for limited time.
π§ Have questions? Reach us at: support@submastery.com
π± Or WhatsApp: +91 9084510846
β οΈ Note - The course access is instant.
| Welcome You | |||
| Module 1 : ISO 19011:2018 - guideline for auditing management systems | |||
| Lesson 1 - ISO 19011:2018 Introduction (18:00) | |||
| Audit Byte_1st party, 2nd party & 3rd party auditor explained (4:00) | |||
| Audit Byte - 7 Principles of Auditing (3:00) | |||
| Lesson 2 - Risk Based Approach w.r.t ISO 13485 (7:00) | |||
| π Challenge Quiz | |||
| Module 2 : Nonconformity Writing Structure | |||
| NC Writing (4 Components) (9:00) | |||
| Audit Byte - Difference b/w major, minor & observation (7:00) | |||
| π Challenge Quiz | |||
| Module 3 : NC Clause and Structure Writing Activity | |||
| 01_Clause Mapping Exercise (ISO 13485)_Question Sheet (2 pages) | |||
| 02_Clause Mapping y (ISO 13485) Answer Key (2 pages) | |||
| 03_NC Structure Exercise (ISO 9001)_Question - (3 pages) | |||
| 04_NC Structure Exercise (ISO 9001)_Answer Key (3 pages) | |||
| Module 4 : ISO 13485:2016 Introduction | |||
| Lesson 1 - ISO 13485:2016 Introduction (6:00) | |||
| Lesson 2 - History and Major Changes | |||
| Lesson 3 - PDCA Approach in ISO 13485 (7:00) | |||
| Lesson 4 - Clause Structure (3:00) | |||
| Lesson 5 - Medical Device Regulation and Classification (9:00) | |||
| π Challenge Quiz | |||
| Module 5 : Scope_Normative Reference_Terms and Definition | |||
| Lesson 1 - Scope and Normative Reference (3:00) | |||
| Lesson 2 - Terms and Definition (11:00) | |||
| π Challenge Quiz | |||
| Module 6 : Clause 4_Ηͺuality management system | |||
| Lesson 1 - Clause 4.1 - General Requirements (12:00) | |||
| Lesson 2 - Clause 4.2 - Documentation Requirements (12:00) | |||
| π Challenge Quiz | |||
| Module 7 : Clause 5_Management responsibilities | |||
| Lesson 1 - Clause 5.1 to 5.3 (6:00) | |||
| Lesson 2 - Clause 5.4 - Planning | |||
| Lesson 3 - Clause 5.5 - Responsibility Authority and Communication | |||
| Lesson 4 - Clause 5.6 - Management Review (7:00) | |||
| π Challenge Quiz | |||
| Module 8 : Clause 6_Resource management | |||
| Lesson 1 - Clause 6.1 to 6.3 (6:00) | |||
| Lesson 2 - Clause 6.4 - Work Environment & Contamination Control (5:00) | |||
| π Challenge Quiz | |||
| Module 9 : Clause 7_Product realization | |||
| Lesson 1 - Clause 7.1 - Planning of Product Realization and 7.2 - Customer Related Process (12:00) | |||
| Lesson 2 - Clause 7.3 - Design and Development (20:00) | |||
| Lesson 3 - Clause 7.4 - Purchasing (10:00) | |||
| Lesson 4 - Clause 7.5 - Production and Service Provison_Part 1 of 2 (13:00) | |||
| Lesson 5 - Clause 7.5 - Production and Service Provison_Part 2 of 2 (13:00) | |||
| Lesson 6 - Clause 7.6 - Control of Monitoring and Measuring Equipment (6:00) | |||
| π Challenge Quiz | |||
| Modul 10 : Clause 10_Measurement analysis and improvement | |||
| Lesson 1 - Clause 8.1 - General and 8.2 - Monitoring and Measurement (16:00) | |||
| Lesson 2 - Clause 8.3 - Control of Non Conforming Product (10:00) | |||
| Lesson 3 - Clause 8.4 - Analysis of Data (4:00) | |||
| Lesson 4 - Clause 8.5 - Improvement (9:00) | |||
| π Challenge Quiz | |||
| Final Examination - ISO 13485:2016 Lead Auditor Course | |||
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