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| Item Details | Price | ||
|---|---|---|---|
Become a Globally Recognized Exemplar Global Certified Internal Auditor | Audit with Confidence | Lead with Impact | Become More Valuable
Language: English
Instructor: SubMastery | Exemplar Global Certified
Validity Period: 180 days
ISO 13485:2016 Internal 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 13485:2016 Introduction | |||
| Lesson 1 - ISO 13485:2016 Introduction | |||
| Lesson 2 - History and Major Changes | |||
| Lesson 3 - PDCA Approach in ISO 13485 | |||
| Lesson 4 - Clause Structure | |||
| Lesson 5 - Medical Device Regulation and Classification | |||
| π Challenge Quiz | |||
| Module 2 : Scope_Normative Reference_Terms and Definition | |||
| Lesson 1 - Scope and Normative Reference | |||
| Lesson 2 - Terms and Definition | |||
| π Challenge Quiz | |||
| Module 3 : Clause 4_Ηͺuality management system | |||
| Lesson 1 - Clause 4.1 - General Requirements | |||
| Lesson 2 - Clause 4.2 - Documentation Requirements | |||
| π Challenge Quiz | |||
| Module 4 : Clause 5_Management responsibilities | |||
| Lesson 1 - Clause 5.1 to 5.3 | |||
| Lesson 2 - Clause 5.4 - Planning | |||
| Lesson 3 - Clause 5.5 - Responsibility Authority and Communication | |||
| Lesson 4 - Clause 5.6 - Management Review | |||
| π Challenge Quiz | |||
| Module 5 : Clause 6_Resource management | |||
| Lesson 1 - Clause 6.1 to 6.3 | |||
| Lesson 2 - Clause 6.4 - Work Environment & Contamination Control | |||
| π Challenge Quiz | |||
| Module 6 : Clause 7_Product realization | |||
| Lesson 1 - Clause 7.1 - Planning of Product Realization and 7.2 - Customer Related Process | |||
| Lesson 2 - Clause 7.3 - Design and Development | |||
| Lesson 3 - Clause 7.4 - Purchasing | |||
| Lesson 4 - Clause 7.5 - Production and Service Provison_Part 1 of 2 | |||
| Lesson 5 - Clause 7.5 - Production and Service Provison_Part 2 of 2 | |||
| Lesson 6 - Clause 7.6 - Control of Monitoring and Measuring Equipment | |||
| π Challenge Quiz | |||
| Modul 08 : Clause 10_Measurement analysis and improvement | |||
| Lesson 1 - Clause 8.1 - General and 8.2 - Monitoring and Measurement | |||
| Lesson 2 - Clause 8.3 - Control of Non Conforming Product | |||
| Lesson 3 - Clause 8.4 - Analysis of Data | |||
| Lesson 4 - Clause 8.5 - Improvement | |||
| π Challenge Quiz | |||
| Module 09 : Nonconformity Writing Structure | |||
| NC Writing (4 Components) | |||
| Audit Byte - Difference b/w major, minor & observation | |||
| π Challenge Quiz | |||
| Final Examination - IA ISO 13485:2016 | |||
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