Curriculum
- 23 Sections
- 23 Lessons
- 30 Weeks
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- Introduction1
- Lec 1- SCOPE OF ISO 13485 & RELATION WITH ISO 90011
- Lec 2 - Claue # 4.1. General Requirements of QMS1
- Lec 3 - Claue # 4.2 Documentation Requirements1
- Lec-4 titled (Lec 4- Clauses # 5.1. to 5.4)1
- Lec 5- Clauses # 5.5 (Responsibility, authority and communication)1
- Lec 6- Clauses # 5.6 (Management Review)1
- Lec 7- Clauses #6.1 & 6.2 (Provision of Resources & Human Resources)1
- Lec 8- Clauses # 6.3 & 6.4 (Infrastructure & Work Environment and Contamination1
- Lec 9- Clause #7.1 ( Planning to Product Realization)1
- Lec 10 - Clause # 7.2. Customer Related Process1
- Lec 11 - Clause # 7.3 (Part #1)1
- Lec 12 - Clause # 7.3 (Part #2)1
- Lec. 13 - Clause # 7.3. (Part #3)1
- Lec 14- Clause # 7.4. (Purchasing)1
- Lec 15- Clause # 7.5. (Part1 )1
- Lec 16- Clause # 7.5. (Part 2 )1
- Lec 17 Clauses # 7.5. (Part 3 ) & 7.61
- Lec 18- Clauses 8.1 & 8.2 Part 11
- Lec 19- Internal Audit & Monitoring and Measurment of Processes and Products1
- Lec 20- Clause #8.3 Control of Non conforming product1
- Lec 21- Clause #8.4 KPIs & 8.5 Improvement.1
- Lec 22- Course Review1