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Video Session
1. What is ISO and resistration process
2. What is QMS and Goal of QMS
3. Major changes in ISO 9001 2015 wrt to ISO 9001 2008
4. Clasue Over in iso 9001 2015 and PDCA Cycle
5. Quality Management principles
1. Clause -1 Scope
1. Clause -2 Normative reference
1. Clause -4, (4.1) Understanding the organization and its context
2. Clause -4, Case study Internal and External issue
3. Clause -4, (4.2) Understanding the needs & Expectations of the intrested parties
4. Clause -4, Case study- Understanding the needs _ Expectations of the intrested parties
1. Clause -4, (4.3)- Determine the scope of the quality management system
2. Clause Case Study - Scope of Quality management system
3. Clause -4, (4.4)- Quality management system
4. Clause -4, Case study- Turtle Diagram
1. Clause 5, (5.1.1) Leadership and commitment - General
2. Clause 5, (5.1.2) Customer focus
3. Clause 5, (5.2.1) Estabilishing the quality policy
4. Clause 5, (5.2.2) Communicating the quality policy
5. Clause 5, (5.3) Oranization roles, responsibilty and authorities
6. Clause 5, Case study- Oranization roles, responsibilty and authorities
1. Clause 6, (6.1.1, 6.1.2)- Actions to adress risk and opportunities
2. Clause 6, Case Study- Risk and opportunity analysis
3. Clause 6, (6.2.1, 6.2.2) Quality objectives and planning to achieve them
4. Clause 6, Case study- Quality Objective and action plan
5. Clause 6, (6.3)- Planning of changes
6. Clause 6, Case study- Planning of changes
1. Clause 7, (7.1.1) General
2. Clause 7, (7.1.2)- People
3. Clause 7, (7.1.3) Infrastructure
4. Clause 7, (7.1.4) Environment for the operation of process
5. Clause 7, (7.1.5) Monitoring and measuring resources
6. Clause 7, (7.1.6) Organization knowledge
7. Clause 7, Case study- Organization knowledge
8. Clause 7, (7.2)- Competence
9. Clause 7, Case study- Training need and identification & operator skill matrix
10. Clause 7, (7.3)- Awareness
11. Clause 7, (7.4)- Communication
12. Clause 7, Case study-Communication Matrix
13. Clause 7, (7.5)- Documented information
1. Clause 8 - Operational planning and control
1. Clause 8 - (8.2.1) Customer communication
2. Clause 8 - (8.2.2) Determining the requirements for products and services
3. Clause 8 - (8.2.3) Review the requirements for products and services
4. Clause 8 - (8.2.4) Change to requirements for products and services
5. Clause 8 - Case study- Master Development Schedule
6. Clause 8 - Case study- Team Feasibility Commitment
7. Clause 8 - Case study- Contract review check list
1. Clause (8.3) - (8.3.1, 8.3.2)- Design and development- General, Design and development planning
2. Clause (8.3) - (8.3.3)- Design and development inputs
3. Clause (8.3) - (8.3.4)- Design and development Controls
4. Clause (8.3) - (8.3.5)- Design and development output
5. Clause (8.3) - (8.3.6)- Design and development changes
6. Clause (8.3) - Case study- Design input and verification sheet
7. Clause (8.3) - Case study- Process Design input and verification sheet
1. Clause (8.4) - (8.4.1- Control of externally provided process, Products and services
2. Clause (8.4) - (8.4.2)- Type and extent of control
3. Clause (8.4) - Case study- Mater list of supplier and control
4. Clause (8.4) - Case study- Supplier Registration Form
5. Clause (8.4) - Case study- Supplier audit Plan
6. Clause (8.4) - Case study- Supplier auditcheck points
7. Clause (8.4) - Case study- Type and Extent of control
8. Clause (8.4) - (8.4.3)- Information for the external providers
1. Cluase 8, (8.5.1)- Control of production and service provision
2. Cluase 8, (8.5.2)- Idenfication & Traceability
3. Cluase 8, (8.5.3)- Property Belonging to customer or external providers
4. Cluase 8, (8.5.4)- Preservation
5. Cluase 8, (8.5.5)- Post delivery activity
6. Cluase 8, (8.5.6)- Control of changes
1. Cluase 8, (8.6)- Release of products and services
1. Cluase 8, (8.7)- Control of non conferming outputs
Clause 8- (Case study)- 4-M Change Control Management
Clause 8- (Case study)- Deviation logbook
1. Clause 9- (9.1.1)- Monitoring, measurement, analysis and evaluation- General
2. Clause 9- (9.1.2)- Customer Satisfaction
3. Clause 9- (9.1.3)- Analysis and evaluation
4. Clause 9- (9.2)- Internal audit
5. Clause 9- (9.3)- Management Review
6. Clause 9- (Case study)- Customer satisfaction servey
7. Clause 9- (Case study)- Internal audit plan and check sheet
1. Clause 10- (10.1)- Improvement- General
2. Clause 10- (10.2)- Nonconfermity and corrective action
3. Clause 10- (10.3)- Continual improvement
NC Writing Video
1. ISO 9001 2015 Certification rule
2. Definition and Terminology
3. Type of audit
4. Audit planning and reporting
5. Non-conformance Report, Report of audit, Report Writing
6. Responsibility of an auditor
7. Type of NC
8. How to write NC
9. Audit Non Conformity Report
10. Internal audit check sheet
Resources
Download Slides - Introduction πΎ
Download Slides - Clause 4 (All) πΎ
Download Slides - Clause 5 and 6 πΎ
Download Slides - Clauses 7.1 to 7.5 πΎ
Download Slides - Clause 8.1 to 8.3 πΎ
Download Slides - Clauses 8.4 πΎ
Download Slides - Clauses 8.5 to 8.7 πΎ
Download Slides - Clause 9 and 10 πΎ
Download Slides - Auditing Skills & NC Writing πΎ
Bonus Resources π
Key Formats [Editable] π
ISO 9001:2015 - Internal Audit Checksheet πΎ
ISO 9001 Audit NC Format with Case Studyβ
List of Documented Information - ISO 9001:2015
Any Question / Feedback? Link Inside ποΈββοΈ
Final Examination - ISO 9001:2015 Internal Auditor Course