Introduction
- History of ISO 9001 Revisions
- Pre-Course Diagnostic Test
What has changed in ISO 9001:2015 - High level overview
- 9001:2008 vs 9001:2015 High Level Comparison
- Five terms now have a new name
- No Quality Manual
- No Management Representative
- No Exclusion Clause
- Process Approach
- Preventive Action is out, and Risk Based Thinking is in
- DOWNLOAD - Key changes from ISO 9001:2008
ISO 9001:2015 Explained (Clause 1,2 and 3)
- SCOPE OF THE STANDARD (Clause 1)
- NORMATIVE REFERENCES (Clause 2)
- TERMS AND DEFINITIONS (Clause 3)
- DOWNLOAD - Clause 1, 2 and 3
- Practice Activity - QUIZ - Clause 1, 2 and 3
CONTEXT OF THE ORGANIZATION (Clause 4)
- CONTEXT OF THE ORGANIZATION (Clause 4)
- 4.1 Understanding the Organization and its Context
- 4.2 Needs and Expectations of Interested Parties
- 4.3 Determining the scope of the quality management system
- 4.4 Quality management system and its processes
- DOWNLOAD - Clause 4
- Practice Activity - QUIZ - Clause 4
LEADERSHIP (Clause 5)
- LEADERSHIP (Clause 5)
- 5.1 Leadership and commitment
- 5.2 Policy
- 5.3 Organizational roles, responsibilities and authorities
- DOWNLOAD - Clause 5
- Practice Activity - QUIZ - Clause 5
PLANNING (Clause 6)
- PLANNING (Clause 6)
- 6.1 Actions to address risks and opportunities
- 6.2 Quality objectives and planning to achieve them
- 6.3 Planning of changes
- DOWNLOAD - Clause 6
- Practice Activity - QUIZ - Clause 6
SUPPORT (Clause 7)
- SUPPORT (Clause 7)
- 7.1 Resources
- 7.1.1 General
- 7.1.2 People
- 7.1.3 Infrastructure
- 7.1.4 Environment for the operation of processes
- 7.1.5 Monitoring and measuring resources
- 7.1.6 Organizational knowledge
- 7.2 Competence
- 7.3 Awareness
- 7.4 Communication
- 7.5 Documented information
- DOWNLOAD - Clause 7
- Practice Activity - Quiz - Clause 7
OPERATION (Clause 8)
- OPERATION (Clause 8)
- 8.1 Operational planning and control
- 8.2 Requirements for products and services
- 8.3.1 General
- 8.3.2 Design and development planning
- 8.3.3 Design and development inputs
- Definitions - Design review, verification and validation
- 8.3.4 Design and development controls
- 8.3.5 Design and development outputs
- 8.3.6 Design and development changes
- 8.4.1 General
- 8.4.2 Type and extent of control
- 8.4.3 Information for external providers
- 8.5 Production and service provision
- 8.6 Release of products and services
- 8.7 Control of nonconforming outputs
- DOWNLOAD - Clause 8
- Practice Activity - QUIZ - Clause 8
PERFORMANCE EVALUATION (Clause 9)
- PERFORMANCE EVALUATION (Clause 9)
- 9.1 Monitoring, measurement, analysis and evaluation
- 9.2 Internal audit
- 9.3 Management review
- DOWNLOAD - Clause 9
- Practice Activity - QUIZ - Clause 9
IMPROVEMENT (Clause 10)
- IMPROVEMENT (Clause 10)
- 10.1 General
- 10.2 Nonconformity and corrective action
- 10.3 Continual improvement
- DOWNLOAD - Clause 10
- Practice Activity - Quiz - Clause 10
Resources for Transition from ISO 9001:2008 to ISO 9001:2015
- Transition Timeline
- Quick Overview of Standard Clauses
- Quality Manual - To have it or not to have it?
- Organizational Knowledge - Implementation Approach
- Actions to address risks and opportunities - Implementation Approach
- Download Slides for Section 11
Making of ISO 9001:2015 Standard
- Who is Responsible for Revision?
- Why the standard is being revised?
- ISO 9001:2015 Revision Timeline
- High Level Structure - HLS
