ISO 9001 – Revision 2015
The class will provide an overview of the ISO 9001 revision process, the new element/clause “High Level Structure” (HSL), the introduction of the “risk based thinking” concept, and a summary of the main changes. Upon request we can provide a detailed, section by section, review of the requirements of the ISO 9001: 2015 international standard.
This course consists of a balance of lecture, practical exercises and supplemental handout information. The instructor will guide students through implementation, audit scenarios and group discussions. This training is also intended for those organizations that have implemented or plan to implement other industry specific Quality Management System standards based on ISO 9001.
- Introduction to Quality Management Systems
- The ISO 9001 revision process
- The Process approach
- The PDCA cycle
- Risk based thinking
- Terms and definitions
- ISO/DIS 9001:2015 Requirements
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Clause 4 – Context of the organization
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Clause 5 – Leadership requirements
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Clause 6 – Planning for the quality management system
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Clause 7 – Support
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Clause 8 – Operation
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Clause 9 – Performance evaluation
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Clause 10 – Improvement
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- Next steps in the implementation of ISO 9001:2015