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QUALITY ASSURANCE ( ISO 9001:2015 ) QUALITY MANAGEMENT SYSTEM - Coggle…
QUALITY ASSURANCE
( ISO 9001:2015 )
QUALITY MANAGEMENT SYSTEM
Actions to provide adequate confidence that a product or service will satisfy requirements such as ISO9001 QMS.
ISO9001 :
Non-conformities/Observation (OFI).
Audit based on quality management system standard.
A standard that sets out the requirements for a quality management system (QMS).
Business Excellence
Assessment based on Business Excellence criteria, core values and concepts.
Score (Overall/Category)
Excellence in strategies, business practices, and stakeholder-related performance results that have been validated by assessments using proven business excellence frameworks.
Key Improvement to ISO9001:2015
Understand organizational context
Strengthen Process approach
Focus on risk based thinking
A greater emphasis on leadership engagement
Structure
Less emphasis on documentation
Document Information
Maintained Documented Information
Document (Manual, Work Instruction, Form)
Example: Quality Policy, Scope of QMS
Retained Documented Information
Record
Example: Evidence of competence, Evaluation of external providers performance