“Context Of the Organization” ISO 9001:2015 Bob Deysher Senior Consultant Quality Support Group, Inc.
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©2015 QSG, Inc. ©2014
Expected Outcome Understand how “Context of the Organization” Or ganization” is integrated into your Quality Management System or Is ISO 9001:2015 a template for an effective Quality Management System or an effective Business Management System? QMS BMS ©2015 QSG, Inc.
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Agenda (*) • Understand the Organization and its Context – Analyzing the External External Environment – Analyzing the Internal Internal Environmen Environmentt
• Understanding the Needs and Expectations of Interested Parties • Determining the Scope of the Quality Management System • Putting it all Together (*) ISO 9004 is used extensively in preparing this presentation ©2015 QSG, Inc.
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ISO 9001:2015 Structure 4 Context of the organization
5 Leadership
Understanding of the
organization and its context
Understanding the needs and expectations of interested parties Scope of management systems
6 Planning for the quality management system
Leadership and commitment
Action to address risk and opportunity
Quality policy
Quality objectives
Organizational roles, responsibilities and authorities
8 Operations
7 Support
Resources
Competence
9 Performance and evaluation
Operations planning and control
Monitoring, measurement. analysis and evaluation
General
Determination of requirements for products and services
Internal audit
Nonconformity and corrective action
Design and development of
Management review
Awareness Planning of changes
10 Improvement
Continual Improvement
products and services Communication
QMS
Documented Information
Control of externally provided products and services
Check Act
Production and service provisions
Plan
Release of products and services
Control of nonconforming process outputs, products and services
©2015 QSG, Inc.
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Understanding the Organization and its Context This is a New Requirement The organization should understand their internal and external environments • Determine the issues that are relevant to the organization in both environments • Assess those issues, issues, and if not mitigated, mitigated, which could prevent prevent the success of quality management system implementation • Using these issues, understand how they will influence the quality changes in their organization on a continual basis.
ISO/DIS 9001, clause 4.1 ©2015 QSG, Inc. 5
