“Context Of the Organization” ISO 9001:2015 - Quality Support Group
"Context Of the Organization" ISO 9001:2015
Bob Deysher Senior Consultant Quality Support Group, Inc. bob.deysher@
?20154 QSG, Inc.
Expected Outcome
Understand how "Context of the Organization" 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
?2015 QSG, Inc.
BMS
2
Agenda (*)
? Understand the Organization and its Context
? Analyzing the External Environment ? Analyzing the Internal Environment
? 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.
3
4 Context of the organization
5 Leadership
ISO 9001:2015 Structure
6 Planning for the quality management system
7 Support
8 Operations
9 Performance and evaluation
10 Improvement
Understanding of the organization and its context
Understanding the needs and expectations of interested parties
Scope of management systems
QMS
Leadership and commitment
Quality policy
Organizational roles, responsibilities and authorities
Action to address risk and opportunity
Quality objectives
Planning of changes
Plan
Resources Competence Awareness
Communication Documented Information
Operations planning and control
Determination of requirements for products and services
Design and development of products and services
Control of externally provided products and services
Production and service provisions
Release of products and services
Monitoring, measurement. analysis and evaluation
Internal audit
Management review
General
Nonconformity and corrective action
Continual Improvement
Check Act
Control of nonconforming process outputs, products and services
?2015 QSG, Inc.
Do
4
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, and if not mitigated, which could 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
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