Context-Presentation June 2015 PDF

“Context Of the Organization” ISO 9001:2015 Bob Deysher Senior Consultant Quality Support Group, Inc. [email protected]

©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