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ISO 9001:2015
Bob Deysher
Senior Consultant
Quality Support Group, Inc.
bob.deysher@qualitysupportgroup.com
2015 QSG,Inc.
2015QSG, Inc.
Agenda
Compare and Contrast Leadership
ISO 9001:2008 vs ISO 9001:2015
Other Topics
Planning the Quality Management System
Scope
Exclusions
Organizational Knowledge
Evaluation
Internal Audit
2015 QSG, Inc. 2
ISO 9001:2015 Structure
4 Context of 5 Leadership 6 Planning for the 7 Support 8 Operations 9 Performance 10 Improvement
the quality management and evaluation
organization system
Quality
Competence Determination
Quality policy Internal audit Nonconformity
Understanding objectives of requirements and corrective
the needs and for products and action
services
expectations
of interested Organizational
Awareness Continual
Planning of Design and Management
parties roles, review Improvement
changes development of
responsibilities
and products and
Scope of services
management authorities
Communication
systems
Control of
QMS
Documented
externally
provided
products and Check Act
services
Information
Production and
Plan service
provisions
Release of
products and
services
Control of non-
conforming
process
outputs,
products and
services
QMS
BMS
2015 QSG, Inc. 8
Leadership
Quality Policy
The quality policy is divided into two sub-clauses:
5.2.1 provides leadership by formulating the quality policy
5.2.2 provides leadership by implementing the quality policy
Ensure that the policy is available to relevant interested parties.
QMS
NOTE 1 In this International Standard, the terms product or service only apply to products
and services intended for, or required by, a customer.
NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.