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ISO 9001:2015
Bob Deysher
Senior Consultant
Quality Support Group, Inc.
bob.deysher@qualitysupportgroup.com
2015 QSG, Inc.
2014
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
BMS
2015 QSG, Inc.
Agenda (*)
Understand the Organization and its Context
Analyzing the External Environment
Analyzing the Internal Environment
5 Leadership
Understanding
of the
organization
and its context
Understanding
the needs and
expectations
of interested
parties
Scope of
management
systems
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
products and
services
Management
review
Awareness
Planning of
changes
10 Improvement
Continual
Improvement
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
Do
10
11
12
13
Customers
Owners/Share Holders
Sustained profitability
Transparency
Society
Environmental protection
Ethical behavior
Compliance with statutory and regulatory requirements
NOTE Although most organizations use similar descriptions for their interested parties (e.g.
customers, owners/shareholders, suppliers and partners, people in the organization), the
composition of those categories can differ significantly over time and between organizations,
industries, nations and cultures.
2015 QSG, Inc.
14
Your Environment
Competitor
Customer
Supplier
Community
Your Organization
People
Products/Services
Processes
Regulatory
Body
Customer
Customer
Supplier
Competitor
Suppliers
Supplier
Customers
Customer
15
16
17
Environmental Scanning
StrategicFocuses on Long-Term Needs within the
organizational context to ensure the QMS/BMS is
appropriate.
TacticalFocuses on the Processes within the
organizational context to ensure QMS/BMS is effective.
OperationalFocuses on the Metrics within the
organizational context to ensure QMS/BMS is efficient.
18
Strategic
Review the vision, mission, charter, purpose, values,
and historical evolution for the organization.
Identify the internal and external customers, vendors,
competitors, and the trends affecting the operation of
the organization.
Speak with the all level of people within the
organization to obtain their perspectives, opinions,
values, and needs.
19
Tactical
Be cognizant of the high-level process workflows for the
organization.
Identify similarities and differences in the structure and
major workflows with a comparable/similar organization
providing the same product or service.
Speak with managers and leaders within the
organization to obtain their thoughts, opinions, ideas,
and challenges.
20
Operational
Review forms, logs, records, software, and
equipment used in performing tasks within the
organizational context (Management Review Rollup).
Become familiar with job descriptions and the work
environment where the work is performed.
Observe workers performing the actual tasks; speak
with those doing the work to understand their
frustrations and why work is done certain ways.
21
External/Internal
Environment
+
Interested Parties
Strategy
Objectives
QMS
2015 QSG, Inc.
22
Questions???
23
References
ISO 9000 Introduction and Support Package:
Guidance on the Concept and Use of the Process
Approach for management systems, ISO/TC 176/
SC 2/N 544R3
ISO 9001:2015
ISO 9004:2009
Urgo & Associates; The Policies & Procedures
Authority Newsletter
24