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Quality

Management: Challenges and Direction, 2015


Paul Palmes
Business Standards Architects, Inc
Fargo, ND and Prescott, WI

Just

when you thought


you had it all figured
out

Quality is

Knowing Exactly What your Customer Wants


Providing More than Expected, and
Doing so in the most Efficient and Effective
Manner Possible.

Quality is Not

Administratium

Leadership ISO 9001:2015


CLAUSE 5.1: Top management shall demonstrate leadership and commitment with respect to the quality
management system by:
a) taking accountability for the effectiveness of the quality management system;
b) ensuring that the quality policy and quality objectives are established for the quality management
system and are compatible with the context and strategic direction of the organization;
c) ensuring the integration of the quality management system requirements into the organizations
business processes;
d) promoting the use of the process approach and risk-based thinking;
e) ensuring that the resources needed for the quality management system are available;
f) communicating the importance of effective quality management and of conforming to the quality

management system requirements;


g) ensuring that the quality management system achieves its intended results;
h) engaging, directing and supporting persons to contribute to the effectiveness of the quality
management system;
i) promoting improvement;

j) supporting other relevant management roles to demonstrate their leadership as it applies to their
areas of responsibility.

Leadership ISO 9001:2015


a) taking accountability for the effectiveness of the
quality management system;
b) ensuring that the quality policy and quality
objectives are established for the quality
management
system and are compatible with the context and
strategic direction of the organization;
c) ensuring the integration of the quality
management system requirements into the
organizations
business processes;
d) promoting the use of the process approach and
risk-based thinking;

Leadership ISO 9001:2015


e) ensuring that the resources needed for the quality
management system are available;
f) communicating the importance of effective quality
management and of conforming to the quality
management system requirements;
g) ensuring that the quality management system
achieves its intended results;
h) engaging, directing and supporting persons to
contribute to the effectiveness of the quality
management system;
i) promoting improvement;
j) supporting other relevant management roles to
demonstrate their leadership as it applies to their
areas of responsibility.

5.3 Organizational roles,


responsibilities and authorities
Top management shall ensure that the responsibilities and authorities
for relevant roles are assigned, communicated and understood
throughout the organization.
Top management shall assign the responsibility and authority for:
a) ensuring that the quality management system conforms to the
requirements of this International Standard;
b) ensuring that the processes are delivering their intended outputs;
c) reporting on the performance of the quality management system
and on opportunities for improvement (see 10.1) to top
management;
d) ensuring the promotion of customer focus throughout the
organization;
e) ensuring that the integrity of the quality management system is
maintained when changes to the quality management system are
planned and implemented.

Bottom Line

Its not a Bolt-on anymore


Leadership Involvement

QMS Responsibilities can be Distributed


Involving leaders

Harmonization of
management system
standards

11

Positioning of some ISO (and other) standards


Aerospace
I.T.
Service

ISO 27001

Supply chain
security

AS 9100

ISO 20000

Telecomm

TL 9000

Economic growth

Automotive
ISO/TS 16949

Environmental
(Reqts)
ISO 55000
ISO 14001

Environmental
(Guidelines)

Asset
Mgt.

Energy

ISO 50001

ISO 9001

ISO 22000

ISO 31000

ISO 9004

ISO 14064

ISO 20121

(OHSAS 18001)
Future ISO Std

Health &
Safety

(SA 8000)

Social resp.
Requirements

Social
responsibility
ISO 37001

Greenhouse
Gas

Quality
(Guidelines)

Sustainable
Purchasing

ISO 18617

Environmental
integrity

Food
safety

Risk
management

Sustainable
Development

ISO 14004

Quality
(Reqts)

ISO 28001

Information
Security

Anti- ISO 26000


bribery

Social resp.
Guidance

ISO 39001

ISO 22301

ISO 14040

Life cycle

Sustainable
events

Road
safety

Business
continuity

12

Need for Alignment of management system


standards!

ISO Joint Technical Coordination Group (JTCG):


Joint vision for management system standards
High level structure for all ISO management systems
standards
Identical sub-clause titles under the high level structure
Generic core vocabulary for management system standards

Aim is to make life easier for those who wish to have


a single management system

13

Annex SL High Level Structure


1.
2.
3.
4.

5.
6.

Scope
Normative references
Terms and definitions
Context of the organization

Understanding the organization and its


context
Needs and expectations of interested
parties
Determining the scope
Management System

Leadership

Leadership and commitment


Policy
Roles, responsibility and authority

Planning

Actions to address risks &


opportunities
Objectives and plans to achieve
them

7. Support

Resources
Competence
Awareness
Communication
Documented information

8. Operation

Operational planning and control

9. Performance evaluation

Monitoring, measurement,

analysis & evaluation


Internal audit
Management review

10. Improvement

Non conformity and corrective

action
Continual Improvement

14

Questions

Thank you
Paul Palmes
701-371-8224
pcpalmes@cableone.net

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