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concentric (ken-sĕn’trĭk) adjective - Having a common center. | acommoncenter.com

concentric (ken-sĕn’trĭk) adjective - Having a common center.

Changes to ISO 9001:2015Presented by Jim Thompson266 Meeting Street - Suite B | Charleston, SC 29401843.469.8279 | acommoncenter.comJanuary 26th, 2016 | ASQ Charleston

© Concentric Management Systems, Inc. 2015 | All rights reserved




YOUR QUALITY RESOURCE HUB

Where we are:• HQ in downtown Charleston, SC• New location in Sao Paulo, Brazil• Staff throughout NA, SA & Europe

What we do:• Management system products• Software implementation• Training & consultation• SME placement


Stages of Standard Development

Source: http://www.iso.org/iso/home/standards/management-standards/iso_9000/iso9001_revision.htm

Published

9/23/15


Final Draft

(FDIS)

http://www.iso.org/iso/home/standards/management-standards/iso_9000/iso9001_revision.htm


Focus of presentation:


Key Changes

• System integration through Annex SL structure• More relevant to various organizations• Reinforced focus on achieving desired results• Connection with strategic planning of

organization• From preventive to risk-based thinking• Risks and opportunities associated with change• Improvement & control of organizational

knowledge

concentric (ken-sĕn’trĭk) adjective - Having a common center. | acommoncenter.com© Concentric Management Systems, Inc. 2015 | All rights reserved

© 2015 Concentric Management Systems, Inc.


Strengthen the Core of Your Business

New Structure in ISO 9001:2015

Setting the Stage

Contents

(Table of Contents)Forward Introduction 2 Normative reference 3 Terms & definitions1 Scope

Plan Do Check Act4 Context of the

organization5 Leadership 6 Planning 8 Operation

9 Performance

evaluation10 Improvement

4.1 Understanding the

organization & its context

4.2 Understanding the needs

& expectations of interested

parties

4.3 Determining the scope of

the QMS

4.4 QMS & its processes

5.1 Leadership &

commitment

6.1 Actions to address risks

& opportunities

6.2 Quality objectives &

planning to achieve them

9.1 Monitoring,

measurement, analysis &

evaluation

10.2 Nonconformity &

corrective action

10.3 Continual improvement5.3 Organizational roles,

responsibilities & authorities

9.2 Internal audit

9.3 Management review

5.2 Policy

6.3 Planning of changes

7 Support

7.1 Resources

7.3 Awareness

7.4 Communication

7.5 Documented information

7.2 Competence

10.1 General8.1 Operational planning &

control

8.5 Production & service

provision

8.7 Control of

nonconforming outputs

8.6 Release of products &

services

8.2 Requirements for

products & services

8.3 Design & development of

products & services

8.4 Control of externally

provided processes, products

& services

InformativeAnnex A (informative)

Clarification of new structure, terminology &

concepts

Annex B (informative)

Other international standards on quality

management & quality management systems

developed by ISO/TC 176

Bibliography

Citations [1] – [28]



Strengthen the Core of Your Business

7


ActCheckDoPlan

4 Context of the

organization5 Leadership 6 Planning 8 Operation

9 Performance

evaluation10 Improvement7 Support

8.1 Operational planning &

control

8.5 Production & service

provision

8.7 Control of

nonconforming process

outputs

8.6 Release of products &

services8.2 Requirements for

products & services8.3 Design & development

of products & services

8.4 Control of externally

provided processes,

products & services

8.4.1 General

8.4.2 Type & extent of

control

8.4.3 Information for

external providers

8.3.6 Design &

development changes

8.5.3 Property belonging to

customers or external

providers

8.5.1 Control of production

& service provision

8.5.2 Identification &

traceability

8.5.6 Control of changes

8.5.4 Preservation

8.5.5 Post-delivery activities

8.2.1 Customer

communication

8.2.2 Determination of

requirements related to

products & services

8.2.3 Review of

requirements related to

products & services

8.3.1 General

8.3.2 Design &

development planning

8.3.3 Design &

development Inputs

8.3.4 Design &

development controls

8.3.5 Design &

development outputs

8.2.4 Changes to

requirements for products &

services

Clause 8 – Operation


Source: http://asq.org/quality-press

How to Purchase

http://asq.org/quality-press

Pro’s ISO 9001:2015


• Flexibility

• Inclusion of service

organizations

• Focus on risk

• Integration of various

systems

• Connected to strategy

Business Improvement

Integration

Quality

Con’s ISO 9001:2015


• Generic = Confusion

• Context of the huh?

• Where are the

records?

• Who will be the

leader?

• Auditor interpretation

No

Context of organization


• Who are you?

• Components (processes)

of your system?

• Internal vs. external

processes?

• Needs & expectations of

interested parties?

• Who is an interested

party?

Employees CustomersRecruiters

WarehouseSuppliersLogistics

Dept

Service Dept

End UsersInstallation

Techs

To record or not to record…


• Information

• Documented information

• Maintaining documented

information

• Retaining documented

information

…that is the question

Follow the leader


• Management

representative not a

single person

• Who will be driver?

• Will driver know

requirements?

Variance in interpretation


Q: Will auditors need to be retrained on the

new requirements?

A: Yes. Additional training in the new

requirements is strongly recommended.


Transition planning

Q: What is the expectation regarding

transitioning?

A: Get started now with a plan with a

transition/implementation plan.

•Gap Assessment

•Implementation Plan

2016

•Transition Audit

•Initial Audit for newly registered companies limited to 2015 version after March

2017•Monitor

transition of key suppliers

•Continue to improve

2018


Training recommendations

• Audit Program Managers

• Lead Auditors

• Internal Auditors

• Process Owners

• Leadership Awareness

• All employee awareness


Implementation Resources• Globally - ASQ

• ASQ.org

• ASQ TV

• Regionally

• SC Technical Colleges

• SC Department of Commerce

• SCMEP

• Locally

• Asqcharleston.org

• Concentric


Concentric Resources


• Articles• Key Links• Videos• Webinar

Registration• Transition

Tools


February 23rd – 25th, 2016 | 8am-5pm | Charleston, SCPresented by: Concentric + Trident Technical College

Only $999 for 24hr Class | 2 students/company max

ISO 9001:2015 Lead Auditor Training+ADD a 4th day to make this a Lead Internal Auditor Class per ISO/TS 16949:2009

requirements. 4th Day is Friday, February 26th, 2016

Registration Link: http://www.acommoncenter.com/iso90012015

Upcoming Training


http://www.eventbrite.com/e/iso-90012015-lead-internal-auditor-training-24-hrs-august-2015-tickets-17152761371?ref=ebtnebregn

http://www.eventbrite.com/e/iso-90012015-lead-internal-auditor-training-24-hrs-august-2015-tickets-17152761371?ref=ebtnebregn


Co

nta

ct

Us

Concentric – 266 Meeting St, Charleston, SC

843.469.8279

acommoncenter.com

[email protected]

facebook.com/CMSiCharleston

twitter.com/acommoncenter

concentric-management-systems-inc.

Jim Megan Ronii


Sidney Monica

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