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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

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)

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

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

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

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

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

Service Dept

End UsersInstallation

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

•Transition Audit

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

2017•Monitor

transition of key suppliers

•Continue to improve

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

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

Concentric – 266 Meeting St, Charleston, SC

843.469.8279

acommoncenter.com

info@cmsicharleston.com

facebook.com/CMSiCharleston

twitter.com/acommoncenter

concentric-management-systems-inc.

Jim Megan Ronii

Sidney Monica

Changes to ISO 9001:2015 - WordPress.com · ISO 9001:2015 Lead Auditor Training +ADD a 4th day to...

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