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DNV Business Assurance. All rights reserved.October 31st, 2013

ISO 9001 Global Certification Numbers

3

Source: ISO Survey 2012

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Dr. Nigel Croft

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Dr. Nigel H. Croft is recognized as one of the worlds foremost experts in quality

management and conformity assessment of management systems. He has been activelyinvolved in quality since 1974, when he began his career in the British steel industry as astudent apprentice. Among his many professional activities, Dr. Croft currently holds seniormanagement positions and serves as non-executive board member of a number ofcommercial and non-profit organizations in Europe, the Middle East, Asia and the Americas.

He holds the post of visiting professor at the Business School of UUM (University of NorthMalaysia), one of the leading Management Universities in the region, and also acts as aLead Consultant for UNIDO, the United National Industrial Development Organization.Within the standards development arena, Dr. Croftl has been an active member ofISO/TC176 (the ISO Technical Committee responsible for the ISO 9000 series of standards)since 1995, and currently serves as Chair of SC2, the subcommittee responsible for the ISO9001 and ISO 9004 standards development. He also represents TC 176 at the strategic-levelISO/ILAC/IAF Joint Working Group which provides oversight of global management systemscertification.

Born in the UK, but with dual British and Brazilian citizenship, Dr Croft holds a first classhonours degree in Natural Sciences from Cambridge University, England, and a Doctorate inMaterials Science from Sheffield University. He is a Chartered Engineer and CharteredQuality Professional in the UK, a Fellow of the Chartered Quality Institute and a SeniorMember of the American Society for Quality.

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Disclaimer

Any opinions expressed by the presenter arepersonal viewpoints, and no formal endorsementof ISO, IAF, ISO/TC176 or ISO/CASCO should

be impliedInformation about the revision of ISO 9001 is notfinal and should not be used for making changesto existing quality management systems.

(C) Nigel H Croft 2013 - All rights reserved 2

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Webinar Outline

BackgroundISO Directives Annex SL the need for

harmonization of management systemstandardsISO 9001:2015 what to expect

Transition arrangementsQ&A


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Background


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Overall Scenario of ISO/TC176

Development of generic quality management systemstandards that have broad application:

all market sectorsboth private and public organizations

Approx. 1,200,000 worldwide certifications to ISO 9001BUT

Its about more than just certification

Certification to ISO 9001 should be a result of a well-implementedquality management system!Other ISO/TC 176 products are aimed to assist organizations inimproving their quality management system.ISO engaging more with IAF and others to defend the ISO Brand


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ISO/TC176/SC2 Vision

SC2s products* are recognized andrespected worldwide , and used byorganizations as an integral componentof sustainable development

* ISO 9001, ISO 9004, and other guidance documents


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ISO/TC176/SC2 Mission

To develop, maintain and support a portfolio of products that enable organizations to improve their performance and to benefit from the implementation ofa robust quality management system.To establish generic quality management systemrequirements that provide the foundations to buildconfidence in goods and services deliveredthroughout the supply chain to organizations and

people worldwide.To provide guidance and support , where needed, toensure the continued credibility of our products.


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3 core concepts*

Identify the processes needed to achieve theplanned resultsContinually monitor the risks (Cause andeffect)Manage the processes and the system usingPlan-Do-Check-Act

(C) Nigel H Croft 2013 - All rights reserved

* = Nigel Crofts understanding

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Annex SL the needfor harmonization


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Need for Alignment ofmanagement system standards!

ISO Joint Technical Coordination Group(JTCG):

Joint vision for management system standards

High level structure for all ISO management systemsstandardsIdentical sub-clause titles under the high levelstructure

Generic core vocabulary for management systemstandards

Aim is to make life easier for those who wish tohave a single management system


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ISO Directives Part 1:2012 Annex SL

Incorporates the recommendations of the JTCGworkDefines the common structure and format for allnew ISO management system standards andrevisions to existing standardsCommon text (approx 30% or more of each

standard will be identical text) Significant impact on future revisions of ISO9001 and ISO 14001


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Revision of ISO 9001


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The Global Challenges forQuality Management Systems

Increased customer expectations for confidence inproducts and servicesIncreasing use of QMS standards for global trade

Increasing use of ISO 9001 by various industry sectorsCredibility of 3rd party certificationDrive for greater efficiency (lean initiatives)Increased sophistication of quality management tools

Increasing regulatory emphasis on public health andsafety (e.g., food; medical devices)Multiple management systems standards, programsand schemes.


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Key objectives for ISO 9001:2015

Extracts from ISO 9001:2015 Design Specification:Provide stable core set of requirements for next 10 years or soMaintain current focus on effective process management to

produce desired outcomesTake account of changes in QMS practices and technology sincethe last major revision (in 2000)

Apply Annex SL of ISO Directives to enhance compatibility& alignment with other ISO management system standards

Facilitate effective organizational implementation and effectiveconformity assessment by 1 st , 2 nd and 3 rd partiesSimplified language and writing styles to aid understandingand consistent interpretations of requirements.


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Where we are now2010 2012

Preparing the groundwork.

June 2013Preliminary meeting of WG24

Oct 2012New Work Item Proposal and Design Specification for Revision approvedunanimously by ISO/TC176/SC2 membership

Nov 2012 April 2013WG 24 develops and agrees Working Drafts

June 2013

Committee Draft circulated to SC2 membership for Ballot & CommentSept 2013

Committee Draft approved (approx. 80% approval; 51 Yes; 11 No; 3 abstain) Approx. 2800 comments received (compared to approx. 6000 for same stageof Year 2000 revision)


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Some key changes...........Complete reformatting to align with Annex SLGoods and services instead of productMore emphasis on addressing risks & opportunities

Elimination of the term preventive actionthe concept still remains, and is actually reinforcedthroughout the standard (by addressing risk)

External provision of goods and services instead of

purchasing includes outsourced processesElimination of specific requirements forQuality ManualManagement representative


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Some examples of what to expect(Based on Annex SL)..


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4.1 Understanding the organizationand its context

The organization shall determine external andinternal issues that are relevant to its purposeand that affect its ability to achieve the intended

outcome(s) of its XXX management system.

NOTE: XXX = quality, environmental,

information security etc.ISO 9001:2015 might use the term goodsand services instead of product


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4.2 Understanding the needs andexpectations of interested parties

The organization shall determinethe interested parties that are relevant to the XXX managementsystem, andthe related requirements of these interested parties

ISO 9001 is likely to add text requiring the organizationto include

direct customersend userssuppliers, distributers, retailers or others involved in the supply chainRegulators


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4.4 XXX management systemThe organization shall establish, implement, maintain andcontinually improve an XXX management system,including the processes needed and their interactions,in accordance with the requirements of this InternationalStandard.

(This is key to maintaining the process approach,which will now be embedded in ALL ISO managementsystem standards)

(Beefed-up version of current clause 4.1 of ISO9001:2008 likely to be incorporated into this clause)


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6.1 Actions to address risks &opportunities

The organization shall consider the issues referred to in 4.1 and therequirements referred to in 4.2 and determine the risks and opportunities thatneed to be addressed to

assure the management system can achieve its intended outcome(s)

prevent undesired effectsrealize opportunities for improvement.The organization shall:a) evaluate the need to plan actions to address these risks andopportunities , andb) where applicable

integrate and implement these actions into its XXX management systemprocesses (see 8.1)ensure information will be available to evaluate if the actions have beeneffective (see 9.1).


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7.1 Resources

The organization shall determine and providethe resources needed for the establishment,implementation, maintenance and continual

improvement of the quality management system. Additional text for ISO 9001 likely to include:

InfrastructureProcess environmentMonitoring & MeasurementKnowledge management


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Probable ISO 9001 adders for

Clause 8This is where most of the current ISO 9001:2008 Clause7 will be included.

Customer related processes

Operational planningControl of external providers (Purchasing and outsourcingaddressed together)Creation or change of product (Incorporates design &development from ISO 9001:2008)Product realizationMonitoring and measurement of productNonconforming goods and services


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Probable ISO 9001 addersfor Clause 9

Customer satisfaction

Analysis and evaluation of dataGreater emphasis on product conformity


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What next?Nov 2013

WG 24 face-to-face meeting in Porto.Review of Strategic-level commentsDisposition where possible of ALL commentsDefine path forward for sticky issues

Nov 2013 March 2014

WG 24 electronic working to develop Draft DISProbable face-to-face meeting of WG24 to agree on DIS text

April 2014Forecast publication of DIS for Ballot and Comment

Nov 2014

Face-to-face meeting to review results of DIS Ballot April 2015

Publication of FDIS

Sept 2015Publication of ISO 9001:2015


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Concerns and criticisms..Some do not like or accept the Annex SL approachConcerns that some requirements are being watered down(Design & Development; Calibration and others)Concerns about auditability of some requirements

Some want more prescriptive requirements. But some want less prescriptive requirements!!

Some ambiguous / inconsistent terminology in the CDIntroduction of the concept of Relevant Interested partiesElimination of Preventive action; Management Representative;

Quality ManualConcerns that new clause structure means we risk losing theProcess Approach (I strongly disagree!)


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Additional possibilities:

SC2 is looking at the possibility to developspecific implementation guidance for ISO9001:2015 ( not decided yet )

Generic implementation guidance (possibly to benumbered as ISO 9002)Updated guidance for small businessesService sector (revive and revise the old ISO 9004-2?)Sector guidance (possible way to address concernsfrom Automotive Sector?)

Application for one-off projects (updated ISO 10006)(C) Nigel H Croft 2013 - All rights reserved 45

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Transition to ISO 9001:2015

Scheduled publication date September 2015ISO/TC176, ISO/CASCO and IAF haveapproved a 3-year transition period

All organizations will be strongly encouraged tostart the transition as soon as the DIS ispublished (mid-2014)

Aim is to avoid peak of audits to the new standardnear end of transition period Avoid overload of CB resources


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What you should do now.

No immediate action requiredStay tuned to whats happening with therevision to ISO 9001

Risk-based thinkingwww.iso.org Periodic updates will be made available byISO/TC176/SC2/WG23

Start working on understanding andincorporating changes from mid-2014 (afterpublication of the DIS)


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THANK YOU! ANYQUESTIONS?

[email protected]


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Selected questionsWhy was risk integrated into the latest revision by the standard development team? How do

you see the future of QMS and other management systems aligning with enterprise riskmanagement?

Dr. Croft, when we are developing requirements in a certifiable standard such as ISO 9001,the auditability of the requirement is paramount; otherwise conformity assessment againstthe standard becomes even more difficult. How is the auditability of requirements assessedduring the development phase?

Dr. Croft, the ISO 9001:2008 very clearly stated which Procedures, at a minimum, arerequired. I did not find any shall clauses as to which Procedure re required. Can you guideme, please?

Dr. Croft. This sub-clause is not strong enough. Delete and restate: "Ensure that processapproach is used," Reason: ISO 9001:2000 and ISO 2008 were promoting "Process

Approach in 4.1 a. through f." Most Registrar Auditors have not followed it. Make itmandatory.

Dr. Croft. 5.2 in the DIS states: "ensuring that quality policies and quality objectives areestablished for the QMS". Does this mean that Top Management has to establish more thanone Quality Policy for the organization?

5

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Thank you for your time.For more information on ISO 9001:2015

join us for a day workshop.

Houston TX - November 18th

Atlanta GA December 2 nd Oakland CA December 12 th Cincinnati OH December 17 th

You will be receiving information to register forthese workshops and to download todays

presentation by email this afternoon.1 877 368 3530

Documents

Iso 9001 2015 Webinar