ISO-DIS 9001 Seminar Handout Final.pdf

8/10/2019 ISO-DIS 9001 Seminar Handout Final.pdf

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Improving performance,reducing risk

ISO/DIS 9001:2014 and the shape of things to come

Presented byLloyds Register Quality Assurance (Singapore)


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Introduction


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What we do

Established in 1985198519851985 by Lloyds Register (LR). 1111stststst Certification Body to gain UKASUKASUKASUKAS

accreditationaccreditationaccreditationaccreditation in 1986198619861986.

LRQA held more than 50505050 Accreditationsglobally. Provides CertificationCertificationCertificationCertification, 2222ndndndnd PartyPartyPartyParty AuditAuditAuditAudit and

TTTTrainingrainingrainingraining to internationally recognisedmanagement system standards.

1111,,,,100100100100 assessorsassessorsassessorsassessors worldwide in 47474747 countriescountriescountriescountries.

LRQALRQALRQALRQA offers CERTIFICATIONCERTIFICATIONCERTIFICATIONCERTIFICATION & TRAININGTRAININGTRAININGTRAINING services in the following management system standards:ISO 9001, ISO 14001, OHSAS 18001, ISO 22000, FSSC 22000, HACCP, ISO/PAS 28007ISO/PAS 28007ISO/PAS 28007ISO/PAS 28007, ISO 28000ISO 28000ISO 28000ISO 28000, ISO 22301,ISO 22301,ISO 22301,ISO 22301,ISO 50001ISO 50001ISO 50001ISO 50001, ISO/TS 29001, ISO/TS 16949, ISO 13485, GDPMDS, BRC, ISO 14064,,,, ISO 29990ISO 29990ISO 29990ISO 29990, AS 91XX, TAPA,

etc.


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Objectives of the seminar

This seminar will:

1. Introduce you to Annex SL, the new high level structure (HLS) of all

ISO Standards.

2. Provide an overview of what is new to the standard and what has

changed from ISO 9001:2008.

3. Help you identify the potential implications for your organisation

of the changes to ISO 9001.

4. Help you identify what you need to do to plan for yourorganisations transition to ISO 9001:2015.

5. Provide you with a usefulusefulusefuluseful referencereferencereferencereference guideguideguideguide.


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Disclaimer

Whilst every care has been taken to ensure that the

dates indicated in this presentation are correct,timescales - that are out of our control - can change.


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The current timescale to publication

June2012

Draft designspec. and

WDO

December2012

Approveddesign specand WD1

April2013

CD forcommentand ballot

May2014

ISO/DIS9001:2014published

forcomment

(3 months)

March2015

ProposedFDIS

publication

September2015

ProposedISO

9001:2015publication

ProposedTransition

Period

3 years fromstandard

publication

Please note that these timescales are subject to change.


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What does ISO/DIS 9001:2014mean for me and myorganisation?


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How significant are the changes to my organisation?

Implications foryour

organisation

Dependent on

yourorganisationscircumstances


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ISO/DIS 9001:2014

Key areas of change to documented requirements

Clause No:Clause No:Clause No:Clause No: TitleTitleTitleTitle ItemItemItemItem ChangeChangeChangeChange

1: Scope Scope Now states intended result(s)

2: Normative References Normative References Essentially these are requirements

3: Terms and Definitions Terms and Definitions Some amendments and clarifications

4: Context of theorganization

Context of theorganization

New requirements

5: Leadership Leadership Greater area of focus, integral to business processes andaccountability

6: Planning Risks/OpportunitiesPlanning of changes

New requirementGreater area of focus

7: Support KnowledgeDocumentedInformation

New requirementNew requirement

8: Operation OutsourcingDesign & DevelopmentPost Delivery Activities

New requirementRequirements made clearerGreater area of focus

9: Performance Evaluation Performance indicatorsManagement Review

Greater area of focus on risk(s) and performanceGreater area of focus

10: Improvement Continual Improvement Clarification on approach and structure, removal of

preventive action


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The role of Annex SL in theISO/DIS 9001:2014


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Annex SL - Implications

Annex SL is the structure for all new and revised ISO Standards.

Annex SL (previously ISO Guide 83) defines the framework for a genericmanagement system.

All new ISO management systems standards (MSS) will adhere to this

framework and all current MSS will migrate at their next revision.

Whilst the structure and terminology has changed, there is nonononorequirementrequirementrequirementrequirement to use these terms or to follow the numbering or structurewithin your management system


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Annex SL - Every ISO standard now has to demonstrate

1. MARKET RELEVANCE

Have the needs of all users been considered?

2. COMPATIBILITY Is it compatible with other standards and there is no overlap or conflict?

3. TOPIC COVERAGE

Is it sector specific, could a generic standard be used?

4. FLEXIBILITY

Will it allow an organisation to add to/ innovate for competitive advantage?

5. FREE TRADE

Could it form a technical barrier to global trade?

6. APPLICABILITY

How would an organisation prove conformity?

7. EXCLUSIONS

Is the purpose deliberately to exclude competitors?

8. EASE OF USE

Could the user of the standard easily implement the requirements?


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Annex SL - The standard clauses

ISO 9001:2008ISO 9001:2008ISO 9001:2008ISO 9001:2008 ISO 9001: 2015ISO 9001: 2015ISO 9001: 2015ISO 9001: 2015

0. Introduction 0. Introduction

1. Scope 1. Scope

2. Normative Reference 2. Normative Reference

3. Terms and Definitions 3. Terms and Definitions

4. Quality Management Systems 4. Context of the organization

5. Management Responsibility5. Leadership

6. Planning for the quality management system

6. Resource Management 7. Support

7. Product Realisation 8. Operation

8. Measurement, Analysis &Improvement

9. Performance Evaluation

10.Improvement


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Management of Risk,Opportunity and Change


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What is risk based thinking?

Risk-based thinking is something we all do automatically and often sub-consciously.

The concept of risk has always been implicit in ISO 9001 this revisionmakes it more explicit and builds it into the whole management system.

Risk-based thinking is already part of the process approach.

Risk-based thinking makes preventive action part of the routine.

Risk is often thought of only in the negative sense. However, risk-basedthinking can also help to identify opportunities. This can be considered tobe the positive side of risk.

Source - ISO/TC 176/SC 2/WG23 N065


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How does risk relate to ISO 9001 - the main objectives

To provide confidence in the organisations ability to consistently providecustomers with conforming goods and services.

To enhance customer satisfaction.

The concept ofThe concept ofThe concept ofThe concept of riskriskriskrisk in the context of ISO 9001 relates toin the context of ISO 9001 relates toin the context of ISO 9001 relates toin the context of ISO 9001 relates tothe uncertainty in achieving these objectivesthe uncertainty in achieving these objectivesthe uncertainty in achieving these objectivesthe uncertainty in achieving these objectives

Source - ISO/TC 176/SC 2/WG23 N065


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Risks & Opportunities A simple example

SustainableHappiness

SustainableBusiness

CustomerCustomerCustomerCustomer

RegulatorRegulatorRegulatorRegulator

CompetitorCompetitorCompetitorCompetitor

SupplierSupplierSupplierSupplier

Interest GroupInterest GroupInterest GroupInterest Group

Community atCommunity atCommunity atCommunity at

largelargelargelarge

NeighbourNeighbourNeighbourNeighbour

GovernmentGovernmentGovernmentGovernment

FamilyFamilyFamilyFamilymembersmembersmembersmembers

TownTownTownTown

CouncilCouncilCouncilCouncil

EmployerEmployerEmployerEmployer


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Risks & Opportunities A simple example

RiskRiskRiskRisk

InconsiderateInconsiderateInconsiderateInconsiderate NeighbourNeighbourNeighbourNeighbour

OpportunitiesOpportunitiesOpportunitiesOpportunities

MoveMoveMoveMove househousehousehouse (rent(rent(rent(rent out/out/out/out/

buybuybuybuy new)new)new)new) SoftSoftSoftSoft talktalktalktalk

EngageEngageEngageEngage towntowntowntown councilcouncilcouncilcouncil / ///policepolicepolicepolice

SustainableHappiness

Town Council


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Risks & Opportunities a simple example

RiskRiskRiskRisk

IncreaseIncreaseIncreaseIncrease inininin pricepricepriceprice ofofofof rawrawrawrawmaterialsmaterialsmaterialsmaterials bybybyby suppliersuppliersuppliersupplier

OpportunitiesOpportunitiesOpportunitiesOpportunities

UseUseUseUse alternativealternativealternativealternative materialsmaterialsmaterialsmaterials ObtainObtainObtainObtain fromfromfromfrom alternativealternativealternativealternative sourcessourcessourcessources

BulkBulkBulkBulk purchasepurchasepurchasepurchase

ReviseReviseReviseRevise thethethethe designdesigndesigndesign totototo eliminateeliminateeliminateeliminate

materialmaterialmaterialmaterial needsneedsneedsneeds TerminateTerminateTerminateTerminate productproductproductproduct

Sustainable

Business

Customer


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Improving performance,

reducing risk

Whats new?

The requirements of each clause


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ISO/DIS 9001:2014

Key areas of change to documented requirements

Clause No:Clause No:Clause No:Clause No: TitleTitleTitleTitle ItemItemItemItem ChangeChangeChangeChange

1: Scope Scope Now states intended result(s)

2: Normative References Normative References Essentially these are requirements

3: Terms and Definitions Terms and Definitions Some amendments and clarifications

4: Context of theorganization

Context of theorganization

New requirements

5: Leadership Leadership Greater area of focus, integral to business processes and

accountability

6: Planning Risks/OpportunitiesPlanning of changes

New requirementGreater area of focus

7: Support KnowledgeDocumentedInformation

New requirementNew requirement

8: Operation OutsourcingDesign & DevelopmentPost Delivery Activities

New requirementRequirements made clearerGreater area of focus

9: Performance Evaluation Performance indicatorsManagement Review

Greater area of focus on risk(s) and performanceGreater area of focus

10: Improvement Continual Improvement Clarification on approach and structure, removal of

preventive action


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Whats new? Clauses 1, 2, 3

Clause 1: ScopeClause 1: ScopeClause 1: ScopeClause 1: Scope

Clause 2: Normative referencesClause 2: Normative referencesClause 2: Normative referencesClause 2: Normative references

Clause 3: Terms and definitionsClause 3: Terms and definitionsClause 3: Terms and definitionsClause 3: Terms and definitions

Now states intended result(s)

No substantive change

Terms and definitions are stillunder active discussion and are not

finalised


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Whats new? - Clause 4 onwards becomes the HLS

4.

CONTEXT OFTHE

ORGANIZATION

5.

LEADERSHIP

6.

PLANNING

7.

SUPPORT

8.

OPERATION

9.PERFORMANCEEVALUATION

10.IMPROVEMENT

PLAN DO CHECK ACT

The High Level Structure (HLS) - Annex SLAnnex SLAnnex SLAnnex SL ---- provides a set

of core elements that will be in all ISO managementsystems standards.


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Whats new? - Clauses 4 onwards becomes the HLS

Model of a process-based quality management system (Ref: ISO/DIS9001:2014)


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Whats new? - Clauses 4 onwards becomes the HLS

Schematic Presentation of a Single Process (Ref: ISO/DIS 9001:2014)


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reducing risk

Implications

How will these changes affect my

organisation?


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Annex SL - Implications

Annex SL will drive management systems standards

(MSS) integration, thereby delivering increased benefitsand efficiencies while providing a more complete viewof an organisation often spanning multiple sites,geographies and suppliers.

As organisations begin to understand and appreciatethe value of different management systems allspeaking a common language, it will be organisationsand - and in turn the consumer - who stand to be thetrue beneficiaries.


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Implications: Organizational context

Organisations will need to determine the external andinternal factors that are relevant to their purpose andthat affect their ability to achieve the intended resultsof the management system.

This may have implications for the design of themanagement system and the alignment of strategy andstructure within organisations.


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Implications: Leadership

There are now more areas where top management needto demonstrate their involvement and engagement withthe quality management system, such as:

Ensuring integration of QMS requirements into the

organisations processes.

Promoting awareness of the process approach.

Assuring the QMS achieves its intended results.

Supporting other relevant management roles todemonstrate their leadership.


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Implications: Risk

Organisations need to identify risks to ensure thatpolicy and objectives can be achieved. For significantrisks measures need to be put in place to manage them.

This is an extension of the current planning

requirements. This strengthens the need fororganisations to look ahead so that the managementsystem delivers for the future as well as the present.


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Implications: Change

The organisation will need to manage change throughthe management system and also maintain the systemwhile the organisation changes itself.

This is recognition that the management system is both

the controlling mechanism of the organisation and partof it at the same time.


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Implications: Performance

Performance requirements include the preparation ofperformance analysis as a significant input into themanagement review process.

This will strengthen the link between management

system performance and the quality of product/servicedelivery.


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Implications: Integration

The introduction of high level common text andstructure for all management systems standardsthrough the adoption of Annex SL will helporganisations using more than one standard to alignaspects and/or integrate elements or the whole of their

management system.


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ISO 9001:2015 Certification Transition Timeline

September 2015 start of a probable 3 yearsSeptember 2015 start of a probable 3 yearsSeptember 2015 start of a probable 3 yearsSeptember 2015 start of a probable 3 years

transition period to September 2018 (rules &transition period to September 2018 (rules &transition period to September 2018 (rules &transition period to September 2018 (rules &guidance tbc)guidance tbc)guidance tbc)guidance tbc)

2018201820182018201720172017201720162016201620162015201520152015

September 2015September 2015September 2015September 2015PublishedPublishedPublishedPublished ISOISOISOISO 9001900190019001

StandardStandardStandardStandard


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reducing risk

What next?

How significant are the changes for me andmy organisation?

What should my organisation be doingnext?


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How significant are the changes to my organisation?

Implications

for yourorganisation

Dependent

on yourorganisationscircumstances

Maturity ofyour QMS

Level ofinvolvement

of topmanagement

Approach torisk

management

Use of a

process basedapproach


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Questions

What areas represent the

biggest change for yourorganisation?

What do you see as thebiggest challenge in yourorganisation for transition

to ISO 9001:2015?

D fi i i t


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Defining your requirements

Context ofyour

organisation

Knowledgemanagement

process

Integratedmanagement

system

Risk managementprocess

Process-basedapproach

Systematicchange

management

Now you have an overview of the changes,which pieces are missing in your organisation?

Top managementengaged and

Involved in the QMS

D l i t iti l ith LRQA


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Developing your transition plan with LRQA

LRQA's experienced sector experts will develop a bespoke trainingpackage for your organisation.


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LRQA Training Solutions

ISO/DIS 9001:2014 Appreciation and InterpretationISO/DIS 9001:2014 Appreciation and InterpretationISO/DIS 9001:2014 Appreciation and InterpretationISO/DIS 9001:2014 Appreciation and Interpretation((((2 Days)2 Days)2 Days)2 Days)

UnderstandingUnderstandingUnderstandingUnderstandingISO/DIS 9001:2014ISO/DIS 9001:2014ISO/DIS 9001:2014ISO/DIS 9001:2014for Managementfor Managementfor Managementfor Management

((((1 Day)1 Day)1 Day)1 Day)

UnderstandingUnderstandingUnderstandingUnderstandingISO/DIS 9001:2014ISO/DIS 9001:2014ISO/DIS 9001:2014ISO/DIS 9001:2014for Procurement &for Procurement &for Procurement &for Procurement &

LogisticsLogisticsLogisticsLogistics

(2 Days)(2 Days)(2 Days)(2 Days)

UnderstandingUnderstandingUnderstandingUnderstandingISO/DISISO/DISISO/DISISO/DIS 9001:20149001:20149001:20149001:2014

for Humanfor Humanfor Humanfor HumanResourceResourceResourceResource

ManagementManagementManagementManagement(2 Days)(2 Days)(2 Days)(2 Days)

ISO 9001:2015ISO 9001:2015ISO 9001:2015ISO 9001:2015 TrainingTrainingTrainingTraining----LedLedLedLedTransitionTransitionTransitionTransition ProgrammeProgrammeProgrammeProgramme(Training(Training(Training(Training & Facilitated& Facilitated& Facilitated& Facilitated

Workshop)Workshop)Workshop)Workshop)10 Days, 410 Days, 410 Days, 410 Days, 4 MMMModulesodulesodulesodules,,,,

delivereddelivereddelivereddelivered over 3over 3over 3over 3 months.**months.**months.**months.**

Knowledg

e

Knowledg

e

Knowledg

e

Knowledg

e

Development

Development

Development

Development

Competency

Competency

Competency

Competency

Develo

pment

Develo

pment

Develo

pment

Develo

pment

ISO 9001:2015ISO 9001:2015ISO 9001:2015ISO 9001:2015QMS InternalQMS InternalQMS InternalQMS Internal

AuditorAuditorAuditorAuditorTraining **Training **Training **Training **

(2 Days)(2 Days)(2 Days)(2 Days)

** Under development, be available upon approval from Global Training, UK

ISO 9001:2015ISO 9001:2015ISO 9001:2015ISO 9001:2015QMS InternalQMS InternalQMS InternalQMS Internal

AuditorAuditorAuditorAuditor

RefresherRefresherRefresherRefresherTraining **Training **Training **Training **

(1(1(1(1 Day)Day)Day)Day)


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LRQA Training Information

Gap Analysis


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Gap Analysis

Which gap analysis is best for me and my organisation?

Gap Analysis Light Full Gap Analysis

Identify areas for improvementrelating specifically to thechanges in the DIS.

Giving you a gap analysis reportto support your transition.

Looks at your managementsystem in terms of Annex SL andall of the changes relating to theDIS.

The resulting analysis report will

make you an expert on theimplications of the revisions foryour organisation.

Achievements


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Achievements

Final outcomes for your organisation

An in-depth understandingof what your organisationneeds to address to meet thenew and enhancedrequirements of ISO9001:2015.

A transition plan and processthat takes you and yourorganisation to being LRQAcertified against ISO9001:2015.

You and your organisationhave the opportunity to bepioneers in implementingISO 9001:2015 and to gaincompetitive advantagethrough improvedperformance.

UNDERSTAND TRANSITION ADVANTAGE


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Much of your existing system will, no doubt, meet large parts of thenew standard so you will not be starting from scratch.

You have three years to transition to the new standard from thepublication date.

Remember, it is your QMS that needs to be upgraded to delivertangible benefits to your organisation.

The whole concept of having a QMS is to take preventive action tomanage the risk to the on-going success of your organisation in anever changing world.

If you would like additional help such as a Gap Analysis against thenew standard, on site training of your existing auditors, or want us todeliver a management briefing, LRQA is here to help.

Summary


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Join the discussion

@LRQA

www.linkedin.com/company/lrqa

www.lrqa.com/isostandardsupdate

[email protected]


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Useful external resources

www.iso.org International Organization for Standardization

www.iioc.org International Independent Organisation forCertification

www.irca.org International Register of Certified Auditors

www.thecqi.org Chartered Quality Institute

www.iaf.nu International Accreditation Forum


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We can help with our unique service offerings

Business AssuranceBusiness AssuranceBusiness AssuranceBusiness Assurance from LRQA helps you to

manage your systemssystemssystemssystems and risksrisksrisksrisks to improveimproveimproveimprove andprotectprotectprotectprotect the currentcurrentcurrentcurrent and future performancefuture performancefuture performancefuture performance ofyour organisation

Contact LRQA through our website for more information andContact LRQA through our website for more information andContact LRQA through our website for more information andContact LRQA through our website for more information andprofessional support to successfully move into this new era for ISOprofessional support to successfully move into this new era for ISOprofessional support to successfully move into this new era for ISOprofessional support to successfully move into this new era for ISO

9001 and other management system standards with clarity and9001 and other management system standards with clarity and9001 and other management system standards with clarity and9001 and other management system standards with clarity andease.ease.ease.ease.

www.lrqa.com.sgwww.lrqa.com.sgwww.lrqa.com.sgwww.lrqa.com.sg


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Lloyds Register and variants of it are trading names of Lloyds Register Group Limited, its subsidiaries and affiliates.

Copyright Lloyds Register Quality Assurance Limited 2014. A member of the Lloyds Register group.


Foong WaiFoong WaiFoong WaiFoong Wai KiongKiongKiongKiong

Business Centre Manager

LRQA Singapore

T +65 6891 7288 E [email protected]

www.lrqa.com.sg

LRQA Singapore460 Alexandra Road, #28-01/02, PSA Building, Singapore 119963

Documents

ISO-DIS 9001 Seminar Handout Final.pdf