technical update on iso 9001:2015 colin macnee duncan macnee limited

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Technical update onTechnical update on

ISO 9001:2015 ISO 9001:2015

Colin MacNeeColin MacNee

Duncan MacNee LimitedDuncan MacNee Limited


CaveatCaveat

The views expressed are my own and do not The views expressed are my own and do not represent represent

BSIBSI

CQICQI

IAFIAF

IBMIBM

IRCAIRCA

ISOISO


ContentContent What is the process for updating ISO standards?What is the process for updating ISO standards?

What are the stagesWhat are the stages Who is involvedWho is involved

What is the current situation?What is the current situation? Background:1994, 2000 and 2008 revisions, User Surveys and QMPsBackground:1994, 2000 and 2008 revisions, User Surveys and QMPs The ISO 9001:2015 Project plan, what we have achieved and what we The ISO 9001:2015 Project plan, what we have achieved and what we

have still to dohave still to do Current major revisions of ISO 9001, ISO 14001 and ISO 27001 Current major revisions of ISO 9001, ISO 14001 and ISO 27001

(Reference to Annex SL)(Reference to Annex SL)

How IRCA auditors influence the development?How IRCA auditors influence the development? When to contributeWhen to contribute How to contributeHow to contribute

What ISO 9001:2015 could look like?What ISO 9001:2015 could look like? Annex SL plus possible changesAnnex SL plus possible changes


ISO Development ISO Development Process Process 1 of 31 of 3

The ISO/IEC Directives Part 1 and Consolidated The ISO/IEC Directives Part 1 and Consolidated ISO SupplementISO Supplement11 describes in detail the describes in detail the following stages:following stages:

1.1. Preliminary Preliminary - Preliminary work item (PWI)- Preliminary work item (PWI)

2.2. Proposal Proposal - New work item proposal (NP or NWIP) - New work item proposal (NP or NWIP)

3.3. Preparatory Preparatory – working draft(s) (– working draft(s) (WDWD))

4.4. Committee Committee – committee draft(s) (– committee draft(s) (CDCD))

5.5. Enquiry Enquiry – draft international standard (– draft international standard (DISDIS))

6.6. Approval Approval – final draft international standard (– final draft international standard (FDISFDIS))7.7. Publication Publication – international standard (– international standard (ISIS))

11 Third edition, 2012 (based on the ninth edition of the ISO/IEC Directives, Part 1) Third edition, 2012 (based on the ninth edition of the ISO/IEC Directives, Part 1)



Who will receive the documents?Who will receive the documents?

Member bodies. E.g. Member bodies. E.g. JISCJISC (Japanese Industrial (Japanese Industrial Standards Committee)Standards Committee) Participating Countries: 73Participating Countries: 73 Observing Countries: 16 Observing Countries: 16

Internal liaison to SC 2 (ISO: 8, IEC: 3)Internal liaison to SC 2 (ISO: 8, IEC: 3) External liaison to SC 2 (21)External liaison to SC 2 (21)

ALLALL of the above are allowed to of the above are allowed to commentcomment..

ONLYONLY member bodies are allowed to member bodies are allowed to votevote..



VotingVoting

CD: CD: 22//33 positive of total of member bodies voting positive of total of member bodies voting DIS: DIS: 22//33 positive AND not more than ¼ negative of positive AND not more than ¼ negative of

total of member bodies voting total of member bodies voting FDIS: FDIS: 22//33 positive AND not more than ¼ negative of positive AND not more than ¼ negative of

total of member bodies voting total of member bodies voting

Not counted in the total vote: Not counted in the total vote: AbstentionsAbstentions Negative votes without technical justification Negative votes without technical justification


Current SituationCurrent Situation BackgroundBackground

1994, 2000 and 2008 revisions1994, 2000 and 2008 revisions User SurveysUser Surveys Quality Management Principles (QMPs)Quality Management Principles (QMPs)

The ISO 9001:2015 Project planThe ISO 9001:2015 Project plan What we have achievedWhat we have achieved What we have still to doWhat we have still to do

3 major ISO MSSs in development – all using Annex SL3 major ISO MSSs in development – all using Annex SL ISO/IEC 27001 (expected later this year)ISO/IEC 27001 (expected later this year) ISO 14001 (expected early 2015)ISO 14001 (expected early 2015) ISO 9001 (expected late 2015)ISO 9001 (expected late 2015)

ISO 22301:2012 developed using an early draftISO 22301:2012 developed using an early draft


ISO/CD 9001ISO/CD 9001

2013

CD ballot opens: June 2013CD ballot closes: August 2013

It is standard practice for the CD to be distributed only to member body mirror committees. However, some member bodies may distribute the CD to the public (free or for sale)


ISO/DIS 9001ISO/DIS 9001

2014

DIS ballot opens: April 2014DIS ballot closes: August 2014

It is standard practice for the DIS to be distributed to members of the public (free or for sale). Some member bodies provide electronic tools for viewing and commenting on the DIS.


ISO/FDIS 9001ISO/FDIS 9001

2015

FDIS ballot opens: July 2015FDIS ballot closes: August 2015

ISO 9001 published: September 2015


MSS – HMSS – Highigh L Levelevel SStructuretructure 1 of 31 of 3

IntroductionIntroduction

1. Scope1. Scope

2. Normative references2. Normative references

3. Terms and definition3. Terms and definition

AppendixAppendix

BibliographyBibliography

4. Context of the organization4. Context of the organization

5. Leadership5. Leadership

6. Planning6. Planning

7. Support7. Support

8. Operation8. Operation

9. Performance evaluation9. Performance evaluation

10. Improvement10. Improvement




4.1 Understanding the organization and its context4.1 Understanding the organization and its context

4.2 Understanding the needs and expectations of interested parties4.2 Understanding the needs and expectations of interested parties

4.3 Determining the scope of the XXX management system4.3 Determining the scope of the XXX management system

4.4 XXX management system4.4 XXX management system


5.1 Leadership and commitment5.1 Leadership and commitment

5.2 Policy5.2 Policy

5.3 Organization roles, responsibilities and authorities5.3 Organization roles, responsibilities and authorities


6.1 Actions to address risks and opportunities6.1 Actions to address risks and opportunities

6.2 XXX objectives and planning to achieve them6.2 XXX objectives and planning to achieve them



7. Support7. Support

7.1 Resources7.1 Resources

7.2 Competence7.2 Competence

7.3 Awareness7.3 Awareness

7.4 Communication7.4 Communication

7.5 Documented information7.5 Documented information

7.5.1 General7.5.1 General

7.5.2 Creating and updating7.5.2 Creating and updating

7.5.3 Control of documented 7.5.3 Control of documented informationinformation


8.1 Operational planning and 8.1 Operational planning and controlcontrol


9.1 Monitoring, measurement, 9.1 Monitoring, measurement, analysis and evaluationanalysis and evaluation

9.2 Internal audit9.2 Internal audit

9.3 Management review9.3 Management review


10.1 Nonconformity and 10.1 Nonconformity and corrective actioncorrective action

10.2 Continual improvement10.2 Continual improvement


MSS – Common Terms MSS – Common Terms and Definitionsand Definitions

OrganizationOrganization

Interested party (preferred Interested party (preferred term)term)

Stakeholder (admitted term)Stakeholder (admitted term)

RequirementRequirement

Management systemManagement system

Top managementTop management

EffectivenessEffectiveness

PolicyPolicy

ObjectiveObjective

RiskRisk

CompetenceCompetence

Documented informationDocumented information

ProcessProcess

PerformancePerformance

Outsource (verb)Outsource (verb)

MonitoringMonitoring

MeasurementMeasurement

AuditAudit

ConformityConformity

NonconformityNonconformity

CorrectionCorrection

Corrective actionCorrective action

Continual improvementContinual improvement


PossiblePossible** ISO 9001:2015 ISO 9001:2015 1 of 31 of 3


4.1 Understanding the organization and its context4.1 Understanding the organization and its context

4.2 Understanding the needs and expectations of interested parties4.2 Understanding the needs and expectations of interested parties

4.3 Determining the scope of the quality management system4.3 Determining the scope of the quality management system

4.4 Quality management system4.4 Quality management system


5.1 Leadership and commitment5.1 Leadership and commitment

5.2 Policy5.2 Policy

5.3 Organization roles, responsibilities and authorities5.3 Organization roles, responsibilities and authorities


6.1 Actions to address risks and opportunities6.1 Actions to address risks and opportunities

6.2 Quality objectives and planning to achieve them6.2 Quality objectives and planning to achieve them

6.3 Planning of changes6.3 Planning of changes

*Note: This structure is based on a early draft of ISO CD 9001:2015


PossiblePossible ** ISO 9001:2015 ISO 9001:2015

2 of 32 of 37. Support7. Support

7.1 Resources7.1 Resources 7.1.1 General7.1.1 General

7.1.2 Infrastructure7.1.2 Infrastructure

7.1.3 Process environment7.1.3 Process environment

7.1.4 Monitoring and measuring 7.1.4 Monitoring and measuring devicesdevices

7.1.5 Knowledge7.1.5 Knowledge

7.2 Competence7.2 Competence

7.3 Awareness7.3 Awareness

7.4 Communication7.4 Communication

7.5 Documented information7.5 Documented information

7.5.1 General7.5.1 General

7.5.2 Creating and updating7.5.2 Creating and updating

7.5.3 Control of documented 7.5.3 Control of documented informationinformation




9.1 Monitoring, measurement, 9.1 Monitoring, measurement, analysis and evaluationanalysis and evaluation9.1.1 General9.1.1 General

9.1.2 Customer satisfaction9.1.2 Customer satisfaction

9.1.3 Analysis and evaluation of 9.1.3 Analysis and evaluation of datadata

9.2 Internal audit9.2 Internal audit

9.3 Management review9.3 Management review


10.1 Nonconformity and 10.1 Nonconformity and corrective actioncorrective action

10.2 Continual improvement10.2 Continual improvement*Note: This structure is based on a early draft of ISO CD 9001:2015


PossiblePossible ** ISO 9001:2015 ISO 9001:2015

3 of 33 of 38. Operation8. Operation


8.2 Determination of market needs 8.2 Determination of market needs and interactions with customersand interactions with customers8.2.1 General8.2.1 General

8.2.2 Determination of 8.2.2 Determination of requirements related to the goods requirements related to the goods and servicesand services

8.2.3 Review of requirements 8.2.3 Review of requirements related to the goods and servicesrelated to the goods and services

8.2.4 Customer communication8.2.4 Customer communication

8.3 Operational planning8.3 Operational planning

8.4 Control of external provision of 8.4 Control of external provision of goods and servicesgoods and services8.4.1 General8.4.1 General

8.4.2 Type and extent of control of 8.4.2 Type and extent of control of external provisionexternal provision

8.4.3 Documented information for 8.4.3 Documented information for external providersexternal providers

8.5 Development of goods and 8.5 Development of goods and servicesservices8.5.1 Development processes8.5.1 Development processes

8.5.2 Development controls8.5.2 Development controls

8.5.3 Development transfer8.5.3 Development transfer

8.6 Realization of goods and 8.6 Realization of goods and servicesservices8.6.1 Control of production of 8.6.1 Control of production of goods and provision of servicesgoods and provision of services

8.6.2 Identification and traceability8.6.2 Identification and traceability

8.6.3 Property belonging to 8.6.3 Property belonging to customers or external providerscustomers or external providers

8.6.4 Preservation of goods or 8.6.4 Preservation of goods or servicesservices

8.6.5 Post delivery activities8.6.5 Post delivery activities

8.6.6 Control of changes8.6.6 Control of changes

8.7 Release of goods or services8.7 Release of goods or services

8.8 Nonconforming goods and 8.8 Nonconforming goods and servicesservices

*Note: This structure is based on a early draft of ISO CD 9001:2015


Thank YouThank You

Any Questions?Any Questions?

technical update on iso 9001:2015 colin macnee duncan macnee limited

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