EXPLORING THE CHANGES COMING IN EXPLORING THE CHANGES COMING IN EXPLORING THE CHANGES COMING IN EXPLORING THE CHANGES COMING IN

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

Thomas Bowles, MSEE, ASQ CQEThomas Bowles, MSEE, ASQ CQEThomas Bowles, MSEE, ASQ CQEThomas Bowles, MSEE, ASQ CQE

Director of Quality AssuranceDirector of Quality AssuranceDirector of Quality AssuranceDirector of Quality Assurance

FUTEK Advanced Sensor Technology, Inc.FUTEK Advanced Sensor Technology, Inc.FUTEK Advanced Sensor Technology, Inc.FUTEK Advanced Sensor Technology, Inc.

April 14, 2015April 14, 2015April 14, 2015April 14, 2015

TOPICS

� Goals and Focus

� Status of the Revision

� New Terminology

� New Structure by Section

� Risk Management

� Timetable for Implementation

� Companion ISO Standards:

� ISO 13485, ISO 14001, ISO 17025, AS9100C

FIRST MAJOR REVISION SINCE 2000

� ISO technical committee ISO/TC 176 Quality management and quality assurance subcommittee SC 2

� 9001:2008 was really a consolidation of 9001, 9002 and 9003 with no substantive technical changes

� Over 1.2 million organizations world-wide are certified to the ISO 9001 Standard

9001:2000

9002:2000 9001:2008 9001:2015

9003:2000

GOALS OF THE COMMITTEE

Although Although Although Although the revised standard will not change the current the revised standard will not change the current the revised standard will not change the current the revised standard will not change the current requirements, it will standardize the language as well as the requirements, it will standardize the language as well as the requirements, it will standardize the language as well as the requirements, it will standardize the language as well as the approaches to management. approaches to management. approaches to management. approaches to management. It will follow the It will follow the It will follow the It will follow the new Annex SL new Annex SL new Annex SL new Annex SL template.template.template.template.

� The goal is to provide a stable framework of requirements for The goal is to provide a stable framework of requirements for The goal is to provide a stable framework of requirements for The goal is to provide a stable framework of requirements for the next 10 years. The revision is based on the introduction of the next 10 years. The revision is based on the introduction of the next 10 years. The revision is based on the introduction of the next 10 years. The revision is based on the introduction of seven major quality management principles:seven major quality management principles:seven major quality management principles:seven major quality management principles:

1. 1. 1. 1. Enhanced Enhanced Enhanced Enhanced customer focuscustomer focuscustomer focuscustomer focus2. 2. 2. 2. Focused leadershipFocused leadershipFocused leadershipFocused leadership3. Engagement of 3. Engagement of 3. Engagement of 3. Engagement of peoplepeoplepeoplepeople4. 4. 4. 4. A system approach to managementA system approach to managementA system approach to managementA system approach to management5. Improvement5. Improvement5. Improvement5. Improvement6. 6. 6. 6. EvidenceEvidenceEvidenceEvidence----based Decision Makingbased Decision Makingbased Decision Makingbased Decision Making7777. . . . Mutually beneficial supplier relationshipsMutually beneficial supplier relationshipsMutually beneficial supplier relationshipsMutually beneficial supplier relationships

STATUS OF THE REVISION

2012 2012 2012 2012 –––– Working Drafts (WDsWorking Drafts (WDsWorking Drafts (WDsWorking Drafts (WDs))))

2013 2013 2013 2013 –––– Committee Draft (Committee Draft (Committee Draft (Committee Draft (CDCDCDCD))))

April 2014 April 2014 April 2014 April 2014 –––– Draft International Standard (DISDraft International Standard (DISDraft International Standard (DISDraft International Standard (DIS))))

July 2015 July 2015 July 2015 July 2015 –––– Final Draft International Std. (FDISFinal Draft International Std. (FDISFinal Draft International Std. (FDISFinal Draft International Std. (FDIS))))

Sept. 2015 Sept. 2015 Sept. 2015 Sept. 2015 –––– Publish International Standard (Publish International Standard (Publish International Standard (Publish International Standard (ISISISIS))))

Sept. Sept. Sept. Sept. 2015201520152015----2018 2018 2018 2018 –––– 3333----year year year year implementation periodimplementation periodimplementation periodimplementation period

NEW TERMINOLOGY

� “ProductProductProductProduct” is replaced by “Goods Goods Goods Goods and and and and ServicesServicesServicesServices”

� “DocumentDocumentDocumentDocument” and “RecordsRecordsRecordsRecords” are now “Documented Documented Documented Documented InformationInformationInformationInformation” eliminating the long standing distinction between documents and records.

� Preventative Actions Preventative Actions Preventative Actions Preventative Actions are gone in favor of the new risk-based approach

� “ManagementManagementManagementManagement” is now called “LeadershipLeadershipLeadershipLeadership”

� “ProductsProductsProductsProducts” is now “OutputOutputOutputOutput” to emphasize process based approach

� “Continual ImprovementContinual ImprovementContinual ImprovementContinual Improvement” is now just “ImprovementImprovementImprovementImprovement”

� “OutsourceOutsourceOutsourceOutsource” term is now “External ProviderExternal ProviderExternal ProviderExternal Provider”

NEW STRUCTURE – FRONT MATTER

� Front Matter sections remains the same:2008200820082008 2015201520152015

1.0 Scope1.0 Scope1.0 Scope1.0 Scope 1.0 Scope1.0 Scope1.0 Scope1.0 Scope

2.0 Normative References2.0 Normative References2.0 Normative References2.0 Normative References 2.0 Normative References2.0 Normative References2.0 Normative References2.0 Normative References

3.0 Terms and Definitions3.0 Terms and Definitions3.0 Terms and Definitions3.0 Terms and Definitions 3.0 Terms and Definitions3.0 Terms and Definitions3.0 Terms and Definitions3.0 Terms and Definitions

NEW STRUCTURE – BODY OF TEXT

� The body of the Standard is completely restructured:

2008200820082008 2015201520152015

4. Quality Management 4. Quality Management 4. Quality Management 4. Quality Management SystemSystemSystemSystem 4. Context 4. Context 4. Context 4. Context of the of the of the of the organizationorganizationorganizationorganization

5. Management Responsibility5. Management Responsibility5. Management Responsibility5. Management Responsibility 5. Leadership5. Leadership5. Leadership5. Leadership

(5.4 Planning)(5.4 Planning)(5.4 Planning)(5.4 Planning) 6. Planning6. Planning6. Planning6. Planning

6. Resource 6. Resource 6. Resource 6. Resource ManagementManagementManagementManagement 7. Support7. Support7. Support7. Support

7. Product 7. Product 7. Product 7. Product RealizationRealizationRealizationRealization 8. Operation8. Operation8. Operation8. Operation

8. 8. 8. 8. Measurement/Analysis/ImprovementMeasurement/Analysis/ImprovementMeasurement/Analysis/ImprovementMeasurement/Analysis/Improvement 9. Performance Evaluation 9. Performance Evaluation 9. Performance Evaluation 9. Performance Evaluation

10. Improvement10. Improvement10. Improvement10. Improvement

NEW STRUCTURE – BODY OF TEXT

� The new structure emphasizes Plan-Do-Check-Act

2015

4. Context of the organization

PlanPlanPlanPlan 5. Leadership

6. Planning

7. Support

DoDoDoDo 8. Operation

CheckCheckCheckCheck 9. Performance Evaluation

Act Act Act Act 10. Improvement

4. CONTEXT OF THE ORGANIZATION

� Context - The purpose of this new section is that the organization shall determine internal and external issues that are relevant to its purpose and that affect its ability to achieve the intended outcomes.

� Interested Parties – Stakeholders

� Quality Management System

� Scope of QMS – Must define the scope or your QMS� Clause 4.3 Allows you to exclude part of the standard from elements of

your scope with justification

5. LEADERSHIP

� Leadership and commitment

� Quality Policy

� Recognizing the Recognizing the Recognizing the Recognizing the needs and expectations of customersneeds and expectations of customersneeds and expectations of customersneeds and expectations of customers

� Roles, Responsibility and Authority

� Why the focus on “Leadership” & away from “Management”?Why the focus on “Leadership” & away from “Management”?Why the focus on “Leadership” & away from “Management”?Why the focus on “Leadership” & away from “Management”?

� Management is mostly about processes. Management is mostly about processes. Management is mostly about processes. Management is mostly about processes. Leadership Leadership Leadership Leadership is more about is more about is more about is more about

behavior. behavior. behavior. behavior. Leadership is Leadership is Leadership is Leadership is the ability to motivate groups of people towards the ability to motivate groups of people towards the ability to motivate groups of people towards the ability to motivate groups of people towards

a common goal.a common goal.a common goal.a common goal.

6. PLANNING

� Actions to address risks and opportunities

� Objectives and plans to achieve them

� Planning of changes to the QMS

7. SUPPORT

� Resources

� Competence

� Awareness

� Communication

� Documented Information

8. OPERATION

� Operational planning and control

� Determination of market needs and interaction with customers

� Operational planning process & contingency planning

� Control of external provisions of goods and services

� Development of goods and services

� Production of goods and provision of services

� Release of goods and services

� Nonconforming goods and services

9. PERFORMANCE EVALUATION

� Monitoring, Measurement, Analysis and

Evaluation

� Internal Audit

� Management Review

10. IMPROVEMENT

� Nonconformity and Corrective action

� Improvement

RISK MANAGEMENT

RiskRiskRiskRisk----based based based based thinking has always thinking has always thinking has always thinking has always been been been been implicit in ISO 9001; now it's explicit. implicit in ISO 9001; now it's explicit. implicit in ISO 9001; now it's explicit. implicit in ISO 9001; now it's explicit. ISO ISO ISO ISO 9001 9001 9001 9001 has has has has always been about anticipating and preventing mistakes, which always been about anticipating and preventing mistakes, which always been about anticipating and preventing mistakes, which always been about anticipating and preventing mistakes, which is why is why is why is why we train peoplewe train peoplewe train peoplewe train people, why , why , why , why we plan our work, why we assign roles and responsibilities, we plan our work, why we assign roles and responsibilities, we plan our work, why we assign roles and responsibilities, we plan our work, why we assign roles and responsibilities, why we why we why we why we validate and verify results, why we audit and review activities, validate and verify results, why we audit and review activities, validate and verify results, why we audit and review activities, validate and verify results, why we audit and review activities, and why and why and why and why we we we we monitor, measure, and control processes. monitor, measure, and control processes. monitor, measure, and control processes. monitor, measure, and control processes.

Risk Management is not dictated by one section. Documented Risk Management is not dictated by one section. Documented Risk Management is not dictated by one section. Documented Risk Management is not dictated by one section. Documented riskriskriskrisk----based based based based thinking, analysis and thinking, analysis and thinking, analysis and thinking, analysis and actions are required across the board in these areas:actions are required across the board in these areas:actions are required across the board in these areas:actions are required across the board in these areas:

� 4.4.2 Process approach

� 5.1.2 Leadership and commitment with respect to the needs and expectations of customers

� 6.1 Actions to address risks and opportunities (avoidance, mitigation or acceptance)

� 6.3 Planning of changes to the QMS

� 8.3 Operational planning process

� 8.4.2 Type and extent of control of external provision

� 9.1 Monitoring, measurement, analysis and performance evaluation

� 9.2 Internal Audit

� 10.2 Improvement of the quality management system

TIMING OF IMPLEMENTATION OF THE NEW STANDARD

� Plan is to release the new standard this year

� The subcommittee has voted for a 3-year

implementation cycle

� Individual implementation strategies will

depend on the organization's renewal cycle and

the interpretation of their accreditation body

COMPANION ISO STANDARDS

� ISO 13485:2012 – Already risk-based process

approach. Was revised in 2012 with no changes

to the standard. Was in lock-step with 9001 word-

by-word, but no more!!!! Is being revised but not to

the Annex SL management structure as 9001.

� AS9100C – Already risk-based process approach.

Was revised in 2009 with some significant

changes. Was in lock-step with 9001, but no

more!!!! The standard is in revision – due late 2015

COMPANION ISO STANDARDS

� ISO 17025:2005 – Never tracked with 9001

and is not risk-based. Next revision may follow

the new Annex SL template. (2016?)

� ISO 14001:2004 – Not risk-based. Does

employ Plan, Do, Check, Act concepts, but

stresses strategic planning and continual

improvement. Is being revised to the same

format as 9001:2015 on the same schedule.

CONCLUSION

� The change is coming. It has broad application and will The change is coming. It has broad application and will The change is coming. It has broad application and will The change is coming. It has broad application and will affect every aspect of the organization as well as the affect every aspect of the organization as well as the affect every aspect of the organization as well as the affect every aspect of the organization as well as the customer and supplier relationships.customer and supplier relationships.customer and supplier relationships.customer and supplier relationships.

� Preparing and planning for it early will ease the transition.Preparing and planning for it early will ease the transition.Preparing and planning for it early will ease the transition.Preparing and planning for it early will ease the transition.

I am happy to provide an electronic copy of this presentation to I am happy to provide an electronic copy of this presentation to I am happy to provide an electronic copy of this presentation to I am happy to provide an electronic copy of this presentation to anyone that can benefit from it.anyone that can benefit from it.anyone that can benefit from it.anyone that can benefit from it.

Just eJust eJust eJust e----mail me and request a copy at: mail me and request a copy at: mail me and request a copy at: mail me and request a copy at: thomas@futek.comthomas@futek.comthomas@futek.comthomas@futek.com