business assurance iso 9001:2015 draft international standard

Business Assurance

ISO 9001:2015 Draft International Standard

A Survey of Proposal Changes to ISO9001:2008

Tel : 82-2-3157-1557

Fax : 82-2-6944-8199

[email protected]

www.gcerti.com

(주)지써티 인증원

Tel : 82-2-3157-1557 Fax : 82-2-6944-8199 [email protected] GCERTI www.gcerti.com

ISO SYSTEMS CERTIFICATION BODY / TRAINING CERTIFICATION BODY

Korea

Agenda

1. What is ISO

2. ISO 9000 Document Group

3. Why ISO 9001 is being revised

4. Caution and Disclaimer

5. ISO Management System Standards

6. What is changing

7. Key Changes

8. High Level Structure

9. Context of the Organization

10. Terminology : Changes and Concepts

11. Other Considerations

12. Tentative Transition Timelines

13. What should we be doing?

14. ISO 9001 Survey Result

15. How important is it to incorporate the following concepts into

ISO 9001?

16. ISO 9001 Certifications in the US

17. ISO 9001 Worldwide total

18. Factors which Influenced Organization to Become Certified

19. ISO 9001 & 14001 Certifications in the KOREA



Korea

1. What is ISO?

★ ISO is the International Organization for Standardization, headquartered in

Geneva, Switzerland

– www.iso.org

★ISO is a worldwide federation of the national standards organizations of 157

countries

– Accredia is the Italy member body

★More than 19,000 International Standards and growing

2. ISO 9000 Document Group

★ISO 9000:2005 Fundamentals and Vocabulary

★ISO 9001:2008 Quality Management Systems Requirements

★ ISO 9004:2009 Managing for the Sustained Success of an Organization

The Certified Body or Registrar

★ISO 17021

★IRCA and RAB QSA

★IAF and Mandatory Documents



Korea

3. Why ISO 9001 is being Revised

★Maintain Relevance

★Integration among all standards

★Consistent foundation for the long-term (next 10-25 years)

★Increase adoption of the standard

★Address increased variety of business users

– Service industries – Office environments

★Address increasing complexity of business environment

– Non-office/virtual office

4. Caution and Disclaimer

★ISO 9001:2015 as a Draft International Standard is not available publicly

★No portion of the Draft International Standard may be

– Reproduced

– Transmitted

– Stored

– Copied, recorded, etc.

★Available information is from TC176 member organizations

– Public webinars

– Commentaries

– Limited information releases



Korea

5. ISO Management System Standards

★ 2012: all Management Systems standards will have common Framework

– High level structure

– Common text and terminology

– New standards and revisions to existing standards

★ The Common Framework: Appendix 3 of ISO/IEC Directives, Part 1 Annex

SL

– Annex SL is the generally used shorthand

6. What is Changing?

ISO 9001:2008

0. Introduction

1. Scope

2. Normative References

3. Terms and Definitions

4. Quality Management System

5. Management Responsibility

6. Resource Management

7. Product Realization

8. Measurement, Analysis and

Improvement

ISO 9001:2015

0. Introduction

1. Scope

2. Normative References

3. Terms and Definitions


5. Leadership

6. Planning

7. Support

8. Operations

9. Performance Evaluations

10.Improvement



Korea

7. Key Changes

★ Emphasis on Risk-based management

– Preventive action

★ Increase emphasis on achieving value for organization and its customers

★ Documented Information

– Decreased emphasis on documentation

– Expands concept of documentation

– Replaces Documents and Records

★ Organizational Context

– Responsiveness to business environment

★ Outsourcing is now External Provision

★ Enhanced leadership requirements

★ No requirement for Management Representative

★ No requirement for Quality Manual



Korea

8. High Level Structure

ISO9001:2008 ISO9001:2015

0. Introduction 0. Introduction

1. Scope 1. Scope

2. Normative references 2. Normative references

3. Terms and definitions 3. Terms and definitions

4. 품질경영 시스템 Quality Management System

4. Context of the organization

4.1 일반 요구사항 4.1 Understanding the organization and its context

4.2 문서화 요구사항 7.5 참조

4.2 Understanding the needs and expectations Of interested parties

4.3 Determining the scope of the quality management system

4.4 Quality Management System

4.4.1 General 4.4.2 Process approach

5. 경영책임 Management Responsibility

5. Leadership

5.2 경영실천

5.1 Leadership and commitment 5.1.1 Leadership and commitment with respect to the quality

management system 5.1.2 Leadership and commitment with respect to the respect

to and expectations of customers

5.3 고객중심 5.2 Quality Policy

5.4 품질정책 5.3 Organizational roles, responsibilities and authorities

5.5 기획 6. Planning

6.1 Actions to address risks and opportunities

6.2 Quality objectives and planning To achieve them

6.3 Planning of changes

5.4 책임, 권한 및 의사소통 5.3. 책임 권한 참조 / 7.4. 의사소통

5.5 경영검토 9.3. 경영검토 참조

6. 자원 관리 Resource Management

7. Support

6.1 자원 확보

7.1 Resources 7.1. General 7.1.2 Infrastructure 7.1.3 Process environment 7.1.4 Monitoring and measuring devices 7.1.5 Knowledge

6.2 인적 자원 7.2 Competence



Korea

7.3 Awareness

7.4 Communication

6.3 기반 구조 7.1 infrastructure 참조

6.4 업무 환경 7.1 workplace criteria 참조

7.5 documented information

7.5 1 General

7.5.2 Creating and updating

7.5.3 Control of documented information

7. 제품 실현 Product Realization 8. Operation

7.1 제품 실현의 기획 8.1 Operational planning and control

7.2 고객 관련 프로세스

8.2 Determination of market needs and interactions with customers

8.2.1 Determination of requirements related to the goods and services

8.2.3 Review of requirements related to the goods and services

8.2.4 Customer communication

7.3 설계 및 개발 8.3 Operational planning process

7.4 구매

8.4 Control of external provision of goods and services 8.4.1 General 8.4.2 Type and extent of control of external provision 8.4.3 Documented information for external providers

7.5 생산 및 서비스 제공

8.5 Development of goods and services 8.5.1 Development processes 8.5.2 Development controls 8.5.3 Development transfer

7.6 모니터링 장비 및 측정 장비의 관리

8.6 Production of goods and provision of services 8.6.1 Control of production of goods and provision of services8.6.2 Identification and traceability 8.6.4 Preservation of goods and services 8.6.5 Post delivery activities 8.6.6 Control of changes

8.7 Release of goods and services

8.8 Nonconforming gods and services

8. 측정, 분석 및 개선 Measurement, Analysis and Improvement

9. Performance evaluation

8.1 일반사항

9.1 Monitoring, measurement, analysis and evaluation 9.1.1 General 9.1.2 Customer satisfaction 9.1.3 Analysis and evaluation of data

8.2 모니터링 및 측정 9.2 Internal audit

9.3 Management review

8.3 부적합 제품의 관리 8.8 참조



Korea

8.4 데이터의 분석 9.1 참조

8.5 개선 10. Improvement

10.1 Nonconformity and corrective action

10.2 Improvement


4.1 Understanding the organization and its context The organization must determine external and internal issues relevant to its purpose and that affect its ability to achieve the intended outcomes(s) of its QMS 4.2 Understanding the needs and expectations of interested parties The organization shall determine a) the interested parties that are relevant to the quality management system, and

b) the requirements of these interested parties The organization shall consider the following relevant interested parties a) direct customers

b) end users

c) suppliers, distributors, retailers or others involved in the supply chain

d) regulators; and

e) any other relevant interested parties. 4.4 Quality management system The organization shall establish, implement, maintain and continually improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of this International Standard. "Process approach" is maintained, and it will be embedded in all ISO management system standards. 5.1 Leadership and commitment Top management shall demonstrate leadership and commitment with respect to the quality management system by * ensuring the integration of the quality management system requirements into the organization‘s business processes;

* promoting awareness of the process approach



Korea

* supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility. Top management shall demonstrate leadership and commitment with respect to customer focus 6.1 Actions to address risks and opportunities When planning for the quality management system, the organization shall consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed to a) assure the quality management system can achieve its intended outcome(s),

b) assure that the organization can consistently achieve conformity of goods and services and customer satisfaction,

c) prevent, or reduce, undesired effects, and

d) achieve continual improvement. The organization shall plan: a) actions to address these risks and opportunities, and

b) how to

1) integrate and implement the actions into its quality management system processes (see 4.4), and

2) evaluate the effectiveness of these actions. 7.1 Resources The organization shall determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system. Resources may include : 7.1.2 Infrastructure 7.1.3 Process environment 7.1.4 Monitoring and measuring devices 7.1.5 Knowledge 8.1 Operational planning and control The organization shall plan, implement and control the processes needed to meet requirements and to implement the actions determined in 6.1, by a) establishing criteria for the processes

b) implementing control of the processes in accordance with the criteria, and

c) keeping documented information to the extent necessary to have confidence that the processes have been carried out as planned. The organization shall control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary.



Korea

The organization shall ensure that outsourced processes are the operation of a function or process of the organization by an external provider is controlled (see 8.4). 8.4 Control of external provision of goods and services The organization shall ensure that externally provided goods and services conform to specified requirements. Note : These include Outsourcing. 9 Performance evaluation

9.1 Monitoring, measurement, analysis and evaluation 9.2 Internal Audit 9.3 Management review

10 Improvement 10.1 Nonconformity and corrective action 10.2 Improvement Comment * Note that "Preventive action" is not included as separate clause. However, this may be considered as part of 6.1 (although not too explicitly stated.)



Korea

10. Terminology: Changes and Concepts 1.Product is now Goods and Services 2.Process Approach is now stated requirement (Clause 4.4.2) 3.“Risk” is defined as effect of uncertainty 1.ISO 31000 4.Design and Development is now Development 5.Monitoring and Measurement are now separate 1.Monitoring: status of a system, a process or an activity 2.Measurement: a process to determine a value 6.Context of Organization 1.From stakeholders, industry groups, trading partners, others 2.Laws, regulations, standards, codes of practice, Industry regulation, corporate governance, others 3.Economic, financial, environmental, socail 4.Industry or government analysis 7.Media information 11. Other Considerations Change to the standard brings challenges –To the user community –To Certified Bodies/Registrars

ISO 9001:2008 is central to other standards　 – AS9100 Aerospace / – TS16949 Automotive – FSSC22001 Food Safety

Comments and Feedback can still be provided to TC176　 12. Tentative Transition Timeline

1) February 2014 Draft International Standard

2) July 2015 Final Draft International Standard

3) September 2015 Publish International Standard

4) December 2015 Publish International Standard

5) January 2016 Begin Implementation

6) 2019 Complete 3-year Implementation Period



Korea

13. What should we be doing? Learn about the key change Evaluate the impact on your organization Begin planning to revise your management system Keep informed of the Draft International Standard Begin a dialogue with your Registrar 14. ISO 9001 Survey Result

5%4%

27%64%

5% : No Longer relevant

4% ; Others (Please specify)

27% : Fine as it is

64% : Okay with enhancement

5%

4%



Korea

15. How important is it to incorporate the following concepts into ISO 9001?

16. ISO 9001 Certifications in the US

2010 : 25,101 업체 / 2011 : 25,811 업체 / 2012 : 26,177 업체



Korea

17. ISO 9001 World wide total

18. Factors which Influenced Organization to Become Certified



Korea

19. ISO 9001 & 14001 Certifications in the KOREA

until Apr. 2014

1. 현재까지 인증받은 업체수 until Apr. 2014

Standards/Year 2011 2012 2013 Apr. 2014

ISO9001 16,146 16,473 27,098 27,397

ISO14001 6,928 7,264 7,747 7,898

2. 현재까지 규격별 인증유지, 발급, 취소 현황

until Apr. 2014

구분 ISO 9001 ISO 14001

인증유지 17,397 7,898

인증발급 53,633 18,998

인증취소 36,236 11,100



Korea

3. 현재까지 코드별 인증업체 수

until Apr. 2014

코드 ISO 9001 ISO 14001

[17] 기초 금속 및 조립금속 제품 3,414 1,305

[18] 기계 및 장비 2,920 1,112

[19] 전기 및 광학기기 3,752 2,052