ISO 9001 : 2015

The New

ISO 9001:2015Are you ready for changes?

Divyesh Sanghani

Are you ready for changes?

Prepared by: Divyesh Sanghani

Background

First published in 1987, ISO 9000 has consistently been ISO’s most popular series of standards.

building on 25 years of success, ISO technical committee ISO/TC 176,Quality management and quality assurance, subcommittee SC 2, Quality systems, is busy laying the groundwork for the next generation of quality management standards.

Are you ready for Changes?

ISO 9001 revisions since beginning

1987

19942000

2008

2015

Revisions


ISO 9000 Series

They have: Consistently been ISO’s best-selling

standards ; Firmly established a common platform and

language for organizations to discuss quality ; By defining requirements in ISO 9001, Quality

management systems, that give a base-level confidence in an organization’s ability to provide conforming products, they have facilitated world trade.




Latest ISO 9000 series

ISO9001:2008 is Quality management systems – Requirements

PreviousAdd latest Versions

ISO9004:2009 is Managing for the sustained success of an organization – A quality management approach


Looking to the FutureAre you ready for the Changes?

The vision of standard preparation committee is looking a head to the needs of future.


REVISION OF QUALITY PRINCIPLES

Basic Principles are revisited from eight to seven



5. Improvement

2. Leadership

7. RelationshipManagement

4. Process Approach

1.Customer Focus

6. Evidenced-Based decisionmaking

3. EngagementOf People

Quality Principles

The Revised Quality PrinciplesAre you ready for the changes?


ISO 9001:2015 Time lineAre you ready for changes?


6. Planning

7. Support

9. Performance Evaluation

10. Improvement

1. Scope

2. Normative references

4. Context of organization

5. Leadership

Ten Clauses

3. Terms and definition 8. Operations

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Proposed Clauses:

1. Scope2. Normative references3. Terms and Definitions

3.01. Organization

3.02. Interested Party (preferred term)

3.03. Requirement

3.04. Management System

3.05. Top management

3.06. Effectiveness

3.07. Policy



Proposed Clauses:

3.08. Objective

3.09. Risk

3.10. Competence

3.11. Documented information

3.12. Process

3.13. Performance

3.14. Outsource (verb)

3.15. Monitoring

3.16. Measurement process

3.17. Audit



Proposed Clauses:

3.18. Conformity

3.19. Non-conformity

3.20. Correction

3.21. Corrective Action

3.22. Continual improvement



WELCOME TO REQUIREMENTS

Clause 4



Clause 4. Context of The Organization

4.1 Understanding the Organization and its context

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



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Clause 5. Leadership

5.1 Leadership & Commitment

5.2 Quality Policy

5.3 Organizational Roles, Responsibilities & Authorities

5. Leadership


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Clause 6. Planning

6.1 Actions to address risks &opportunities

6.2 Quality objectives & planning To achieve them

6.3 Planning of changes

6. Planning



Clause 7. Support

7. Support

7.2

7.5

7.3

7.4

7.1Resources

Competence

Awareness

Documented Information

Communication



7.5 Documented Information

7.5

General

Creating & Updating

Control of DocumentedInformation


Clause 8. Operation

8.1 Operational Planning & Control

8.2 Determination of Market needs & interactions with customers

8.3 Operational Planning process

8.4 Control of external Provision of Goods & Services

8.5 Development of Goods & Services

8.6 Production of goods and provision of services

8.7 Release of goods and services

8.8 Nonconforming goods & services

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Note for consideration

The new clause 8 is covered the requirements of clause 7 in last version.

Clause 7.3 design & development in previous versions is simplified to clause 8.5 development of goods and services. The new standard resolved many problems related to design and development.



Clause 9. Performance evaluation

9.1.

9.2.

9.3.

Monitoring, measurement , analysis and evaluation 9.1.1.General, 9.1.2.customer satisfaction, 9.1.3. Analysis & evaluation of data

Internal Audit

Management Review



10.1 Nonconformity and Corrective Action

10.1 Nonconformity and Corrective Action

10.2 Improvement10.2 Improvement

Clause 10. Continual ImprovementAre you ready for the changes?


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ISO 9001 : 2015

Documents

Transcript of ISO 9001 : 2015