A Review ISO 9001:2015 Draft

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A Review ISO 9001:2015

Draft

ISO 9001

ISO 9001 –

–

– Why is it changing?

–

Why is it changing?

Disclaimers

Verbal statements made by the presenter may represent personal opinions and/or interpretations. The presentation includes information related to the revision process up to and including April 2015.Further changes may occur

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QUEST GLOBAL MANAGEMENT SERVICES QUEST GLOBAL MANAGEMENT SERVICES QUEST GLOBAL MANAGEMENT SERVICES QUEST GLOBAL MANAGEMENT SERVICES

ISO 9001 History

1st edition – ISO 9001:1987 (20 elements)

2st edition – ISO 9001:1994 (small revision)

3rd edition – ISO 9001:2000 (process approach)

4th edition – ISO 9001:2008 (minor revision)

5th

5

5 th

th

th edition

edition

edition –

edition

–

– FDIS

FDIS

FDIS (New

(New Structure

(New

Structure

Structure &

Structure

&

& Risk

Risk

Risk Based

Based

Based Thinking)

Based

Thinking)

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Reason for Revision

The world changes:

Increased prominence of services

Globalization

More complex supply chain

Increased interested parties’ expectations

Information availability

ISO standards are reviewed for suitability and effectiveness every

5-8 years (last update in 2008)

Need the New Common Structure

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QUEST GLOBAL MANAGEMENT SYSTEMS QUEST GLOBAL MANAGEMENT SYSTEMS QUEST GLOBAL MANAGEMENT SYSTEMS QUEST GLOBAL MANAGEMENT SYSTEMS

ISO 9001 – Under Revision

• Review based on ISO Working Draft 9001 – 6/13.

• Further revisions likely to occur.

• Firms may wish to consider these changes and plan

accordingly .

• New revisions slated for release

Sept

Sept 2015

2015

2015 with

2015

with

with full

full

implementation

implementation Sept

Sept

Sept 2018

Sept

2018

2018....

• Draft revisions now

21

21 21 pages

pages

pages of

of requirements

of

requirements

requirements compared

compared

compared to

to

9

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Objective of Revisions

Enhance an organization’s ability to satisfy customers.

Maintain relevance, provide integrated approach to

organizational management, and integrate with other

management systems.

Reflect needs of all user groups and increasingly complex

operating environments.

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What’s New?

Risk management is being added with focus on risk-based thinking.

Identification

Identification of

of

of risk

of

risk

risk and

and

and risk

risk control

risk

control

control now

now

now aaaa requirement

requirement

requirement.

Standardized core text, structure, definitions enable organizations

with multiple management systems to achieve improved integration

& implementation.

Major focus on achieving value for organization and its customers.

Revisions allow ISO 9001 to be more applicable by “service-based”

organizations.

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QMS Structure Re-organized

4

4 4....Context

Context

Context of

of

of Organization

Organization

Organization –

Organization

addresses needs and expectations of interested parties, scope

of QMS

5

5 5.... Leadership

Leadership

addresses

management

commitment,

policy,

roles,

responsibility & authority

6

6 6.... Planning

Planning

includes risks, opportunities, objectives and plans to achieve

them, the planning of changes

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Structure Re-organized

7

77 7.... Support

Support

includes

resources,

competence,

awareness,

communication, documented information

8

8 8.... Operation

Operation

includes planning & control, determine market needs,

interaction w/customers, planning process, control of

external provisions of goods/services, production of

goods, provision of services, release of goods/services,

non-conforming goods/services

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Structure Outlined

9

9 9.... Performance

Performance

Performance Evaluation

Evaluation

includes monitoring, measurement, analysis &

evaluation, internal audit, management review

10

10 10.... Improvement

Improvement

addresses non-conformity & corrective action,

improvement

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Timeline to Revision Release and

Client Transition

2013

2014

2015

June 2013 CD (Committee Draft)

April 2014 DIS

(Draft International Standard)

July 2015 FDIS July 2015 FDISJuly 2015 FDIS July 2015 FDIS

(Final Draft International Standard) (Final Draft International Standard)(Final Draft International Standard) (Final Draft International Standard)

September 2015

(Published International Standard)

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Timeline to Revision Release and

Client Transition

2015

2016

2017

2018

September 2015

Published International Standard

September 2015 start of 3 years

transition period to September 2018

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SOME NEW ELEMENTS OF THE NEW VERSION

THE CLAUSES ARE 10 USING THE NEW "HIGH-LEVEL

STRUCTURE":

1. Scope

2. Normative references

3. Terms and definitions

4. Context of the organisation

5. Leadership

6. Planning for the quality management system

7. Support

8. Operation

9. Performance evaluation

10. Improvement

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What has changed

ISO 9001:2008 ISO DIS 9001:2015

0 Introduction

1 Scope

2 Normative references

3 Terms and definitions

4 Quality management system

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

4.1 General requirements

4.4 Quality management system and its processes

4.2 Documentation requirements

7.5 Documented information

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ISO 9001:2008

ISO DIS 9001:2015

5 Management responsibility

5 Leadership

5.1 Management commitment

5.1 Leadership and commitment

5.2 Customer focus

5.1.2 Customer focus

5.3 Quality policy

5.2 Quality policy

5.4 Planning

6 Planning for the quality management system

6.1 Actions to address risks and opportunities

6.2 Quality objectives and

planning to achieve

them

6.3 Planning of changes

5.5 Responsibility, authority and

communication

5.3 Organizational roles, responsibilities and

authorities

7.4 Communication

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

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

6 Resource management

7 Support

6.1 Provision of resources

7.1 Resources

6.2 Human resources

7.2 Competence

7.3 Awareness

7.4 Communication

6.3 Infrastructure

7.1.3 Infrastructure

6.4 Work environment

7.1.4 Environment for the operation of

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

7 Product realization

8 Operation

7.1 Planning of product realization

8.1 Operational planning and control

7.2 Customer-related processes

8.2 Determination of requirements for

products and services

7.3 Design and development

8.3 Design and Development of products

and services

7.4 Purchasing

8.4 Control of externally provided

products and services

7.5 Production and service provision

8.5 Production and service provision

7.6 Control of monitoring and measuring

equipment

7.1.5 Monitoring and measuring resources

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

8 Measurement, analysis and

improvement

9 Performance evaluation

8.1 General

9.1 Monitoring, measurement, analysis and evaluation

8.2 Monitoring and

measurement

9.2 Internal audit

9.3 Management review

8.3 Control of nonconforming

product

8.7 Control of nonconforming process outputs, products

and services

9.1 Monitoring, measurement, analysis and evaluation

8.4 Analysis of data

9.1 Monitoring, measurement, analysis and evaluation

8.5 Improvement

10 Improvement

10.1 General

10.2 Nonconformity and corrective action

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What Should an

Organization do Now?

Nothing at this time

( well almost nothing)

( well almost nothing).

Still too early in the 2015

Still too early in the 2015 revision process of ISO 9001 to make any

Still too early in the 2015

significant changes to an existing QMS.

Some issues drafted may change

Some issues drafted may change or disappear in upcoming drafts or with

Some issues drafted may change

final version.

Looking ahead…existing registered system documentation

Looking ahead…existing registered system documentation should conform

Looking ahead…existing registered system documentation

with some small adjustments. In most cases, existing registered

organizations should have enough documentation and records.

Since risk is documented in most sections of proposed revision to ISO 9001

Since risk is documented in most sections of proposed revision to ISO 9001,

Since risk is documented in most sections of proposed revision to ISO 9001

consider starting your risk management plan, if you don’t have one. Begin

thinking how to address risk in your business.

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What do you need to do?

Go for ISO 9001 2008 Certification

Transition to ISO 9001:2015

Transition period is three year

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