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1 Developed from ISO/TC 176/SC 2/WG23 N063, N064 & N065 ISO 9001:2015 Revision overview - Quality experts Presented by Jack West January 2014

ISO 9001:2015 Revision overview - Oxebridge · PDF file1 Developed from ISO/TC 176/SC 2/WG23 N063, N064 & N065 ISO 9001:2015 Revision overview - Quality experts Presented by Jack West

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Page 1: ISO 9001:2015 Revision overview - Oxebridge · PDF file1 Developed from ISO/TC 176/SC 2/WG23 N063, N064 & N065 ISO 9001:2015 Revision overview - Quality experts Presented by Jack West

1

Developed from ISO/TC 176/SC 2/WG23 N063, N064 & N065

ISO 9001:2015 Revision overview - Quality experts

Presented by

Jack West

January 2014

Page 2: ISO 9001:2015 Revision overview - Oxebridge · PDF file1 Developed from ISO/TC 176/SC 2/WG23 N063, N064 & N065 ISO 9001:2015 Revision overview - Quality experts Presented by Jack West

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Purpose of presentation

The intention of this presentation is to:

To provide an overview of changes and likely impacts of the 2015 revision of ISO 9001

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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 December 2013

further changes are likely to occur as the revision process progresses

you may wish to consider the changes as these occur and plan accordingly

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What was considered?

the results of an extensive web-based user survey

the increasing diversity of ISO 9001 users

developments in knowledge and technologies

broader user interests

changes in industry

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Revision intent

ISO 9001 needs to:

maintain relevance

integrate with other management systems

provide an integrated approach to organizational management

provide a consistent foundation for the next 10 years

reflect the increasingly complex environments in which organizations operate

ensure the new standard reflects the needs of all potential user groups

enhance an organization's ability to satisfy its customers

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Main changes

use of the High Level Structure (HLS)

improved applicability for services

fewer prescribed requirements

increased emphasis on organizational context

boundaries of the QMS must now be defined

consideration of exclusions

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risk-based thinking throughout the standard supersedes a single clause on preventive action

the term ‘documented information’ replaces ‘documents and records’

the term ‘outsourcing’ is replaced by ‘external provision’

increased leadership requirements

no requirement for a management representative

Main changes

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High level structure

a new common format has been developed for

use in all management system standards

standardized core text and structure

standardized core definitions

Organizations implementing multiple management systems (e.g. quality,

environmental, information security) can achieve better integration and easier implementation

The high level structure and common text is public information and can be found in Annex SL of the

www.iso.org/directives

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1 Scope

2 Normative references

3 Terms and definitions

4 Context of the organization context interested parties scope of QMS quality management system

5 Leadership general management commitment policy roles, responsibility and authority

6 Planning actions to address risks and opportunities objectives and plans to achieve them planning of changes

Structure 1/3

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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 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 non conforming goods and services

Structure 2/3

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9 Performance evaluation

monitoring, measurement, analysis and evaluation

internal audit

management review

10 Improvement

Non-conformity and corrective action

improvement

Structure 3/3

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QMS Structure

4 Context of the organization

Understanding of the organization and its context

Expectations of interested parties

Scope of management system

QMS

5 Leadership

Leadership and commitment

Quality policy

Roles, responsibilities and authorities

6 Planning

Actions to address risk and opportunity

Quality objectives

7 Support

Resources

Competence

Awareness

Communication

8 Operation

Operations of planning and control

Determination of market needs and interactions with customers

Operational planning process

Control of external provision of goods and services

Development of goods and services

9 Performance and evaluation

Monitoring, measurement, analysis and evaluation

Internal audit

Management review

10 Improvement

Nonconformity and corrective action

Continual improvement

PLAN DO CHECK ACT

Documented information

Planning of changes

Production of goods and provision of services

Release of goods and services

Nonconforming goods and services

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objectives must include reference to who, what, when

planning of changes

explicit reference to knowledge management

no need for a Quality Manual

operational planning includes addressing risks

greater emphasis on processes achieving requirements for goods or services and customer satisfaction

Changes to requirements

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control of changes

monitoring and measurement

internal audits now require the consideration of related risks

management review to take into consideration strategic direction of the organization

Changes to requirements

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ISO 9001:2015 “Risk Based Thinking” Most significant Change?

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Provide an overview of how the future ISO 9001:2015 standard addresses the topic of “risk”.

Purpose of presentation

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What is “risk-based thinking”?

risk-based thinking is something we all do automatically and often sub-consciously

The concept of risk has always been implicit in ISO 9001 – this revision makes it more explicit and builds it into the whole management system

risk-based thinking is already part of the process approach

risk-based thinking makes preventive action part of the routine

risk is often thought of only in the negative sense. Risk-based thinking can also help to identify opportunities. This can be considered to be the positive side of risk

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Where is risk addressed in

the current draft of

ISO 9001:2015?

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The main objectives of ISO 9001

to provide confidence in the organization’s ability to consistently provide customers with conforming goods and services

To enhance customer satisfaction

The concept of “risk” in the context of ISO 9001 relates to the uncertainty in achieving these objectives

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Risk in the clauses - Process Approach, Leadership, Planning

in Clause 4 the organization is required to determine the risks which can affect its ability to meet these objectives

in Clause 5 top management are required to commit to ensuring Clause 4 is followed

in Clause 6 the organization is required to take action to address risks and opportunities

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Risk in Clauses – Operation, Evaluation, Improvement

Clause 8 - the organization is required to have processes which identify and address risk in its operations

Clause 9 the organization is required to monitor, measure, analyse and evaluate the risks and opportunities

In Clause 10 the organization is required to improve by responding to changes in risk

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Why should I adopt “risk-based thinking”?

to improve customer confidence and satisfaction

to assure consistency of quality of goods and services

to establish a proactive culture of prevention and improvement

Successful companies intuitively take a risk-based approach

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What should I do?

Use a risk-driven approach in your organizational processes

identify what the risks and opportunities are in your organization – it depends on context

ISO 9001:2015 will not automatically require you to carry out a full, formal risk assessment, or to maintain a “risk register”

ISO 31000 (“Risk management — Principles and guidelines”) will be a useful reference (but not mandated)

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What should I do? (continued)

analyse and prioritize the risks and opportunities in your organization

what is acceptable?

what is unacceptable?

plan actions to address the risks

how can I avoid or eliminate the risk?

how can I mitigate the risk?

implement the plan – take action

check the effectiveness of the actions – does it work?

learn from experience – continual improvement

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Additional updates and information will be made

available as the revision process proceeds

What is next?

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ISO 9001:2015 Timeline

June 2013 CD

(Committee Draft)

April 2014 DIS

(Draft International Standard)

July 2015 FDIS

(Final Draft International Standard)

September 2015

Published International Standard

2015 2014 2013

Draft DIS

NOW Jan 2014

Draft DIS

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ISO 9001:2015 Certification Transition Timeline

September 2015 start of 3 years transition period to September 2018

2018 2017 2016 2015

September 2015

Published International Standard

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Updated information will be made available

as the revision process proceeds

What’s next?

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Thanks for your atttention