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ISO 9001:2015

Revision Overview - General users

Technical Update

Fasilitator

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M. Aristian
Country Manager WQA APAC
aristian@wqa-sea.co.id
08174949991

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Disclaimer

All statements made by the facilitator in this presentation may


represent WQA interpretations. and are not formally endorsed
by ISO or its subcommittee TC176/SC2, responsible for the ISO
9001 revision
The presentation includes information related to DIS
Further changes may occur

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Objective

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To provide an overview of the revision of ISO


9001 which will be published in 2015

Key
Revision

High
Level
Structure

New
Structure
Terminology
Concept

Time frame
&
Transition

OVERVIEW
ISO 9001:2015
Base on DIS
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Outline

ISO Fact
Reason for Revision
Development Process
Time Frame & Transition Period
Main Change
Organization Action

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01
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ISO Fact
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ISO Fact

ISO is an independent, non-governmental


membership organization and the
world's largest developer of voluntary
International Standards.
ISO is a worldwide federation of national
standards bodies (ISO member bodies)
ISO is an international standard that direct & control the
organization to achieve their goal or target, that released by
International Organization for Standardization

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ISO Fact

International Organization
for Standardization

Based in Switzerland

Made up of over 160 National


Standards Bodies (NSBs)

Almost 20,000 standards in the ISO


portfolio

All standards are based on


INTERNATIONAL CONSENSUS

ISO standards are usually developed by its Technical Committees


(TCs) and Sub-committees (SCs)

ISO/TC176/SC2 (Quality Systems) is responsible for ISO 9001

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ISO Fact

International
Organization
for
Standardization would have different
acronyms in different languages .
-English IOS
-French OIN or Organisation
internationale de normalisation)

Decided to give it the short form ISO.


ISO is derived from the Greek isos, meaning equal.
Whatever the country, whatever the language, we are always ISO.
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ISO 9001 Fact

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ISO 9001:2008 specifies


management system

requirements

for

quality

needs to demonstrate its ability to consistently provide product that


meets with :
customer requirement
applicable statutory and regulatory requirements

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ISO Fact

ISO 9001 are among ISO's most well known standards ever
It is implemented by more than a million organizations in some
175 countries.

Number of certificate

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USA

India

Italy

Germany

Italy

China

All requirements of ISO 9001:2008 are generic and are intended


to be applicable to all organizations, regardless of type, size and
product provided.

Growth

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ISO 9001 Revision History

1994
2000

1987

2008
2015

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ISO 9001 Evolution

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ISO 9000:1987
ISO 9000:1987 had the same structure as the UK Standard BS 5750, with three "models
ISO 9001:1987 Model for quality assurance in design, development, production, installation, and
servicing.
ISO 9002:1987 Model for quality assurance in production, installation, and servicing
ISO 9003:1987 Model for quality assurance in final inspection and test covered only the final
inspection of finished product,
It was also influenced by existing U.S. Defense Std("MIL SPECS) & well-suited to manufacturing.

ISO 9000:1994
Emphasized Quality Assurance via preventive actions, instead of just checking final product, and continued
to require evidence of compliance with documented procedures.

ISO 9001:2000
Replaced all three former standards of 1994 issue, ISO 9001, ISO 9002 and ISO 9003.
The 2000 version sought to make a radical change in thinking by actually placing the concept of process
management also demanded involvement by upper executives in order to integrate quality into the business
system and avoid delegation of quality functions to junior administrators.

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Reason for revision


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Reason for Revision

All ISO standards are reviewed every five years

Keep it current and ensure it stay up-to-date


Respond to the latest trends
Compatible with other management systems

Growth of
Service Business
Decrease Doc
Simplify

Risk Management

multiple
Management
System

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Reason for Revision

In the last 25 years, many other Management Systems


Standards have come into use world wide
Organizations that use multiple Management System
Standards are increasingly demanding a common format
and language that is aligned between those standards

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Development Process
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Development Process

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Development Process

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Several stages when developing ISO standard

1.
2.
3.
4.
5.

Working Draft (WD)


Committee Draft (CD)
Draft International Standard (DIS)
Final Draft International Standard (FDIS)
International Standard (IS)

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04
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Time frame & Transition Period


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???

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When will the new version be published?


ISO 9001:2015 is due to be published by the end of 2015.

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Time Frame Revision Process

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Transition ???

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I am certified to ISO 9001:2008. What does this


mean for me?
Organizations are granted a
three-year transition period
after the revision has been
published to migrate their
quality management system
to the new edition of the
standard.

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Transition Timeline

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Main Change
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Key inputs

Key inputs into ISO 9001:2015

12,000+ responses to online user survey


Output from the Future Concepts Task Group ISO/TC176 SC 2
Revision of the 8 Quality Management Principles
Ensure the implementation in ISO 9001 and in the existing
requirements
High Level Structure
New requirements for ISO management system standards

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Key Revision

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Quality
Management
Principle

Applicability

Adopt
HLS
Risk
Base
Approach
New Structure
Terminology
Concept

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Revision of Quality Management Principles

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ISO 9001:2008

ISO 9001:2015

1. Costumer Focus

1. Customer Focus

2. Leadership

2. Leadership

3. Involvement People

3. Engagement of people

4. Process Approach

4. Process approach

5. System approach to
management
6. Continual improvement
7. Factual approach to decision
making
8. Mutually beneficial supplier
relationships

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5. Improvement
6. Evidence based decision
making
7. Relationship management

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Revision of Quality Management Principles

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ISO 9001:2008

ISO 9001:2015

Involvement People

Engagement People

The revised principle still describes the involvement of people at all levels.
It adds that it is essential for these people to be competent, empowered, and
engaged to create and deliver value.

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Revision of Quality Management Principles

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ISO 9001:2008

ISO 9001:2015

Process approach

Process approach

System approach to
management
It continues to focus on understanding
and managing activities as interrelated
processes within a system.

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Revision of Quality Management Principles

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ISO 9001:2008

ISO 9001:2015

Continual Improvement

Improvement

Improvement can also arise as a result of periodic breakthroughs,


reactive change or as a result of re organization.
Thus, the title of this is now Improvement
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Revision of Quality Management Principles

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ISO 9001:2008

ISO 9001:2015

Factual approach to
decision making

Evidence based
decision making

The revised principle still addresses decisions that are based on the
analysis of data and information
It states that evidence-based analysis leads to decisions with greater
objectivity and confidence.
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Revision of Quality Management Principles

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ISO 9001:2008

ISO 9001:2015

Mutually beneficial supplier


relationships

Relationship management

This principle has expanded from supplier relationship to relations with


interested parties.
For example, the draft ISO 9001:2015, clause 4.2, identifies possible
interested parties as direct customers, end users, suppliers, distributors,
retailers, and regulators.
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High Level Structure

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Adopt High Level Structure

Mandated by ISOs Technical Management Board


Platform for identical structure, core text and common terms
and core definitions for use in all Management System
Standards in the future

This will ensure consistency among future and


revised management system standards and
make integrated use simpler. It will also make
the standards easier to read and, in so doing,
be understood by users.

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High Level Structure

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Scope

Normative reference

Term & definition

Context of the organization

Leadership

Planning

Support

Operation

Performance Operation

10

Improvement

Base on annex SL

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High Level Structure

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Purpose - Enhance the consistency


management system standards

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and

alignment

of

different

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High Level Structure

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Purpose - Enhance the consistency


management system standards

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and

alignment

of

different

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Clause Link

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ISO 9001:2008

ISO 9001:2015

Scope

Scope

Normative reference

Normative reference

Term & definition

Term & definition

Quality Management System

Context of the organization

4.1

General Requirement

Leadership

4.2

Documentation Requirement

Planning

Management Responsibility

Support

Resource Management

Operation

Product Realization

Performance Operation

10

Improvement

Measurement, Analysis &


Improvement

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High Level Structure

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The clause structure and some of the terminology have been


changed to improve alignment with other management systems
standards
Changes in the structure and terminology do not need to be
reflected in the documentation of an organizations quality
management system

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Terminology Change

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ISO 9001:2008

ISO 9001:2015

Product

Product and Services

Documentation , Record

Documented information

Work environment

Environment for the operational of process

Purchase product

Externally provided product and services

Supplier

External Provider

Management Responsibility

Leadership

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Leadership

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Terminology Change

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Organizations can choose to use terms which suit their


operations, for example:
using 'records, 'documentation, 'protocols, etc. rather than documented
information
'supplier, 'partner, vendor etc. rather than 'external provider

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New Concept

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Risk Base Thinking


- Increase emphasis on Risk Base Thinking
- No reference for Preventive Action

Decrease the emphasis on Documentation


- No mandatory requirement for Documented Procedures
-No specific requirement for Quality Manual
- Increase the flexibility on the use of documentation
.

Enhance Leadership Requirement


- No mandatory requirement for Management Representative.

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New Concept

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Applicability No Exclussion
The new standard does not make any reference to exclusions.
Standard clarifies that the organization can not decide a requirement
to be not applicable if it falls under the scope of its QMS.
Also non-applicability is not allowed if that could lead to failure to achieve
the conformity or to enhance customer satisfaction.

Emphasis achievement of Quality Objective


-What will be done
- What Resources will be required
- Who will be resposnible
- When it will be compelted
-How the result will be evaluated

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Risk base thinking

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Requirement for a risk-based thinking (risk based approach)


replace preventive action
ie: implies the need for risk assessment and risk management
activities

ISO 9001:2015
Risk Base Thinking

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ISO 9001:2008
Preventive Action

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Risk base thinking

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risk-based thinking is not new


risk-based thinking is something you do already
risk-based thinking is continuous
risk-based thinking ensures greater knowledge and preparedness
risk-based thinking increases the probability of reaching objectives
risk-based thinking reduces the probability of poor results
risk-based thinking makes prevention a habit

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Risk base thinking

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Quiz

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ISO/DIS 9001:2015 requires organizations to


prepare a Quality Manual.

True
False

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Quiz

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ISO/DIS 9001:2015 requires organizations to to


appoint a Management Representative.

True
False

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Quiz

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How many mandatory procedures are required


in ISO/DIS 9001:2015?.

Six
None

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Quiz

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In ISO/DIS 9001:2015 records and documents


are now called documented information..

True
False

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Quiz

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In ISO/DIS 9001:2015 there is no requirement


related to Preventive Actions.

True
False

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Matrix Correlation

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ISO/DIS 9001:2015
4
4.1
4.2

Context of the organization


Understanding the
organization and its context

ISO 9001:2008
1.0
1.1

Scope
General

Understanding the needs and 1.1

General

expectations of interested
4.3
4.4

parties
Determining the scope of the 1.2
4.2.2
quality management system
Quality management system 4
4.1
and its processes

Application
Quality manual
Quality management system
General requirements

Organisation shall:
Determined external and internal issue
Shall monitor and review the information
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ISO/DIS 9001:2015

ISO 9001:2008

Leadership

Management responsibility

5.1

Leadership and commitment

5.1

Management commitment

5.1.1 Leadership and commitment for


the quality management system

5.1

Management commitment

5.1.2 Customer focus

5.2

Customer focus

5.2

Quality policy

5.3

Quality policy

5.3

Organizational roles,

5.5.1 Responsibility and authority


5.5.2 Management representative

responsibilities and authorities

Increase the leadership and commitment from Top Management

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ISO/DIS 9001:2015

ISO 9001:2008

Planning for the quality


management system

5.4.2 Quality management system


planning

6.1

Actions to address risks and

5.4.2 Quality management system


planning
8.5.3 Preventive action
5.4.1 Quality objectives

opportunities
6.2

Quality objectives and planning


to achieve them

6.3

Planning of changes

5.4.2 Quality management system


planning

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ISO/FDIS 9001:2015

7
7.1
7.1.1
7.1.2
7.1.3
7.1.4

Support
Resources
General
People
Infrastructure
Environment for the operation of

ISO 9001:2008
6
6
6.1
6.1
6.3
6.4

Resource management
Resource management
Provision of resources
Provision of resources
Infrastructure
Work environment

7.6

Control of monitoring and

processes
7.1.5 Monitoring and measuring
resources
7.1.6 Organizational knowledge
7.2
Competence

measuring equipment
New
6.2.1 General
6.2.2 Competence, training and
awareness

7.3

Awareness

6.2.2 Competence, training and


awareness

7.4

Communication

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5.5.3 Internal communication


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ISO/FDIS 9001:2015

ISO 9001:2008

7.5

Documented information 4.2

7.5.1

General

4.2.1 General

7.5.2

Creating and updating

4.2.3 Control of documents


4.2.4 Control of records

7.5.3

Control of documented

4.2.3 Control of documents


4.2.4 Control of records

Information

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Documentation requirements

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ISO/FDIS 9001:2015

ISO 9001:2008

Operation

Product realization

8.1

Operational planning and

7.1

Planning of product realization

8.2

control
Determination of requirements
for products and services

7.2

Customer-related processes

8.2.1 Customer communication

7.2.3 Customer communication

8.2.2 Determination of requirements

7.2.1 Determination of requirements

related to products and services


8.2.3 Review of requirements related

related to the product


7.2.2 Review of requirements related

to the products and services

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to the product

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ISO/FDIS 9001:2015
8.3

Design and development of products

8.3.1
8.3.2
8.3.3
8.3.4

and services
General
Design and development planning
Design and development Inputs
Design and development controls

ISO 9001:2008
7.3

Design and development

New
7.3.1
7.3.2
7.3.4
7.3.5
7.3.6

Design and development planning


Design and development inputs
Design and development review
Design and development verification
Design and development validation

8.3.5 Design and development outputs


8.3.6 Design and development changes

7.3.3 Design and development outputs


7.3.7 Control of design and development

8.4

changes
7.4.1 Purchasing process

Control of externally provided

products and services


8.4.1 General
8.4.2 Type and extent of control of external
provision
8.4.3 Information for external providers
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7.4.1 Purchasing process


7.4.1 Purchasing process
7.4.3 Verification of purchased product
7.4.2 Purchasing information
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ISO/FDIS 9001:2015

ISO 9001:2008

8.5 Production and service provision


8.5.1 Control of production and service

7.5 Production and service provision


7.5.1 Control of production and service

provision
8.5.2 Identification and traceability
8.5.3 Property belonging to customers or

provision
7.5.3 Identification and traceability
7.5.4 Customer property

external providers
8.5.4 Preservation
8.5.5 Post-delivery activities

7.5.5 Preservation of product


7.5.1 Control of production and service

8.5.6 Control of changes

provision
7.3.7 Control of design and development

8.6

Release of products and services

8.7

Control of nonconforming process

changes
8.2.4 Monitoring and measurement of
processes
7.4.3 Verification of purchased product
8.3 Control of nonconforming product

outputs, products and services


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ISO/FDIS 9001:2015

ISO 9001:2008

Performance evaluation

New

9.1

Monitoring, measurement,

8 Measurement, analysis and

analysis and evaluation

improvement

9.1.1 General

8.1

9.1.2 Customer satisfaction

8.2.1 Customer satisfaction

9.1.3 Analysis and evaluation

8.4

9.2

Internal audit

8.2.2 Internal audit

9.3

Management review

5.6

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General
Analysis of data
Management review

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ISO/FDIS 9001:2015
10

Improvement

ISO 9001:2008
8.5

Improvement

10.1 General

8.5.1 Continual improvement

10.2 Nonconformity and corrective

8.3

action
10.3 Continual Improvement

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Control of nonconforming
product
8.5.2 Corrective action
8.5.1 Continual improvement

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06
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Organization Action
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Organization Opportunity

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Knows what is going on and is ready to implement the new


requirements
Takes full advantage of the revision of ISO 9001 to
improve business performance
Integrates its activities within the scope of multiple
Management System Standards
Decrease the emphasis on documentation when this is not
mandated or does not add value

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Key changes you do not need to make

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Remove your management representatives.


While there is no requirement in DIS 9001:2015 for a management
representative, this does not prevent organisations from choosing to retain
this role if they so wish.

Some of the duties


traditionally assigned to
the
management
representative by top
management
will,
in
future,
need
to
be
undertaken directly by
top management

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Key changes you do not need to make

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Throw out Quality Manuals and Documented Procedures.


While DIS 9001:2015 sets
out no requirement for
organizations to hold either
a Quality Manual or
Documented Procedures, if
this documentation is in
place, needed and working
well, there is no need for it
to be withdrawn

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Key changes you do not need to make

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Refresh existing documentation to use the new terms and definitions


contained within DIS 9001:2015.

Once again, organizations are


free to make the judgment as
to whether this effort would be
worthwhile. If organizations
are more comfortable using
their own terminology, eg
records
instead
of
documented information

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Remember..
Dont make any changes yet!

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Questions
and

Answers

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For detail information regarding ISO 9001:2015


Please contact :
WQA Asia Pacific
Graha ISKA 165, 5th Floor
Jl. Pramuka Raya no. 165
Jakarta, 10570
Phone : 021 4260769
Hotline +628111496821
jakarta@wqa-sea.com
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