ISO 9001:2015

Technical Update
ISO 9001:2015
Revision Overview - General users

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

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

Objective
OVERVIEW
ISO 9001:2015
Base on DIS
Key
Revision
Time frame
&
Transition
High
Level
Structure
New
Structure
Terminology
Concept
To provide an overview of the revision of ISO
9001 which will be published in 2015
www.thmemgallery.com

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

01ISO Fact

ISO Fact
ISO is an independent, non-governmental
membership organization and the
world's largest developer of voluntary
International Standards.
ISO is an international standard that direct & control the
organization to achieve their goal or target, that released by
International Organization for Standarization

ISO Fact
 International Organization
for Standardization
̶ Based in Switzerland
̶ Made up of over 160 National
Standards Bodies (“NSB’s”)
̶ Almost 20,000 standards in the ISO
portfolio
̶ All standards are based on
INTERNATIONAL CONSENSUS
 ISO standards are usually developed by its Technical Committees
(“TC’s”) and Sub-committees (“SC’s”)
̶ ISO/TC176/SC2 (Quality Systems) is responsible for ISO 9001

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

ISO Fact
 needs to demonstrate its ability to consistently provide product that
meets with :
customer requirement
applicable statutory and regulatory requirements
ISO 9001:2008 specifies requirements for a quality
management system

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.
 All requirements of ISO 9001:2008 are generic and are intended
to be applicable to all organizations, regardless of type, size and
product provided.
Number of certificate
China
Italy
Germany
Growth
Italy
India
USA

ISO 9001 Revision History
1987
2000
1994
2008
2015

ISO 9001 Evolution
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.

02Reason for revision

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

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

03Development Process

Development Process

04Time frame & Transition Period

???
When will the new version be published?
ISO 9001:2015 is due to be published by the end of 2015.

Time Frame Revision Process

Transition ???
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.

Transition Timeline

05Main Change

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

Company Logo
Key Revision
Quality
Management
Principle
Adopt
HLS
New Structure
Terminology
Concept
Risk
Base
Approach
Applicability

ISO 9001:2008 ISO 9001:2015
Revision of Quality Management Principles
1. Costumer Focus
2. Leadership
3. Involvement People
4. Process Approach
5. System approach to
management
6. Continual improvement
7. Factual approach to decision
making
8. Mutually beneficial supplier
relationships
1. Customer Focus
2. Leadership
3. Engagement of people
4. Process approach
5. Improvement
6. Evidence – based decision
making
7. Relationship management

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.

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.

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”

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.

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.

High Level Structure
 Mandated by ISO’s 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
Adopt High Level Structure
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.

Scope
Normative reference2
1
3
Context of the organization
Leadership
Planning
4
5
6
Support
Operation
Performance Operation
8
7
9
Improvement10
Term & definition
Normative reference
Base on annex SL

Purpose - Enhance the consistency and alignment of different
management system standards

Clause Link
Scope
1
3
Context of the organization
Leadership
Planning
4
5
6
Support
Operation
Performance Operation
7
8
9
Improvement10
Term & definition
Normative reference
Scope
1
3
Quality Management System
Management Responsibility
Resource Management
4
5
6
Product Realization
Measurement, Analysis &
Improvement
7
8
Term & definition
Normative reference
General Requirement4.1
Documentation Requirement4.2
ISO 9001:2008 ISO 9001:2015

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 organization’s quality
management system

Terminology Change
Product and ServicesProduct
ISO 9001:2015ISO 9001:2008
Documented informationDocumentation , Record
Environment for the operational of processWork environment
Externally provided product and servicesPurchase product
External ProviderSupplier
LeadershipManagement Responsibility

Company Logo
Leadership

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’
Terminology Change

New Concept
- Increase emphasis on Risk Base Thinking
- No reference for Preventive Action
- No mandatory requirement for Documented Procedures
-No specific requirement for Quality Manual
- Increase the flexibility on the use of documentation
.
- No mandatory requirement for Management Representative.
Risk Base Thinking
Decrease the emphasis on Documentation
Enhance Leadership Requirement

New Concept
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.
Applicability – No Exclussion

Risk base thinking
Requirement for a risk-based thinking (risk based approach)
replace preventive action
ie: implies the need for risk assessment and risk management
activities
ISO 9001:2008
Preventive Action
ISO 9001:2015
Risk Base Thinking

 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
Risk base thinking

Risk base thinking

Matrix Correlation
ISO/DIS 9001:2015 ISO 9001:2008
4 Context of the organization 1.0 Scope
4.1 Understanding the
organization and its context
1.1 General
4.2 Understanding the needs and
expectations of interested
parties
1.1 General
4.3 Determining the scope of the
quality management system
1.2 Application
4.2.2 Quality manual
4.4 Quality management system
and its processes
4 Quality management system
4.1 General requirements
Organisation shall:
• Determined external and internal issue
• Shall monitor and review the information

5 Leadership 5 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,
responsibilities and authorities
5.5.1 Responsibility and authority
5.5.2 Management representative
ISO/DIS 9001:2015 ISO 9001:2008
Matrix Correlation
Increase the leadership and commitment from Top Management

ISO/DIS 9001:2015 ISO 9001:2008
6 Planning for the quality
management system
5.4.2 Quality management system
planning
6.1 Actions to address risks and
opportunities
5.4.2 Quality management system
planning
8.5.3 Preventive action
6.2 Quality objectives and planning
to achieve them
5.4.1 Quality objectives
6.3 Planning of changes 5.4.2 Quality management system
planning
Matrix Correlation

7 Support 6 Resource management
7.1 Resources 6 Resource management
7.1.1 General 6.1 Provision of resources
7.1.2 People 6.1 Provision of resources
7.1.3 Infrastructure 6.3 Infrastructure
7.1.4 Environment for the operation of
processes
6.4 Work environment
7.1.5 Monitoring and measuring
resources
7.6 Control of monitoring and
measuring equipment
7.1.6 Organizational knowledge New
7.2 Competence 6.2.1 General
6.2.2 Competence, training and
awareness
7.3 Awareness 6.2.2 Competence, training and
awareness
7.4 Communication 5.5.3 Internal communication
ISO/FDIS 9001:2015 ISO 9001:2008
Matrix Correlation

Matrix Correlation

7.5 Documented information 4.2 Documentation requirements
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
Information
4.2.3 Control of documents
4.2.4 Control of records
ISO/FDIS 9001:2015 ISO 9001:2008
Matrix Correlation

8 Operation 7 Product realization
8.1 Operational planning and
control
7.1 Planning of product realization
8.2 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
related to products and services
7.2.1 Determination of requirements
related to the product
8.2.3 Review of requirements related
to the products and services
7.2.2 Review of requirements related
to the product
ISO/FDIS 9001:2015 ISO 9001:2008
Matrix Correlation

8.3 Design and development of products
and services
7.3 Design and development
8.3.1 General New
8.3.2 Design and development planning 7.3.1 Design and development planning
8.3.3 Design and development Inputs 7.3.2 Design and development inputs
8.3.4 Design and development controls 7.3.4 Design and development review
7.3.5 Design and development verification
7.3.6 Design and development validation
8.3.5 Design and development outputs 7.3.3 Design and development outputs
8.3.6 Design and development changes 7.3.7 Control of design and development
changes
8.4 Control of externally provided
products and services
7.4.1 Purchasing process
8.4.1 General 7.4.1 Purchasing process
8.4.2 Type and extent of control of external
provision
7.4.1 Purchasing process
7.4.3 Verification of purchased product
8.4.3 Information for external providers 7.4.2 Purchasing information
ISO/FDIS 9001:2015 ISO 9001:2008
Matrix Correlation

8.5 Production and service provision 7.5 Production and service provision
8.5.1 Control of production and service
provision
7.5.1 Control of production and service
provision
8.5.2 Identification and traceability 7.5.3 Identification and traceability
8.5.3 Property belonging to customers or
external providers
7.5.4 Customer property
8.5.4 Preservation 7.5.5 Preservation of product
8.5.5 Post-delivery activities 7.5.1 Control of production and service
provision
8.5.6 Control of changes 7.3.7 Control of design and development
changes
8.6 Release of products and services 8.2.4 Monitoring and measurement of
processes
7.4.3 Verification of purchased product
8.7 Control of nonconforming process
outputs, products and services
8.3 Control of nonconforming product
ISO/FDIS 9001:2015 ISO 9001:2008

9 Performance evaluation New
9.1 Monitoring, measurement,
analysis and evaluation
88 Measurement, analysis and
improvement
9.1.1 General 8.1 General
9.1.2 Customer satisfaction 8.2.1 Customer satisfaction
9.1.3 Analysis and evaluation 8.4 Analysis of data
9.2 Internal audit 8.2.2 Internal audit
9.3 Management review 5.6 Management review
ISO/FDIS 9001:2015 ISO 9001:2008
Matrix Correlation

10 Improvement 8.5 Improvement
10.1 General 8.5.1 Continual improvement
10.2 Nonconformity and corrective
action
8.3 Control of nonconforming
product
8.5.2 Corrective action
10.3 Continual Improvement 8.5.1 Continual improvement
ISO/FDIS 9001:2015 ISO 9001:2008
Matrix Correlation

06Organization Action

Organization Opportunity
 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

Remove your management representatives.
While there is no requirement in DIS 9001:2014 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
Key changes you do not need to make

Throw out Quality Manuals and Documented Procedures.
While DIS 9001:2014 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

Refresh existing documentation to use the new terms and definitions
contained within DIS 9001:2014.
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

Remember…..
Don’t make any changes yet!

Questions
and
Answers

Worldwide Quality Assurance - Asia Pacific
Graha Iska 165
Jl. Pramuka Raya no. 165
Jakarta, Indonesia
Phone. 390 0631
jakarta@wqa-sea.com
www.wqa-apac.com

ISO 9001:2015

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