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Fasilitator
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M. Aristian
Country Manager WQA APAC
aristian@wqa-sea.co.id
08174949991
www.wqa-apac.com
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Disclaimer
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Objective
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Key
Revision
High
Level
Structure
New
Structure
Terminology
Concept
Time frame
&
Transition
OVERVIEW
ISO 9001:2015
Base on DIS
More than just a certificate
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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
More than just a certificate
ISO Fact
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ISO Fact
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ISO Fact
International Organization
for Standardization
Based in Switzerland
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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)
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requirements
for
quality
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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
USA
India
Italy
Germany
Italy
China
Growth
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1994
2000
1987
2008
2015
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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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02
More than just a certificate
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Growth of
Service Business
Decrease Doc
Simplify
Risk Management
multiple
Management
System
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03
More than just a certificate
Development Process
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Development Process
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Development Process
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1.
2.
3.
4.
5.
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Company Logo
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04
More than just a certificate
???
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Transition ???
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Transition Timeline
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05
More than just a certificate
Main Change
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Key inputs
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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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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
5. Improvement
6. Evidence based decision
making
7. Relationship management
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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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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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ISO 9001:2008
ISO 9001:2015
Continual Improvement
Improvement
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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.
More than just a certificate
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ISO 9001:2008
ISO 9001:2015
Relationship management
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Scope
Normative reference
Leadership
Planning
Support
Operation
Performance Operation
10
Improvement
Base on annex SL
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and
alignment
of
different
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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
4.1
General Requirement
Leadership
4.2
Documentation Requirement
Planning
Management Responsibility
Support
Resource Management
Operation
Product Realization
Performance Operation
10
Improvement
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Terminology Change
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ISO 9001:2008
ISO 9001:2015
Product
Documentation , Record
Documented information
Work environment
Purchase product
Supplier
External Provider
Management Responsibility
Leadership
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Leadership
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Terminology Change
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New Concept
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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.
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ISO 9001:2015
Risk Base Thinking
ISO 9001:2008
Preventive Action
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Quiz
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True
False
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Quiz
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True
False
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Quiz
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Six
None
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Quiz
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True
False
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Quiz
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True
False
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Matrix Correlation
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ISO/DIS 9001:2015
4
4.1
4.2
ISO 9001:2008
1.0
1.1
Scope
General
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
More than just a certificate
www.wqa-apac.com
Matrix Correlation
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ISO/DIS 9001:2015
ISO 9001:2008
Leadership
Management responsibility
5.1
5.1
Management commitment
5.1
Management commitment
5.2
Customer focus
5.2
Quality policy
5.3
Quality policy
5.3
Organizational roles,
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ISO/DIS 9001:2015
ISO 9001:2008
6.1
opportunities
6.2
6.3
Planning of changes
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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
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
7.4
Communication
Matrix Correlation
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ISO/FDIS 9001:2015
ISO 9001:2008
7.5
7.5.1
General
4.2.1 General
7.5.2
7.5.3
Control of documented
Information
Documentation requirements
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ISO/FDIS 9001:2015
ISO 9001:2008
Operation
Product realization
8.1
7.1
8.2
control
Determination of requirements
for products and services
7.2
Customer-related processes
to the product
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ISO/FDIS 9001:2015
8.3
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
New
7.3.1
7.3.2
7.3.4
7.3.5
7.3.6
8.4
changes
7.4.1 Purchasing process
Matrix Correlation
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ISO/FDIS 9001:2015
ISO 9001:2008
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
provision
7.3.7 Control of design and development
8.6
8.7
changes
8.2.4 Monitoring and measurement of
processes
7.4.3 Verification of purchased product
8.3 Control of nonconforming product
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ISO/FDIS 9001:2015
ISO 9001:2008
Performance evaluation
New
9.1
Monitoring, measurement,
improvement
9.1.1 General
8.1
8.4
9.2
Internal audit
9.3
Management review
5.6
General
Analysis of data
Management review
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Matrix Correlation
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ISO/FDIS 9001:2015
10
Improvement
ISO 9001:2008
8.5
Improvement
10.1 General
8.3
action
10.3 Continual Improvement
Control of nonconforming
product
8.5.2 Corrective action
8.5.1 Continual improvement
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06
More than just a certificate
Organization Action
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Organization Opportunity
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and
Answers
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