Download - ISO 9001 2015 Overview
Technical Update
ISO 9001:2015 Revision Overview - General users
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M. AristianCountry Manager – WQA APAC
Fasilitator
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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
OVERVIEWISO 9001:2015
Base on DIS
Key Revision
Time frame&
TransitionHighLevel
Structure
New Structure
TerminologyConcept
To provide an overview of the revision of ISO 9001 which will be published in 2015
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ISO Fact
Reason for Revision
Development Process
Time Frame & Transition Period
Main Change
Organization Action
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01ISO Fact
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ISO is an independent, non-governmentalmembership organization and theworld's largest developer of voluntaryInternational Standards.
ISO is a worldwide federation of nationalstandards bodies (ISO member bodies)
ISO is an international standard that direct & control theorganization to achieve their goal or target, that released byInternational Organization for Standardization
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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
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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 forStandardization would have differentacronyms in different languages .
-English IOS-French OIN or Organisationinternationale de normalisation)
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ISO 9001 Fact
needs to demonstrate its ability to consistently provide product thatmeets with :
customer requirementapplicable statutory and regulatory requirements
ISO 9001:2008 specifies requirements for a qualitymanagement system
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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
Chi
na
Italy
Ger
man
y
Growth
Italy
Indi
a
USA
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1987
2000
1994
2008
2015
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ISO 9001 Evolution
ISO 9000:1987ISO 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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02Reason for revision
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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 BusinessDecrease DocSimplify
Risk Management
multiple Management System
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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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03 Development Process
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Several stages when developing ISO standard
1. Working Draft (WD)2. Committee Draft (CD)3. Draft International Standard (DIS)4. Final Draft International Standard (FDIS)5. International Standard (IS)
Development Process
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04 Time frame & Transition Period
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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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Transition ???
I am certified to ISO 9001:2008. What does thismean for me?
Organizations are granted athree-year transition periodafter the revision has beenpublished to migrate theirquality management systemto the new edition of thestandard.
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05 Main Change
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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
Quality Management
Principle
Adopt HLS
New StructureTerminology
Concept
RiskBase
Approach
Applicability
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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 management6. Continual improvement
7. Factual approach to decision making8. Mutually beneficial supplier relationships
1. Customer Focus
2. Leadership
3. Engagement of people
4. Process approach
5. Improvement
6. Evidence – based decision making7. Relationship management
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Revision of Quality Management Principles
ISO 9001:2008 ISO 9001:2015Involvement 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
ISO 9001:2008 ISO 9001:2015Process approach Process approach
System approach to management
It continues to focus on understandingand managing activities as interrelatedprocesses within a system.
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ISO 9001:2008 ISO 9001:2015Continual Improvement Improvement
Revision of Quality Management Principles
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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ISO 9001:2008 ISO 9001:2015Factual approach to
decision makingEvidence – based decision making
Revision of Quality Management Principles
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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ISO 9001:2008 ISO 9001:2015Mutually beneficial supplier
relationshipsRelationship management
Revision of Quality Management Principles
This principle has expanded from supplier relationship to relations withinterested parties.
For example, the draft ISO 9001:2015, clause 4.2, identifies possibleinterested parties as direct customers, end users, suppliers, distributors,retailers, and regulators.
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High Level Structure
Mandated by ISO’s Technical Management Board
Platform for identical structure, core text and common termsand core definitions for use in all Management SystemStandards in the future
Adopt High Level Structure
This will ensure consistency among future andrevised management system standards andmake integrated use simpler. It will also makethe standards easier to read and, in so doing,be understood by users.
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High Level Structure
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
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High Level Structure
Purpose - Enhance the consistency and alignment of differentmanagement system standards
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High Level Structure
Purpose - Enhance the consistency and alignment of differentmanagement system standards
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Clause Link
Scope
Normative reference2
1
3
Context of the organization
Leadership
Planning
4
5
6
Support
Operation
Performance Operation
7
8
9
Improvement10
Term & definition
Normative reference
Scope
Normative reference2
1
3
Quality Management System
Management Responsibility
Resource Management
4
5
6
Product Realization
Measurement, Analysis &Improvement
7
8
Term & definition
Normative reference
General Requirement 4.1
Documentation Requirement 4.2
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High Level Structure
The clause structure and some of the terminology have beenchanged to improve alignment with other management systemsstandards
Changes in the structure and terminology do not need to bereflected in the documentation of an organization’s qualitymanagement system
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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 Provider Supplier
LeadershipManagement Responsibility
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Leadership
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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
- 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
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New Concept
The new standard does not make any reference to exclusions. Standard clarifies that the organization can not decide a requirementto 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 achievethe conformity or to enhance customer satisfaction.
Applicability – No Exclussion
-What will be done- What Resources will be required- Who will be resposnible- When it will be compelted-How the result will be evaluated
Emphasis achievement of Quality Objective
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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 9001:2008Preventive Action
ISO 9001:2015Risk 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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ISO/DIS 9001:2015 requires organizations toprepare a Quality Manual.
True
False
Quiz
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ISO/DIS 9001:2015 requires organizations to toappoint a Management Representative.
True
False
Quiz
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How many mandatory procedures are requiredin ISO/DIS 9001:2015?.
Six
None
Quiz
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In ISO/DIS 9001:2015 records and documentsare now called documented information..
True
False
Quiz
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In ISO/DIS 9001:2015 there is no requirementrelated to Preventive Actions.
True
False
Quiz
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Matrix Correlation
ISO/DIS 9001:2015 ISO 9001:20084 Context of the organization 1.0 Scope4.1 Understanding the
organization and its context1.1 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 Application4.2.2 Quality manual
4.4 Quality management system
and its processes
4 Quality management system4.1 General requirements
Organisation shall:• Determined external and internal issue• Shall monitor and review the information
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5 Leadership 5 Management responsibility5.1 Leadership and commitment 5.1 Management commitment5.1.1 Leadership and commitment for the quality management system
5.1 Management commitment
5.1.2 Customer focus 5.2 Customer focus5.2 Quality policy 5.3 Quality policy5.3 Organizational roles,
responsibilities and authorities
5.5.1 Responsibility and authority5.5.2 Management representative
ISO/DIS 9001:2015 ISO 9001:2008
Matrix Correlation
Increase the leadership and commitment from Top Management
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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 action6.2 Quality objectives and planning
to achieve them
5.4.1 Quality objectives
6.3 Planning of changes 5.4.2 Quality management system
planning
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7 Support 6 Resource management7.1 Resources 6 Resource management7.1.1 General 6.1 Provision of resources7.1.2 People 6.1 Provision of resources7.1.3 Infrastructure 6.3 Infrastructure7.1.4 Environment for the operation of
processes
6.4 Work environment
7.1.5 Monitoring and measuring
resources
7.6 Control of monitoring and
measuring equipment7.1.6 Organizational knowledge New7.2 Competence 6.2.1 General
6.2.2 Competence, training and
awareness
7.3 Awareness 6.2.2 Competence, training and
awareness7.4 Communication 5.5.3 Internal communication
ISO/FDIS 9001:2015 ISO 9001:2008
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7.5 Documented information 4.2 Documentation requirements7.5.1 General 4.2.1 General7.5.2 Creating and updating 4.2.3 Control of documents
4.2.4 Control of records
7.5.3 Control of documented
Information4.2.3 Control of documents4.2.4 Control of records
ISO/FDIS 9001:2015 ISO 9001:2008
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8 Operation 7 Product realization8.1 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 communication8.2.2 Determination of requirements
related to products and services
7.2.1 Determination of requirements
related to the product8.2.3 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
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8.3 Design and development of products
and services
7.3 Design and development
8.3.1 General New8.3.2 Design and development planning 7.3.1 Design and development planning8.3.3 Design and development Inputs 7.3.2 Design and development inputs8.3.4 Design and development controls 7.3.4 Design and development review
7.3.5 Design and development verification7.3.6 Design and development validation
8.3.5 Design and development outputs 7.3.3 Design and development outputs8.3.6 Design and development changes 7.3.7 Control of design and development
changes8.4 Control of externally provided
products and services
7.4.1 Purchasing process
8.4.1 General 7.4.1 Purchasing process8.4.2 Type and extent of control of external
provision
7.4.1 Purchasing process7.4.3 Verification of purchased product
8.4.3 Information for external providers 7.4.2 Purchasing information
ISO/FDIS 9001:2015 ISO 9001:2008
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8.5 Production and service provision 7.5 Production and service provision8.5.1 Control of production and service
provision
7.5.1 Control of production and service
provision8.5.2 Identification and traceability 7.5.3 Identification and traceability8.5.3 Property belonging to customers or
external providers
7.5.4 Customer property
8.5.4 Preservation 7.5.5 Preservation of product8.5.5 Post-delivery activities 7.5.1 Control of production and service
provision8.5.6 Control of changes 7.3.7 Control of design and development
changes8.6 Release of products and services 8.2.4 Monitoring and measurement of
processes7.4.3 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
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9 Performance evaluation New 9.1 Monitoring, measurement,
analysis and evaluation
88 Measurement, analysis and
improvement
9.1.1 General 8.1 General9.1.2 Customer satisfaction 8.2.1 Customer satisfaction9.1.3 Analysis and evaluation 8.4 Analysis of data9.2 Internal audit 8.2.2 Internal audit9.3 Management review 5.6 Management review
ISO/FDIS 9001:2015 ISO 9001:2008
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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
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06 Organization Action
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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
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Remove your management representatives.
While there is no requirement in DIS 9001:2015 for a managementrepresentative, this does not prevent organisations from choosing to retainthis role if they so wish.
Some of the dutiestraditionally assigned tothe managementrepresentative by topmanagement will, infuture, need to beundertaken directly bytop management
Key changes you do not need to make
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Throw out Quality Manuals and Documented Procedures.
Key changes you do not need to make
While DIS 9001:2015 setsout no requirement fororganizations to hold eithera Quality Manual orDocumented Procedures, ifthis documentation is inplace, needed and workingwell, there is no need for itto be withdrawn
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Refresh existing documentation to use the new terms and definitionscontained within DIS 9001:2015.
Key changes you do not need to make
Once again, organizations arefree to make the judgment asto whether this effort would beworthwhile. If organizationsare more comfortable usingtheir own terminology, eg“records” instead of“documented information
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Remember….. Don’t make any changes yet!
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Questionsand
Answers
For detail information regarding ISO 9001:2015 Please contact :
WQA Asia PacificGraha ISKA 165, 5th FloorJl. Pramuka Raya no. 165 Jakarta, 10570Phone : 021 4260769 Hotline [email protected]