iso 9001:2015

Technical Update

ISO 9001:2015 Revision Overview - General users

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M. AristianCountry Manager WQA- APAC

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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



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



01ISO Fact


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ISO is an independent, non-governmentalmembership organization and theworld's largest developer of voluntaryInternational Standards.

ISO is an international standard that direct & control theorganization to achieve their goal or target, that released byInternational Organization for Standarization



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



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)



ISO 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




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



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.




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



03 Development Process


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04 Time frame & Transition Period



???

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




Company Logo

Key Revision

Quality Management

Principle

Adopt HLS

New StructureTerminology

Concept

RiskBase

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 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





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.





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.




ISO 9001:2008 ISO 9001:2015Continual 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 9001:2015Factual approach to

decision makingEvidence – 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 9001:2015Mutually beneficial supplier

relationshipsRelationship management


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.




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.





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 differentmanagement 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 Requirement 4.1

Documentation Requirement 4.2

ISO 9001:2008 ISO 9001:2015www.thmemgallery.com




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




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





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 Changewww.thmemgallery.com



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 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




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




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 thinkingwww.thmemgallery.com



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




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




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

Matrix Correlationwww.thmemgallery.com



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




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




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




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




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




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




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




06 Organization 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 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 makewww.thmemgallery.com



Throw out Quality Manuals and Documented Procedures.

Key changes you do not need to make

While DIS 9001:2014 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




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

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




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




Questionsand

Answers


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iso 9001:2015

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