1. Update of the upcoming ISO 9001
Tina Bohlin, 2014-06-12
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2. Seminar Outline
1. ISO & TC 176 Quality management & quality assurance
2. ISO 9001 - background
3. Key inputs into the revision of ISO 9001
4. Main changes in ISO 9001:2015
5. Timeline for the revision process & Transition Plan
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3. ISO
ISO = International Organization for Standardization
– 164 countries and > 19 100 standards
– Consensus, voluntary, openness och stakeholder driven
– Technical Committees (TC)
– National experts nominated by each country
– 1 country - 1 vote
ISO/TC 176 Quality management and quality assurance
– SC1 Concepts and terminology
– SC2 Quality systems
– SC3 Supporting technologies
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4. New ISO 9001:2015 – on it’s way..….
Different stages to a published standard
WD
CD
DIS
FDIS
IS
May 2013
July 2014
Feb. 2015
Sep. 2015
Dec. 2012
May 2012
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5. ISO 9001:2015
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6. What is the aim of ISO 9001?
Increase customer satisfaction
through improved operational consistency
and continual improvement
&
Give market trust
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7. ISO 9001 – History
 1st edition – ISO 9001:1987
 2st edition – ISO 9001:1994
 3rd edition – ISO 9001:2000
 4th edition – ISO 9001:2008
 5th edition – Review 2012
 Publication Sep. 2015
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8. Key inputs into ISO 9001:2015
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1. 12,000+ responses to online user survey
2. Output from the “Future Concepts” Task Group
ISO/TC176 SC 2
3. Revision of the 8 Quality Management Principles
Ensure the implementation in ISO 9001 and in the existing requirements
4. High Level Structure (Annex SL, ISO Directives)
New requirements for ISO management system standards
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9. 3. Review of Quality Management Principles
1. Customer focus
2. Leadership
3. Involvement of 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
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10. 4. High level structure –
New structure and terminology
 ”Annex SL” – ISO Directives, Part 1
 Identical structure for all future ISO management
system standards
 Common terms and definitions
 Identical common text
Annex SL can be found at www.iso.org/directives
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11. 4. High level structure –
Annex SL (ISO Directives)
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Clause 1 Scope
Clause 2 Normative references
Clause 3 Terms and definitions
Clause 4 Context of the organization
Clause 5 Leadership
Clause 6 Planning
Clause 7 Support
Clause 8 Operation
Clause 9 Performance evaluation
Clause 10 Improvement
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12. 4 Quality management system
4.1 General requirements
4.2 Documentation requirements
5 Management responsibility
6 Resource management
7 Product realization
8 Measurement, analysis and
improvement
ISO 9001:2008 ISO 9001:2015
4 Context of the organization
5 Leadership
6 Planning
7 Support
8 Operation
10 Improvement
9 Performance evaluation
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13. ISO 9001:2008  2015
 Use of the High Level Structure (HLS)
 More compatible with services
 Organizational context must be understood
 Enhanced leadership requirements (no
“management representative”)
 Better alignment with business management
processes
 Integration of “risk based thinking”
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14. ISO 9001:2008  2015 (contd…)
 More focus and clarity around the process work
 Change management a higher priority
 Increased flexibility regarding documentation
 Purchasing is replaced by external provision
 Changes to key terms and definitions
Customer Focus
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15. ISO 9001:2015
Certification Transition Timeline
Sept 2015
Publication
September 2015 start of 3 years transition period to
September 2018
2018201720162015
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16.  DIS referral – vote and comments (July 10th – Oct. 10th)
 Systematic review of ISO 9004 Managing for the sustained
success of an organization -- A quality management approach
 ISO/TS 9002 Guidelines for the use of ISO 9001
 Preparation for TC 176-meeting in Tel Aviv, Israel (Nov. 2014)
 Product support on ISO/TC176 website (www.iso.org)
 Expected changes to industry-specific standards and guiding
standards based on ISO 9001 24
Next step……
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17. From Sweden to the world
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ISO TC 176
94 P- & 24 O-members
Canada chairman & secretary
SIS TK 304
43 Sw. organisations
Colleges/Universities
Companies
Trade organisations
Local authorities
Government agencies
Others
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18. SIS/TK 304 Kvalitetsledning
Arbetslivsresurs AR, Billerud Korsnäs, Bureau Veritas Certification,
CANEA Partner Group, Det Norske Veritas Certification , Deva
Mecaneyes, Ericsson, European-Quality Scandinavia, Försvarets
Materielverk FMV, Gidlöf Consulting, Goodpoint, GR Avd Meritea,
Göteborgs Universitet, Intertek Certification, ISS Facility Services,
Linnéuniversitetet, Lyreco, Nogap, P & L Nordic, Posten, Resalus,
Riksbyggen, Ringhals, Sandvik, Sandvik Machining Solutions Sverige,
Sandvik Materials Technology, SFK Certifiering, SP Sveriges Tekniska
Forskningsinstitut, SSC Swedish Space Corporation, Statens
institutionsstyrelse, Stockholm Vatten, Stora Enso,
Strålsäkerhetsmyndigheten, Swedac - Styrelsen för ackreditering &
teknisk kontroll, Swedish Tissue, Thörn & Co, Trafikverket, Vattenfall
Research and Development, Volvo Personvagnar, Volvo Technology,
Västra Götalandsregionen, QiM, Qualineer
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19. More questions?
Projekt Manager Tina Bohlin
Tel. +46 8-555 520 58
E-mail: tina.bohlin@sis.se
www.sis.se/tk304
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20. Thank you
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