The document discusses the timeline and process for revising ISO 9001 to release version ISO 9001:2015. Key points include: - ISO has standardized a common structure, terminology and definitions for management system standards, which ISO 9001:2015 will follow. - Three management system standards have already been published in the new harmonized format, and seven others are in progress, including ISO 9001 and ISO 14001. - The timeline estimates a draft international standard ballot in June 2014 and final publication of ISO 9001:2015 in December 2015.

1. ISO 9001:2015
19.12.2012
Markku Ahlberg
A-Quality Oy
markku.ahlberg@elisanet.fi

2. A-Quality Oy
• A-Quality Oy (perustettu 1989)
• Toim.joht Markku Ahlberg
– TkL, insev evp, Pvlaatujoht 1997-2008
• Toimialat:
– Auditoinnit (ISO 9001, ISO 14001, AQAP)
– Koulutustilaisuudet
– Konsultointi
• Pätevyydet:
– IRCA pääarvioija vuodesta 1990
– Inspecta Sertifiointi Oy pääarvioija vuodesta 1990
• Jäsenyydet
– ISO TC 176 national committee (SFS TK 105) (1995-2011)
– NATO AC 327 (1997 – 2008)
markku.ahlberg@elisanet.fi
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3. ISO 9001
Schedule of versions
• ISO 9001:1987
• ISO 9001:1994
• ISO 9001:2000
• ISO 9001:2008
• ISO 9001:2015 (estimation)
markku.ahlberg@elisanet.fi
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4. ISO 9001
Likely revision timing for ISO 9001
• March 2012 Vote to revise
• June 2012 Issue NWIP
• November 2012 Start work at plenary meeting
• December 2013 First CD issued
• June 2014 DIS for ballot
• September 2015 FDIS ballot
• December 2015 ISO 9001:2015 issued
markku.ahlberg@elisanet.fi
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5. ISO Guide 83
• Draft, voting terminated 2011-09-06
• High level structure and identical text for
management system standards and common
core management system terms and
definitions
markku.ahlberg@elisanet.fi
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6. ISO Guide 83
Results of the ballot (30.9.2011)
• 19 approval
• 6 disapproval
– AUS, CAN, FRA,GER,POL,USA
• 3 abstention
6/25 = 24 %, approved
markku.ahlberg@elisanet.fi
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7. ISO 9001:2015
• ISO on saanut kesällä 2012 päätökseen työn,
jossa johtamisjärjestelmästandardeille
(management system standards) on luotu
yhteinen rakenne, terminologia ja määritelmät.
• Kolme johtamisjärjestelmästandardia on jo
julkaistu uudessa harmonisoidussa muodossa,
seitsemän kohdalla työ on meneillään. ISO 9001
ja ISO 14001 seuraavat versiot tulevat
noudattamaan uusittua rakennetta
markku.ahlberg@elisanet.fi
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8. ISO 9001:2015
• Kolme johtamisjärjestelmästandardia on
jo julkaistu uudessa harmonisoidussa
muodossa
– ISO 30301:2011 Information and
documentation
– ISO 22301:2012 Societal security
– ISO 20121:2012 Event sustainability
management systems
markku.ahlberg@elisanet.fi
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9. ISO 9001:2015
• Kaikien johtamisjärjestelmästandardeja
laativien teknisten komiteoiden on noudatettava
“ISO/IEC Directives, Part 1 – Consolidated ISO
Supplement - Procedures spesific to ISO”
dokumentissa esitettyä rakennetta
• Tässä harmonisoidaan standardin rakenne,
terminogia ja määritelmät, mutta annetaan
standardien kehittäjille joustavuutta integroida
heidän spesifiset tekniset aiheet ja vaatimukset
markku.ahlberg@elisanet.fi
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10. ISO 9001:2015
Common high-level structure
1. Scope
2. Normative reference
3. Terms and definitions
4. Context of the organisation
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance evalution
10. Improvement
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11. ISO 9001:2015
Contents
4. Context of the organisation
• 4.1 Determine external and internal issues of the
organisation
• 4.2 Understand the needs and expectations of
interested parties
• 4.3 Determine the scope of the quality
management system (QMS)
• 4.4 Establish, implement, maintain and
continually improve the QMS
markku.ahlberg@elisanet.fi
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12. ISO 9001:2015
Contents
5. Leadership
• 5.1 Top management to demonstrate leadership and
commitment
– Ensuring policies and objectives are established
– Ensuring the QMS requirements are integrated into the business
processes
– Ensuring resources are available
– Promoting continual improvement
• 5.2 Establish quality policy that provides a framework for
setting quality objectives
• 5.3 Top management shall ensure assignment of roles and
responsibilities
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13. ISO 9001:2015
Contents
Example of identical text:
• 5.3 Top management shall ensure that
responsibilities and authorities for relevant
roles are assigned and communicated
within the organization
markku.ahlberg@elisanet.fi
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14. ISO 9001:2015
Contents
6. Planning
Risks and opportunities, objectives and plans
• 6.1 Ensure the QMS can achieve intended
outcomes, prevent or reduce undesired effects,
and achieve continual improvement
• 6.2 Ensure quality objectives are consistent with
quality policy, measurable, communicated,
monitored and updated
markku.ahlberg@elisanet.fi
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15. ISO 9001:2015
Contents
6. Planning
Risks and opportunities, objectives and
plans
• The new text recognizes the use of the broad
concept of risk and the need to understand
risk in the context of the management
system
markku.ahlberg@elisanet.fi
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16. ISO 9001:2015
Contents
7. Support
Resources, competence, awareness, communication
• 7.1 The organization shall provide the infrastructure,
including buildings, workspaces, utilities, process
equipment and supporting services
• 7.2 Ensure competence of individuals based on education,
training or experience
• 7.3 Ensure awareness of quality policy, benefits of
improved quality performance and implications of not
conforming to management system requirements
• 7.4 Creating, updating and controlling documented
information
markku.ahlberg@elisanet.fi
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17. ISO 9001:2015
Contents
7. Support
Resources, Competence, Awareness,
Communication, Documented information
• There are subtle language issues such as
change from document and records to
documented information
markku.ahlberg@elisanet.fi
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18. ISO 9001:2015
Contents
8. Operation
• 8.1 Planning of product realization
• 8.2 Requirements related to product
• 8.3 Customer communication
• 8.4 Design and development processes
• 8.5 Purchasing
• 8.6 Control and validation of production and service
provision
• 8.7 Identification
• 8.8 Care of customer property
• 8.9 Preservation of product
markku.ahlberg@elisanet.fi
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19. ISO 9001:2015
Contents
9. Performance evalution
Monitoring, measurement, analysis, evaluation,
internal audits and management review
• 9.1 Measure customer satisfaction
• 9.2 Monitor and measurement of processes and
product
• 9.3 Control of monitoring and measurement
equipment
markku.ahlberg@elisanet.fi
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20. ISO 9001:2015
Contents
10. Improvement
Nonconformities, corrective action and
continual improvement
• 10.1 Analysis of data
– Information relating to conformity to requirements and
customer satisfaction
– Characteristics and trends
– Opportunities for preventive action
– Information concerning suppliers
markku.ahlberg@elisanet.fi
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21. ISO 9001:2015
Contents
10. Improvement
Nonconformities, corrective action and
continual improvement
• It also encourages everyone to view
preventive action as a broader concept than
simply preventing an incident from re-
occurring
markku.ahlberg@elisanet.fi
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