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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)
ISO 9001Schedule of versions
• ISO 9001:1987• ISO 9001:1994• ISO 9001:2000• ISO 9001:2008• ISO 9001:2015 (estimation)
ISO 9001Likely 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
ISO Guide 83• Draft, voting terminated 2011-09-06
• High level structure and identical text formanagement system standards and commoncore management system terms anddefinitions
ISO Guide 83Results of the ballot (30.9.2011)
• 19 approval• 6 disapproval– AUS, CAN, FRA,GER,POL,USA
• 3 abstention
6/25 = 24 %, approved
ISO 9001:2015
• ISO on saanut kesällä 2012 päätökseen työn,jossa johtamisjärjestelmästandardeille(management system standards) on luotuyhteinen rakenne, terminologia ja määritelmät.
• Kolme johtamisjärjestelmästandardia on jojulkaistu uudessa harmonisoidussa muodossa,seitsemän kohdalla työ on meneillään. ISO 9001ja ISO 14001 seuraavat versiot tulevatnoudattamaan uusittua rakennetta
ISO 9001:2015
• Kolme johtamisjärjestelmästandardia onjo julkaistu uudessa harmonisoidussamuodossa– ISO 30301:2011 Information and
documentation– ISO 22301:2012 Societal security– ISO 20121:2012 Event sustainability
management systems
ISO 9001:2015
• Kaikien johtamisjärjestelmästandardejalaativien teknisten komiteoiden on noudatettava“ISO/IEC Directives, Part 1 – Consolidated ISOSupplement - Procedures spesific to ISO”dokumentissa esitettyä rakennetta
• Tässä harmonisoidaan standardin rakenne,terminogia ja määritelmät, mutta annetaanstandardien kehittäjille joustavuutta integroidaheidän spesifiset tekniset aiheet ja vaatimukset
ISO 9001:2015Common high-level structure1. Scope2. Normative reference3. Terms and definitions4. Context of the organisation5. Leadership6. Planning7. Support8. Operation9. Performance evalution10. Improvement
ISO 9001:2015Contents4. 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
ISO 9001:2015Contents5. 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 forsetting quality objectives
• 5.3 Top management shall ensure assignment of roles andresponsibilities
ISO 9001:2015ContentsExample of identical text:
• 5.3 Top management shall ensure thatresponsibilities and authorities for relevantroles are assigned and communicatedwithin the organization
ISO 9001:2015Contents6. 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 withquality policy, measurable, communicated,monitored and updated
ISO 9001:2015Contents6. Planning Risks and opportunities, objectives and
plans
• The new text recognizes the use of the broadconcept of risk and the need to understandrisk in the context of the managementsystem
ISO 9001:2015Contents7. Support Resources, competence, awareness, communication• 7.1 The organization shall provide the infrastructure,
including buildings, workspaces, utilities, processequipment and supporting services
• 7.2 Ensure competence of individuals based on education,training or experience
• 7.3 Ensure awareness of quality policy, benefits ofimproved quality performance and implications of notconforming to management system requirements
• 7.4 Creating, updating and controlling documentedinformation
ISO 9001:2015Contents7. Support Resources, Competence, Awareness,
Communication, Documented information• There are subtle language issues such as
change from document and records todocumented information
ISO 9001:2015Contents8. 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
ISO 9001:2015Contents9. 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
ISO 9001:2015Contents10. 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
ISO 9001:2015Contents10. Improvement Nonconformities, corrective action and
continual improvement• It also encourages everyone to view
preventive action as a broader concept thansimply preventing an incident from re-occurring
