Implementation of the QMS according to ISO 9001:2000 in the SO SR

1. SO SR Implementation of the QMS according to ISO 9001:2000 in the SO SR Mária Dologová, SO SR Strategic Management Seminar, Split,November 23, 2007

2. SO SR • Agenda • Background & choice of the QMS • Implementation - basic approach • Implementation - Strategy; Tactics, system • Monitoring, measurement, analysis, improvement • QMS players • Fit with the Eurostat Quality assurance framework • Further improvement of the system

3. SO SR Background & Choice of QMS

4. SO SR Background & Choice of QMS SO SR demanding environment Requirements + highly regulated environment at national& EU level +increasing pressure to provide value to interested . .parties by fulfilling strong Q requirements Resources - limited stimulus ... more and more *) reflected in LEG, CoP

5. SO SR Background & Choice of QMS ... the need for an institution-wide QMS.based on: • long-term view, leadership • customer orientation + ability to provide value . to customers (+ other stakeholders) • process approach, minimisation of activities . not adding value • continual improvement (incl. QMS) • ... to assure our customers and ourselves that we are able to provide products that consistently fulfil requirements • ... to improve the value of SO SR

6. SO SR Background & Choice of QMS 2004 strategic decision: QMS based on ISO 9001:2000 + strategic mgnt, CAF, CoP = framework for continual performance improvement with the aim to increase the value of SO SR

7. SO SR QMS ISO (9001:2000) implementation - basic approach -

8. SO SR QMS ISO – basic approach System of ISO 9001 (process-based)

9. SO SR 5 P 8 Strategy Tactics, System Resources Realisation planning Realisation Monitoring, measurement, analysis Review, evaluation Corrective, preventive action What do we want to achieve? 4, 5 8 .... how (ways)? 6 A 8 .... with what? 7 8 How will we realise it? 7 D 8 We are realising it 8 Improvement 8 C How were we realising it (how did we realise it)? 8 Did we achieve what we wanted? 8 A Measures QMS ISO – basic approach System of value creation & ISO requirements 4. Quality management system 5. Management responsibility 6. Resource management 7. Product realisation 8. Measurement, analysis andimprovement

10. SO SR QMS ISO – basic approach Basic approach important: SO SR did not destroy its own system SO SR addapted its own management system according to the QMS - ISO requirements

11. SO SR QMS ISO (9001:2000) implementation - strategy -

12. SO SR vision mission quality policy common shared values strategic objectives, quality objectivesfor the chosen scenario Generic strategy, direction & method of development QMS ISO implementation – strategy SO SR development strategy - basic architecture -

13. SO SR QMS ISO (9001:2000) implementation - tactics, system -

14. SO SR QMS ISO implementation – tactics, system Identification & specification of SO SR processes • QMSs require / assume the existence of the process approach • QMS ISO – mandatory introduces it • EFQM, CAF, CoP, ... – assume the organisation . already has it

15. SO SR QMS ISO implementation – tactics, system it allows a comfortable analysis: value creation . for customer versus cost consumption it allows to provide value to customers / . stakeholders in an effective way = by optimal . allocation of resources Benefit no.1 of the process approach:

16. SO SR QMS ISO implementation – tactics, system Role of the process in creation value / adding valueto stakeholders provide necessary managerial suport: from strategy ... to operation directly contribute to creation of value for (the main) stakeholder: e.g. from customer requirements ... to customer satisfaction provide necessary resources:from info sources ... to work environment Supporting / managerial processes Value-adding processes Supporting / resource processes

17. Strategic -, tactical -, operational mgnt SO SR Managerial processes Value-adding process I Customer & his requirements Customer & his satisfaction NA & macroeconomic stat., Business stat., Social stat. & demography, Reg. Offices *** Compreh. products & dissemination Resource processes Info sources mgnt HRM, ICT-M, M-Infra, work env., purch.*), FM *)incl. outsourced R&D QMS ISO implementation – tactics, system

18. Strategic -, tactical -, operational mgnt SO SR Info sources mgnt Resource processes ..6 ICT-M M-Infrastr. HRM FM ..5 ..3 ..4 ..3 QMS ISO implementation – tactics, system Managerial processes EXAMPLE Standardisation -Effectiveness Value-adding process Customer & his requirements Customer & his satisfaction Communication with customer; definition of way of obtaining data Creation of prod. & publ. DB & other working DB Preparation & realisation of stat. survey. & data processing Creation of product & dissemination *) number of subprocesses

19. SO SR QMS ISO implementation – tactics, system Description of processes SO SR processes described by internal directives, each consisting of: • Main part: description of the process flow • Annexes: • Process identification sheet • Graphic representation of the process • List of related regulations • List of records • List of forms created by the directive • List of abbreviations used • Distribution list

20. SO SR QMS ISO implementation – tactics, system Process identification sheet= the core in the process description • managerial part • performance indicators • process parameters • targets • monitoring/measuring/analysis • improvements • records • descriptive part • aim of the process /subp. • process owner, operators • input (from ...) • output (to ...) • activities • resources, regulations

21. SO SR current general set up: - meet customer specification & his satisfaction - meet Q criteria (reporting - via Q reports) - keep regulations - max. input into central DB - maintain knowledge . = the main process parameter QMS ISO implementation – tactics, system Aim of the process - aim of subprocesses - The set up of managerial tools depends on the aim of the process/ subprocess (it reflects the org. objectives) performance indicators / targets process parameters / targets monitoring, measuring, analyses Improvement, records

22. SO SR QMS ISO implementation – tactics, system Descriptive part, Graphic representation - example

23. SO SR QMS ISO implementation – tactics, system • Basic QMS SO SR documentation architecture • Strategic documents: development strategy / strategic statements, Q policy, - strateg. objectives/ Q objectives, Q manual • Documented procedures required by ISO standard (control of documents, - of records, - of non-conforming product, internal audits, corrective/ preventive actions) • Documents needed to ensure effective planning, operation and control of processes (policies, conceptions, plans …, internal legislation (directives re processes, …), instructions, external legislation + binding documents) • Records

24. SO SR QMS ISO (9001:2000) - monitoring, measurement, analysis, improvement-

25. SO SR QMS ISO monitoring, measurement, analysis, improvement Operational level: - KPI, other process parameters, improvements regular evaluation in all processes formulation (text), frequency of monitoring, frequency of evaluation, target value System level: - internal audits conducted annually as a planned activity in all processes - to assess whether the QMS conforms to planned arrangements, to ISO 9001:2000 requir., to requir. established by SO SR - self-assessment(Code of Practice, DESAP) assurance of internal auditor competence level - external audits Certification audit (Oct 2006, by Bureau Veritas Certification) Supervisory audit(Nov 2007, 2008) Re-certification audit(2009) audit like activities – peer review and other (court of auditors, ...)

26. SO SR A P C D QMS ISO monitoring, measurement, analysis, improvement Top management level: Management review planned activity conducted annually -to ensure QMS suitability, adequacy, effectiveness and - to assess opportunities for improvement. - evaluation of Q policy, Q objectives, process comp., - audit results, feedback from customers, - process performance, product conformity, - corr/prev actions, - environm. changes - impact on QMS, - summary evaluation of QMS, improvement recomm. • Continual improvements, sources: • Level of meeting Quality policy & Quality objectives • Audit results • Results from monitoring & measurement of processes • Corrective & preventive actions • Management review

27. SO SR QMS ISO (9001:2000) - main players-

28. SO SR QMS ISO – main players • QMS players • Quality Manager(top mgnt representative), QM status • Quality Council(members of top mgnt meeting), QC status • Process owners(prevailing top mgnt members) • Process operators(employees involved in the process) • Internal auditors (selected employees) • QMS consultant- EOQ Quality Systems Manager, • - EOQ Mgnt System Senior Consul. • Responsibilities & authorities defined in: • SO SR organisational scheme/order • QM status, QC status • Directives for concrete processes • Directives for Doc., - IA, - Corr/prev actions • Job description

29. SO SR QMS ISO (9001:2000) - fit with the Eurostat Quality assurance framework-

30. Key process variabl. User satisf. survey SO SR Q reviews QMS documentation Monitoring/meas./analysis • strategic doc. (incl. QM) • documented ISO proced. • process descriptions • other planning documents, • instructions, ... • records • performance indicators • other process parameters • customer, ... satisf. surveys • internal audits, self-assesm. • external audits (audit like a) • mgnt review Q indicators Self-assessment Q reports Process description, product docum., Q guidelines QMS ISO – fit with EQAF QMS ISO = suitable basis for a systematic implementation of the EQAF

31. SO SR QMS ISO (9001:2000 - advantages, potential problems-

32. SO SR QMS ISO – advantages, problems • Advantages of QMS ISO • ensures integral process based approach to quality (instead of partial approach) – institution-wide • creates conditions for effective development of the organisation through improving performance • suitable basis for implementation of other systems (e.g. EFQM, CAF, ...) • certified by independent certification body

33. SO SR QMS ISO – advantages, problems • Potential problems • Demanding as for: • knowledge and skills of the „system engineer“to import requirements into the system in the right way (i.e. to develop, not to deform the system) • change of the way of thinking of managers: mgnt by objectives, managing people, willingness to improve system (to add value) and at the same time to reduce costs (process management)

34. SO SR QMS ISO – advantages, problems • Risks related to QMS ISO implementation • misunderstanding and lack of self-identificationwith foundations of the system • bureaucratic approach (also of consultancy and certification org.!) ... focus on documented procedures / records instead of performance improvement • resistance of employees • misunderstanding of the basic ISO requirements by managers - ... of process approach

35. SO SR QMS ISO (9001:2000) - further improvement-

36. SO SR QMS ISO – improvement • Inspiration from models like: • EFQM Excellence Model • Common Assessment Framework • ISO 9004 • Malcolm Baldrige NQA • ... many other models • the improved QMS may consist of the pillars from existing models taken as inspiration and from the own developed pillars ... creating one integral QMS

37. SO SR Thank you for your attention

38. SO SR Workshop - Setting up the system - Problem statement You intend to improve the value of your NSI through enhancing the statistical product portfolio – by focusing on knowledge products (i.e. value-added products). How can you realise this intention (using process approach)? (What impact will this intention have on the processes (on the QMS) of your NSI? Is the process approach advantageous? If yes / not - why?)

39. SO SR

40. SO SR Background & Choice of QMS Continual performance improvement through ... enhancing customer satisfaction (and of other interested parties) by application of 8 principles: • Customer focus • Leadership • Involvement of people • Process approach • System approach to management • Continual improvement • Factual approach to decision making • Mutually beneficial supplier relationship

41. SO SR main objective Increase systematically value of theinstitution – credibility, effectiveness and acknowledgement at national and international level. QMS ISO implementation – strategy Strategic / quality objectives composition partial objectives Main area - Core activity - active co-ordination and creation of the NSS in EU context; -active participation in the development of ESS and in the statistical activities of important international institutions. Marketing dev. Knowledge mgnt dev. Human res. dev. IS/ICT use & safety. Fin. mgnt dev. . Functional areas

42. SO SR strategies measures, targets action programmes ... how do we want to measure achievements? ... what will we do, who, when? ... how do we want to achieve the objective? QMS ISO implementation – strategy ... for each objective Managerial approach - MBO -

43. SO SR Process Sub-processes Activities QMS ISO implementation – tactics, system Use of the label „process“, if • Processowner is defined • Process owner has responsibilities AND authority in relation to outputs / outcomes (responsible for process design & performance) • Process owner has at his disposal resources for maintenance and improvement of the process (HR, ..., fin. resources) Three levels: - process - subprocess - activity

44. SO SR QMS ISO implementation – tactics, system Description of processes Basic approach to description: • keep reasonable level of explicit process description • elaborate general directives in the first step • describe main facts, relations, responsibilities • use references to all existing more detailed documents, elaborate new detailed instructions only if necessary (according to process owner decision)