Reorganizacija niza normi sustava upravljanja kvalitetom

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Reorganizacija niza normi sustava upravljanja kvalitetom mr. sc Nenad Nikolić, dipl. ing. fizike

Zagreb, HGK, 2014-05-22

Hrvatski zavod za norme • nacionalno normirno tijelo Republike Hrvatske • predstavlja Republiku Hrvatsku u međunarodnim i regionalnim organizacijama za normizaciju • dostupnost informacija i dokumenata • mjesto dogovora i postizanja nacionalnog konsenzusa • • • •

HZN je osnovan 2005. godine (DZNM) javna ustanova državni proračun, do 30% vlastiti prihodi ograničenja prihoda uslijed stupnja gospodarskog razvoja i ograničenog jezičnog područja Nenad Nikolić - Hrvatski zavod za norme 2014-05-22

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Hrvatski zavod za norme  HZN

trenutačno ima 173 aktivnih TO-a s oko 2600 članova iz industrije, inženjerskih komora, znanstvenih i obrazovnih ustanova, strukovnih udruga te tijela državne uprave u 18 područja normizacije  18 odbora Tehničke uprave (za dijelove pojedinih područja za koje ne postoji iskazani interes u Republici Hrvatskoj) Nenad Nikolić - Hrvatski zavod za norme 2014-05-22

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HZN/TO 176, Upravljanje kvalitetom i osiguravanje kvalitete  

  

Odgovarajući međunarodni odbori: ISO/TC 176, Quality management and quality assurance ISO/TC 262, Risk Management Odgovarajući europski odbori: CEN/TC 279, Value management - Value analysis, functional analysis CEN/TC 362, Project Committee - Healthcare services - Quality management systems CEN/TC 389, Innovation Management Nenad Nikolić - Hrvatski zavod za norme 2014-05-22

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ISO/TC 176, Quality management and quality assurance ISO/TC 176/SC 1 Concepts and terminology ISO/TC 176/SC 2 Quality systems ISO/TC 176/SC 3 Supporting technologies Nenad Nikolić - Hrvatski zavod za norme 2014-05-22

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ISO/TC 176, Quality management and quality assurance ISO/TC 176/SC 1/WG 1, Development of ISO 9000 ISO/TC 176/SC 1/WG 2, Consistency of use of concepts, terms and definitions in ISO/TC 176 standards ISO/TC 176/SC 1/WG 3, Harmonization of terms and definitions with other bodies ISO/TC 176/SC 2/WG 24, Revision of ISO 9001 Nenad Nikolić - Hrvatski zavod za norme 2014-05-22

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ISO/TC 176, Quality management and quality assurance ISO/TC 176/SC 3/WG 16, Joint WG with TC 207/SC2 for the revision of ISO 19011

ISO/TC 176/WG 3, Quality management for electoral assurance ISO/TC 176/WG 4, Quality management systems Application of ISO 9001 in local government *ISO/TC 207, Environmental management Nenad Nikolić - Hrvatski zavod za norme 2014-05-22

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ISO/TC 176, norme ISO 9000:2005 Quality management systems -- Fundamentals and vocabulary – novi DIS ISO 9001:2008 Quality management systems – Requirements – novi DIS ISO 9004:2009 Managing for the sustained success of an organization -- A quality management approach ISO 10001:2007 Quality management -- Customer satisfaction -- Guidelines for codes of conduct for organizations ISO 10002:2004 (2014) Quality management -- Customer satisfaction -- Guidelines for complaints handling in organizations - novi FDIS ISO 10003:2007 Quality management -- Customer satisfaction -- Guidelines for dispute resolution external to organizations ISO 10004:2012 Quality management -- Customer satisfaction -- Guidelines for monitoring and measuring Nenad Nikolić - Hrvatski zavod za norme 2014-05-22

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ISO/TC 176, norme ISO 10005:2005 Quality management systems -- Guidelines for quality plans ISO 10006:2003 Quality management systems -- Guidelines for quality management in projects ISO 10007:2003 Quality management systems -- Guidelines for configuration management ISO 10008:2013 Quality management -- Customer satisfaction -- Guidelines for business-toconsumer electronic commerce transactions ISO 10012:2003 Measurement management systems -- Requirements for measurement processes and measuring equipment ISO/TR 10013:2001 Guidelines for quality management system documentation ISO 10014:2006 Quality management -- Guidelines for realizing financial and economic benefits Nenad Nikolić - Hrvatski zavod za norme 2014-05-22

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ISO/TC 176, norme ISO 10015:1999 Quality management -- Guidelines for training ISO/TR 10017:2003 Guidance on statistical techniques for ISO 9001:2000 ISO 10018:2012 Quality management -- Guidelines on people involvement and competence ISO 10019:2005 Guidelines for the selection of quality management system consultants and use of their services ISO/TS 16949:2009 Quality management systems -- Particular requirements for the application of ISO 9001:2008 for automotive production and relevant service part organizations ISO/TS 17582:2014 Quality management systems -- Particular requirements for the application of ISO 9001:2008 for electoral organizations at all levels of government novo ISO 18091:2014 Quality management systems -- Guidelines for the application of ISO 9001:2008 in local government - novo ISO 19011:2011 Guidelines for auditing management systems Nenad Nikolić - Hrvatski zavod za norme 2014-05-22

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Životni vijek norme • priprema, glasovanje, prihvaćanje, objava, tisak • periodički pregled norme: svakih 5 godina (teži se prema 4 godine – informatika, postoje dvojbe oko toga)   

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potvrdi se dotadašnja norma nešto se doda (amandmani) ili preradi (preradba, novo izdanje) odbaci se i povuče ponekadi se, ako je potrebno, objavi potpuno nova norma

 ispravak (tehnički postupak) Nenad Nikolić - Hrvatski zavod za norme 2014-05-22

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ISO 9000:2015, Quality management systems -- Fundamentals and vocabulary Koje se promjene očekuju? - potpuna prerada norme, norma bi mogla biti znatno većeg obujma - promjene su u koncepciji, nazivlju, dosadašnjim definicijama, uvode se nove definicije - promjene su u stavljanju težišta na cjelokupnom uspjehu organizacije, izračunima, procjenama, materijalnim i nematerijalnim pokazateljima - norma se manje bavi administracijom ili formom a više primjenom novih ekonomskih saznanja, pokazatelja i metoda - norma zahtjeva puno šire obrazovanje kako kadrova unutar organizacije tako i kadrova koji dolaze u audit (između ostalog, potrebna su dodatna pravna, ekonomska, knjigovodstvena i financijska znanja, …) Nenad Nikolić - Hrvatski zavod za norme 2014-05-22

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ISO 9000:2015, Quality management systems -- Fundamentals and vocabulary  

- sustainable success <organization> success (3.2.13) over a period of time Note 1 to entry: Sustainable success emphasizes the need for a balance between economic-financial interests of an organization (3.1.4) and those of the social and ecological environment. Note 2 to entry: Sustainable success relates to the interested parties (3.4.5) of an organization (3.4.1) such as customers (3.4.6), owners, people in an organization (3.4.1), suppliers (3.4.7), bankers, unions, partners or society. Nenad Nikolić - Hrvatski zavod za norme 2014-05-22

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ISO 9000:2015, Quality management systems -- Fundamentals and vocabulary - confidence in organization’s ability to provide satisfactory products

U prethodnom izdanju norme nije se govorilo o proizvodima, već jedino o uspostavi sustava upravljanja kvalitetom. Očito je da sama činjenica da je organizacija uspostavila sustav upravljanja kvalitetom potrošačima i kupcima nije dovoljna. Kupci i potrošači očito žele dodatnu sigurnost da ta organizacija s takvim sustavom upravljanja kvalitetom je onda i sposobna proizvoditi proizvode koji zadovoljavaju kupce i potrošače tih proizvoda. Nenad Nikolić - Hrvatski zavod za norme 2014-05-22

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ISO 9000:2015, Quality management systems -- Fundamentals and vocabulary - The concept of organization purpose Organizations are formed to fulfil a specific purpose and that purpose drives everything an organization does. For an organization to survive in the long term its purpose needs to be outwardly looking towards the external environment (2.1.2) in which it operates. No longer is business performance measured solely in terms of economic performance.

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ISO 9000:2015, Quality management systems -- Fundamentals and vocabulary - The concept of organization purpose Profit or surplus is important as a resource, a measure of success and must be sufficient to cover the risks but when perceived as a primary purpose of an organization it encourages managers to look inwardly at financial returns instead of outwardly at the contribution an organization makes to society which is the ultimate judge of its performance.

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ISO 9000:2015, Quality management systems -- Fundamentals and vocabulary - The concept of external environment 3.2 organization's environment combination of internal and external factors and conditions that can affect the achievement of an organization's objectives and its behaviour towards its interested parties

An organization is bounded by its external environment and can adapt to that environment or seek to shape it to survive and achieve its aims.

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ISO 9000:2015, Quality management systems -- Fundamentals and vocabulary - The concept of interested parties Organizations need to attract, capture and retain the support of those organizations and individuals they depend upon for their success. These are an organization’s interested parties and include customers, investors, employees, suppliers and society. Each has a distinct role in influencing the manner in which an organization fulfils its mission so that managing the expectations of these groups of interested parties becomes a critical success factor in any organization.

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ISO 9000:2015, Quality management systems -- Fundamentals and vocabulary - The concept of quality a) satisfying interested party needs and expectations where the gap is the degree of satisfaction regardless of the stipulated requirements. Higher quality in this sense generally costs more as better features are provided; b) conformity with customer requirements where the gap is the degree of conformity regardless of the significance of any nonconformities; Higher quality in this sense generally costs less as mistakes and waste is eliminated;

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ISO 9000:2015, Quality management systems -- Fundamentals and vocabulary - The concept of quality c) freedom from deficiencies where the gap is the level of deficiency regardless of significance. Higher quality in this sense generally costs less as mistakes are eliminated.     

a) maintaining competitiveness; b) maintaining reputation and brand equity; c) managing innovation; d) minimising waste and reducing internal costs; e) achieving sustained success

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ISO 9000:2015, Quality management systems -- Fundamentals and vocabulary - The concept of quality management The purpose of quality management is therefore to provide an organization with the capability of delivering the required outputs and managing that capability in a way that produces the desired outcomes for all the interested parties. Quality as the priority Quality needs to be the first priority in any organization. Companies that put ‘profits first’ have found themselves losing market position because of the inferior quality and price competitiveness of their goods and services.

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ISO 9000:2015, Quality management systems -- Fundamentals and vocabulary

- The concept of quality management Quality as the priority (od ranije) Quality planning Quality control Quality improvement Quality assurance

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ISO 9000:2015, Quality management systems -- Fundamentals and vocabulary Fundamental Principles Customer focus Leadership Engagement of People Process Approach Improvement Evidence-based decision making Relationship Management

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ISO 9000:2015, Quality management systems -- Fundamentals and vocabulary requirement (definicija bez promjena) need or expectation that is stated, generally implied or obligatory 3.1.4 quality requirement requirement (3.1.3) related to quality (3.1.2) 3.1.5 statutory requirement obligatory requirement (3.1.3) specified by a legislative body 3.1.6 regulatory requirement obligatory requirement (3.1.3) specified by an authority mandated by a legislative body Nenad Nikolić - Hrvatski zavod za norme 2014-05-22

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ISO 9000:2015, Quality management systems -- Fundamentals and vocabulary performance measurable result  Note 1 to entry: Performance can relate either to quantitative or qualitative findings.  Note 2 to entry: Performance can relate to the management (3.2.9) of activities, processes (3.5.1), products (3.5.4)  (including services (3.5.11), systems (3.2.8) or organizations (3.4.1). Nenad Nikolić - Hrvatski zavod za norme 2014-05-22

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ISO 9000:2015, Quality management systems -- Fundamentals and vocabulary risk effect of uncertainty Note 1 to entry: An effect is a deviation from the expected — positive or negative. Note 2 to entry: Uncertainty is the state, even partial, of deficiency of information (3.8.1) related to, understanding or knowledge (3.8.11) of, an event, its consequence, or likelihood. Note 3 to entry: Risk is often characterized by reference to potential events (ISO Guide 73, 3.5.1.3) and consequences (ISO Guide 73, 3.6.1.3), or a combination of these. Note 4 to entry: Risk is often expressed in terms of a combination of the consequences of an event (including changes in circumstances) and the associated likelihood (ISO Guide 73, 3.6.1.1) of occurrence. Note 5 to entry: The term “risk” is sometimes used only when there is the possibility of negative cosequence

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ISO 9000:2015, Quality management systems -- Fundamentals and vocabulary management (upravljanje) coordinated activities to direct and control an organization (3.4.1) Note 1 to entry: Management can include establishing policies (3.2.4) and objectives (3.2.6) and processes (3.5.1) to achieve these objectives (3.2.6) Note 2 to entry: In English, the term “management” sometimes refers to people, i.e. a person or group of people with authority and responsibility for the conduct and control of an organization (3.4.1) (uprava). When “management” is used in this sense, it should always be used with some form of qualifier to avoid confusion with the concept “management” defined above. For example, “management shall…” is deprecated whereas “top management (3.2.1) shall…” is acceptable. Otherwise different words should be adopted to convey the concept when related to people e.g. managerial or managers. Note 2 je ponovljena napomena iz ISO 9000:2005 zbog učestalog pogrešnog prevođenja i uporabe naziva “management”. Nenad Nikolić - Hrvatski zavod za norme 2014-05-22

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ISO 9000:2015, Quality management systems -- Fundamentals and vocabulary outsource make an arrangement where an external organization (3.4.1) performs part of an organization’s (3.4.1) function or process (3.5.1) Note 1 to entry: An external organization (3.4.1) is outside the scope of the management system (3.2.10), although the outsourced function or process (3.5.1) is within the scope. quality management system consultant person who assists the organization (3.4.1) on quality management system realization (3.3.5), giving advice or information (3.8.1) NOTE 1 to entry: The consultant can also assist in realizing parts of a quality management system(3.3.3). NOTE 2 This International Standard provides guidance on how to distinguish a competent quality management system consultant from one who is not competent. [ISO 10019] Nenad Nikolić - Hrvatski zavod za norme 2014-05-22

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ISO 9000:2015, Quality management systems -- Fundamentals and vocabulary interested party (preferred term) stakeholder (admitted term) person or organization (3.4.1) that can affect, be affected by, or perceive themselves to be affected by a decision or activity EXAMPLE Customers (3.4.6), owners, people in an organization (3.4.1), suppliers (3.4.7), bankers, unions, partners or society that may include competitors or opposing pressure groups.

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ISO 9000:2015, Quality management systems -- Fundamentals and vocabulary design and development design development set of processes (3.5.1) that transforms requirements (3.1.3) for an object (3.1.1) into more detailed requirements (3.1.3) Note 1 to entry: The requirements (3.1.3) forming input to design and development can be expressed in a broader, more general sense than the requirements (3.1.3) forming the output of design and development. In a project (3.14.1) there can be several design and development stages. Note 2 to entry: In English the words “design” and “development” and the term “design and development” are sometimes used synonymously and sometimes used to define different stages of the overall design and development. In French the words “conception” and “developpement” and the term “conception et developpement” are sometimes used synonymously and sometimes used to define different stages of the overall design and development. Note 3 to entry: A qualifier can be applied to indicate the nature of what is being designed and developed (e.g. product (3.5.4) design and development or process (3.5.1) design and development). Nenad Nikolić - Hrvatski zavod za norme 2014-05-22

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ISO 9000:2015, Quality management systems -- Fundamentals and vocabulary traceability ability to trace the history, application or location of an object (3.1.1) Note 1 to definition: When considering product (3.5.4), traceability can relate to: the origin of materials and parts; the processing history; and the distribution and location of the product (3.5.4) after delivery Note 2 to entry: In the field of metrology the definition in VIM:1993, 6.10, is the accepted definition.

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ISO 9000:2015, Quality management systems -- Fundamentals and vocabulary determination activity to find out something Note 1 to entry: Something in this definition means one or more characteristics and their characteristic values review determination (3.9.1) of the suitability, adequacy and effectiveness () of an object (3.1.1) to achieve established objectives (3.2.6) EXAMPLE Management review, design and development review, review of customer requirements, nonconformity review and peer review. Note to 1 entry: Review can also include the determination () of efficiency (3.3.12). monitoring (v) determining (3.9.1) the status of a system (3.2.8), a process (3.5.1) or an activity Note 1 to entry: To determine the status there may be a need to check, supervise or critically observe. Note 2 to entry: Monitoring is generally a determination (3.9.1) of the object (3.1.1) being monitored, carried out at different stages or at different times Nenad Nikolić - Hrvatski zavod za norme 2014-05-22

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ISO 9001: 2015, Quality management systems - Requirements Annex B Fundamental Principles Customer focus Leadership Engagement of People Process Approach Improvement Evidence-based decision making Relationship Management preuzeto iz ISO 9000: 2015

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ISO 9001: 2015, Quality management systems - Requirements

Terms and definitions – novo! - u nacrtu ISO 9001/DIS su ubačene na 15 stranica definicije iz ISO 9000 kao pomoć, što predstavlja novost. Ostaju nedoumice: Products and services Goods and services Nenad Nikolić - Hrvatski zavod za norme 2014-05-22

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ISO 9001: 2015, Quality management systems - Requirements Annex A – Clarification of new structure, technology and concepts Structure and terminology Products and services (hardware, services, software and processed materials) Context of organisation Understanding of organisatuion and its context Understanding the needs and expecxtations of interested parties Risk-based approach Applicability No more specific references to “exclusions” (of requirements) - applicability of requirements due to size of organization, management model, the range of activities, the nature of risks and opportunities Nenad Nikolić - Hrvatski zavod za norme 2014-05-22

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ISO 9001: 2015, Quality management systems - Requirements Annex A – Clarification of new structure, technology and concepts Documented information Organizational knowledge (past, existing and additional knowledge, people) Control of external provided products and services (outsourcing)

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ISO 9001: 2015, Quality management systems - Requirements Otvorena pitanja sustainable success Kako ustanoviti da je organizacija u stanju održivog razvoja? (financijski pokazatelji?) statutory requirement Kako ustanoviti da organizacija poštuje zakone? (porezi, korupcija, uprava, …) Koji su to sve zahtjevi, koje točke norme, oba pitanja protežu se kroz više dijelova norme. Hoće li padati broj certifikata? Nenad Nikolić - Hrvatski zavod za norme 2014-05-22

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ISO 9001: 2015, Quality management systems - Requirements Nova tehnička specifikacija: ISO/TS 9002 Quality management systems – Guidance for the application of ISO 9001:2015  

    

This Technical Specification gives guidelines for the application of ISO 9001:2015 It does not add to, or otherwise change, the requirements of ISO 9001:2015. In the case of conflicting interpretations of ISO 9001:2015 on the one hand, and this Technical Specification on the other, the interpretation of the text in ISO 9001:2015 takes precedence. The use of “should” in this Technical Specification does not weaken the requirements expressed as “shall” in ISO 9001:2015. This Technical Specification gives guidance for the following users: a) suppliers involved in the application of ISO 9001; b) customers and third parties. While the guidance in this Technical Specification is generally intended to be generic and applicable to all organizations, it does include examples of the application of ISO 9001 to specific types of organization (e.g. small and medium enterprises) as well as to those involved with specific types of outputs (e.g. services or software) Nenad Nikolić - Hrvatski zavod za norme 2014-05-22

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Hrvatski zavod za norme ISO/DIS 9001 and ISO/DIS 9000 Quality Management System Published 2014-05-19 ISO 9001 and ISO 9000 Quality Management Systems have been published as a Draft International Standard (DIS). Main changes include the same high-level structure used by other management system standards which will help companies implementing more than one standard, the identification of risk and risk control as requirements in the standard, the requirement of top management to take a more active role in aligning quality policies with business needs, and a number of changes in terminology Both drafts are available from the ISOWebstore and members are also invited to sell the draft which can be found on ISOSTD.

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Hrvatski zavod za norme

www.hzn.hr nenad.nikolic@hzn.hr Hvala!

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