{"id":17037,"date":"2025-02-17T12:52:39","date_gmt":"2025-02-17T10:52:39","guid":{"rendered":"https:\/\/lindstromgroup.com\/si\/?p=17037"},"modified":"2025-02-17T12:59:17","modified_gmt":"2025-02-17T10:59:17","slug":"zagotavljanje-kakovosti-z-iso-9001","status":"publish","type":"post","link":"https:\/\/lindstromgroup.com\/si\/uncategorized\/zagotavljanje-kakovosti-z-iso-9001\/","title":{"rendered":"Zagotavljanje kakovosti z ISO 9001: Pogled od znotraj"},"content":{"rendered":"\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-28f84493 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:66.66%\">\n<p>ISO 9001 je globalno priznani standard za <a href=\"https:\/\/www.iso.org\/standard\/62085.html\">sisteme vodenja kakovosti (QMS: Quality management systems)<\/a>. Trenutna razli\u010dica je ISO 9001:2015, ki dolo\u010da zahteve za QMS, vklju\u010dno z: <\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Procesi za na\u010drtovanje, nadzor in zagotavljanje kakovosti<\/li>\n\n\n\n<li>Metodami za spremljanje in merjenje u\u010dinkovitosti<\/li>\n\n\n\n<li>Smernicami za dokumentacijo, notranje presoje ter korektivne in preventivne ukrepe<\/li>\n<\/ul>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:33.33%\">\n<figure class=\"wp-block-image aligncenter size-full is-resized\"><img decoding=\"async\" width=\"591\" height=\"709\" src=\"https:\/\/d2ris6qfzcz0wn.cloudfront.net\/wp-content\/uploads\/sites\/12\/2024\/10\/image-10.png\" alt=\"\" class=\"wp-image-17215\" style=\"width:263px;height:auto\" srcset=\"https:\/\/d2ris6qfzcz0wn.cloudfront.net\/wp-content\/uploads\/sites\/12\/2024\/10\/image-10.png 591w, https:\/\/d2ris6qfzcz0wn.cloudfront.net\/wp-content\/uploads\/sites\/12\/2024\/10\/image-10-250x300.png 250w\" sizes=\"(max-width: 591px) 100vw, 591px\" \/><\/figure>\n<\/div>\n<\/div>\n\n\n\n<p class=\"has-white-color has-purple-background-color has-text-color has-background has-link-color wp-elements-4191ecc5de7f87b44fbe1100edd46b92\">Z ISO 9001 certifikatom dokazujemo, da dosledno zagotavljamo izdelke in storitve, ki ustrezajo zahtevam strank in regulativnim standardom. Ta standard od nas zahteva mo\u010dno osredoto\u010denost na stranke ter nenehno izbolj\u0161evanje procesov, da zagotovimo kakovostno izku\u0161njo.<\/p>\n\n\n\n<p class=\"has-white-color has-purple-background-color has-text-color has-background has-link-color wp-elements-0092c9d7fe2af3bc7f94a387a91efda1\">Za globlji vpogled v na\u010dela ISO 9001 smo se pogovarjali s <strong>Harri Puputtijem, direktorjem kakovosti in skladnosti<\/strong> pri Lindstr\u00f6mu.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Na\u0161 celostni pristop k upravljanju kakovosti<\/h2>\n\n\n\n<p>ISO 9001 velja za organizacije vseh velikosti in sektorjev. V devetdesetih letih smo bili med prvimi podjetji, ki smo certificirali na\u0161 sistem vodenja kakovosti v skladu z zahtevami ISO 9000, in to certifikacijo ohranjamo \u0161e danes.<\/p>\n\n\n\n<p><\/p>\n\n\n\n<p>ISO 9001 je zgolj usmerjevalni dokument \u2013 od vodstvene ekipe pa je nato je odvisno, kako sprejema odlo\u010ditve glede strategije, vizije in usmeritve podjetja. Harri pojasnjuje: <em>\u201cISO 9001 nam ne daje ni\u010d drugega kot smernice. Organizacija mora sama sprejemati in dokumentirati svoje odlo\u010ditve.\u201d<\/em><\/p>\n\n\n\n<p><\/p>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-28f84493 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:33.33%\">\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" width=\"768\" height=\"966\" src=\"https:\/\/d2ris6qfzcz0wn.cloudfront.net\/wp-content\/uploads\/sites\/12\/2024\/10\/image-10.jpg\" alt=\"\" class=\"wp-image-17216\" srcset=\"https:\/\/d2ris6qfzcz0wn.cloudfront.net\/wp-content\/uploads\/sites\/12\/2024\/10\/image-10.jpg 768w, https:\/\/d2ris6qfzcz0wn.cloudfront.net\/wp-content\/uploads\/sites\/12\/2024\/10\/image-10-239x300.jpg 239w\" sizes=\"(max-width: 768px) 100vw, 768px\" \/><\/figure>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:66.66%\">\n<p>Na\u0161 sistem vodenja kakovosti obravnavamo celostno, saj podpira \u0161ir\u0161o poslovno strategijo podjetja. Harri prevaja definicije standarda v poslovni jezik, da na\u0161i vodje bolje razumejo, kako nam ISO 9001 pomaga pri doseganju strate\u0161kih ciljev.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>Standardi sistemov vodenja so zasnovani za podporo va\u0161emu poslovanju. Ti standardi zahtevajo, da dokumentirate svoje procese, kar krepi zaupanje in ozave\u0161\u010denost znotraj podjetja. S tem omogo\u010dajo bolj\u0161e sodelovanje pri doseganju skupnih ciljev.<\/p>\n<cite>Harri Puputti, direktor kakovosti in skladnosti<\/cite><\/blockquote>\n<\/div>\n<\/div>\n\n\n\n<h2 class=\"wp-block-heading\">Klju\u010dna na\u010dela ISO 9001<\/h2>\n\n\n\n<p>ISO 9001 temelji na <a href=\"https:\/\/www.iso.org\/files\/live\/sites\/isoorg\/files\/store\/en\/PUB100080.pdf\">sedmih na\u010delih upravljanja kakovosti<\/a>, ki podjetjem pomagajo pri dobi\u010dkonosni rasti, ustvarjanju vrednosti za stranke in zagotavljanju njihovega zadovoljstva.<\/p>\n\n\n\n<p>Harri izpostavlja ta na\u010dela in njihovo uporabo pri Lindstr\u00f6mu:<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>Osredoto\u010denost na stranke:<\/strong><br>Razumemo poslovne potrebe na\u0161ih strank in njihove klju\u010dne zahteve. Njihova izku\u0161nja je na\u0161a prednostna naloga \u2013 vedno jih poslu\u0161amo in upo\u0161tevamo njihove povratne informacije.<\/li>\n\n\n\n<li><strong>Vodenje:<\/strong><br>Na\u0161a vodstvena ekipa, usmerjena z vrednotami podjetja, vodi in izvaja na\u0161 sistem vodenja kakovosti.<\/li>\n\n\n\n<li><strong>Vklju\u010denost zaposlenih:<\/strong><br>V sodelovanju s komunikacijsko ekipo skrbimo, da vsak zaposleni razume na\u0161e politike, postopke in smernice ter njihovo povezavo s poslovnimi cilji. V razvoj strategije vklju\u010dujemo vse zaposlene.<\/li>\n\n\n\n<li><strong>Procesni pristop:<\/strong><br>Na\u0161e procese v celoti opredelimo v skladu z zahtevami ISO 9001.<\/li>\n\n\n\n<li><strong>Nenehno izbolj\u0161evanje:<\/strong><br>Prepoznavamo tveganja za na\u0161e strate\u0161ke cilje in hkrati odkrivamo prilo\u017enosti za rast.<\/li>\n\n\n\n<li><strong>Odlo\u010danje na podlagi dokazov:<\/strong><br>Ukrepanje na\u010drtujemo na podlagi ocen uspe\u0161nosti in drugih virov podatkov.<\/li>\n\n\n\n<li><strong>Upravljanje odnosov:<\/strong><br>Skrbimo za odnose z vsemi dele\u017eniki, vklju\u010dno z dobavitelji, partnerji, strankami, zaposlenimi, zakonodajnimi organi in javnimi organizacijami.<\/li>\n<\/ol>\n\n\n\n<div style=\"height:22px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>Harri pojasnjuje: &#8220;Ko delujemo v skladu z na\u0161imi procesi, lahko strankam pravo\u010dasno in na pravo mesto dostavimo \u010dista in skrbno pripravljena delovna obla\u010dila. Na\u0161i dolgoro\u010dni odnosi s partnerji in strankami so najbolj\u0161i dokaz tega.&#8221;<\/p>\n\n\n\n<div style=\"height:22px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"inherit-container-width wp-block-group is-style-side-padding has-white-background-color has-background is-layout-constrained wp-container-core-group-is-layout-24a295e1 wp-block-group-is-layout-constrained\" style=\"border-width:7px;margin-top:0;margin-bottom:0;padding-top:var(--wp--preset--spacing--40);padding-right:var(--wp--preset--spacing--40);padding-bottom:var(--wp--preset--spacing--40);padding-left:var(--wp--preset--spacing--40)\">\n<h3 class=\"wp-block-heading has-grey-100-color has-text-color has-link-color wp-elements-bd0d4ae553bf831fb5b494d6672211d2\"><strong>Farmacevtski vidik:<\/strong><br><strong>Izpolnjevanje tudi najzahtevnej\u0161ih standardov v panogi<\/strong><\/h3>\n\n\n\n<p class=\"has-grey-100-color has-text-color has-link-color wp-elements-28f7e15510d12470726a293744965ac7\">Zavedamo se klju\u010dnih izzivov na\u0161ih farmacevtskih strank, kot je <a href=\"https:\/\/lindstromgroup.com\/si\/delovna-oblacila\/standard-en-14065-zagotavljanje-mikrobioloske-varnosti-v-procesu-pranja-delovnih-oblacil\/\">mikrobiolo\u0161ka navzkri\u017ena kontaminacija<\/a>. Zato smo razvili specializirane postopke, s katerimi zagotavljamo, da na\u0161a delovna obla\u010dila izpolnjujejo najvi\u0161je higienske standarde.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-style-default is-layout-flow wp-container-core-quote-is-layout-22223934 wp-block-quote-is-layout-flow\">\n<p class=\"has-grey-100-color has-text-color has-link-color has-body-font-size wp-elements-b9760a75bb37a906d14d118bba345b52\">Obla\u010denje zdravstvenih delavcev pomeni izpolnjevanje tudi najkompleksnej\u0161ih zahtev. Prepri\u010dan sem, da smo za na\u0161e zaposlene izbrali udobna obla\u010dila, ki poleg tega ustrezajo tudi zahtevam predpisov.<\/p>\n<cite>David Mendl, operativni direktor v lekarnah Dr. Max<\/cite><\/blockquote>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-container-core-quote-is-layout-22223934 wp-block-quote-is-layout-flow\">\n<p class=\"has-grey-100-color has-text-color has-link-color wp-elements-c5af2aa69f6ff2aebc8413b468bd99a6\">Lindstr\u00f6m izkazuje strokovnost in poglobljeno razumevanje specifi\u010dnih potreb farmacevtskih podjetij. \u017de ve\u010dkrat nam je pomagal uspe\u0161no prestati mednarodne revizije, na primer za WHO in EU GMP.<\/p>\n<cite>G. Chen, vodja poslovanja v Pekin\u0161kem in\u0161titutu za biolo\u0161ke proizvode<\/cite><\/blockquote>\n\n\n\n<div style=\"height:16px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n<\/div>\n\n\n\n<h2 class=\"wp-block-heading\">Vloga revizij pri pridobivanju certifikata ISO 9001<\/h2>\n\n\n\n<p>Za pridobitev certifikata ISO 9001 izvajamo tako zunanje kot notranje revizije. Neodvisna organizacija oceni na\u0161 sistem vodenja kakovosti glede na zahteve standarda. Zunanji revizorji poro\u010dajo o pozitivnih ugotovitvah, morebitnih tveganjih neizpolnjevanja zahtev in neposrednih neskladjih. Njihove bogate izku\u0161nje iz drugih podjetij nam omogo\u010dajo dragocene povratne informacije in oceno na\u0161e uspe\u0161nosti.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>Revizije nam pomagajo pri izpopolnjevanju organizacije in podpirajo na\u0161 napredek. Proces revizije je razvojno orodje, ki zagotavlja na\u0161e nenehno izbolj\u0161evanje. Pomembno je, da nas nekdo oceni, poda povratne informacije in predlaga ideje za nadaljnji napredek.<\/p>\n<cite>Harri Puputti, direktor kakovosti in skladnosti<\/cite><\/blockquote>\n\n\n\n<p>Spremljamo vse ugotovitve revizij, izvajamo analize temeljnih vzrokov in na\u010drtujemo naslednje korake. Ko dolo\u010dimo na\u010drt, ga uresni\u010dimo in merimo vpliv na\u0161ih ukrepov.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Krmarjenje skozi prihajajo\u010di val predpisov<\/h2>\n\n\n\n<p>Harri poudarja, da je skladnost zdaj pomembnej\u0161a kot kadarkoli prej. Izpolnjevanje zahtev glede kakovosti nam pomaga razumeti in vklju\u010diti trajnostne predpise v na\u0161e poslovanje.<\/p>\n\n\n\n<p><\/p>\n\n\n\n<p>\u201cOkrepiti moramo svoje procese, da zagotovimo skladnost s prihajajo\u010dim cunamijem novih evropskih predpisov. In ker so podnebne spremembe realnost, moramo biti dobro pripravljeni.\u201d<\/p>\n\n\n\n<p><\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>Podnebne spremembe so seveda tveganje, hkrati pa prina\u0161ajo tudi prilo\u017enosti. Na\u0161 poslovni model kro\u017enega gospodarstva vidimo kot prilo\u017enost \u2013 lahko podpiramo svoje stranke v boju proti negativnim vplivom podnebnih sprememb.<\/p>\n<cite>Harri Puputti, direktor kakovosti in skladnosti<\/cite><\/blockquote>\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<!-- HTML -->\n            <div\n            id=\"block_bdbdb41a869bb71afd471cdc085c33b3\"\n            class=\"banner-cta banner-cta--block_bdbdb41a869bb71afd471cdc085c33b3  relative\"\n        >\n            <div class=\"banner-cta__background\" style=\"background-color: #E52330\"><\/div>\n            <div\n                class=\"flex gap-3 min-h-[100px] content-center self-stretch flex-wrap lindstrom-container lindstrom-container--content banner-cta__content banner-cta__content--horizontal\">\n                <div class=\"flex-grow flex-shrink-0 basis-0 min-w-[270px] w-full banner-cta__text\">\n                                            <h3 class=\"font-bold mt-0 !mb-1 !text-white text-title-small\">\n                            Nudimo prilagojene storitve oskrbe z delovnimi obla\u010dili za razli\u010dne panoge.                        <\/h3>\n                                                        <\/div>\n                \n                                    <div class=\"flex flex-wrap items-start gap-4\">\n                                            <div class=\"flex h-10 border-2 border-white rounded-full banner-cta__button button-outlined--white\">\n                            <a\n                                class=\"!no-underline !text-white bg-transparent py-3 px-5 pr-4 font-bold text-[15px]\/[21px] flex items-center gap-3\"\n                                href=\"https:\/\/lindstromgroup.com\/si\/storitve\/najem-delovnih-oblacil\/\"\n                                target=\"_self\"\n                            >\n                                                                                                    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textiles.<\/p>\n","protected":false},"author":14,"featured_media":17038,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"_eb_attr":"","site-sidebar-layout":"default","site-content-layout":"default","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center 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