{"id":11552,"date":"2019-06-03T09:21:03","date_gmt":"2019-06-03T07:21:03","guid":{"rendered":"https:\/\/www.cai.cz\/?page_id=11552"},"modified":"2019-06-04T10:25:04","modified_gmt":"2019-06-04T08:25:04","slug":"dotazy-a-odpovedi-k-seminari-vyuziti-akreditace-v-regulovane-oblasti-23-1-2019","status":"publish","type":"page","link":"https:\/\/www.cai.cz\/?page_id=11552","title":{"rendered":"Dotazy a odpov\u011bdi k semin\u00e1\u0159i Vyu\u017eit\u00ed akreditace v regulovan\u00e9 oblasti – 23. 1. 2019"},"content":{"rendered":"\n

V\u00e1\u017een\u00ed klienti,<\/p>

n\u00ed\u017ee naleznete odpov\u011bdi na dotazy zaslan\u00e9 po semin\u00e1\u0159i Vyu\u017eit\u00ed akreditace v regulovan\u00e9 oblasti, kter\u00fd se konal 23. 1. 2019 v Praze. <\/p>

Na z\u00e1klad\u011b projeven\u00e9ho z\u00e1jmu \u010cIA zva\u017euje realizaci workshopu zam\u011b\u0159en\u00e9ho na aplikovateln\u00e9 po\u017eadavky norem \u010cSN EN ISO\/IEC 17020:2012, \u010cSN EN ISO\/IEC 17021-1:2016 a \u010cSN EN ISO\/IEC 17025:2018. <\/p><\/blockquote>\n\n\n\n

Pro mne bylo zaj\u00edmav\u00e9 t\u00e9ma k legislativn\u00edmu procesu. Domn\u00edv\u00e1m se, \u017ee novely z\u00e1kon\u016f 22\/1997 Sb. a 90\/2016 Sb. pomalu reaguj\u00ed na v\u00fdvoj v t\u00e9to oblasti. Sch\u00e1z\u00ed mi nap\u0159. vazba na p\u0159ipravovan\u00fd z\u00e1kon o vyhrazen\u00fdch technick\u00fdch za\u0159\u00edzen\u00edch. \u0158e\u0161\u00ed se?<\/strong><\/p>\n\n\n\n

\u010cIA nen\u00ed p\u0159edkladatelem ani jednoho z ozna\u010den\u00fdch z\u00e1kon\u016f a spekulovat o jejich vazb\u00e1ch mu nep\u0159\u00edslu\u0161\u00ed. <\/em><\/p>\n\n\n\n

Byl-li po\u0159\u00edzen zvukov\u00fd z\u00e1znam, kde bude ulo\u017een?<\/strong>

Ne.<\/em><\/p>\n\n\n\n

P\u0159\u00edklady osv\u011bd\u010den\u00ed COV, \u010d\u00e1st autorizace\/ozn\u00e1men\u00ed – NV 163\/2002.<\/strong><\/p>\n\n\n\n

N\u00e1vod na vypln\u011bn\u00ed p\u0159\u00edlohy \u010d.3 pro COV je zve\u0159ejn\u011bn na webu \u010cIA.<\/em><\/p>\n\n\n\n

Jak\u00e9 jsou pl\u00e1novan\u00e9 konkr\u00e9tn\u00ed zm\u011bny v p\u0159ipravovan\u00e9 nov\u00e9 revizi dokumentu EA 2\/17? <\/strong><\/p>\n\n\n\n

Nov\u00e1 revize EA-2\/17 bude d\u00e1vat v\u011bt\u0161\u00ed d\u016fraz na tzv. preferovan\u00e9 normy. Budou nov\u011b specifikov\u00e1ny aplikovateln\u00e9 po\u017eadavky pro jednotliv\u00e9 normy. Nov\u011b bude vzor p\u0159\u00edlohy k osvad\u010den\u00ed o akreditaci zahrnut v t\u011ble dokumentu a bude z\u00e1vazn\u00fd. Nov\u011b budou v informativn\u00ed p\u0159\u00edloze stanoveny po\u017eadavky na po\u010dty witness audit\u016f. <\/p>\n\n\n\n

Bude mo\u017en\u00e9 vstoupit do p\u0159ipom\u00ednkov\u00e9ho \u0159\u00edzen\u00ed k nov\u00e9 revizi dokumentu EA 2\/17?<\/strong><\/p>\n\n\n\n

Vyjma p\u0159ipom\u00ednkov\u00e1n\u00ed v EA bude dokument p\u0159ipom\u00ednkov\u00e1n v r\u00e1mci IMP EU.<\/p>\n\n\n\n

Kdy\u017e AO a OS mohou navz\u00e1jem kombinovat a vy\u017e\u00edvat spole\u010dn\u00e9 prvky norem (17020, 17065, 17021, 17025), jak toto posoud\u00ed \u010cIA p\u0159i pousuzov\u00e1n\u00ed COV, IO, COSM? To znamen\u00e1, \u017ee p\u0159i auditu IO bude posuzovat i COV \u010di COSM?<\/strong><\/p>\n\n\n\n

V p\u0159\u00edpad\u011b z\u00e1jmu ze strany subjektu \u010cIA prov\u00e1d\u00ed tzv. soub\u011b\u017en\u00e9 posuzov\u00e1n\u00ed, viz p\u0159\u00edloha \u010d.3 MPA 00-01-..
P\u0159i akreditaci pro \u00fa\u010dely autorizace\/ozn\u00e1men\u00ed jsou pro IO posuzov\u00e1ny tak\u00e9 aplikovateln\u00e9 po\u017eadavky z dal\u0161\u00edch norem relevantn\u00edch pro konkr\u00e9tn\u00ed modul, tj. posup posuzov\u00e1n\u00ed shody – v\u00edce viz. EA-2\/17M:2016.<\/em><\/p>\n\n\n\n

Spad\u00e1 do \u010dinnosti inspek\u010dn\u00edch org\u00e1n\u016f inspekce dle po\u017eadavk\u016f nap\u0159. TKP Md\u010cR?<\/strong><\/p>\n\n\n\n

Vhodnost vyu\u017eit\u00ed inspekce pro posouzen\u00ed shody s po\u017eadavky uveden\u00fdmi v p\u0159edm\u011btn\u00fdch dokumentech je nutno posoudit pr\u00e1v\u011b na z\u00e1klad\u011b konkr\u00e9tn\u00edch po\u017eadavk\u016f. Obecn\u011b nelze vhodnost inspekce vylou\u010dit.<\/p>\n\n\n\n

Forma semin\u00e1\u0159e bez mo\u017enosti dotaz\u016f na m\u00edst\u011b je naprosto nevyhovuj\u00edc\u00ed a pro subjekty nep\u0159\u00ednosn\u00e1. Problematiku nelze \u0159e\u0161it koresponden\u010dn\u011b.<\/strong><\/p>\n\n\n\n

S ohledem na z\u00e1jem \u010cIA a \u00daNMZ postupovat jednotn\u011b a nerozd\u00edln\u011b, rozhodl se \u010cIA za souhlasu \u00daNMZ, \u017ee na tomto semin\u00e1\u0159i nebude prostor pro diskuzi. Sou\u010dasn\u011b bylo neumo\u017en\u011bn\u00ed diskuze reakc\u00ed na informaci o pl\u00e1novan\u00e9 diskuzi AAAO nad Pokynem P1. Dal\u0161\u00edm z d\u016fvod\u016f byla ne\u00fa\u010dast veden\u00ed \u00daNMZ na tomto semin\u00e1\u0159i.<\/p>\n\n\n\n

P\u0159edn\u00e1\u0161ka Mgr. V\u00e1chy se mi l\u00edbila, ale upozornila na roz\u0161\u00ed\u0159en\u00ed definice WA v MPA 00_01_18 oproti ISO 17011. AAAO to pova\u017euje za nekorektn\u00ed a po\u017eaduje d\u016fsledn\u00e9 pou\u017eit\u00ed definic z normy.<\/strong><\/p>\n\n\n\n

Definice v MPA 00-01 kombinuje definice ISO\/IEC 17011:
MPA 00-01-..:
Witness audit (sv\u011bdeck\u00e9 posuzov\u00e1n\u00ed): pozorov\u00e1n\u00ed akredita\u010dn\u00edho org\u00e1nu, jak subjekt prov\u00e1d\u00ed \u010dinnosti posuzov\u00e1n\u00ed shody, v jejich\u017e rozsahu je o akreditaci \u017e\u00e1d\u00e1no, nebo v n\u011bm\u017e je ud\u011blena.
ISO\/IEC 17011:
3.6 rozsah akreditace – konkr\u00e9tn\u00ed \u010dinnosti posuzov\u00e1n\u00ed shody, v jejich\u017e rozsahu je o akreditaci (3.1) \u017e\u00e1d\u00e1no, nebo v n\u011bm\u017e je ud\u011blena.
3.25 sv\u011bdeck\u00e9 posuzov\u00e1n\u00ed – pozorov\u00e1n\u00ed akredita\u010dn\u00edho org\u00e1nu (3.2), jak org\u00e1n posuzov\u00e1n\u00ed shody (3.4) prov\u00e1d\u00ed \u010dinnosti posuzov\u00e1n\u00ed shody spadaj\u00edc\u00ed do jeho rozsahu akreditace (3.6).<\/p>\n\n\n\n

Technick\u00fd dokument ERA 000MRA1044, kter\u00fd roz\u0161i\u0159uje po\u017eadavky pro COV podle 17065 pro \u00fa\u010dely autorizace.<\/strong><\/p>\n\n\n\n

Viz Informace k ERA.<\/em><\/p>\n\n\n\n

Akreditace pro \u00fa\u010dely autorizace\/ozn\u00e1men\u00ed – ale ve variant\u011b jak to opravdu bude v praxi prov\u00e1d\u011bt \u010cIA a jak to pravdu bude akceptovat a zpracov\u00e1vat UNMZ.<\/strong><\/p>\n\n\n\n

N\u00e1vod na vypln\u011bn\u00ed p\u0159\u00edlohy \u010d.3 pro COV je zve\u0159ejn\u011bn na webu \u010cIA.<\/p>\n\n\n\n

Kdo je v tuto chv\u00edli oznamuj\u00edc\u00ed autoritou podle z\u00e1kona 22\/1997 pro sm\u011brnici (EU) 2016\/797 – sou\u010dasn\u00fd stav neumo\u017e\u0148uje \u010dinnost podle t\u00e9to sm\u011brnice p\u0159esto, \u017ee nov\u00e9 technick\u00e9 specifikace podle t\u00e9to sm\u011brnice ji\u017e byly vyd\u00e1ny (budou vyd\u00e1v\u00e1ny) s okam\u017eitou platnost\u00ed.<\/strong><\/p>\n\n\n\n

\u00daNMZ: Dosud \u010dlensk\u00fd st\u00e1t nejmenoval oznamuj\u00edc\u00ed org\u00e1n tak jak je uvedeno ve sm\u011brnici (EU) 2016\/797. V dan\u00e9 chv\u00edli se jedn\u00e1 s MD\u010cR. <\/em><\/p>\n\n\n\n

Ozn\u00e1men\u00ed prvn\u00ed p\u0159\u00edle\u017eitosti k proveden\u00ed WA v jednom\u011bs\u00ed\u010dn\u00edm p\u0159edstihu je ve v\u011bt\u0161in\u011b p\u0159\u00edpadech nere\u00e1ln\u00e9.<\/strong><\/p>\n\n\n\n

S ohledem na \u010dasovou vyt\u00ed\u017eenost intern\u00edch i extern\u00edch pracovn\u00edk\u016f je 30 dn\u00ed ohl\u00e1\u0161en\u00ed p\u0159ipravenosti na WA nezbytn\u00e9.<\/p>\n\n\n\n

Kdo je nebo bude gestorem pro zdrav. prost\u0159edky, kdy\u017e pro AO\/NB\/OS nen\u00ed\/nebude pot\u0159eba akreditace? Bude to MPO (\u00daNMZ) nebo MZ\u010cR (S\u00daKL)?<\/strong><\/p>\n\n\n\n

\u00daNMZ: MZ\u010cR jmenovalo \u00daNMZ org\u00e1nem odpov\u011bdn\u00fdm za ozn\u00e1men\u00e9 subjekty podle MDR a IVDR. Nicm\u00e9n\u011b adaptace je\u0161t\u011b nen\u00ed provedena a z\u00e1konem tak stanoveno nebylo. Vyj\u00e1d\u0159en\u00ed k mo\u017enosti akreditace v dan\u00e9 oblasti jsme V\u00e1m v minulosti ji\u017e zaslali. <\/p>\n\n\n\n

Dotaz k Pokynu P1
Pro ozn\u00e1men\u00fd subjekt je velmi d\u016fle\u017eit\u00e9, aby mohl reagovat pru\u017en\u011b a ekonomicky, jinak ztr\u00e1c\u00ed konkurenceschopnost. V n\u00e1vaznosti na to i v\u00fdrobci ztr\u00e1c\u00ed svoji pozici na trhu, pokud nemohou uv\u00e1d\u011bt na trh sv\u016fj v\u00fdrobek z d\u016fvodu, \u017ee \u201ejejich\u201c ozn\u00e1men\u00fd subjekt nen\u00ed v\u010das notifikov\u00e1n a tud\u00ed\u017e jim nem\u016f\u017ee certifikovat jejich v\u00fdrobek.
Na\u0161e zku\u0161enost z minula
OS m\u011bl z\u00e1jem o notifikaci podle hEN. Ve chv\u00edli, kdy tato norma byla je\u0161t\u011b ve f\u00e1zi prEN, OS u\u017e za\u017e\u00e1dal \u010cIA o roz\u0161\u00ed\u0159en\u00ed akreditace COV o tuto normu nejl\u00e9pe v r\u00e1mci pravideln\u00e9ho dozoru (u\u0161et\u0159en\u00ed n\u00e1klad\u016f za mimo\u0159\u00e1dn\u00fd dozor). \u010cIA vydal osv\u011bd\u010den\u00ed o akreditaci s uveden\u00edm t\u00e9to prEN. B\u011bhem nap\u0159. 4 m\u011bs\u00edc\u016f vy\u0161la tato prEN jako EN a byla zharmonizov\u00e1na. V tuto chv\u00edli OS za\u017e\u00e1dal \u00daNMZ o notifikaci a dokl\u00e1dal osv\u011bd\u010den\u00edm o akreditaci s prEN. \u00daNMZ notifikoval OS na p\u0159\u00edslu\u0161nou hEN. P\u0159i n\u00e1sledn\u00e9m pravideln\u00e9m dozoru \u010cIA vydal osv\u011bd\u010den\u00ed o akreditaci na hEN.
Navrhovan\u00e1 sou\u010dasnost
OS\/COV se nech\u00e1 akreditovat \u010cIA na prEN v r\u00e1mci pravideln\u00e9ho dozoru a ve chv\u00edli, kdy norma bude harmonizovan\u00e1, za\u017e\u00e1d\u00e1 \u00daNMZ o notifikaci podle Pokynu P1 Varinta B. Podle t\u00e9to varianty v\u0161ak OS mus\u00ed dolo\u017eit takov\u00e9 n\u00e1le\u017eitosti, kter\u00e9 jsou uvedeny ve Variant\u011b A, a kter\u00e9 posuzuje \u010cIA. To zjevn\u011b nut\u00ed OS, aby pou\u017eili Variantu A (\u00daNMZ to ostatn\u011b tak i doporu\u010duje).
Pokud se tedy OS rozhodne j\u00edt cestou podle Varianty A, tedy nechat se od \u010cIA zakreditovat pro \u00fa\u010dely notifikace, m\u00e1 to h\u00e1\u010dek. \u010cIA akredituje pro \u00fa\u010dely notifikace pouze normy, kter\u00e9 ji\u017e pro\u0161ly harmonizac\u00ed.
Tedy postup by byl n\u00e1sleduj\u00edc\u00ed
OS v\u00ed, \u017ee se p\u0159ipravuje a vyjde nov\u00e1 harmonizovan\u00e1 norma, ale nem\u016f\u017ee si za\u017e\u00e1dat o akreditaci, dokud je norma ve f\u00e1zi prEN nebo EN bez harmonizace. Ve chv\u00edli, kdy je norma zharmonizov\u00e1na, COV za\u017e\u00e1d\u00e1 o roz\u0161\u00ed\u0159en\u00ed akreditace pro \u00fa\u010dely notifikace (co\u017e vyvol\u00e1 ve v\u011bt\u0161in\u011b p\u0159\u00edpad\u016f mimo\u0159\u00e1dn\u00fd dozor, a tedy op\u011bt vy\u0161\u0161\u00ed n\u00e1klady). I p\u0159i dobr\u00e9 v\u016fli zabere akreditace minim\u00e1ln\u011b 2 m\u011bs\u00edce. Pot\u00e9 OS za\u017e\u00e1d\u00e1 \u00daNMZ o notifikaci, co\u017e zabere dal\u0161\u00ed 4 m\u011bs\u00edce. Z toho vych\u00e1z\u00ed – minim\u00e1ln\u011b 6 m\u011bs\u00edc\u016f plus n\u00e1klady za mimo\u0159\u00e1dnou akreditaci, ne\u017e je OS notifikov\u00e1n. A to je\u0161t\u011b uva\u017eujeme skute\u010dnost, \u017ee je hEN harmonizov\u00e1na s p\u0159echodov\u00fdm obdob\u00edm.
Co ale ve chv\u00edli, kdy p\u0159echodov\u00e9 obdob\u00ed nen\u00ed, nap\u0159. novelizace hEN? 6 m\u011bs\u00edc\u016f bez notifikace znamen\u00e1 ztr\u00e1tu konkurenceschopnosti jak OS tak i v\u00fdrobc\u016f, jak bylo zm\u00edn\u011bno na za\u010d\u00e1tku.<\/strong><\/p>\n\n\n\n

\u00daNMZ: K v\u00fd\u0161e uveden\u00e9 problematice sd\u011bluji, \u017ee by danou z\u00e1le\u017eitost m\u011bla \u0159e\u0161it flexibilita. Domn\u00edv\u00e1m se, \u017ee se stejnou situac\u00ed se setk\u00e1vaj\u00ed v\u0161echny ostatn\u00ed ozn\u00e1men\u00e9 subjekty v dan\u00e9 oblasti. Proto doporu\u010duji toto \u0159e\u0161it na pracovn\u00edch skupin\u00e1ch n\u00e1rodn\u00edch akredita\u010dn\u00edch org\u00e1n\u016f s t\u00edm, \u017ee by se k tomu m\u011bla vyj\u00e1d\u0159it EK. <\/p>\n","protected":false},"excerpt":{"rendered":"

V\u00e1\u017een\u00ed klienti, n\u00ed\u017ee naleznete odpov\u011bdi na dotazy zaslan\u00e9 po semin\u00e1\u0159i Vyu\u017eit\u00ed akreditace v regulovan\u00e9 oblasti, kter\u00fd se konal 23. 1. 2019 v Praze. Na z\u00e1klad\u011b…<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_price":"","_stock":"","_tribe_ticket_header":"","_tribe_default_ticket_provider":"","_tribe_ticket_capacity":"0","_ticket_start_date":"","_ticket_end_date":"","_tribe_ticket_show_description":"","_tribe_ticket_show_not_going":false,"_tribe_ticket_use_global_stock":"","_tribe_ticket_global_stock_level":"","_global_stock_mode":"","_global_stock_cap":"","_tribe_rsvp_for_event":"","_tribe_ticket_going_count":"","_tribe_ticket_not_going_count":"","_tribe_tickets_list":"[]","_tribe_ticket_has_attendee_info_fields":false,"footnotes":"","_tec_slr_enabled":"","_tec_slr_layout":""},"class_list":["post-11552","page","type-page","status-publish","hentry"],"acf":[],"ticketed":false,"_links":{"self":[{"href":"https:\/\/www.cai.cz\/index.php?rest_route=\/wp\/v2\/pages\/11552","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.cai.cz\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.cai.cz\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.cai.cz\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.cai.cz\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=11552"}],"version-history":[{"count":5,"href":"https:\/\/www.cai.cz\/index.php?rest_route=\/wp\/v2\/pages\/11552\/revisions"}],"predecessor-version":[{"id":11589,"href":"https:\/\/www.cai.cz\/index.php?rest_route=\/wp\/v2\/pages\/11552\/revisions\/11589"}],"wp:attachment":[{"href":"https:\/\/www.cai.cz\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=11552"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}